AzTrials
AzTrials

Ulcerative ColitisPhase 3NCT06052059

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

A Phase 3 study testing IV Tulisokibart and SC Tulisokibart in people with Ulcerative Colitis, run by Merck Sharp & Dohme LLC at 476 sites in 45 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. 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 according to the… Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Ulcerative Colitis
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
1,109 participants
Where
476 sitesin 45 countries
Study dates
25 Oct 2023to 1 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
  • Has moderately to severely active UC
  • Weight ≥40 kg
  • Satisfies at least 1 of the following criteria:
  • Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
  • Protocol specified corticosteroid dependence
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  • Has been intolerant to 1 or more protocol-specified UC treatments
  • Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
  • Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority
  • A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy

Who cannot join

  • Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
  • Has a current diagnosis of fulminant colitis and/or toxic megacolon
  • Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin)
  • Has a current or impending need for colostomy or ileostomy
  • Has had a total proctocolectomy or partial colectomy
  • Has received fecal microbial transplantation within 4 weeks before randomization
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  • Has had UC exacerbation requiring hospitalization within 2 weeks before screening
  • Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
  • Has any active or serious infections without resolution after adequate treatment
  • Has had cytomegalovirus infection that resolved less than 4 weeks before screening
  • Has a transplanted organ which requires continued immunosuppression
  • Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
  • Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
  • Has confirmed or suspected COVID-19
  • Has a history of drug or alcohol abuse within 6 months prior to screening
  • Has had major surgery within 3 months before screening or has a major surgery planned during the study
  • Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
  • Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
  • Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
  • Has received protocol-specified prohibited medications
  • Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Trial locations and contacts

476 sites in 45 countries.

476 sites in 45 countries

United States76 sites

  • Clinnova Research ( Site 3803)

    Anaheim, California, 92805

  • University of Michigan ( Site 0143)

    Ann Arbor, Michigan, 48109

  • Emory University School of Medicine ( Site 3818)

    Atlanta, Georgia, 30322

  • Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)

    Atlanta, Georgia, 30342

  • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)

    Aurora, Colorado, 80045

  • Baton Rouge General Medical Center - Bluebonnet ( Site 0112)

    Baton Rouge, Louisiana, 70809

  • Washington Gastroenterology - Bellevue ( Site 3844)

    Bellevue, Washington, 98004-4631

  • Walter Reed National Military Medical Center ( Site 0121)

    Bethesda, Maryland, 20889

  • Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)

    Boston, Massachusetts, 02114

  • Connecticut Clinical Research Institute ( Site 0126)

    Bristol, Connecticut, 06010

  • University of North Carolina Medical Center ( Site 0140)

    Chapel Hill, North Carolina, 27514

  • University of Chicago Medical Center ( Site 0134)

    Chicago, Illinois, 60637

  • Gastroenterology Consultants of Clearwater ( Site 0152)

    Clearwater, Florida, 33756

  • Clinical Research Institute of Michigan, LLC ( Site 0108)

    Clinton Township, Michigan, 48038

  • Iowa Digestive Disease Center ( Site 0123)

    Clive, Iowa, 50325

  • Peak Gastroenterology Associates ( Site 0116)

    Colorado Springs, Colorado, 80907

  • Southern California Research Center ( Site 3828)

    Coronado, California, 92118

  • Atlanta Center for Gastroenterology ( Site 0155)

    Decatur, Georgia, 30033

  • Digestive Health Specialists ( Site 0135)

    Dothan, Alabama, 36301

  • South Denver Gastroenterology, PC ( Site 3849)

    Englewood, Colorado, 80113

  • IMC-Gulf Coast Gastroenterology ( Site 0157)

    Fairhope, Alabama, 36532

  • Michigan Center of Medical Research (MICHMER) ( Site 3850)

    Farmington Hills, Michigan, 48334

  • University of Florida College of Medicine-Gastroenterology ( Site 3821)

    Gainesville, Florida, 32610

  • GI Alliance - Garland ( Site 0109)

    Garland, Texas, 75044

  • Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)

    Glen Burnie, Maryland, 21061

  • GI Alliance - Glenview ( Site 0168)

    Glenview, Illinois, 60026

  • Carolina Digestive Diseases and Endoscopy Center ( Site 3809)

    Greenville, North Carolina, 27834

  • GI ALLIANCE - GURNEE ( Site 0107)

    Gurnee, Illinois, 60031

  • Medical Research Center of Connecticut ( Site 0151)

    Hamden, Connecticut, 06518

  • Baylor College of Medicine Medical Center ( Site 3812)

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)

    Houston, Texas, 77030

  • Clinical Trial Network ( Site 3819)

    Houston, Texas, 77074

  • Nature Coast Clinical Research - Inverness ( Site 3806)

    Inverness, Florida, 34452

  • Central Florida Gastro Research ( Site 0124)

    Kissimmee, Florida, 34741

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)

    La Jolla, California, 92037

  • BVL Research - Kansas ( Site 3847)

    Liberty, Missouri, 64068

  • Research Solutions of Arizona ( Site 3816)

    Litchfield Park, Arizona, 85340

  • Rocky Mountain Gastroenterology/Topography Health ( Site 3838)

    Littleton, Colorado, 80120

  • Cedars-Sinai Medical Center ( Site 0119)

    Los Angeles, California, 90048

  • University of Louisville Hospital-Clinical Trials Unit ( Site 0165)

    Louisville, Kentucky, 40202

  • GI Alliance - Lubbock ( Site 0167)

    Lubbock, Texas, 79410

  • Caprock Gastro Research ( Site 0101)

    Lubbock, Texas, 79424

  • GI Alliance: Mansfield ( Site 0161)

    Mansfield, Texas, 76063

  • Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)

    Miami, Florida, 33134

  • Circuit Clinical /Middletown Medical PC ( Site 3831)

    Middletown, New York, 10940

  • Medical College of Wisconsin ( Site 0141)

    Milwaukee, Wisconsin, 53226

  • Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)

    Nashville, Tennessee, 37204

  • Quality Medical Research ( Site 3807)

    Nashville, Tennessee, 37211

  • Yale University School of Medicine-Digestive Disease ( Site 0163)

    New Haven, Connecticut, 06510

  • Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154)

    New Orleans, Louisiana, 70112

  • NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846)

    New York, New York, 10016

  • Lenox Hill Hospital ( Site 0128)

    New York, New York, 10075

  • New York Gastroenterology Associates ( Site 0159)

    New York, New York, 10128

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)

    Orange, California, 92868

  • Gastroenterology Associates of Orangeburg ( Site 0149)

    Orangeburg, South Carolina, 29118

  • Orlando Health ( Site 0145)

    Orlando, Florida, 32806

  • Hospital of the University of Pennsylvania ( Site 0170)

