AzTrials
AzTrials

Crohn's DiseasePhase 3NCT06430801

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

A Phase 3 study testing IV Tulisokibart and SC Tulisokibart in people with Crohn's Disease, run by Merck Sharp & Dohme LLC at 499 sites in 47 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per… Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
IV Tulisokibart and SC Tulisokibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,200 participants
Where
499 sitesin 47 countries
Study dates
5 Jun 2024to 12 Nov 2029
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
  • Has moderately to severely active CD.
  • Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
  • Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.

Who cannot join

  • Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
  • Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
  • Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
  • Has current stoma or need for colostomy or ileostomy.
  • Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
  • Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
Show all 14Show fewer
  • Has surgical bowel resection within 3 months of study.
  • Has prior or current gastrointestinal dysplasia.
  • Has chronic infection requiring ongoing antimicrobial treatment.
  • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
  • Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • Has active tuberculosis.
  • Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
  • Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

Trial locations and contacts

499 sites in 47 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

499 sites in 47 countries

United States87 sites, 71 recruiting

  • Clinnova Research ( Site 5110)

    Anaheim, California, 92805

    Study Coordinator, 949-889-0249

    Recruiting

  • University of Michigan ( Site 5060)

    Ann Arbor, Michigan, 48109

    Study Coordinator, 734-615-4843

    Recruiting

  • Morehouse School Of Medicine ( Site 5071)

    Atlanta, Georgia, 30310

    Study Coordinator, 404-616-1000

    Recruiting

  • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)

    Aurora, Colorado, 80045

    Study Coordinator, 720-848-2777

    Recruiting

  • Washington Gastroenterology - Bellevue ( Site 5040)

    Bellevue, Washington, 98004

    Active, not recruiting

  • Walter Reed National Military Medical Center ( Site 5006)

    Bethesda, Maryland, 20889

    Study Coordinator, 301-295-6814

    Recruiting

  • Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)

    Boston, Massachusetts, 02114

    Study Coordinator, 334-836-3341

    Recruiting

  • University of North Carolina Medical Center ( Site 5034)

    Chapel Hill, North Carolina, 27514

    Study Coordinator, 984-974-3777

    Recruiting

  • Atrium Health Gastroenterology MMP ( Site 5105)

    Charlotte, North Carolina, 28204

    Study Coordinator, 704-355-0282

    Recruiting

  • Javara - Tryon Medical Partners ( Site 5046)

    Charlotte, North Carolina, 28210

    Completed

  • Eagle Clinical Research ( Site 5089)

    Chicago, Illinois, 60621

    Completed

  • University of Chicago Medical Center ( Site 5066)

    Chicago, Illinois, 60637

    Study Coordinator, 773-834-2193

    Recruiting

  • Gastroenterology Consultants of Clearwater ( Site 5052)

    Clearwater, Florida, 33756

    Active, not recruiting

  • Clinical Research Institute of Michigan, LLC ( Site 5002)

    Clinton Township, Michigan, 48038

    Study Coordinator, 586-598-3329

    Recruiting

  • Iowa Digestive Disease Center ( Site 5007)

    Clive, Iowa, 50325

    Study Coordinator, 515-225-6050

    Recruiting

  • Peak Gastroenterology Associates ( Site 5023)

    Colorado Springs, Colorado, 80907

    Study Coordinator, 719-310-6719

    Recruiting

  • Southern California Research Center ( Site 5044)

    Coronado, California, 92118

    Study Coordinator, 619-522-0330

    Recruiting

  • Baylor University Medical Center ( Site 5031)

    Dallas, Texas, 75246

    Study Coordinator, 214-820-2687

    Recruiting

  • GI Alliance - Dallas - Gaston Avenue ( Site 5054)

    Dallas, Texas, 75246

    Completed

  • Atlanta Center for Gastroenterology ( Site 5035)

    Decatur, Georgia, 30033

    Completed

  • Epic Medical Research - Mesquite ( Site 5153)

    Denton, Texas, 76201

    Study Coordinator, 940-252-0504

    Recruiting

  • Digestive Health Specialists ( Site 5064)

    Dothan, Alabama, 36301

    Completed

  • South Denver Gastroenterology, PC ( Site 5132)

    Englewood, Colorado, 80113

    Study Coordinator, 303-406-4288

    Recruiting

  • Endeavor Health ( Site 5018)

    Evanston, Illinois, 60201

    Study Coordinator, 847-971-9992

    Recruiting

  • Covenant Metabolic Specialists, LLC ( Site 5150)

    Fort Myers, Florida, 33912

    Study Coordinator, 941-500-3200

    Recruiting

  • Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)

    Great Neck, New York, 11021

    Study Coordinator, 516-504-3955

    Recruiting

  • GI ALLIANCE - GURNEE ( Site 5003)

    Gurnee, Illinois, 60031

    Study Coordinator, 224-441-2217

    Recruiting

  • HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-1115

    Recruiting

  • Medical Research Center of Connecticut ( Site 5005)

    Hamden, Connecticut, 06518

    Completed

  • Penn State University Milton S. Hershey Medical Center ( Site 5102)

    Hershey, Pennsylvania, 17033

    Study Coordinator, 800-243-1455

    Recruiting

  • Baylor College of Medicine Medical Center ( Site 5020)

    Houston, Texas, 77030

    Study Coordinator, 713-798-5765

    Recruiting

  • Michael E. DeBakey VA Medical Center ( Site 5086)

    Houston, Texas, 77030

    Study Coordinator, 713-798-5765

    Recruiting

  • Indiana University Health University Hospital ( Site 5022)

    Indianapolis, Indiana, 46202

    Study Coordinator, 317-944-3332

    Recruiting

  • Nature Coast Clinical Research - Inverness ( Site 5042)

    Inverness, Florida, 34452

    Study Coordinator, 352-341-2100

    Recruiting

  • University of Kansas Medical Center ( Site 5091)

    Kansas City, Kansas, 66160

    Study Coordinator, 913-588-6158

    Recruiting

  • Mid-America GI Clinical Research ( Site 5130)

    Kansas City, Missouri, 64111

    Study Coordinator, 816-561-2000

    Recruiting

  • Rocky Mountain Gastroenterology ( Site 5082)

    Lakewood, Colorado, 80228

    Study Coordinator, 303-463-3900

    Recruiting

  • Om Research LLC ( Site 5038)

    Lancaster, California, 93534

    Study Coordinator, 661-388-2239

    Recruiting

  • BVL Research - Kansas ( Site 5099)

    Liberty, Missouri, 64068

    Study Coordinator, 816-222-4241

    Recruiting

  • University of Arkansas for Medical Sciences ( Site 5147)

    Little Rock, Arkansas, 72205

    Study Coordinator, 501-398-8622

    Recruiting

  • Cedars Sinai Medical Center ( Site 5080)

    Los Angeles, California, 90048

    Study Coordinator, 310-423-0035

    Recruiting

  • UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)

    Los Angeles, California, 90095

    Study Coordinator, 310-206-3778

    Recruiting

  • University of Louisville Hospital ( Site 5120)

    Louisville, Kentucky, 40202

    Study Coordinator, 502-852-1958

    Recruiting

  • GI Alliance - Lubbock ( Site 5012)

    Lubbock, Texas, 79410

    Completed

  • Caprock Gastro Research ( Site 5077)

    Lubbock, Texas, 79424

    Study Coordinator, 808-239-1823

    Recruiting

  • Gastroenterology Associates of Central Georgia ( Site 5048)

    Macon, Georgia, 31201

    Study Coordinator, 478-464-2600

    Recruiting

  • GI Alliance: Mansfield ( Site 5015)

    Mansfield, Texas, 76063

    Study Coordinator, 817-415-9664

    Recruiting

  • Atlantic Medical Research ( Site 5073)

    Margate, Florida, 33063

    Active, not recruiting

  • Great Lakes Gastroenterology Research, LLC ( Site 5016)

    Mentor, Ohio, 44060

    Study Coordinator, 440-205-1225

    Recruiting

  • Sanchez Clinical Research ( Site 5144)

    Miami, Florida, 33157

    Study Coordinator, 305-590-8555

    Recruiting

  • Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)

    Middletown, New York, 12589

    Completed

  • Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)

    Nashville, Tennessee, 37204

    Study Coordinator, 615-322-2312

    Recruiting

  • Quality Medical Research ( Site 5114)

    Nashville, Tennessee, 37211

    Study Coordinator, 615-835-4750

    Recruiting

  • Yale University School of Medicine-Digestive Disease ( Site 5019)

    New Haven, Connecticut, 06510

    Study Coordinator, 203-785-4138

    Recruiting

  • NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)

    New York, New York, 10016

    Study Coordinator, 646-754-3433

    Recruiting

  • Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)

    New York, New York, 10065

    Study Coordinator, 646-697-0985

    Recruiting

  • New York Gastroenterology Associates ( Site 5013)

    New York, New York, 10075

    Study Coordinator, 212-369-2490

    Recruiting

  • Digestive Disease Specialists Inc. ( Site 5117)

    Oklahoma City, Oklahoma, 73114

    Study Coordinator, 405-702-1300

    Recruiting

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)

    Orange, California, 92868

    Study Coordinator, 714-456-7890

    Recruiting

  • AdventHealth Orlando ( Site 5131)

    Orlando, Florida, 32803

    Study Coordinator, 407-303-5503

    Recruiting

  • Endoscopic Research Inc ( Site 5061)

    Orlando, Florida, 32803

    Study Coordinator, 407-896-1726 ext 314

    Recruiting

  • Orlando Health-Digestive Health Institute ( Site 5010)

    Orlando, Florida, 32806

    Completed

  • Om Research LLC ( Site 5045)

    Oxnard, California, 93030

    Study Coordinator, 661-388-2239

    Recruiting

  • Thomas Jefferson University Hospital ( Site 5133)

    Philadelphia, Pennsylvania, 19107

    Study Coordinator, 609-472-1549

    Recruiting

  • Arizona Arthritis & Rheumatology Research, PC ( Site 5094)

    Phoenix, Arizona, 85032

    Completed

  • Northwell Mather Hospital ( Site 5138)

    Port Jefferson, New York, 11777

    Study Coordinator, 631-686-1409

    Recruiting

  • University Gastroenterology - Providence - West River Street ( Site 5057)

    Providence, Rhode Island, 02904

    Study Coordinator, 401-821-6306

    Recruiting

  • Richmond VA Medical Center ( Site 5021)

    Richmond, Virginia, 23249

    Study Coordinator, 804-675-5000

    Recruiting

  • Mayo Clinic in Rochester, Minnesota ( Site 5024)

    Rochester, Minnesota, 55905

    Study Coordinator, 507-284-2511

    Recruiting

  • Southern Star Research Institute ( Site 5000)