    Philadelphia, Pennsylvania, 19104

  • University Gastroenterology ( Site 0164)

    Providence, Rhode Island, 02904

  • Richmond VA Medical Center ( Site 3845)

    Richmond, Virginia, 23249

  • Mayo Clinic in Rochester, Minnesota ( Site 0147)

    Rochester, Minnesota, 55905

  • CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122)

    San Antonio, Texas, 78212

  • Southern Star Research Institute ( Site 0106)

    San Antonio, Texas, 78229

  • GI Alliance - San Marcos ( Site 0130)

    San Marcos, Texas, 78666

  • One of a Kind Clinical Research Center ( Site 3852)

    Scottsdale, Arizona, 85258

  • University of Washington Medical Center - Montlake ( Site 0137)

    Seattle, Washington, 98195

  • GI Alliance - Southlake ( Site 0104)

    Southlake, Texas, 76092-9167

  • Washington University School of Medicine ( Site 0129)

    St Louis, Missouri, 63110

  • GI Alliance - Sun City ( Site 0103)

    Sun City, Arizona, 85351

  • Washington Gastroenterology - Tacoma ( Site 0102)

    Tacoma, Washington, 98405

  • USF Health ( Site 0169)

    Tampa, Florida, 33612

  • Clinical Research Institute of Michigan, LLC ( Site 0150)

    Troy, Michigan, 48098

  • Tyler Research Institute ( Site 0105)

    Tyler, Texas, 75701

  • Emerson Clinical Research Institute ( Site 3820)

    Washington D.C., District of Columbia, 20009

  • Texas Digestive Disease Consultants ( Site 0136)

    Webster, Texas, 77598

  • Velocity Clinical Research, Salt Lake City ( Site 3801)

    West Jordan, Utah, 84088

  • Huron Gastroenterology ( Site 3836)

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan54 sites

  • Tokatsu Tsujinaka Hospital ( Site 2832)

    Abiko, Chiba, 270-1168

  • Asahikawa City Hospital ( Site 2840)

    Asahikawa, Hokkaido, 070-8610

  • Asahikawa Medical University Hospital ( Site 2815)

    Asahikawa, Hokkaido, 078-8510

  • Institute of Science Tokyo Hospital ( Site 2827)

    Bunkyō, Tokyo, 113-8519

  • Ginza Central Clinic ( Site 2824)

    Chūō, Tokyo, 104-0061

  • Sai Gastroenterology/Proctology Clinic ( Site 2814)

    Fujiidera, Osaka, 583-0027

  • Fukui Prefectural Hospital ( Site 2844)

    Fukui, 910-0846

  • Fukuoka University Hospital ( Site 2818)

    Fukuoka, 814-0180

  • National Hospital Organization Fukuyama Medical Center ( Site 2831)

    Fukuyama, Hiroshima, 720-0825

  • Hamamatsu University Hospital ( Site 2874)

    Hamamatsu, Shizuoka, 431-3192

  • Matsuda Hospital ( Site 2826)

    Hamamatsu, Shizuoka, 432-8061

  • Kansai Medical University Hospital ( Site 2823)

    Hirakata, Osaka, 573-1191

  • Hiroshima University Hospital ( Site 2845)

    Hiroshima, 734-8551

  • Hitachi General Hospital ( Site 2856)

    Hitachi, Ibaraki, 317-0077

  • Kagoshima University Hospital ( Site 2848)

    Kagoshima, 890-8520

  • Kagoshima IBD Gastroenterology Clinic ( Site 2821)

    Kagoshima, 892-0843

  • Gokeikai Ofuna Chuo Hospital ( Site 2801)

    Kamakura, Kanagawa, 247-0056

  • Ishikawa Prefectural Central Hospital ( Site 2835)

    Kanazawa, Ishikawa-ken, 920-8530

  • Kanazawa University Hospital ( Site 2839)

    Kanazawa, Ishikawa-ken, 920-8641

  • Tsujinaka Hospital - Kashiwanoha ( Site 2802)

    Kashiwa, Chiba, 277-0871

  • St. Marianna University Hospital ( Site 2852)

    Kawasaki, Kanagawa, 216-8511

  • Kitakyushu Municipal Medical Center ( Site 2873)

    Kitakyushu, Fukuoka, 802-8561

  • Yamanashi Prefectural Central Hospital ( Site 2836)

    Kofu, Yamanashi, 400-8506

  • Kurume University Hospital ( Site 2846)

    Kurume, Fukuoka, 830-0011

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 2819)

    Kyoto, 602-8566

  • National Hospital Organization Kyoto Medical Center ( Site 2813)

    Kyoto, 612-8555

  • Gunma University Hospital ( Site 2850)

    Maebashi, Gunma, 371-8511

  • Ehime Prefectural Central Hospital ( Site 2868)

    Matsuyama, Ehime, 790-0024

  • The Jikei University Hospital ( Site 2843)

    Minato, Tokyo, 105-8471

  • Toranomon Hospital ( Site 2828)

    Minato-ku, Tokyo, 105-8470

  • Kitasato University Kitasato Institute Hospital ( Site 2817)

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital ( Site 2804)

    Mitaka-shi, Tokyo, 181-8611

  • Iwate Medical University Uchimaru Medical Center ( Site 2833)

    Morioka, Iwate, 020-8505

  • Aichi Medical University Hospital ( Site 2841)

    Nagakute, Aichi-ken, 480-1195

  • Hyogo Medical University Hospital ( Site 2830)

    Nishinomiya, Hyōgo, 663-8501

  • Ishida Clinic of IBD and Gastroenterology ( Site 2820)

    Ōita, 870-0823

  • Okayama University Hospital ( Site 2870)

    Okayama, 700-8558

  • Infusion Clinic ( Site 2806)

    Osaka, 530-0011

  • National Hospital Organization Osaka National Hospital ( Site 2869)

    Osaka, 540-0006

  • Saga University Hospital ( Site 2812)

    Saga, 849-8501

  • Tokitokai Tokito Clinic Coloproctology Center ( Site 2811)

    Saitama, 336-0963

  • Toho University Sakura Medical Center ( Site 2805)

    Sakura, Chiba, 285-8741

  • Sapporo Tokushukai Hospital ( Site 2808)

    Sapporo, Hokkaido, 004-0041

  • Sapporo Medical University Hospital ( Site 2829)

    Sapporo, Hokkaido, 060-8543

  • Medical Corporation Sapporo IBD Clinic ( Site 2842)

    Sapporo, Hokkaido, 064-0919

  • Sapporohigashi Tokushukai Hospital ( Site 2860)

    Sapporo, Hokkaido, 065-0033

  • National Hospital Organization Shizuoka Medical Center ( Site 2837)