    San Antonio, Texas, 78229

    Study Coordinator, 210-581-2812

    Recruiting

  • Clinical Applications Laboratories ( Site 5123)

    San Diego, California, 92103

    Study Coordinator, 619-260-1012

    Recruiting

  • Swedish Medical Center ( Site 5112)

    Seattle, Washington, 98104

    Completed

  • University of Washington ( Site 5115)

    Seattle, Washington, 98195

    Study Coordinator, 414-805-3000

    Recruiting

  • Sanford USD Medical Center ( Site 5129)

    Sioux Falls, South Dakota, 57105

    Study Coordinator, 605-333-1000

    Recruiting

  • GI Alliance - Southlake ( Site 5109)

    Southlake, Texas, 76092-9167

    Study Coordinator, 817-424-1525

    Recruiting

  • Washington University School of Medicine ( Site 5058)

    St Louis, Missouri, 63110

    Study Coordinator, 314-273-0301

    Recruiting

  • GI Alliance - Sun City ( Site 5118)

    Sun City, Arizona, 85351

    Study Coordinator, 623-972-2116

    Recruiting

  • Washington Gastroenterology - Tacoma ( Site 5004)

    Tacoma, Washington, 98405

    Study Coordinator, 253-272-5127

    Recruiting

  • USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)

    Tampa, Florida, 33612

    Study Coordinator, 813-396-2254

    Recruiting

  • Cotton O'Neil Digestive Health Center ( Site 5033)

    Topeka, Kansas, 66606

    Study Coordinator, 785-270-4386

    Recruiting

  • University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)

    Tucson, Arizona, 85724

    Study Coordinator, 520-626-8000

    Recruiting

  • Tyler Research Institute ( Site 5001)

    Tyler, Texas, 75701

    Study Coordinator, 903-630-6211

    Recruiting

  • Frontier Clinical Research, LLC ( Site 5098)

    Uniontown, Pennsylvania, 15401

    Study Coordinator, 724-550-4099

    Recruiting

  • Covenant Metabolic Specialists, LLC ( Site 5143)

    University Park, Florida, 34201

    Study Coordinator, 941-500-3200

    Recruiting

  • Amicis Research Center ( Site 5055)

    Valencia, California, 91355

    Completed

  • Emerson Clinical Research Institute ( Site 5051)

    Washington D.C., District of Columbia, 20009

    Study Coordinator, 202-239-0777

    Recruiting

  • Southern Clinical Research ( Site 5095)

    Zachary, Louisiana, 70791

    Completed

Other trials in United States

Japan55 sites, 43 recruiting

  • Tokatsu Tsujinaka Hospital ( Site 3403)

    Abiko, Chiba, 270-1168

    Study Coordinator, +81-4-7184-9000

    Recruiting

  • Institute of Science Tokyo Hospital ( Site 3437)

    Bunkyō, Tokyo, 113-8519

    Study Coordinator, +81338136111

    Recruiting

  • Ginza Central Clinic ( Site 3407)

    Chūō, Tokyo, 104-0061

    Completed

  • Fukuoka University Hospital ( Site 3417)

    Fukuoka, 814-0180

    Study Coordinator, +81-92-801-1011

    Recruiting

  • Japanese Red Cross Fukuoka Hospital ( Site 3462)

    Fukuoka, 815-8555

    Completed

  • National Hospital Organization Fukuyama Medical Center ( Site 3442)

    Fukuyama, Hiroshima, 720-8520

    Completed

  • University of the Ryukyus Hospital ( Site 3459)

    Ginowan, Okinawa, 901-2725

    Study Coordinator, +81988953331

    Recruiting

  • Hamamatsu University Hospital ( Site 3449)

    Hamamatsu, Shizuoka, 431-3192

    Study Coordinator, +81534352111

    Recruiting

  • Matsuda Hospital ( Site 3404)

    Hamamatsu, Shizuoka, 432-8061

    Study Coordinator, +81-53-448-5121

    Recruiting

  • Kansai Medical University Hospital ( Site 3409)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81728040101

    Recruiting

  • Hiroshima University Hospital ( Site 3418)

    Hiroshima, 734-8551

    Study Coordinator, +81822575555

    Recruiting

  • Hitachi General Hospital ( Site 3438)

    Hitachi, Ibaraki, 317-0077

    Study Coordinator, +81294231111

    Recruiting

  • Kagoshima University Hospital ( Site 3425)

    Kagoshima, 890-8520

    Completed

  • Kagoshima IBD Gastroenterology Clinic ( Site 3428)

    Kagoshima, 892-0843

    Study Coordinator, +81-99-813-7548

    Recruiting

  • Gokeikai Ofuna Chuo Hospital ( Site 3412)

    Kamakura, Kanagawa, 247-0056

    Study Coordinator, +81467452111

    Recruiting

  • Kanazawa University Hospital ( Site 3436)

    Kanazawa, Ishikawa-ken, 920-8641

    Study Coordinator, +81-76-265-2000

    Recruiting

  • Tsujinaka Hospital - Kashiwanoha ( Site 3402)

    Kashiwa, Chiba, 277-0871

    Study Coordinator, +81-4-7137-3737

    Recruiting

  • Saitama Medical Center ( Site 3452)

    Kawagoe, Saitama, 350-8550

    Study Coordinator, +81-49-228-3807

    Recruiting

  • St. Marianna University Hospital ( Site 3440)

    Kawasaki, Kanagawa, 216-8511

    Study Coordinator, +81-44-977-8111

    Recruiting

  • Yamanashi Prefectural Central Hospital ( Site 3435)

    Kofu, Yamanashi, 400-8506

    Study Coordinator, +81552537111

    Recruiting

  • Coloproctology Center Takano Hospital ( Site 3466)

    Kumamoto, 862-0971

    Study Coordinator, +81-96-320-6500

    Recruiting

  • Kurume University Hospital ( Site 3419)

    Kurume, Fukuoka, 830-0011

    Study Coordinator, +81-942-35-3311

    Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 3406)

    Kyoto, 602-8566

    Study Coordinator, +81-75-251-5111

    Recruiting

  • National Hospital Organization Kyoto Medical Center ( Site 3411)

    Kyoto, 612-8555

    Study Coordinator, +81-75-641-9161

    Recruiting

  • Gunma University Hospital ( Site 3432)

    Maebashi, Gunma, 371-8511

    Study Coordinator, +81272207111

    Recruiting

  • Kitasato University Kitasato Institute Hospital ( Site 3458)

    Minato, Tokyo, 108-8642

    Study Coordinator, +81334446161

    Recruiting

  • Toranomon Hospital ( Site 3433)

    Minato-ku, Tokyo, 105-8470

    Study Coordinator, +81335881111

    Recruiting

  • Kyorin University Hospital ( Site 3443)

    Mitaka, Tokyo, 181-8611

    Study Coordinator, 81422475511

    Recruiting

  • The Jikei University Hospital ( Site 3414)

    Mitato, Tokyo, 105-8471

    Study Coordinator, +81334331111

    Recruiting

  • Aichi Medical University Hospital ( Site 3429)

    Nagakute, Aichi-ken, 480-1195

    Completed

  • Nagoya University Hospital ( Site 3445)

    Nagoya, Aichi-ken, 466-8560

    Study Coordinator, +81527412111

    Recruiting

  • Nagoya City University Hospital ( Site 3446)

    Nagoya, Aichi-ken, 467-8602

    Completed

  • Hyogo Medical University Hospital ( Site 3430)

    Nishinomiya, Hyōgo, 663-8501

    Study Coordinator, +81798456111

    Recruiting

  • Okayama University Hospital ( Site 3454)

    Okayama, 700-8558

    Completed

  • Kinshukai Grand Front Osaka Medical Clinic ( Site 3408)

    Osaka, 530-0011

    Study Coordinator, +81-6-6359-2123

    Recruiting

  • National Hospital Organization Osaka National Hospital ( Site 3453)

    Osaka, 540-0006

    Study Coordinator, +81-6-6942-1331

    Recruiting

  • Saga University Hospital ( Site 3424)

    Saga, 849-8501

    Active, not recruiting

  • Toho University Sakura Medical Center ( Site 3413)

    Sakura, Chiba, 285-8741

    Study Coordinator, 81434628811

    Recruiting

  • Sapporo Tokushukai Hospital ( Site 3427)

    Sapporo, Hokkaido, 004-0041

    Study Coordinator, +81-11-890-1110

    Recruiting

  • Sapporo Medical University Hospital ( Site 3460)

    Sapporo, Hokkaido, 060-8543

    Completed

  • Medical Corporation Sapporo IBD Clinic ( Site 3420)

    Sapporo, Hokkaido, 064-0919

    Study Coordinator, +81-11-213-0397

    Recruiting

  • Sapporohigashi Tokushukai Hospital ( Site 3441)

    Sapporo, Hokkaido, 065-0033

    Study Coordinator, +81117221110

    Recruiting

  • Tohoku University Hospital ( Site 3447)

    Sendai, Miyagi, 980-8574

    Study Coordinator, +81-22-717-7000

    Recruiting

  • National Hospital Organization Shizuoka Medical Center ( Site 3401)

    Shimizu, Shizuoka, 411-8611

    Study Coordinator, +81-55-975-2000

    Recruiting

  • Tokyo Medical University Hospital ( Site 3456)

    Shinjuku, Tokyo, 160-0023

    Study Coordinator, +81-3-3342-6111

    Recruiting

  • National Center for Global Health and Medicine ( Site 3423)

    Shinjuku, Tokyo, 162-8655

    Study Coordinator, +81332027181

    Recruiting

  • Iwate Medical University Hospital ( Site 3457)

    Shiwa-gun, Iwate, 028-3695

    Study Coordinator, ＋81196136111

    Recruiting

  • Tokyo Yamate Medical Center ( Site 3415)

    Tokyo, 169-0073

    Study Coordinator, 0333640251

    Recruiting

  • Toyama Prefectural Central Hospital ( Site 3410)

    Toyama, 930-0975

    Study Coordinator, +81764241531

    Recruiting

  • Mie University Hospital ( Site 3405)

    Tsu, Mie-ken, 514-8507

    Completed

  • Tsuchiura Kyodo General Hospital ( Site 3463)

    Tsuchiura, Ibaraki, 300-0028

    Completed

  • Tsukuba Memorial Hospital ( Site 3461)

    Tsukuba, Ibaraki, 300-2622

    Completed

  • Yamagata University Hospital ( Site 3426)

    Yamagata, 990-9585

    Study Coordinator, +81-23-633-1122

    Recruiting

  • Matsushima Hospital ( Site 3450)