    Shimizu, Shizuoka, 411-8611

  • NTT Medical Center Tokyo ( Site 2834)

    Shinagawa-ku, Tokyo, 141-0022

  • Tokyo Yamate Medical Center ( Site 2803)

    Tokyo, 169-0073

  • Toyama Prefectural Central Hospital ( Site 2807)

    Toyama, 930-0975

  • Mie University Hospital ( Site 2838)

    Tsu, Mie-ken, 514-8507

  • Yamagata University Hospital ( Site 2849)

    Yamagata, 990-9585

  • Matsushima Hospital ( Site 2822)

    Yokohama, Kanagawa, 220-0041

  • Yokohama City University Medical Center ( Site 2865)

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

China38 sites

  • Beijing Friendship Hospital Affiliate of Capital University ( Site 3923)

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital ( Site 3909)

    Beijing, Beijing Municipality, 100191

  • Beijing Luhe Hospital Capital Medical University ( Site 3911)

    Beijing, Beijing Municipality, 101199

  • Binzhou Medical University Hospital ( Site 3953)

    Binzhou, Shandong, 256603

  • The Second Xiangya Hospital of Central South University ( Site 3930)

    Changsha, Hunan, 410011

  • Changzhou No.2 People's Hospital ( Site 3950)

    Changzhou, Jiangsu, 213100

  • West China Hospital, Sichuan University ( Site 3951)

    Chengdu, Sichuan, 610041

  • Chongqing University Three Gorges Hospital ( Site 3928)

    Chongqing, Chongqing Municipality, 404000

  • Dongguan People's Hospital-Gastroenterology department ( Site 3944)

    Dongguan, Guangdong, 523059

  • The First Affiliated Hospital Of Fujian Medical University ( Site 3904)

    Fuzhou, Fujian, 350005

  • Guangzhou Medical University 2nd Hospital ( Site 3908)

    Guangzhou, Guangdong, 510260

  • Southern Medical University Nanfang Hospital-Gastroenterology ( Site 3914)

    Guangzhou, Guangdong, 510515

  • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3906)

    Guangzhou, Guangdong, 510655

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3916)

    Hangzhou, Zhejiang, 310000

  • The First Affiliated Hospital of Anhui Medical University ( Site 3957)

    Hefei, Anhui, 230022

  • Anhui Provincial Hospital ( Site 3947)

    Hefei, Anhui, 230036

  • Huizhou Municipal Central Hospital ( Site 3917)

    Huizhou, Guangdong, 516001

  • First Affiliated Hospital of Kunming Medical University ( Site 3925)

    Kunming, Yunnan, 650032

  • The First Affiliated Hospital of Nanchang University ( Site 3926)

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3900)

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University ( Site 3919)

    Nanjing, Jiangsu, 210009

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine-Gastroneterology ( Site 3903)

    Shanghai, Shanghai Municipality, 200025

  • Shanghai East Hospital ( Site 3922)

    Shanghai, Shanghai Municipality, 200120

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 3915)

    Shanghai, Shanghai Municipality

  • Yuebei People's Hospital Guangdong ( Site 3948)

    Shaoguan, Guangdong, 512026

  • The University of Hong Kong-Shenzhen Hospital ( Site 3955)

    Shenzhen, Guangdong, 518053

  • Shenzhen Hospital of Southern Medical University ( Site 3905)

    Shenzhen, Guangdong, 518110

  • The Second Hospital of Hebei Medical University ( Site 3934)

    Shijiazhuang, Hebei, 050000

  • Taihe Hospital ( Site 3941)

    Shiyan, Hubei, 442099

  • Taian City Central Hospital-gastroenterology department ( Site 3946)

    Taian, Shandong, 271000

  • Tianjin Medical University General Hospital ( Site 3945)

    Tianjin, Tianjin Municipality, 300052

  • The First Teaching Hospital of Xinjiang Medical University. ( Site 3937)

    Ürümqi, Xinjiang, 830054

  • The Central Hospital of Wuhan ( Site 3939)

    Wuhan, Hubei, 430014

  • Renmin Hospital of Wuhan University ( Site 3912)

    Wuhan, Hubei, 430060

  • Wuxi People's Hospital ( Site 3920)

    Wuxi, Jiangsu, 214023

  • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3929)

    Xi'an, Shaanxi, 710038

  • The First Affiliated hospital of Xiamen University-Gastroenterology ( Site 3954)

    Xiamen, Fujian, 361003

  • The Second Affiliated Hospital of Zhengzhou University ( Site 3935)

    Zhengzhou, Henan, 450014

Other trials in China

Poland21 sites

  • M2M Med ( Site 1526)

    Chorzów, Silesian Voivodeship, 41-500

  • Vita Longa Sp. Zoo ( Site 1527)

    Katowice, Silesian Voivodeship, 40-748

  • Topolowa Medicenter Ryszawa & Wspolnicy sp.j. ( Site 1500)

    Krakow, Lesser Poland Voivodeship, 31-506

  • PROMED P. LACH R. GLOWACKI SP. J. ( Site 1529)

    Krakow, Lesser Poland Voivodeship, 31-513

  • Med-Gastr Sp. z o.o., sp.k ( Site 1515)

    Lodz, Łódź Voivodeship, 91-034

  • AmiCare Centrum Medyczne - Zgierska ( Site 1517)

    Lodz, Łódź Voivodeship, 91-495

  • Allmedica ( Site 1508)

    Nowy Targ, Lesser Poland Voivodeship, 34-400

  • Pratia Poznan ( Site 1530)

    Poznan, Greater Poland Voivodeship, 60-192

  • Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1523)

    Poznan, Greater Poland Voivodeship, 60-324

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1502)

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Sonomed Sp. z o. o. ( Site 1516)

    Szczecin, West Pomeranian Voivodeship, 71-685

  • Gastromed Sp. z o. o. ( Site 1513)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • NZOZ FOR MED sp. z o.o. ( Site 1511)

    Wadowice, Lesser Poland Voivodeship, 34-100

  • Centrum Zdrowia MDM ( Site 1512)

    Warsaw, Masovian Voivodeship, 00-189

  • ETG Warszawa ( Site 1525)

    Warsaw, Masovian Voivodeship, 02-677

  • Vivamed Sp. z o.o. ( Site 1510)

    Warsaw, Masovian Voivodeship, 03-580

  • WIP Warsaw IBD Point Profesor Kierkuś ( Site 1503)

    Warsaw, Masovian Voivodeship, 04-501

  • Planetmed ( Site 1506)

    Wroclaw, Lower Silesian Voivodeship, 52-210

  • Vistamed & Vertigo Sp. z o.o. ( Site 1528)