    Yokohama, Kanagawa, 220-0041

    Study Coordinator, +81-45-321-7311

    Recruiting

  • Yokohama City University Medical Center ( Site 3439)

    Yokohama, Kanagawa, 232-0024

    Study Coordinator, +81452615656

    Recruiting

Other trials in Japan

China34 sites, 32 recruiting

  • Peking University Third Hospital ( Site 3910)

    Beijing, Beijing Municipality, 100089

    Study Coordinator, 010-82266699

    Recruiting

  • The Second Xiangya Hospital of Central South University-gastroenterology department ( Site 3905)

    Changsha, Hunan, 410011

    Study Coordinator, 0731-85295194

    Recruiting

  • West China Hospital, Sichuan University ( Site 3929)

    Chengdu, Sichuan, 610041

    Study Coordinator, 028-85422114

    Recruiting

  • Chongqing General Hospital ( Site 3940)

    Chongqing, Chongqing Municipality, 401121

    Study Coordinator, 023-63390710

    Recruiting

  • Dongguan People's Hospital ( Site 3933)

    Dongguan, Guangdong, 523059

    Study Coordinator, 0769-28636801

    Recruiting

  • The First Affiliated Hospital Of Fujian Medical University ( Site 3916)

    Fuzhou, Fujian, 350005

    Study Coordinator, 0591-87981262

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University ( Site 3901)

    Guangzhou, Guangdong, 510655

    Study Coordinator, +86 20-87608185

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3907)

    Guangzhou, Guangdong, 526100

    Study Coordinator, 020 3825 5347

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3902)

    Hangzhou, Zhejiang, 310016

    Study Coordinator, 0571777880

    Recruiting

  • Anhui Provincial Hospital ( Site 3922)

    Hefei, Anhui, 230071

    Study Coordinator, 0551-62283160

    Recruiting

  • Huai'an First People's Hospital ( Site 3948)

    Huaian, Jiangsu, 230000

    Study Coordinator, 0517-84907287

    Recruiting

  • Huizhou Municipal Central Hospital ( Site 3915)

    Huizhou, Guangdong, 516001

    Study Coordinator, (0752)2288288

    Recruiting

  • First Affiliated Hospital of Kunming Medical University ( Site 3928)

    Kunming, Yunnan, 650032

    Study Coordinator, 0871-65324888

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3937)

    Nanjing, Jiangsu, 210008

    Study Coordinator, +8602583106666

    Recruiting

  • Zhongda Hospital Southeast University-Gastroenterology ( Site 3911)

    Nanjing, Jiangsu, 210009

    Study Coordinator, +8602583272114

    Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 3931)

    Shanghai, Shanghai Municipality, 200025

    Study Coordinator, 021-64370045

    Recruiting

  • Huashan Hospital of Fudan University ( Site 3946)

    Shanghai, Shanghai Municipality, 200040

    Study Coordinator, 021-52887120

    Recruiting

  • Shanghai East Hospital ( Site 3914)

    Shanghai, Shanghai Municipality, 200120

    Study Coordinator, 021-38804518

    Recruiting

  • Yuebei People's Hospital ( Site 3912)

    Shaoguan, Guangdong, 512026

    Study Coordinator, 0751-6913882

    Recruiting

  • The University of Hong Kong-Shenzhen Hospital ( Site 3930)

    Shenzhen, Guangdong, 518053

    Study Coordinator, +86 755-86913132

    Recruiting

  • Shenzhen Hospital of Southern Medical University ( Site 3932)

    Shenzhen, Guangdong, 518110

    Study Coordinator, (0755)23329999

    Recruiting

  • The Second Afilliated Hospital of Hebei Medical University ( Site 3913)

    Shijiazhuang, Hebei, 050200

    Study Coordinator, 031166002089

    Recruiting

  • Taihe Hospital ( Site 3944)

    Shiyan, Hubei, 442099

    Study Coordinator, 0719-8801880

    Recruiting

  • Suining Central Hospital ( Site 3927)

    Suining, Sichuan, 629000

    Completed

  • Taizhou Hospital of Zhejiang Province ( Site 3936)

    Taizhou, Zhejiang, 317000

    Study Coordinator, 0576-89218961

    Recruiting

  • Renmin Hospital of Wuhan University ( Site 3921)

    Wuhan, Hubei, 430060

    Study Coordinator, 027-88999120

    Recruiting

  • Wuxi People's Hospital ( Site 3925)

    Wuxi, Jiangsu, 214023

    Study Coordinator, 0510-85350351

    Recruiting

  • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3918)

    Xi'an, Shaanxi, 710038

    Completed

  • The First Affiliated hospital of Xiamen University ( Site 3924)

    Xiamen, Fujian, 361003

    Study Coordinator, 0592-2139767

    Recruiting

  • Zhongshan Hospital Affiliated to Xiamen University ( Site 3923)

    Xiamen, Fujian, 361004

    Study Coordinator, 0592 229 2201

    Recruiting

  • Yangzhou University Affiliated Hospital ( Site 3947)

    Yangzhou, Jiangsu, 225000

    Study Coordinator, +86051482099009

    Recruiting

  • The Second Affiliated Hospital of Zhengzhou University ( Site 3909)

    Zhengzhou, Henan, 450014

    Study Coordinator, 0371-63974128

    Recruiting

  • Affiliated Hospital of Jiangsu University ( Site 3919)

    Zhenjiang, Jiangsu, 212001

    Study Coordinator, 0511-85023852

    Recruiting

  • Changzhou No.2 People's Hospital ( Site 3904)

    Zhenjiang, Jiangsu, 213000

    Study Coordinator, 0519-88104931

    Recruiting

Other trials in China

Poland32 sites, 31 recruiting

  • NZOZ Centrum Medyczne KERmed ( Site 1641)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231

    Study Coordinator, +48533550245

    Recruiting

  • M2M ( Site 1630)

    Chorzów, Silesian Voivodeship, 41-500

    Study Coordinator, +48518424470

    Recruiting

  • Amicare ( Site 1620)

    Jelenia Góra, Lower Silesian Voivodeship, 58-500

    Active, not recruiting

  • Centrum Medyczne Plejady ( Site 1627)

    Krakow, Lesser Poland Voivodeship, 30-363

    Study Coordinator, +48664007799

    Recruiting

  • FutureMeds Krakow ( Site 1628)

    Krakow, Lesser Poland Voivodeship, 31-501

    Study Coordinator, +48124231722

    Recruiting

  • PROMED P. LACH R. GLOWACKI SP. J. ( Site 1636)

    Krakow, Lesser Poland Voivodeship, 31-513

    Study Coordinator, +48124111398

    Recruiting

  • IP Clinic ( Site 1638)

    Lodz, Łódź Voivodeship, 90-752

    Study Coordinator, +422089798

    Recruiting

  • Centrum Medyczne Med-Gastr Sp. z o.o. ( Site 1616)

    Lodz, Łódź Voivodeship, 91-034

    Study Coordinator, +48 42 258 22 33

    Recruiting

  • AmiCare Sp. z o.o. Sp. k. ( Site 1608)

    Lodz, Łódź Voivodeship, 91-495

    Study Coordinator, +48 42 639 49 44

    Recruiting

  • Medrise Sp. z o.o. ( Site 1626)

    Lublin, Lublin Voivodeship, 20-582

    Study Coordinator, +48795404502

    Recruiting

  • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie, Kliniczny Oddział Gastroenterologii, Hepatologii i ( Site 1615)

    Lublin, Lublin Voivodeship, 20-954

    Study Coordinator, +48814485180

    Recruiting

  • Allmedica ( Site 1602)

    Nowy Targ, Lesser Poland Voivodeship, 34-400

    Study Coordinator, +48600616769

    Recruiting

  • Twoja Przychodnia Opolskie Centrum Medyczne ( Site 1633)

    Opole, Opole Voivodeship, 45-819

    Study Coordinator, +48690548825

    Recruiting

  • Medicome Sp. z o.o ( Site 1635)

    Oświęcim, Lesser Poland Voivodeship, 32-600

    Study Coordinator, 48698901491

    Recruiting

  • Pratia S.A. Pratia Poznan ( Site 1603)

    Poznan, Greater Poland Voivodeship, 60-192

    Study Coordinator, +48 512 491 461

    Recruiting

  • EMC Instytut Medyczny S.A,Prywatna Lecznica Certus Ambulatoria,Prywatna Lecznica Certus Szpital Nr1 ( Site 1605)

    Poznan, Greater Poland Voivodeship, 60-309

    Study Coordinator, +48734217034

    Recruiting

  • Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1632)

    Poznan, Greater Poland Voivodeship, 60-324

    Study Coordinator, +48 605 654 590

    Recruiting

  • Endoskopia Sp. z.o.o. ( Site 1637)

    Sopot, Pomeranian Voivodeship, 81-756

    Study Coordinator, +48585552631

    Recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1612)

    Szczecin, West Pomeranian Voivodeship, 71-434

    Study Coordinator, +48914332919

    Recruiting

  • Sonomed Sp. z o. o. ( Site 1617)

    Szczecin, West Pomeranian Voivodeship, 71-685

    Study Coordinator, +48918201110

    Recruiting

  • Gastromed Sp. z o. o. ( Site 1619)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

    Study Coordinator, +48 665 954 004

    Recruiting

  • H-T Centrum Medyczne Endoterapia ( Site 1610)

    Tychy, Silesian Voivodeship, 43-100

    Study Coordinator, +48515342221

    Recruiting

  • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1618)

    Warsaw, Masovian Voivodeship, 00-189

    Study Coordinator, +48663097750

    Recruiting

  • ETG Warszawa ( Site 1629)

    Warsaw, Masovian Voivodeship, 02-677

    Study Coordinator, +48575000243

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Gastroenterologii Onkologiczne ( Site 1624)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, 48 22 546 2328

    Recruiting

  • Vivamed Sp. z o.o. ( Site 1623)

    Warsaw, Masovian Voivodeship, 03-580

    Study Coordinator, +48226792883

    Recruiting

  • WIP Warsaw IBD Point Profesor Kierkuś ( Site 1622)

    Warsaw, Masovian Voivodeship, 04-501

    Study Coordinator, +48 535 553 560

    Recruiting

  • Planetmed ( Site 1600)

    Wroclaw, Lower Silesian Voivodeship, 52-210

    Study Coordinator, +48601749801

    Recruiting

  • Vistamed & Vertigo Sp. z o.o. ( Site 1621)

    Wroclaw, Lower Silesian Voivodeship, 53-149

    Study Coordinator, +48600411536

    Recruiting

  • Melita Medical Sp. z o.o. ( Site 1607)

    Wroclaw, Lower Silesian Voivodeship, 53-611

    Study Coordinator, 717072111

    Recruiting

  • Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 1601)