    Wroclaw, Lower Silesian Voivodeship, 53-149

  • Melita Medical ( Site 1519)

    Wroclaw, Lower Silesian Voivodeship, 53-611

  • Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 1505)

    Wroclaw, Lower Silesian Voivodeship, 54-239

Other trials in Poland

France18 sites

  • CHU d'Amiens-Picardie - Hôpital Sud-Hepato-gastroentérology ( Site 0712)

    Amiens, Somme, 80054

  • CHU Besançon ( Site 0710)

    Besançon, Doubs, 25000

  • Hopital Beaujon ( Site 0716)

    Clichy, Hauts-de-Seine, 92110

  • Hopital Henri Mondor ( Site 0717)

    Créteil, Val-de-Marne, 94010

  • Clinique des Cèdres ( Site 0719)

    Échirolles, Isere, 38130

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0715)

    Le Kremlin-Bicêtre, Val-de-Marne, 94270

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0714)

    Marseille, Bouches-du-Rhone, 13915

  • CHU SAINT ELOI ( Site 0711)

    Montpellier, Languedoc-Roussillon, 34295

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0701)

    Nantes, Pays de la Loire Region, 44093

  • CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0709)

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

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706)

    Nice, Alpes-Maritimes, 06202

  • C.H.U. de Nimes. Hopital Caremeau ( Site 0718)

    Nîmes, Gard, 30029

  • Hôpital Saint Antoine ( Site 0703)

    Paris, 75012

  • Hôpital Saint-Louis ( Site 0702)

    Paris, 75475

  • CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0700)

    Pessac, Aquitaine, 33600

  • centre hospitalier lyon sud ( Site 0707)

    Pierre-Bénite, Rhone, 69310

  • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0705)

    Reims, Champagne-Ardenne, 51092

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0708)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Canada17 sites

  • Barrie GI Associates ( Site 0012)

    Barrie, Ontario, L4M 7G1

  • Heritage Medical Research Clinic ( Site 0004)

    Calgary, Alberta, T2N 4Z6

  • Gastroenterology and internal medicine research institute ( Site 0010)

    Edmonton, Alberta, T5R 1W2

  • Private Practice - Dr. Bruce Musgrave ( Site 0011)

    Kentville, Nova Scotia, B4N 0A3

  • Prairie Institute of Liver and Luminal Advanced Research ( Site 0013)

    Lethbridge, Alberta, T1J 4G9

  • Centre Intégré de Santé et Service Sociaux de Chaudière-Appalaches ( Site 0015)

    Lévis, Quebec, G6V 3Z1

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

    London, Ontario, N6A 5A5

  • London Health Sciences Centre ( Site 0007)

    London, Ontario, N6A 5W9

  • West GTA Research Inc. ( Site 0017)

    Mississauga, Ontario, L5M 2S4

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0018)

    Montreal, Quebec, H2X 0C1

  • Montreal General Hospital ( Site 0003)

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc. ( Site 0019)

    New Westminster, British Columbia, V3L 3W4

  • ABP Research Services Corp. ( Site 0016)

    Ontario, Ontario, L6L 5L7

  • Diex Recherche Quebec ( Site 0008)

    Québec, Quebec, G1V 4T3

  • Toronto Immune & Digestive Health Institute ( Site 0005)

    Toronto, Ontario, M6A 3B4

  • G.I.R.I. GI Research Institute Foundation ( Site 0001)

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates ( Site 0006)

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Italy16 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1208)

    Bologna, 40138

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1202)

    Milan, Lombardy, 20122

  • ASST Fatebenefratelli Sacco-UOC Gastroenterologia ( Site 1200)

    Milan, 20100

  • Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1205)

    Milan, 20132

  • Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207)

    Monserrato, Cagliari, 09042

  • A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1217)

    Naples, Napoli, 80131

  • Ospedale Sacro Cuore Don G. Calabria ( Site 1212)

    Negrar, Verona, 37024

  • Azienda Ospedale - Università Padova-Surgery Oncology and Gastroenterology ( Site 1211)

    Padova, Veneto, 35128

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1210)

    Palermo, Sicily, 90146

  • Fondazione IRCCS Policlinico San Matteo-General Medicine ( Site 1206)

    Pavia, 27100

  • Ospedale Di Circolo-U.O.C. di Gastroenterologia ed Endoscopia Digestiva ( Site 1216)

    Rho, Milano, 20017

  • Fondazione Policlinico Tor Vergata ( Site 1209)

    Rome, Lazio, 00133

  • Azienda Ospedaliera San Camillo Forlanini ( Site 1204)

    Rome, Roma, 00149

  • Fatebenefratelli Isola Tiberina - Gemelli Isola ( Site 1214)

    Rome, Roma, 00186

  • Istituto Clinico Humanitas-IBD center ( Site 1201)

    Rozzano, Lombardy, 20089

  • IRCCS Casa Sollievo della Sofferenza ( Site 1213)

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

Germany14 sites

  • Charité Campus Virchow-Klinikum ( Site 0906)

    Berlin, 13353

  • Universitätsklinikum Brandenburg an der Havel ( Site 0905)

    Brandenburg, 14770

  • MVZ Dachau ( Site 0918)

    Dachau, Bavaria, 85221

  • Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0916)

    Duisburg, North Rhine-Westphalia, 47055

  • Agaplesion Markus Krankenhaus ( Site 0904)

    Frankfurt am Main, Hesse

  • Medizinische Hochschule Hannover ( Site 0913)

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0903)

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Leipzig ( Site 0909)

    Leipzig, Saxony, 04103

  • St. Marien und St. Annastift Krankenhaus ( Site 0901)

    Ludwighafen Am Rhein, Rhineland-Palatinate, 67067

  • Klinikum Lüneburg ( Site 0908)

    Lüneburg, Lower Saxony, 21339

  • Gastroenterologische Gemeinschaftspraxis Minden ( Site 0911)

    Minden, North Rhine-Westphalia, 32423

  • Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II ( Site 0907)

    Munich, Bavaria, 81337

  • Medizinisches Versorgungszentrum Portal 10 ( Site 0914)

    Münster, North Rhine-Westphalia, 48155

  • Universitaetsklinikum Ulm. ( Site 0902)

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

South Korea14 sites

  • Dong-A University Hospital ( Site 3010)

    Busan, Pusan-Kwangyokshi, 49201

  • Yeungnam University Medical Center ( Site 3004)

    Daegu, Taegu-Kwangyokshi, 42415

  • The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011)

    Daejeon, Taejon-Kwangyokshi, 34943

  • Chung-Ang University Hospital ( Site 3008)

    Dongjak-gu, Seoul, 06973

  • Inje University Haeundae Paik Hospital ( Site 3009)

    Haeundae-gu, Pusan-Kwangyokshi, 48108

  • Kyung Hee University Hospital ( Site 3013)

    Seoul, 02447

  • Seoul National University Hospital ( Site 3005)

    Seoul, 03080

  • Kangbuk Samsung Hospital-Internal Medicine ( Site 3002)

    Seoul, 03181

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012)

    Seoul, 03312

  • Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000)

    Seoul, 03722

  • Asan Medical Center ( Site 3007)

    Seoul, 05505

  • Samsung Medical Center ( Site 3001)

    Seoul, 06351

  • The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006)

    Suwon, Kyonggi-do, 16247

  • Wonju Severance Christian Hospital-Internal Medicine ( Site 3003)

    Wŏnju, Kang-won-do, 26426

Other trials in South Korea

Spain11 sites

  • Hospital Germans Trias i Pujol ( Site 3413)

    Badalona, Barcelona, 08916

  • Hospital Universitario de Fuenlabrada-Digestive ( Site 3415)

    Fuenlabrada, Madrid, 28942

  • Hospital Galdakao-Usansolo ( Site 3409)

    Galdakao-Usansolo, Bizkaia, 48960

  • Hospital La Princesa-Gastroenterology ( Site 3411)

    Madrid, Madrid, Comunidad de, 28006

  • Fundación Jimenez Diaz ( Site 3420)

    Madrid, Madrid, Comunidad de, 28040

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Aparato Digestivo ( Site 3403)

    Madrid, 28028

  • Hospital Universitario La Paz-Unidad de Enfermedad Inflamatoria Intestinal ( Site 3402)

    Madrid, 28046

  • Hospital Universitari Mutua Terrassa ( Site 3416)

    Terrassa, Barcelona, 08221

  • Hospital Universitario de Torrejon ( Site 3417)

    Torrejón de Ardoz, Madrid, Comunidad de, 28850

  • Hospital Universitari i Politecnic La Fe-Enfermedad Inflamatoria Intestinal ( Site 3405)

    Valencia, Valencia, 46026

  • HOSPITAL CLINICO DE VALENCIA ( Site 3406)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Hungary10 sites

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1007)

    Békéscsaba, Bekescsaba, 5600

  • Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1009)

    Budapest, 1036

  • Semmelweis Egyetem ( Site 1006)

    Budapest, 1085

  • Pannónia Magánorvosi Centrum ( Site 1004)

    Budapest, 1136

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1012)

    Eger, Heves County, 3300

  • Gyöngyösi Bugát Pál Kórház ( Site 1011)

    Gyöngyös, Heves County, 3200

  • Csőszi Endoszkópos KFT ( Site 1001)

    Kecskemét, Bács-Kiskun county, 6000

  • Mohácsi Kórház ( Site 1008)

    Mohács, Baranya, 7700

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1010)

    Tatabánya, Komárom-Esztergom, 2800

  • VeszLife Magánklinika ( Site 1002)

    Veszprém, Veszprém megye, 8200

Other trials in Hungary

Ukraine10 sites

  • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 4115)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

  • Center of Family Medicine Plus-Treatment Prevention Unit ( Site 4103)

    Kyiv, Kyivska Oblast, 04210

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 4100)

    Kyiv, 03057

  • Dobrobut Medical Center ( Site 4101)

    Kyiv, 03151

  • Medical Center of Private Enterprise "Sygma" ( Site 4108)

    Kyiv, 04116

  • Municipal Enterprise "Volyn Regional Clinical Hospital" of V-surgery department (abdominal, colopro ( Site 4113)

    Lutsk, Volyn Oblast, 43005

  • Communal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"-proctology ( Site 4109)

    Lviv, Lviv Oblast, 79010

  • Limited liability company "Medical center Health Clinic"-Gastroenterology, Hepatology and Endocrino ( Site 4107)

    Vinnytsia, Vinnytsia Oblast, 21009

  • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical -Gastroenterology department ( Site 4114)

    Vinnytsia, Vinnytsia Oblast, 21018

  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 4111)

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

United Kingdom10 sites

  • Southmead Hospital ( Site 2004)

    Bristol, Bristol, City of, BS10 5NB

  • Addenbrooke's Hospital ( Site 2005)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Doncaster Royal Infirmary ( Site 2006)

    Doncaster, England, DN2 5LT

  • Royal Devon & Exeter Hospital-IBD Research Group ( Site 2001)

    Exeter, Devon, EX2 5DW

  • Huddersfield Royal Infirmary ( Site 2010)

    Huddersfield, England, HD3 3EA

  • Whipps Cross University Hospital-Clinical Research Unit ( Site 2000)

    London, England, E11 1NR

  • St. George's Hospital ( Site 2007)

    London, England, SW17 0QT

  • University College London Hospital-Clinical Research Facility ( Site 2002)

    London, London, City of, NW1 2PG

  • Southampton General Hospital-Gastroenterology ( Site 2003)

    Southampton, Hampshire, SO16 0YD

  • Walsall Manor Hospital ( Site 2009)

    West Midlands, Walsall, WS2 9PS

Other trials in United Kingdom

Bulgaria9 sites

  • Medconsult Pleven ( Site 0410)

    Pleven, 5800

  • DKC V - Plovdiv ( Site 0402)

    Plovdiv, 4023

  • MC Rusemed ( Site 0408)

    Rousse, 7013

  • MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403)

    Sliven, 8800

  • "Diagnostic - Consultative Center XX - Sofia" EOOD ( Site 0407)

    Sofia, Sofia (stolitsa), 1618

  • Diagnostic Consultative Center 22 - Sofia ( Site 0401)

    Sofia, 1113

  • 4th MHAT ( Site 0409)

    Sofia, 1606

  • Medica Plus Medical Center ( Site 0404)

    Veliko Tarnovo, 5000

  • MC Velingrad 2017 EOOD ( Site 0406)

    Velingrad, Pazardzhik, 4600

Other trials in Bulgaria

Israel9 sites

  • Emek Medical Center ( Site 1106)

    Afula, 1834111

  • Barzilai Medical Center ( Site 1109)

    Ashkelon, 7830604

  • Rambam Health Care Campus ( Site 1101)

    Haifa, 3109601

  • Bnai Zion Medical Center ( Site 1103)

    Haifa, 3339419

  • Edith Wolfson Medical Center ( Site 1104)

    Holon, 5810001

  • Shaare Zedek Medical Center ( Site 1108)

    Jerusalem, 9103102

  • Meir Medical Center. ( Site 1102)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 1107)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 1100)

    Ramat Gan, 5265601

Other trials in Israel

Mexico9 sites

  • ICARO Investigaciones en Medicina ( Site 2405)

    Chihuahua City, 31000

  • PanAmerican Clinical Research - Guadalajara ( Site 2400)