    Wroclaw, Lower Silesian Voivodeship, 54-239

    Study Coordinator, +48666873220

    Recruiting

  • ETG Zamosc ( Site 1631)

    Zamość, Lublin Voivodeship, 22-400

    Study Coordinator, +48537858147

    Recruiting

Other trials in Poland

France21 sites, 17 recruiting

  • CHU d'Amiens-Picardie - Hôpital Sud ( Site 0709)

    Amiens, Somme, 80000

    Study Coordinator, +33322088866

    Recruiting

  • CHU Besançon ( Site 0724)

    Besançon, Doubs, 25000

    Study Coordinator, +33 3 81 66 82 54

    Recruiting

  • Hopital Beaujon ( Site 0729)

    Clichy, Hauts-de-Seine, 92110

    Study Coordinator, +33627203058

    Recruiting

  • Hopital Henri Mondor ( Site 0730)

    Créteil, Val-de-Marne, 94010

    Study Coordinator, 0149812368

    Recruiting

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0708)

    Dijon, Bourgogne-Franche-Comté, 21000

    Study Coordinator, 0380295653

    Recruiting

  • Clinique des Cèdres ( Site 0732)

    Échirolles, Isere, 38130

    Study Coordinator, +33476852121

    Recruiting

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0702)

    Le Kremlin-Bicêtre, Île-de-France Region, 94275

    Completed

  • Hopital Claude Huriez - CHU de Lille ( Site 0715)

    Lille, Nord, 59037

    Study Coordinator, +33320445620

    Recruiting

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0722)

    Marseille, Bouches-du-Rhone, 13915

    Study Coordinator, +334913800

    Recruiting

  • CHU SAINT ELOI ( Site 0701)

    Montpellier, Languedoc-Roussillon, 34295

    Active, not recruiting

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0705)

    Nantes, Loire-Atlantique, 44093

    Study Coordinator, +33 2 40 08 31 52

    Recruiting

  • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0723)

    Neuilly-sur-Seine, Hauts-de-Seine, 92200

    Study Coordinator, +33141430573

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0711)

    Nice, Alpes-Maritimes, 06202

    Study Coordinator, +33492039366

    Recruiting

  • C.H.U. de Nimes. Hopital Caremeau ( Site 0731)

    Nîmes, Gard, 30029

    Study Coordinator, +33 4 66 68 31 83

    Recruiting

  • Hôpital Saint Antoine ( Site 0721)

    Paris, 75012

    Study Coordinator, +33149283171

    Recruiting

  • CHU Bordeaux Haut-Leveque ( Site 0713)

    Pessac, Aquitaine, 33600

    Study Coordinator, +33557623441

    Recruiting

  • centre hospitalier lyon sud ( Site 0716)

    Pierre-Bénite, Rhone, 69310

    Study Coordinator, +33478861289

    Recruiting

  • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0707)

    Reims, Champagne-Ardenne, 51092

    Completed

  • CHU Rangueil ( Site 0710)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33 3 81 66 82 54

    Recruiting

  • Centre Hospitalier de Valence ( Site 0725)

    Valence, Drome, 26953

    Completed

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0717)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

    Study Coordinator, 33383157450

    Recruiting

Other trials in France

Canada17 sites, 15 recruiting

  • Barrie GI Associates ( Site 0016)

    Barrie, Ontario, L4M 7G1

    Study Coordinator, 705-721-3344

    Recruiting

  • Heritage Medical Research Clinic ( Site 0004)

    Calgary, Alberta, T2N 4Z6

    Study Coordinator, (403) 220-6014

    Recruiting

  • Gastroenterology and internal medicine research institute ( Site 0009)

    Edmonton, Alberta, T5R 1W2

    Study Coordinator, 780-499-1192

    Recruiting

  • Private Practice - Dr. Bruce Musgrave ( Site 0014)

    Kentville, Nova Scotia, B4N 0A3

    Study Coordinator, 902-681-9126

    Recruiting

  • Prairie Institute of Liver and Luminal Advanced Research ( Site 0015)

    Lethbridge, Alberta, T1J 4G9

    Study Coordinator, 403-852-7210

    Recruiting

  • Centre de recherche du CISSS de Chaudière-Appalaches - Hôpital Hôtel Dieu de Levis ( Site 0011)

    Lévis, Quebec, G6V 3Z1

    Study Coordinator, 418-835-7121

    Recruiting

  • University Hospital - London Health Sciences Centre ( Site 0002)

    London, Ontario, N6A 5A5

    Study Coordinator, 5196858500x33655

    Recruiting

  • London Health Sciences Centre ( Site 0007)

    London, Ontario, N6A 5W9

    Study Coordinator, 5196858500 Ex#75554

    Recruiting

  • West GTA Research Inc. ( Site 0020)

    Mississauga, Ontario, L5M 2S4

    Study Coordinator, 905-823-0223

    Recruiting

  • Centre Hospitalier de l'Université de Montréal - Gastroenterology ( Site 0013)

    Montreal, Quebec, H2X 0C1

    Study Coordinator, 514-890-8000 x11736

    Recruiting

  • Montreal General Hospital ( Site 0003)

    Montreal, Quebec, H3G 1A4

    Study Coordinator, 514-934-1934 #36536

    Recruiting

  • Fraser Clinical Trials Inc ( Site 0001)

    New Westminster, British Columbia, V3L 3W4

    Study Coordinator, 604-521-4500

    Recruiting

  • ABP Research Services Corp. ( Site 0019)

    Oakville, Ontario, L6L 5L7

    Study Coordinator, 2898631112

    Recruiting

  • Diex Recherche Quebec ( Site 0008)

    Québec, Quebec, G1V 4T3

    Completed

  • Toronto Immune & Digestive Health Institute ( Site 0005)

    Toronto, Ontario, M6A 3B4

    Study Coordinator, 647-812-2113

    Recruiting

  • G.I.R.I. GI Research Institute Foundation ( Site 0018)

    Vancouver, British Columbia, V6Z 2K5

    Study Coordinator, 604-688-6332

    Recruiting

  • TDDA Inc. ( Site 0006)

    Vaughan, Ontario, L4L 4Y7

    Active, not recruiting

Other trials in Canada

Germany17 sites, 15 recruiting

  • Charité Campus Virchow-Klinikum ( Site 0996)

    Berlin, 13353

    Study Coordinator, +49 30 450 665318

    Recruiting

  • Universitätsklinikum Brandenburg an der Havel ( Site 0903)

    Brandenburg, 14770

    Study Coordinator, +49338141267

    Recruiting

  • Evangelisches Krankenhaus Kalk gGmbH ( Site 0986)

    Cologne, North Rhine-Westphalia, 51103

    Completed

  • Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0985)

    Duisburg, North Rhine-Westphalia, 47055

    Study Coordinator, +492037332390

    Recruiting

  • Medizinische Hochschule Hannover ( Site 0999)

    Hanover, Lower Saxony, 30625

    Study Coordinator, +4905115328473

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0995)

    Kiel, Schleswig-Holstein, 24105

    Study Coordinator, +49 431 500 22201

    Recruiting

  • Universitätsklinikum Leipzig ( Site 0997)

    Leipzig, Saxony, 04103

    Study Coordinator, +49 341 97 12226

    Recruiting

  • St. Marien und St. Annastift Krankenhaus ( Site 0987)

    Ludwighafen Am Rhein, Rhineland-Palatinate, 67067

    Study Coordinator, +4962155012224

    Recruiting

  • Klinikum Lüneburg ( Site 0991)

    Lüneburg, Lower Saxony, 21339

    Study Coordinator, +49 4131 772240

    Recruiting

  • Gastroenterologische Gemeinschaftspraxis Minden ( Site 0998)

    Minden, North Rhine-Westphalia, 32423

    Study Coordinator, +4957195193703

    Recruiting

  • Klinikum der Universität München Großhadern ( Site 0990)

    München, Bavaria, 81377

    Study Coordinator, +49-89-44000

    Recruiting

  • klinikum rechts der isar der technischen universität münchen ( Site 0989)

    München, Bavaria, 81675

    Study Coordinator, +49 89 4140-2455

    Recruiting

  • Medizinisches Versorgungszentrum Portal 10 ( Site 0988)

    Münster, North Rhine-Westphalia, 48155

    Completed

  • Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin ( Site 0992)

    Pforzheim, Baden-Wurttemberg, 75179

    Study Coordinator, +49 72314983704

    Recruiting

  • Magen Darm Zentrum Remscheid ( Site 0984)

    Remscheid, North Rhine-Westphalia, 42859

    Study Coordinator, +4921918901050

    Recruiting

  • Universitätsmedizin Rostock ( Site 0993)

    Rostock, Mecklenburg-Vorpommern, 18057

    Study Coordinator, +49 381494147483

    Recruiting

  • Universitaetsklinikum Ulm. ( Site 0994)

    Ulm, Bavaria, 89081

    Study Coordinator, +49 731 500 44727

    Recruiting

Other trials in Germany

South Korea17 sites, 16 recruiting

  • Korea University Ansan Hospital ( Site 3617)

    Ansan-si, Kyonggi-do, 15355

    Study Coordinator, +82314127674

    Recruiting

  • Dong-A University Hospital ( Site 3601)

    Busan, Pusan-Kwangyokshi, 49201

    Study Coordinator, 82-51-240-5677

    Recruiting

  • Kyungpook National Univ.Hospital ( Site 3616)

    Daegu, Taegu-Kwangyokshi, 41944

    Study Coordinator, +82532508096

    Recruiting

  • Yeungnam Univeristy Medical Center ( Site 3610)

    Daegu, Taegu-Kwangyokshi, 42415

    Study Coordinator, +82536203897

    Recruiting

  • Keimyung University Dongsan Medical Center ( Site 3614)

    Daegu, Taegu-Kwangyokshi, 42601

    Study Coordinator, +82532507088

    Recruiting

  • The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3604)

    Daejeon, Taejon-Kwangyokshi, 34943

    Study Coordinator, 82-42-220-9501

    Recruiting

  • Chung-Ang University Hospital ( Site 3606)

    Dongjak-gu, Seoul, 06973

    Study Coordinator, +82-2-6299-1355

    Recruiting

  • Inje University Haeundae Paik Hospital ( Site 3605)

    Haeundae-gu, Pusan-Kwangyokshi, 48108

    Study Coordinator, +82517970475

    Recruiting

  • Kyung Hee University Hospital ( Site 3611)

    Seoul, 02447

    Study Coordinator, 82-2-952-8238

    Recruiting

  • Seoul National University Hospital ( Site 3607)

    Seoul, 03080

    Study Coordinator, +8227408112

    Recruiting

  • Kangbuk Samsung Hospital-Internal Medicine ( Site 3612)