    Guadalajara, Jalisco, 44670

  • Morales Vargas Centro de Investigacion ( Site 2411)

    León, Guanajuato, 37000

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2407)

    Mérida, Yucatán, 97130

  • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 2406)

    Mexico City, Mexico City, 14050

  • Centro de Investigación y Gastroenterología - S.C. ( Site 2410)

    Mexico City, 03330

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2409)

    Monterrey, Nuevo León, 64460

  • Oaxaca Site Management Organization S.C. ( Site 2404)

    Oaxaca City, 68000

  • Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 2403)

    Tlajumulco de Zuniga, Jalisco, 45640

Other trials in Mexico

Netherlands9 sites

  • Onze Lieve Vrouwe Gasthuis ( Site 1405)

    Amsterdam, North Holland, 1051 AC

  • Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1400)

    Amsterdam, North Holland, 1081 HZ

  • Deventer Ziekenhuis ( Site 1411)

    Deventer, Overijssel, 7416 SE

  • Radboudumc ( Site 1402)

    Nijmegen, Gelderland, 6525 GA

  • Erasmus Medisch Centrum ( Site 1410)

    Rotterdam, South Holland, 3015 GD

  • Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1406)

    Rotterdam, South Holland, 3045 PM

  • ETZ Elisabeth-Department of Gastroenterology and Hepatology ( Site 1403)

    Tilburg, North Brabant, 5022 GC

  • Ziekenhuis Bernhoven-Researchbureau ( Site 1401)

    Uden, North Brabant, 5406 PT

  • Universitair Medisch Centrum Utrecht ( Site 1404)

    Utrecht, 3584 CX

Other trials in Netherlands

Turkey (Türkiye)9 sites

  • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 3507)

    Ankara, 06230

  • Hacettepe Universite Hastaneleri ( Site 3500)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 3501)

    Ankara, 06800

  • Antalya Egitim ve Arastirma Hastanesi ( Site 3508)

    Antalya, 07100

  • Trakya University Medical Faculty Hospital ( Site 3510)

    Edirne, 22030

  • Eskisehir Osmangazi University Faculty of Medicine ( Site 3512)

    Eskişehir, 26040

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 3505)

    Istanbul, 34899

  • Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503)

    Istanbul- Fatih, Istanbul, 34098

  • Kocaeli University Medical Faculty Hospital ( Site 3509)

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Australia8 sites

  • Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504)

    Adelaide, South Australia, 5000

  • Royal Brisbane and Women's Hospital ( Site 2500)

    Brisbane, Queensland, 4029

  • Mater Misericordiae Limited-Gastroenterology ( Site 2506)

    Brisbane, Queensland, 4101

  • Monash Health-Gastroenterology ( Site 2505)

    Clayton, Victoria, 3168

  • Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)

    Kingswood, New South Wales, 2747

  • The Alfred Hospital-Gastroenterology ( Site 2503)

    Melbourne, Victoria, 3004

  • St Vincent's Hospital ( Site 2510)

    Melbourne, Victoria, 3065

  • Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508)

    Sydney, New South Wales, 2139

Other trials in Australia

Chile8 sites

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203)

    Santiago, Region M. de Santiago, 7500653

  • FALP-UIDO ( Site 2208)

    Santiago, Region M. de Santiago, 7500921

  • Clínica Universidad de Los Andes ( Site 2202)

    Santiago, Region M. de Santiago, 7620157

  • Clínica Alemana de Santiago ( Site 2209)

    Santiago, Region M. de Santiago, 7650568

  • Clínica MEDS La Dehesa ( Site 2207)

    Santiago, Region M. de Santiago, 7691236

  • CECIM ( Site 2200)

    Santiago, Region M. de Santiago, 8320000

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 2205)

    Santiago, Region M. de Santiago, 8330034

  • Clinical Research Chile SpA ( Site 2201)

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Romania8 sites

  • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606)

    Bucharest, Bucharest, 013823

  • Monza Ares SRL ( Site 1604)

    Bucharest, Bucharest, 021967

  • Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1608)

    Bucharest, Bucharest, 022328

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca-Gastroenterology ( Site 1605)

    Cluj-Napoca, Cluj, 400006

  • GastroMed ( Site 1609)

    Cluj-Napoca, Cluj, 400394

  • Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1607)

    Târgu Mureş, Mureș County, 540205

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L-Gastroenterology ( Site 1601)

    Timișoara, Timiș County, 300002

  • Asociatia Oncohelp ( Site 1610)

    Timișoara, Timiș County, 300239

Other trials in Romania

Slovakia8 sites

  • Cliniq s.r.o. ( Site 1800)

    Bratislava, Bratislava Region, 811 09

  • Breznianske centrum gastroenterologie ( Site 1806)

    Brezno, Banská Bystrica Region, 977 01

  • ENDOMED ( Site 1801)

    Košice, Košice Region, 040 13

  • KM Management ( Site 1804)

    Nitra, Nitra Region, 949 01

  • GASTRO I ( Site 1807)

    Prešov, Presov, 080 01

  • Gastro LM ( Site 1808)

    Prešov, Presov, 080 01

  • Accout Center ( Site 1805)

    Šahy, Nitra Region, 936 01

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 1802)

    Slovakia, Banská Bystrica Region, 974 01

Other trials in Slovakia

Colombia7 sites

  • Clinica de la Costa S.A.S. ( Site 2305)

    Barranquilla, Atlántico, 080020

  • Fundacion Santa Fe de Bogota ( Site 2316)

    Bogota, Cundinamarca, 110111

  • Fundación Valle del Lili ( Site 2307)

    Cali, Valle del Cauca Department, 760032

  • Clínica las Américas ( Site 2318)

    Medellín, Antioquia, 050034

  • Clinica Medellin S.A ( Site 2317)

    Medellín, Antioquia

  • Oncologos del Occidente ( Site 2310)

    Pereira, Risaralda Department, 660001

  • Clinica Somer-Unidad de Investigacion y Docencia ( Site 2303)

    Rionegro, Antioquia, 054040

Other trials in Colombia

Brazil6 sites

  • L2IP - Instituto de Pesquisas Clínicas ( Site 5104)

    Brasília, Federal District, 70200-730

  • Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100)

    Juiz de Fora, Minas Gerais, 36025-290

  • Hospital Moinhos de Vento ( Site 5108)

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Pesquisare Saude ( Site 5112)

    Santo André, São Paulo, 09080-110

  • Centro de Pesquisa Kaiser - CEPEK ( Site 5103)

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

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107)

    São José do Rio Preto, São Paulo, 15090-160

Other trials in Brazil

Croatia6 sites

  • Poliklinika Borzan ( Site 0500)

    Osijek, County of Osijek-Baranja, 31000

  • Klinički Bolnički Centar Split ( Site 0503)

    Split, Split-Dalmatia County, 21000

  • Klinička bolnica Merkur ( Site 0505)

    Zagreb, City of Zagreb, 10000

  • Klinički bolnički centar Zagreb ( Site 0501)

    Zagreb, City of Zagreb, 10000

  • Poliklinika Bates ( Site 0504)

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed ( Site 0502)

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Portugal6 sites

  • Unidade Local de Saude de Braga - Hospital de Braga ( Site 3300)

    Braga, 4710-243

  • Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 3306)

    Lisbon, Lisbon District, 1349-019

  • Hospital dos Lusíadas Lisboa ( Site 3303)

    Lisbon, 1500-458

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3305)

    Lisbon, 1649-035

  • ULSAM - Hospital de Santa Luzia ( Site 3302)

    Viana do Castelo, 4904 - 858

  • Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 3308)

    Viseu, 3504-509

Other trials in Portugal

South Africa6 sites

  • Panorama Medical Centre ( Site 3209)

    Cape Town, Western Cape, 7506

  • Spoke Research ( Site 3210)

    Cape Town, Western Cape, 7700

  • Life Kingsbury Hospital ( Site 3203)

    Cape Town, Western Cape, 7708

  • Private Practice - Dr. M.N. Rajabally ( Site 3213)

    Cape Town, Western Cape, 7800

  • Wits Clinical Research-Research ( Site 3208)

    Johannesburg, Gauteng, 2193

  • Wits Clinical Research-Wits Clinical Research Bara ( Site 3206)

    Soweto, Gauteng, 2013

Other trials in South Africa

Greece5 sites

  • Evangelismos General Hospital of Athens ( Site 4001)

    Athens, Attica, 106 76

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 4000)

    Athens, Attica, 115 27

  • University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 4003)

    Heraklion, Crete, 711 10

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon" ( Site 4006)

    Nikaia Piraeus, Attica, 184 54

  • Ippokrateio General Hospital of Thessaloniki ( Site 4004)

    Thessaloniki, Central Macedonia, 54642

Other trials in Greece

Serbia5 sites

  • Clinical Hospital Center Dragisa Misovic ( Site 1708)

    Belgrade, Beograd, 11 000

  • Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1705)

    Belgrade, Beograd, 11000

  • University Medical Center "Bezanijska kosa"-Gastroenterology and hepatology ( Site 1704)

    Belgrade, Beograd, 11080

  • Clinical Center Kragujevac ( Site 1703)

    Kragujevac, Beograd, 34000

  • General Hospital "Djordje Joanovic" ( Site 1707)

    Zrenjanin, Srednjebanatski Okrug, 23000

Other trials in Serbia

Taiwan5 sites

  • Changhua Christian Hospital ( Site 3104)

    Changhua County, Changhua, 50006

  • China Medical University Hospital ( Site 3100)

    Taichung, 404332

  • National Taiwan University Hospital ( Site 3102)

    Taipei, 10002

  • Chang Gung Medical Foundation-Linkou Branch ( Site 3101)

    Taoyuan, 333

  • National Taiwan University BioMedical Park Hospital ( Site 3103)

    Zhubei, Hsinchu, 302058

Other trials in Taiwan

Argentina4 sites

  • Centro de Investigaciones Médicas Mar del Plata ( Site 2101)

    Mar del Plata, Buenos Aires, 7600

  • CER medical Institute-Gastroenterology ( Site 2110)

    Quilmes, Buenos Aires F.D., B1878DVB

  • Hospital Provincial del Centenario ( Site 2108)

    Rosario, Santa Fe Province, S2002KDT

  • C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103)

    San Miguel de Tucumán, Tucumán Province, T4000IKO

Other trials in Argentina

Czechia4 sites

  • Vojenská Nemocnice Brno-Internal department ( Site 0605)

    Brno, Brno-mesto, 615 00

  • Hepato-Gastroenterologie HK ( Site 0602)

    Hradec Králové, 500 12

  • Institut Klinicke a Experimentalni Mediciny-Klinika hepatogastroentrologie ( Site 0604)

    Prague, Praha 4, 140 21

  • Nemocnice Slany ( Site 0601)

    Slaný, Central Bohemia, 274 01

Other trials in Czechia

Georgia4 sites

  • LTD High Technology Hospital Medcenter ( Site 0802)

    Batumi, Adjara, 6010

  • Caucasus Medical Centre ( Site 0801)

    Tbilisi, Adjara, 0186

  • Caraps Medline ( Site 0803)

    Tbilisi, 0159

  • New Hospitals ( Site 0800)

    Tbilisi, 0162

Other trials in Georgia

Malaysia4 sites

  • Hospital Ampang ( Site 4703)

    Ampang, Selangor, 68000

  • Hospital Sultanah Aminah ( Site 4702)

    Johor Bahru, Johor, 80100

  • Hospital Universiti Sains Malaysia ( Site 4704)

    Kubang Kerian, Kelantan, 16150

  • Hospital Tuanku Jaafar Seremban ( Site 4705)

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

Sweden4 sites

  • Danderyds Sjukhus ( Site 4401)

    Danderyd, Stockholm County, 182 88

  • Universitetssjukhuset i Linköping ( Site 4402)

    Linköping, Östergötland County, 581 85

  • Karolinska Universitetssjukhuset Solna ( Site 4400)

    Stockholm, Stockholm County, 171 64

  • Akademiska Sjukhuset ( Site 4403)

    Uppsala, Uppsala County, 75185

Other trials in Sweden

Austria3 sites

  • Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200)

    Innsbruck, Tyrol, 6020

  • Uniklinikum Salzburg-Innere Medizin I ( Site 0201)

    Salzburg, 5020

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

    Vienna, State of Vienna, 1090

Other trials in Austria

Finland3 sites

  • Pohjois-Karjalan keskussairaala ( Site 4302)

    Joensuu, Pohjois-Karjala, 80210

  • Tampereen yliopistollinen sairaala ( Site 4300)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital ( Site 4301)

    Turku, Southwest Finland, 20520

Other trials in Finland

Latvia3 sites

  • SIA M & M Centrs ( Site 4502)

    Adazi, Ādaži, 2164

  • Liepaja Regional Hospital ( Site 4501)

    Liepāja, 3414

  • P.Stradins Clinical University Hospital Center of Gastroenterology Hepatology and Nutrition ( Site 4503)

    Riga, LV1002

Other trials in Latvia

New Zealand3 sites

  • Aotearoa Clinical Trials ( Site 2900)

    Auckland, 2025

  • Waikato Hospital ( Site 2903)

    Hamilton, Waikato Region, 3204

  • Hutt Valley District Health board HVDHB ( Site 2902)