    Seoul, 03181

    Study Coordinator, +82220018555

    Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3602)

    Seoul, 03312

    Study Coordinator, +82-2-2030-4737

    Recruiting

  • Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3603)

    Seoul, 03722

    Study Coordinator, +82222281990

    Recruiting

  • Asan Medical Center ( Site 3609)

    Seoul, 05505

    Study Coordinator, 82-2-3010-3181

    Recruiting

  • Samsung Medical Center ( Site 3613)

    Seoul, 06351

    Study Coordinator, +82-2-3410-1927

    Recruiting

  • The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3608)

    Suwon, Kyonggi-do, 16247

    Completed

  • Wonju Severance Christian Hospital-Internal Medicine ( Site 3600)

    Wŏnju, Kang-won-do, 26426

    Study Coordinator, +82-33-741-0114

    Recruiting

Other trials in South Korea

Italy15 sites, 14 recruiting

  • A.O.U.C. Policlinico di Bari ( Site 1306)

    Bari, Apulia, 70124

    Study Coordinator, +390805594035

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1308)

    Bologna, 40138

    Study Coordinator, +39 0512144134

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi-MICI ( Site 9002)

    Florence, Tuscany, 50134

    Study Coordinator, +39055794111

    Recruiting

  • Azienda Ospedaliera Universitaria Di Messina G. Martino ( Site 1314)

    Messina, 98125

    Study Coordinator, +39090 2212380

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1304)

    Milan, Lombardy, 20122

    Study Coordinator, +39 0255032141

    Recruiting

  • Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1300)

    Milan, 20132

    Study Coordinator, +390226439415

    Recruiting

  • Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1313)

    Monserrato, Cagliari, 09042

    Study Coordinator, +390706754621

    Recruiting

  • A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1310)

    Naples, Napoli, 80131

    Study Coordinator, +390817062270

    Recruiting

  • Ospedale Sacro Cuore Don G. Calabria-IBD Unit ( Site 1303)

    Negrar, Verona, 37024

    Study Coordinator, +390456013720

    Recruiting

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1302)

    Palermo, Sicily, 90146

    Study Coordinator, +390916802022

    Recruiting

  • Ospedale "Felice Lotti" Di Pontedera ( Site 1311)

    Pontedera, Pisa, 56025

    Study Coordinator, 00390587273305

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas ( Site 1312)

    Roma, 00168

    Study Coordinator, +390630153791

    Recruiting

  • Fondazione Policlinico Tor Vergata ( Site 1307)

    Rome, Lazio, 00133

    Active, not recruiting

  • Istituto Clinico Humanitas-IBD center ( Site 1309)

    Rozzano, Lombardy, 20089

    Study Coordinator, +390282248282

    Recruiting

  • Ospedale Mauriziano - Gastroenterology Unit ( Site 9000)

    Turin, Piedmont, 10128

    Study Coordinator, +390115082534

    Recruiting

Other trials in Italy

Ukraine12 sites, 12 recruiting

  • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 5815)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

    Study Coordinator, +380342528765

    Recruiting

  • Medical Center of Limited ( Site 5806)

    Kyiv, Kyivska Oblast, 04050

    Study Coordinator, +380979132763

    Recruiting

  • Center of Family Medicine Plus ( Site 5803)

    Kyiv, Kyivska Oblast, 04210

    Study Coordinator, +380972094524

    Recruiting

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 5800)

    Kyiv, 03057

    Study Coordinator, +380445213003

    Recruiting

  • Dobrobut Medical Center ( Site 5801)

    Kyiv, 03151

    Study Coordinator, +380671502987

    Recruiting

  • Medical Center of Private Enterprise "Sygma" ( Site 5808)

    Kyiv, 04116

    Study Coordinator, +380503538207

    Recruiting

  • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 5813)

    Lutsk, Volyn Oblast, 43005

    Study Coordinator, +38 0332 77 31 35

    Recruiting

  • Communal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"-proctology ( Site 5809)

    Lviv, Lviv Oblast, 79010

    Study Coordinator, +380632380055

    Recruiting

  • Limited liability company "Medical center Health Clinic" ( Site 5807)

    Vinnytsia, Vinnytsia Oblast, 21009

    Study Coordinator, +380960992929

    Recruiting

  • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 5814)

    Vinnytsia, Vinnytsia Oblast, 21018

    Study Coordinator, +380432570572

    Recruiting

  • Clinic of Scientific and Research Institute of Invalid Rehabilitation of VNMU n.a. M.I.Pyrohov ( Site 5812)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, +380673978046

    Recruiting

  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 5811)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, +380678775448

    Recruiting

Other trials in Ukraine

Spain11 sites, 11 recruiting

  • Complejo Hospitalario Universitario de Ferrol ( Site 2114)

    A Coruña, La Coruna, 15405

    Study Coordinator, 0034981334000

    Recruiting

  • Hospital Germans Trias i Pujol ( Site 2101)

    Badalona, Barcelona, 08916

    Study Coordinator, 34934978909

    Recruiting

  • HOSPITAL CLÍNIC DE BARCELONA-ICMDM - Clinical Institute of Digestive and Metabolic Diseases ( Site 2112)

    Barcelona, Catalonia, 08036

    Study Coordinator, 34932275418

    Recruiting

  • Hospital Universitario La Paz ( Site 2100)

    Madrid, 28046

    Study Coordinator, 912071350

    Recruiting

  • Hospital Universitario Puerta de Hierro ( Site 2102)

    Majadahonda, Madrid, 28222

    Study Coordinator, 911916480

    Recruiting

  • Hospital Montecelo. Complexo Hospitalario de Pontevedra ( Site 2107)

    Pontevedra, 36071

    Study Coordinator, 0034986800000

    Recruiting

  • Hospital Universitario Nuestra Senora de la Candelaria ( Site 2105)

    Santa Cruz de Tenerife, 38010

    Study Coordinator, 922602345

    Recruiting

  • Hospital Universitario de Torrejón ( Site 2108)

    Torrejón de Ardoz, Madrid, 28850

    Study Coordinator, 34916262600

    Recruiting

  • HOSPITAL CLINICO DE VALENCIA-MEDICINA DIGESTIVA ( Site 2103)

    Valencia, 46010

    Study Coordinator, +34961973820

    Recruiting

  • Hospital Universitari i Politecnic La Fe ( Site 2111)

    Valencia, 46026

    Study Coordinator, +34669754974

    Recruiting

  • Hospital Universitario Miguel Servet ( Site 2104)

    Zaragoza, 50009

    Study Coordinator, 34976765526

    Recruiting

Other trials in Spain

Hungary10 sites, 7 recruiting

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1105)

    Békéscsaba, Bekescsaba, 5600

    Study Coordinator, +36304366675

    Recruiting

  • Clinexpert Kft.-Clinexpert Budapest ( Site 1108)

    Budapest, 1033

    Study Coordinator, 0036 1 2108139

    Recruiting

  • Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1107)

    Budapest, 1036

    Completed

  • Semmelweis Egyetem ( Site 1118)

    Budapest, 1082

    Study Coordinator, 36 1 459 1500 /52120

    Recruiting

  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 1100)

    Budapest, 1134

    Completed

  • Pannónia Magánorvosi Centrum ( Site 1103)

    Budapest, 1136

    Study Coordinator, 36 30 347 9212

    Recruiting

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1117)

    Eger, Heves County, 3300

    Completed

  • Gyöngyösi Bugát Pál Kórház ( Site 1111)

    Gyöngyös, Heves County, 3200

    Study Coordinator, 36 37 312 491

    Recruiting

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1115)

    Tatabánya, Komárom-Esztergom, 2800

    Study Coordinator, +3634515488

    Recruiting

  • VeszLife Magánklinika ( Site 1102)

    Veszprém, Veszprém megye, 8200

    Study Coordinator, +36309371646

    Recruiting

Other trials in Hungary

Mexico10 sites, 9 recruiting

  • Centro de Investigación y Gastroenterología - S.C. ( Site 3102)

    Benito Juarez Ciudad de Mexico, Mexico City, 03330

    Study Coordinator, +52 55 9314 4340

    Recruiting

  • Scientia Investigacion Clinica S.C. ( Site 3114)

    Chihuahua City, 31207

    Study Coordinator, 6142783902

    Recruiting

  • JM Research SC ( Site 3109)

    Cuernavaca, Morelos, 62290

    Study Coordinator, +527773333178

    Recruiting

  • Morales Vargas Centro de Investigacion S. C. ( Site 3101)

    León, Guanajuato, 37000

    Study Coordinator, 4775580244

    Recruiting

  • Medical Care and Research SA de CV-GASTROENTEROLOGY ( Site 3110)

    Mérida, Yucatán, 97070

    Study Coordinator, +529999203879

    Recruiting

  • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 3104)

    Mexico City, Mexico City, 14050

    Completed

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Gastroenterología ( Site 3100)

    Monterrey, Nuevo León, 64460

    Study Coordinator, 8111855955

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 3105)

    Oaxaca City, Oaxaca, 68020

    Study Coordinator, +529512570569

    Recruiting

  • Servicios de Oncología Médica Integral, S.A de C.V. ( Site 3108)

    San Pedro Garza García, Nuevo León, 66220

    Study Coordinator, 8110674829

    Recruiting

  • Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 3106)

    Tlajomulco de Zúñiga, Jalisco, 45640

    Study Coordinator, +523311491351

    Recruiting

Other trials in Mexico

United Kingdom10 sites, 8 recruiting

  • Southmead Hospital ( Site 2403)

    Bristol, South Gloucestershire, BS10 5NB

    Study Coordinator, 0117 414 8133

    Recruiting

  • Addenbrooke's Hospital ( Site 2400)

    Cambridge, Cambridgeshire, CB2 2QQ

    Study Coordinator, +441223331130

    Recruiting

  • Doncaster Royal Infirmary ( Site 2401)

    Doncaster, England, DN2 5LT

    Study Coordinator, 01302643331

    Recruiting

  • Royal Devon & Exeter Hospital ... ( Site 2407)

    Exeter, Devon, EX2 5DW

    Active, not recruiting

  • Huddersfield Royal Infirmary ( Site 2409)

    Huddersfield, England, HD3 3EA

    Study Coordinator, 01484342905

    Recruiting

  • Whipps Cross University Hospital-Clinical Research Unit ( Site 2404)

    London, England, E11 1NR

    Study Coordinator, 020 8539 5522

    Recruiting

  • University College London Hospital-Clinical Research Facility ( Site 2405)

    London, London, City of, NW1 2PG

    Study Coordinator, +442034477618

    Recruiting

  • The John Radcliffe Hospital ( Site 2406)