    Lower Hutt, Wellington Region, 5010

Other trials in New Zealand

Switzerland3 sites

  • INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902)

    Bern, Canton of Bern, 3012

  • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901)

    Sankt Gallen, Canton of St. Gallen, 9000

  • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900)

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Belgium2 sites

  • UZ Gent ( Site 0300)

    Ghent, Oost-Vlaanderen, 9000

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

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600)

    Kaunas, Kaunas County, 50161

  • VUL SANTAROS KLINIKOS ( Site 4601)

    Vilnius, Vilniaus Miestas, 08406

Other trials in Lithuania

Norway2 sites

  • Akershus Universitetssykehus ( Site 4200)

    Lørenskog, Akershus, 1478

  • Oslo Universitetssykehus Ullevål ( Site 4201)

    Oslo, 0450

Other trials in Norway

Singapore2 sites

  • Singapore General Hospital ( Site 4801)

    Singapore, Central Singapore, 169608

  • Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 4800)

    Singapore, Central Singapore, 308433

Other trials in Singapore

Dominican Republic1 site

  • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601)

    Santo Domingo, Nacional, 10104

Other trials in Dominican Republic

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. 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 according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. 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 according to the Modified Mayo Score at Week 12.

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.

Being tested
IV Tulisokibart, IV Placebo, SC Tulisokibart, SC Placebo
Keywords
Inflammatory Bowel Disease
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

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

  • IV PlaceboDrug

    Placebo matching IV tulisokibart

  • SC TulisokibartDrug

    Also called PRA023, MK-7240

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

  • SC PlaceboDrug

    Placebo matching SC tulisokibart

Study groups in NCT06052059
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; Drug: 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; Drug: SC Placebo
Study 1: PlaceboPlacebo comparatorParticipants receive IV placebo, followed by an SC placebo regimen.
Receives: Drug: IV Tulisokibart; Drug: IV Placebo; Drug: SC Placebo
Study 1: High Dose ExtensionExperimentalParticipants receive a high dose SC tulisokibart regimen. Participants may be enrolled 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 be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Receives: Drug: SC Tulisokibart; Drug: 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
Study 2: PlaceboPlacebo comparatorParticipants receive IV placebo.
Receives: Drug: IV Tulisokibart; Drug: IV Placebo; Drug: SC Placebo
Study 2: High Dose ExtensionExperimentalParticipants receive a high dose SC tulisokibart regimen. Participants may be enrolled 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 be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Receives: Drug: SC Tulisokibart; Drug: SC Placebo

What is being measured

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

  1. Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12

    The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

    Measured: Week 12

  2. Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52

    The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

    Measured: Week 52

  3. Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12

    The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

    Measured: Week 12

Secondary outcomes (42)

  1. Study 1: Percentage of Participants With One or More Adverse Events (AEs)

    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 percentage of participants who experience an AE will be reported.

    Measured: Up to approximately 52 weeks

  2. Study 1: Percentage of Participants Who Discontinued 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 treatment due to an AE will be reported.

    Measured: Up to approximately 52 weeks

  3. Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2

    The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.

    Measured: Week 2

  4. Study 1: Percentage of Participants With Endoscopic Improvement at Week 12

    Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

    Measured: Week 12

  5. Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12

    The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.

    Measured: Week 12

  6. Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12

    HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).

    Measured: Week 12

  7. Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12

    pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.

    Measured: Week 12

  8. Study 1: Percentage of Participants With Endoscopic Remission at Week 12

    ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.

    Measured: Week 12

  9. Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12

    Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.

    Measured: Week 12

  10. Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12

    Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

    Measured: Week 12

  11. Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12

    The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.

    Measured: Week 12

  12. Study 1: 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 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.

    Measured: Baseline and Week 12

  13. Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

    Measured: Week 12

  14. Percentage of Dx+ Participants With Endoscopic Improvement at Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

    Measured: Week 12

  15. Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12

    HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).

    Measured: Week 12

  16. Study 1: Percentage of Participants with Endoscopic Improvement at Week 52

    Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

    Measured: Week 52

  17. Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52

    The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for ≥90 days before Week 52.

    Measured: Week 52

  18. Study 1: Percentage of Participants Achieving HEMI at Week 52

    HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).

    Measured: Week 52

  19. Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52

    pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.

    Measured: Week 52

  20. Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52

    The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52.

    Measured: Week 12 and Week 52

  21. Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52

    Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.

    Measured: Week 52

  22. Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52

    Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

    Measured: Week 52

  23. Study 1: Percentage of Participants With Endoscopic Remission at Week 52

    ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.

    Measured: Week 52

  24. Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52

    Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

    Measured: Week 12 and Week 52

  25. Study 1: Percentage of Participants Achieving HER at Week 52

    HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).

    Measured: Week 52

  26. Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52

    The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.

    Measured: Week 52

  27. Study 1: 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 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.

    Measured: Baseline and Week 52

  28. Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

    Measured: Week 52

  29. Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

    Measured: Week 52

  30. Study 2: Percentage of Participants With One or More AEs

    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 will be reported.

    Measured: Up to approximately 12 weeks

  31. Study 2: Percentage of Participants Who Discontinued 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 treatment due to an AE will be reported.

    Measured: Up to approximately 12 weeks

  32. Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2

    pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.

    Measured: Week 2

  33. Study 2: Percentage of Participants With Endoscopic Improvement at Week 12

    Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.

    Measured: Week 12

  34. Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12

    The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.

    Measured: Week 12

  35. Study 2: Percentage of Participants Achieving HEMI at Week 12

    HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).

    Measured: Week 12

  36. Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12

    pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.

    Measured: Week 12

  37. Study 2: Percentage of Participants With Endoscopic Remission at Week 12

    ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.

    Measured: Week 12

  38. Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12

    Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity.

    Measured: Week 12

  39. Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12

    Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.

    Measured: Week 12

  40. Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12

    The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.

    Measured: Week 12

  41. Study 2: 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 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.

    Measured: Baseline and Week 12

  42. Study 2: Percentage of Participants Achieving HER at Week 12

    HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation.

    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 posted25 Sep 2023
  2. Study start25 Oct 2023
  3. Primary completion12 Aug 2026
  4. Study completion1 Aug 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
1,109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06052059
Sponsor's protocol ID
7240-001
Other IDs
PR200-301, jRCT2031230563, U1111-1296-0203, U1111-1314-0050, 2023-507473-17-00, 2024-518603-22-00, 2023
Status last verified
Sep 2026
First submitted
18 Sep 2023
Last updated
28 Sep 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IV Tulisokibart and SC Tulisokibart in people with Ulcerative Colitis, run by Merck Sharp & Dohme LLC at 476 sites in 45 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 476 sites in United States, Japan, China, Poland, France and 40 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06052059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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