    Oxford, Oxfordshire, OX3 9DU

    Study Coordinator, 01865 231618

    Recruiting

  • Southampton General Hospital ( Site 2402)

    Southampton, Hampshire, SO16 6YD

    Study Coordinator, 023 8077 7222

    Recruiting

  • Walsall Manor Hospital ( Site 2410)

    West Midlands, Walsall, WS2 9PS

    Active, not recruiting

Other trials in United Kingdom

Brazil9 sites, 9 recruiting

  • Faculdade de Medicina da UNESP ( Site 6308)

    Botucatu, São Paulo, 18618-686

    Study Coordinator, +55 14 3880-1663

    Recruiting

  • Loema Instituto de Pesquisa Clinica ( Site 6302)

    Campinas, São Paulo, 13092-133

    Study Coordinator, +551932353575

    Recruiting

  • CECIP - Centro de Estudos do Interior Paulista ( Site 6316)

    Jaú, São Paulo, 17201-130

    Study Coordinator, +551436220500

    Recruiting

  • Hospital de Clinicas de Porto Alegre ( Site 6310)

    Porto Alegre, Rio Grande do Sul, 90035-903

    Study Coordinator, 55 11 99127 6767

    Recruiting

  • Hospital Ernesto Dornelles ( Site 6312)

    Porto Alegre, Rio Grande do Sul, 90160-093

    Study Coordinator, +555132178584

    Recruiting

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 6311)

    Ribeirão Preto, São Paulo, 14048-900

    Study Coordinator, 55 16 3963 6484

    Recruiting

  • Pesquisare Saude ( Site 6304)

    Santo André, São Paulo, 09080-110

    Study Coordinator, +55 11 4432-2953

    Recruiting

  • Centro de Pesquisa Kaiser - CEPEK ( Site 6306)

    São José do Rio Preto, São Paulo, 15015-110

    Study Coordinator, +551733024793

    Recruiting

  • BR Trials - Ensaios Clinicos e Consultoria ( Site 6301)

    São Paulo, 01236-030

    Study Coordinator, +5511915820176

    Recruiting

Other trials in Brazil

Israel9 sites, 9 recruiting

  • Emek Medical Center ( Site 1206)

    Afula, 1834111

    Study Coordinator, 972-46495766

    Recruiting

  • Barzilai Medical Center ( Site 1209)

    Ashkelon, 7830604

    Study Coordinator, +972-54-5789300

    Recruiting

  • Rambam Health Care Campus ( Site 1201)

    Haifa, 3109601

    Study Coordinator, 0502062249

    Recruiting

  • Bnai Zion Medical Center ( Site 1203)

    Haifa, 3339419

    Study Coordinator, +972-50-6267321

    Recruiting

  • Edith Wolfson Medical Center ( Site 1204)

    Holon, 5810001

    Study Coordinator, +97235028482

    Recruiting

  • Shaare Zedek Medical Center ( Site 1208)

    Jerusalem, 9103102

    Study Coordinator, +972-50-7874311

    Recruiting

  • Meir Medical Center. ( Site 1202)

    Kfar Saba, 4428164

    Study Coordinator, +972-58-5444887

    Recruiting

  • Rabin Medical Center ( Site 1207)

    Petah Tikva, 4941492

    Study Coordinator, +972-54 5989299

    Recruiting

  • Sheba Medical Center ( Site 1200)

    Ramat Gan, 5265601

    Study Coordinator, 97235307072

    Recruiting

Other trials in Israel

Turkey (Türkiye)9 sites, 5 recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2300)

    Ankara, 06100

    Study Coordinator, +905322249998

    Recruiting

  • ANKARA UNIVERSITY IBNI SINA HOSPITAL-Gastroenterology ( Site 2303)

    Ankara, 06230

    Completed

  • Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 2301)

    Ankara, 06800

    Study Coordinator, +905327848568

    Recruiting

  • Antalya Egitim ve Arastırma Hastanesi ( Site 2304)

    Antalya, 07100

    Study Coordinator, +90 242 249 44 00

    Recruiting

  • Ege Universitesi Hastanesi ( Site 2302)

    Bornova, İzmir, 35100

    Active, not recruiting

  • Eskisehir Osmangazi University Faculty of Medicine ( Site 2308)

    Eskişehir, 26040

    Completed

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi ( Site 2306)

    Istanbul, 34098

    Completed

  • Marmara Univetsitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2305)

    Istanbul, 34899

    Study Coordinator, +905052914056

    Recruiting

  • Kocaeli University Medical Faculty Hospital ( Site 2309)

    Kocaeli, 41380

    Study Coordinator, +905378767651

    Recruiting

Other trials in Turkey (Türkiye)

Chile8 sites, 8 recruiting

  • Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 2604)

    Concepción, Biobio, 4070038

    Study Coordinator, +56412722500

    Recruiting

  • Clínica Universidad de Los Andes ( Site 2609)

    Las Condes, Region M. de Santiago, 7620157

    Study Coordinator, +56958373369

    Recruiting

  • FALP-UIDO ( Site 2600)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224205098

    Recruiting

  • Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2602)

    Santiago, Region M. de Santiago, 7650568

    Study Coordinator, 56222101111

    Recruiting

  • Espacio Eme ( Site 2608)

    Santiago, Region M. de Santiago, 7770086

    Study Coordinator, +56937137320

    Recruiting

  • CECIM ( Site 2603)

    Santiago, Region M. de Santiago, 8320000

    Study Coordinator, +56226965804

    Recruiting

  • Hospital hernan henriquez aravena de temuco ( Site 2607)

    Temuco, Araucania, 4781151

    Study Coordinator, 56452556875

    Recruiting

  • Centro de Investigaciones Clinicas Vina del Mar ( Site 2606)

    Viña del Mar, Valparaiso, 2540488

    Study Coordinator, +56323245375

    Recruiting

Other trials in Chile

Netherlands8 sites, 8 recruiting

  • Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1500)

    Amsterdam, North Holland, 1081 HV

    Study Coordinator, +31205666545

    Recruiting

  • University Medical Center Groningen ( Site 1506)

    Groningen, 9713 GZ

    Study Coordinator, 0031503612620

    Recruiting

  • Radboudumc ( Site 1505)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, 0031243619190

    Recruiting

  • Erasmus Medisch Centrum ( Site 1504)

    Rotterdam, South Holland, 3015 GD

    Study Coordinator, +3110-7030792

    Recruiting

  • Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1503)

    Rotterdam, South Holland, 3045 PM

    Study Coordinator, 0031104617430

    Recruiting

  • ETZ Elisabeth ( Site 1501)

    Tilburg, North Brabant, 5022GC

    Study Coordinator, 0031(0)13-2218466

    Recruiting

  • Ziekenhuis Bernhoven ( Site 1508)

    Uden, North Brabant, 5406 PT

    Study Coordinator, +3141-3402933

    Recruiting

  • Universitair Medisch Centrum Utrecht ( Site 1502)

    Utrecht, 3584 CX

    Study Coordinator, 003188-7573618

    Recruiting

Other trials in Netherlands

Portugal7 sites, 7 recruiting

  • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1704)

    Guimarães, Braga District, 4835-044

    Study Coordinator, 00351253540330

    Recruiting

  • Unidade Local de Saude da Região de Leiria - Hospital Santo André ( Site 1706)

    Leiria, 2410-197

    Study Coordinator, 00351244817000

    Recruiting

  • Hospital da Luz Lisboa ( Site 1707)

    Lisbon, 1500-650

    Study Coordinator, 00351217104400

    Recruiting

  • Hospital dos Lusíadas Lisboa ( Site 1701)

    Lisbon

    Study Coordinator, 00351217704040

    Recruiting

  • Unidade Local de Saude do Algarve - Hospital de Portimão ( Site 1700)

    Portimão, Faro District, 8500-338

    Study Coordinator, 00351289891100

    Recruiting

  • ULSAM - Hospital de Santa Luzia ( Site 1703)

    Viana do Castelo, 4900-858

    Study Coordinator, +351258802100

    Recruiting

  • Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 1702)

    Viseu, 3504-509

    Study Coordinator, +351232420500

    Recruiting

Other trials in Portugal

Australia6 sites, 6 recruiting

  • Royal Adelaide Hosp - GI Clinical Trials ( Site 3203)

    Adelaide, South Australia, 5000

    Study Coordinator, +61 8 7074 2200

    Recruiting

  • Royal Brisbane and Women's Hospital ( Site 3200)

    Brisbane, Queensland, 4029

    Study Coordinator, +61736468401

    Recruiting

  • Mater Misericordiae Limited ( Site 3209)

    Brisbane, Queensland, 4101

    Study Coordinator, +61731638195

    Recruiting

  • Monash Health-Gastroenterology ( Site 3206)

    Clayton, Victoria, 3168

    Study Coordinator, +61(0)395943577

    Recruiting

  • Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)

    Concord, New South Wales, 2139

    Study Coordinator, +61 2 9767 5000

    Recruiting

  • The Alfred Hospital-Gastroenterology ( Site 3201)

    Melbourne, Victoria, 3004

    Study Coordinator, +61(0)390760182

    Recruiting

Other trials in Australia

Colombia6 sites, 6 recruiting

  • Fundacion Santa Fe de Bogota ( Site 2703)

    Bogotá, Cundinamarca, 110111

    Study Coordinator, +57 3212108418

    Recruiting

  • Fundación Valle del Lili ( Site 2704)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +573146824542

    Recruiting

  • Salud SURA Industriales ( Site 2706)

    Medellín, Antioquia, 05001

    Study Coordinator, +573134673355

    Recruiting

  • Clinica Medellin S.A ( Site 2705)

    Medellín, Antioquia, 050030

    Study Coordinator, +57 3137694095

    Recruiting

  • IMAT S.A.S ( Site 2700)

    Montería, Departamento de Córdoba, 23002

    Study Coordinator, +57 3135342052

    Recruiting

  • Oncologos del Occidente ( Site 2702)

    Pereira, Risaralda Department, 660001

    Study Coordinator, +57 3002558656

    Recruiting

Other trials in Colombia

Czechia6 sites, 6 recruiting

  • Pratia Czech s.r.o. ( Site 0657)

    Brno, Brno-mesto, 602 00

    Study Coordinator, +420773762325

    Recruiting

  • Vojenská Nemocnice Brno-Internal department ( Site 0655)

    Brno, Brno-mesto, 615 00

    Study Coordinator, +420973445520

    Recruiting

  • Hepato-Gastroenterologie HK ( Site 0652)

    Hradec Králové, 500 12

    Study Coordinator, +420 495 218 475

    Recruiting

  • Institut Klinicke a Experimentalni Mediciny-Klinika hepatogastroentrologie ( Site 0654)

    Prague, Praha 4, 140 21

    Study Coordinator, +420 236 052 139

    Recruiting

  • ISCARE klinické centrum ( Site 0656)

    Prague, 190 00

    Study Coordinator, +420234770800

    Recruiting

  • Nemocnice Slany-Gastroenterologicka a Endoskopicka ambulance ( Site 0651)

    Slaný, Central Bohemia, 274 01

    Study Coordinator, +420312 575 111

    Recruiting

Other trials in Czechia

Romania6 sites, 6 recruiting

  • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1806)

    Bucharest, Bucharest, 013823

    Study Coordinator, 0040319393

    Recruiting

  • Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1808)

    Bucharest, Bucharest, 022328

    Study Coordinator, 0040212750500

    Recruiting

  • Monza Ares SRL ( Site 1804)

    Bucharest, 012015

    Study Coordinator, 0040219178

    Recruiting

  • GastroMed ( Site 1809)

    Cluj-Napoca, Cluj, 400394

    Study Coordinator, 0744332107

    Recruiting

  • Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1807)

    Târgu Mureş, Mureș County, 540205

    Study Coordinator, 0040265217235

    Recruiting

  • ASOCIATIA ONCOHELP ( Site 1805)

    Timișoara, Timiș County, 300239

    Study Coordinator, 0040256495403

    Recruiting

Other trials in Romania

Serbia6 sites, 6 recruiting

  • Clinical Hospital Center Dragisa Misovic ( Site 1906)

    Belgrade, Beograd, 11 000

    Study Coordinator, +381643509133

    Recruiting

  • Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1903)

    Belgrade, Beograd, 11000

    Study Coordinator, +381608838001

    Recruiting

  • University Medical Center "Bezanijska kosa"-Gastroenterology and hepatology ( Site 1900)

    Belgrade, Beograd, 11080

    Study Coordinator, +381641608353

    Recruiting

  • Clinical Center Kragujevac ( Site 1904)

    Kragujevac, Sumadijski Okrug, 34000

    Study Coordinator, +381604401776

    Recruiting

  • Zemun Medical Centre ( Site 1910)

    Zemun, Beograd, 11080

    Study Coordinator, +38163282082

    Recruiting

  • General Hospital "Djordje Joanovic" ( Site 1905)

    Zrenjanin, Srednjebanatski Okrug, 23000

    Study Coordinator, +381606076527

    Recruiting

Other trials in Serbia

South Africa6 sites, 6 recruiting

  • Panorama Medical Centre ( Site 4001)

    Cape Town, Western Cape, 7500

    Study Coordinator, +27219300923

    Recruiting

  • Spoke Research ( Site 4003)

    Cape Town, Western Cape, 7700

    Study Coordinator, +2783284462

    Recruiting

  • Life Kingsbury Hospital ( Site 4000)

    Cape Town, Western Cape, 7708

    Study Coordinator, +27837033097

    Recruiting

  • Wits Clinical Research ( Site 4004)

    Johannesburg, Gauteng, 2193

    Study Coordinator, +27110812179

    Recruiting

  • Private Practice - Dr. M.N. Rajabally ( Site 4007)

    Plumstead, Western Cape, 7800

    Study Coordinator, +27217973550

    Recruiting

  • Wits Clinical Research-Chris Hani Baragwanath Hospital ( Site 4005)

    Soweto, Gauteng, 2013

    Study Coordinator, +27119836501

    Recruiting

Other trials in South Africa

Croatia5 sites, 5 recruiting

  • Poliklinika Borzan ( Site 0500)

    Osijek, County of Osijek-Baranja, 31000

    Study Coordinator, +385914477723

    Recruiting

  • Klinička bolnica Merkur ( Site 0503)

    Zagreb, City of Zagreb, 10000

    Study Coordinator, +38512431390

    Recruiting

  • Klinički bolnički centar Zagreb ( Site 0501)

    Zagreb, City of Zagreb, 10000

    Study Coordinator, +38512388888

    Recruiting

  • Poliklinika Bates ( Site 0504)

    Zagreb, City of Zagreb, 10000

    Study Coordinator, +38512338000

    Recruiting

  • Poliklinika Solmed ( Site 0502)

    Zagreb, City of Zagreb, 10000

    Study Coordinator, +38515620921

    Recruiting

Other trials in Croatia

Greece5 sites, 5 recruiting

  • Evangelismos General Hospital of Athens ( Site 1002)

    Athens, Attica, 106 76

    Study Coordinator, +306977617000

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1004)

    Athens, Attica, 115 27

    Study Coordinator, 0030 2107763359

    Recruiting

  • University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 1000)

    Heraklion, Crete, 711 10

    Study Coordinator, +302813402111

    Recruiting

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon" ( Site 1003)

    Nikaia Piraeus, Attica, 184 54

    Study Coordinator, +302132077000

    Recruiting

  • Ippokrateio General Hospital of Thessaloniki ( Site 1001)

    Thessaloniki, Central Macedonia, 54642

    Study Coordinator, +302313312000

    Recruiting

Other trials in Greece

Malaysia5 sites, 5 recruiting

  • Hospital Ampang ( Site 6106)

    Ampang, Selangor, 68000

    Study Coordinator, +60342896559

    Recruiting

  • Hospital Sultanah Aminah ( Site 6104)

    Johor Bahru, Johor, 80100

    Study Coordinator, +6072257000

    Recruiting

  • Hospital Universiti Sains Malaysia ( Site 6103)

    Kubang Kerian, Kelantan, 16150

    Study Coordinator, +6097673000

    Recruiting

  • Sarawak General Hospital ( Site 6102)

    Kuching, Sarawak, 93586

    Study Coordinator, +6082276820

    Recruiting

  • University Malaya Medical Centre ( Site 6101)

    Lembah Pantai, Kuala Lumpur, 59100

    Study Coordinator, +60479492351

    Recruiting

Other trials in Malaysia

Slovakia5 sites, 4 recruiting

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica-Gastroenterologicke oddelenie ( Site 2002)

    Banská Bystrica, Banská Bystrica Region, 974 01

    Study Coordinator, +421905838606

    Recruiting

  • Cliniq s.r.o. ( Site 2001)

    Bratislava, Bratislava Region, 81109

    Completed

  • KM Management ( Site 2000)

    Nitra, Nitra Region, 949 01

    Study Coordinator, +421377415408

    Recruiting

  • GASTRO I ( Site 2004)

    Prešov, Presov, 080 01

    Study Coordinator, +421903607349

    Recruiting

  • Gastro LM ( Site 2005)

    Prešov, Presov, 080 01

    Study Coordinator, +421905794001

    Recruiting

Other trials in Slovakia

Georgia4 sites, 4 recruiting

  • LTD High Technology Hospital Medcenter ( Site 0802)

    Batumi, Adjara, 6010

    Study Coordinator, +995 577 65 27 66

    Recruiting

  • Caucasus Medical Centre ( Site 0801)

    Tbilisi, Adjara, 0186

    Study Coordinator, +995599235553

    Recruiting

  • New Hospitals ( Site 0800)

    Tbilisi, 0114

    Study Coordinator, +995322190190

    Recruiting

  • Caraps Medline ( Site 0803)

    Tbilisi, 0159

    Study Coordinator, +995 (32) 251-60-60

    Recruiting

Other trials in Georgia

Saudi Arabia4 sites, 4 recruiting

  • King Abdullah Medical City Specialist Hospital ( Site 5230)

    Mecca, Makkah Al Mukarramah, 24246

    Study Coordinator, +966533853299

    Recruiting

  • King Abdul Aziz Medical City - AlRiyadh ( Site 5210)

    Riyadh, Riyadh Region, 11426

    Study Coordinator, +966112520088

    Recruiting

  • King Saud University Medical City ( Site 5220)

    Riyadh, Riyadh Region, 11472

    Study Coordinator, +966502191786

    Recruiting

  • King Faisal Specialist Hospital and Research Center ( Site 5200)

    Riyadh, Riyadh Region, 12713

    Study Coordinator, +966114647272

    Recruiting

Other trials in Saudi Arabia

Switzerland4 sites, 4 recruiting

  • University Hospital Basel-Gastroenterology and Hepatology ( Site 2204)

    Basel, Canton of Basel-City, 4031

    Study Coordinator, +41617777575

    Recruiting

  • INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 2202)

    Bern, Canton of Bern, 3012

    Study Coordinator, +41313023234

    Recruiting

  • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2201)

    Sankt Gallen, Canton of St. Gallen, 9000

    Study Coordinator, 0041714946264

    Recruiting

  • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2200)

    Zurich, Canton of Zurich, 8091

    Study Coordinator, 0041442551111

    Recruiting

Other trials in Switzerland

Austria3 sites, 3 recruiting

  • Medizinische Universitaet Innsbruck-Innere Medizin 1 ( Site 0200)

    Innsbruck, Tyrol, 6020

    Study Coordinator, 0043504813111

    Recruiting

  • Uniklinikum Salzburg-Innere Medizin I ( Site 0201)

    Salzburg, 5020

    Study Coordinator, 0043(0)572550

    Recruiting

  • Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)

    Vienna, State of Vienna, 1090

    Study Coordinator, +4314040062450

    Recruiting

Other trials in Austria

Belgium3 sites, 2 recruiting

  • UZ Gent ( Site 0300)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +32 9 332 51 66

    Recruiting

  • UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)

    Leuven, Vlaams-Brabant, 3000

    Active, not recruiting

  • AZ Delta vzw-Gastroenterology ( Site 0304)

    Roeselare, West-Vlaanderen, 8800

    Study Coordinator, 00 32 51 23 72 15

    Recruiting

Other trials in Belgium

Finland3 sites, 3 recruiting

  • Pohjois-Karjalan Keskussairaala ( Site 5403)

    Joensuu, Pohjois-Karjala, 80210

    Study Coordinator, +358133300

    Recruiting

  • Tampereen yliopistollinen sairaala ( Site 5401)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, +358331169448

    Recruiting

  • Turku University Hospital ( Site 5402)

    Turku, Southwest Finland, 20520

    Study Coordinator, +358504448237

    Recruiting

Other trials in Finland

New Zealand3 sites, 3 recruiting

  • Aotearoa Clinical Trials ( Site 3501)

    Auckland, 2025

    Study Coordinator, +64212070632

    Recruiting

  • Dunedin Hospital ( Site 3505)

    Dunedin, Otago, 9016

    Study Coordinator, +6434740999

    Recruiting

  • Hutt Valley District Health board HVDHB ( Site 3500)

    Lower Hutt, Wellington Region, 5010

    Study Coordinator, +64 4 587 2519

    Recruiting

Other trials in New Zealand

Peru3 sites, 3 recruiting

  • Investigaciones Clínicas / Instituto de Ginecología y Reproducción ( Site 3002)

    Lima, 15023

    Study Coordinator, +51 01 4694064

    Recruiting

  • Hospital Cayetano Heredia ( Site 3003)

    Lima, Lima 31

    Study Coordinator, +51932016758

    Recruiting

  • Hospital Nacional Edgardo Rebagliati Martins-Aparato Digestivo ( Site 0154)

    Lima, Lima11

    Study Coordinator, +51999856018

    Recruiting

Other trials in Peru

Singapore3 sites, 2 recruiting

  • Singapore General Hospital ( Site 6202)

    Singapore, Central Singapore, 169608

    Study Coordinator, +6563213652

    Recruiting

  • Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 6201)

    Singapore, Central Singapore, 308433

    Study Coordinator, +6597235084

    Recruiting

  • Changi General Hospital ( Site 6203)

    Singapore, South East, 529889

    Completed

Other trials in Singapore

Sweden3 sites, 3 recruiting

  • Danderyds Sjukhus ( Site 5501)

    Danderyd, Stockholm County, 182 88

    Study Coordinator, +46812355000

    Recruiting

  • Universitetssjukhuset i Linköping ( Site 5502)

    Linköping, Östergötland County, 581 85

    Study Coordinator, +46101030000

    Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 5500)

    Stockholm, Stockholm County, 171 64

    Study Coordinator, 46812370000

    Recruiting

Other trials in Sweden

Taiwan3 sites, 3 recruiting

  • National Taiwan University Hospital-Internal Medicine ( Site 3700)

    Taipei, 100225

    Study Coordinator, +886223123456

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 3701)

    Taoyuan, 33305

    Study Coordinator, +886975366024

    Recruiting

  • National Taiwan University BioMedical Park Hospital ( Site 3702)

    Zhubei, Hsinchu, 302058

    Study Coordinator, +886-930-169320

    Recruiting

Other trials in Taiwan

Denmark2 sites, 2 recruiting

  • Herlev and Gentofte Hospital ( Site 5300)

    Copenhagen, Capital Region, 2730

    Study Coordinator, +45 38685609

    Recruiting

  • Odense Universitetshospital ( Site 5301)

    Odense C, Region Syddanmark, 5000

    Study Coordinator, +4566113333

    Recruiting

Other trials in Denmark

Latvia2 sites, 2 recruiting

  • SIA M & M Centrs ( Site 5902)

    Adazi, Ādaži, 2164

    Study Coordinator, +37126164281

    Recruiting

  • Pauls Stradins Clinical University Hospital ( Site 5903)

    Riga, LV1002

    Study Coordinator, +37167069210

    Recruiting

Other trials in Latvia

Lithuania2 sites, 2 recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Gastroenterology ( Site 6000)

    Kaunas, Kaunas County, 50161

    Study Coordinator, +37037326379

    Recruiting

  • VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS-Department of Clinical Trials and Pharmacology ( Site 6001)

    Vilnius, LT-08661

    Study Coordinator, +37052365000

    Recruiting

Other trials in Lithuania

Dominican Republic1 site, 1 recruiting

  • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2901)

    Santo Domingo, Nacional, 10104

    Study Coordinator, +18097410000

    Recruiting

Other trials in Dominican Republic

Hong Kong1 site, 1 recruiting

  • Queen Mary Hospital ( Site 3300)

    Hksar

    Study Coordinator, +852 2255 3838

    Recruiting

Other trials in Hong Kong

Ireland1 site

  • Beaumont Hospital, Dublin ( Site 5601)

    Dublin, D09 V2NO

    Completed

Other trials in Ireland

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

Read the detailed description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Conditions
Crohn's Disease
Being tested
IV Tulisokibart, SC Tulisokibart, IV Placebo, SC Placebo
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IV TulisokibartDrug

    Also called PRA023, MK-7240

    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously

  • SC TulisokibartDrug

    Also called PRA023, MK-7240

    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

  • IV PlaceboOther

    Placebo matching IV tulisokibart

  • SC PlaceboOther

    Placebo matching SC tulisokibart

Study groups in NCT06430801
Study groupRoleWhat they receive
Study 1: High Dose Induction, High Dose MaintenanceExperimentalParticipants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Receives: Drug: IV Tulisokibart; Drug: SC Tulisokibart
Study 1: High Dose Induction, Low Dose MaintenanceExperimentalParticipants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Receives: Drug: IV Tulisokibart; Drug: SC Tulisokibart; Other: SC Placebo
Study 1: Low Dose Induction, Low Dose MaintenanceExperimentalParticipants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Receives: Drug: IV Tulisokibart; Drug: SC Tulisokibart; Other: SC Placebo
Study 1: PlaceboPlacebo comparatorParticipants receive IV placebo, followed by an SC placebo regimen.
Receives: Drug: IV Tulisokibart; Other: IV Placebo; Other: SC Placebo
Study 1: High Dose ExtensionExperimentalParticipants receive a high dose SC tulisokibart regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Receives: Drug: SC Tulisokibart
Study 1: Low Dose ExtensionExperimentalParticipants receive a low dose SC tulisokibart and placebo regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Receives: Drug: SC Tulisokibart; Other: SC Placebo
Study 2: High Dose InductionExperimentalParticipants receive high dose IV tulisokibart.
Receives: Drug: IV Tulisokibart
Study 2: Low Dose InductionExperimentalParticipants receive low dose IV tulisokibart.
Receives: Drug: IV Tulisokibart; Other: SC Placebo
Study 2: PlaceboPlacebo comparatorParticipants receive IV placebo.
Receives: Drug: IV Tulisokibart; Other: IV Placebo; Other: SC Placebo
Study 2: High Dose ExtensionExperimentalParticipants receive a high dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Receives: Drug: SC Tulisokibart
Study 2: Low Dose ExtensionExperimentalParticipants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Receives: Drug: SC Tulisokibart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52

    The percentage of participants achieving clinical remission, as defined by CDAI score <150 for Study 1 will be presented.

    Measured: Week 52

  2. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

    Measured: Week 52

  3. Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for Study 1 will be presented.

    Measured: Week 52

  4. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score <150 for Study 1 will be presented.

    Measured: Week 12

  5. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

    Measured: Week 12

  6. Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 1 will be presented.

    Measured: Week 12

  7. Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score <150 for Study 2 will be presented.

    Measured: Week 12

  8. Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.

    Measured: Week 12

  9. Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 2 will be presented.

    Measured: Week 12

Secondary outcomes (32)

  1. Study 1: Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 1 will be presented.

    Measured: Up to approximately 52 weeks

  2. Study 1: Number of Participants Who Discontinue Study Intervention due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 1 will be presented.

    Measured: Up to approximately 52 weeks

  3. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

    Measured: Week 12

  4. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score <150 for Study 1 will be presented.

    Measured: Week 12

  5. Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decrease From Baseline of ≥100 Points) at Week 12

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.

    Measured: Week 12

  6. Study 1: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.

    Measured: Baseline and Week 12

  7. Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 12

  8. Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI Score at Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score <150 for Study 1 and Study 2 will be presented.

    Measured: Week 12

  9. Study 1 and 2: Percentage of Participants in Dx+ Subpopulation Achieving Endoscopic Response at Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a ≥50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for Study 1 and Study 2 will be presented.

    Measured: Week 12

  10. Study 1: Percentage of Participants With Clinical Response (Decrease From Baseline at Least 100 Points) or Clinical Remission (<150) per CDAI Score at Week 6

    The percentage of participants achieving clinical response (defined as decrease from baseline of ≥100 points in CDAI) or clinical remission (defined as CDAI <150) for Study 1 will be presented.

    Measured: Week 6

  11. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

    Measured: Week 52

  12. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52

    The percentage of participants achieving clinical remission, as defined by CDAI score <150 for Study 1 will be presented.

    Measured: Week 52

  13. Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decreased From Baseline of ≥100 Points) at Week 52

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.

    Measured: Week 52

  14. Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 52

  15. Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52

    The percentage of participants achieving sustained clinical remission, as defined by CDAI score <150 for Study 1 will be presented.

    Measured: Week 12 and Week 52

  16. Study 1 [US/FDA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52

    The percentage of participants who are in clinical remission as defined by CDAI score <150 and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.

    Measured: Week 52

  17. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.

    Measured: Week 52

  18. Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for Study 1 will be presented.

    Measured: Week 52

  19. Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score and Endoscopic Remission at Week 52

    The percentage of participants achieving clinical remission as defined by CDAI score <150, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for Study 1 will be presented.

    Measured: Week 52

  20. Study 1: Mean Change From Baseline in FACIT-Fatigue Score at Week 52

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.

    Measured: Baseline and Week 52

  21. Study 1 [EU/EMA Only]: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52

    The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224, with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for Study 1 will be presented.

    Measured: Baseline and Week 52

  22. Study 1: Percentage of Participants With Ulcer-Free Endoscopy at Week 52

    The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for Study 1 will be presented.

    Measured: Week 52

  23. Study 2: Number of Participants Who Experienced an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 2 will be presented.

    Measured: Up to approximately 12 weeks

  24. Study 2: Number of Participants Who Discontinue Study Intervention due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 2 will be presented.

    Measured: Up to approximately 12 weeks

  25. Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.

    Measured: Week 12

  26. Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score <150 for Study 2 will be presented.

    Measured: Week 12

  27. Study 2: Percentage of Participants With Clinical Response per CDAI Score (Decreased From Baseline of ≥100 Points) at Week 12

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 2 will be presented.

    Measured: Week 12

  28. Study 2: Mean Change From Baseline in FACIT-Fatigue Score at Week 12

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for Study 2 will be presented.

    Measured: Baseline and Week 12

  29. Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore >1 in any individual variable for Study 2 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 12

  30. Study 2 [EU/EMA Only]: Mean Change From Baseline in IBDQ Score at Week 12

    The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224, with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for Study 2 will be presented.

    Measured: Baseline and Week 12

  31. Study 2: Percentage of Participants With Clinical Response (Decreased From Baseline of ≥100 Points) or Clinical Remission (<150) per CDAI Score at Week 6

    The percentage of participants achieving clinical response (defined as decrease from baseline of ≥100 points in CDAI) or clinical remission (defined as CDAI <150) for Study 2 will be presented.

    Measured: Week 6

  32. Study 2: Percentage of Participants With Ulcer-Free Endoscopy at Week 12

    The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for Study 2 will be presented.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start5 Jun 2024
  3. Primary completion30 Oct 2028 (estimated)
  4. Study completion12 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06430801
Sponsor's protocol ID
7240-008
Other IDs
MK-7240-008, 2023-508636-61-00, U1111-1298-6080, jRCT2031240196, 2023
Status last verified
Oct 2026
First submitted
21 May 2024
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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