AzTrials
AzTrials

Crohn's DiseasePhase 3VIVID-1NCT03926130

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

A Phase 3 study testing Mirikizumab and Ustekinumab in people with Crohn's Disease, run by Eli Lilly and Company at 580 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease. Read more about this study

Who is it for?
Ages 15 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
Mirikizumab and Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,158 participants
Where
580 sitesin 34 countries
Study dates
23 Jul 2019to 2 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Diagnosis of CD for at least 3 months prior to baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
  • Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

Who cannot join

  • Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
  • Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
  • Have a stoma, ileoanal pouch or ostomy
  • Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
  • Have ever received any monoclonal antibodies binding IL-23

Trial locations and contacts

580 sites in 34 countries.

580 sites in 34 countries

United States140 sites

  • Lovelace Scientific Resources - Albuquerque

    Albuquerque, New Mexico, 87108

  • Radiant Research

    Anderson, South Carolina, 29621

  • inSite Digestive Health Care

    Arcadia, California, 91006

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Amel Med LLC

    Austin, Texas, 78750

  • IMR of South Florida

    Aventura, Florida, 33180

  • Washington Gastroenterology, PLLC

    Bellevue, Washington, 98004

  • University of Alabama-The Kirklin Clinic

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Care Access Research - Wyoming

    Casper, Wyoming, 82601

  • Unc Hospitals

    Chapel Hill, North Carolina, 27599

  • Javara

    Charlotte, North Carolina, 28210

  • University of Virginia Health System

    Charlottesville, Virginia, 22908-0816

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • MGG Group, Inc.., Co., Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Eagle Clinical Research

    Chicago, Illinois, 60621

  • Gastroenterology Consultants of Clearwater

    Clearwater, Florida, 33756

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33761

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Ohio State University Hospital

    Columbus, Ohio, 43210

  • Baylor Scott & White Center for Inflammatory Bowel Diseases

    Dallas, Texas, 75246

  • Advanced Gastroenterology Associates

    Decatur, Texas, 76234

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Digestive Health Specialists

    Dothan, Alabama, 36301

  • Ohio Gastroenterology Group Inc.

    Dublin, Ohio, 43016

  • B G Clinical Research, Inc.

    Encinitas, California, 92024

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715

  • Pediatrics Specialists of Virginia

    Fairfax, Virginia, 22031

  • Revive Research Institute

    Farmington Hills, Michigan, 48334

  • Gastrointestinal Associates

    Flowood, Mississippi, 39232

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

  • Gastro One

    Germantown, Tennessee, 38138

  • Care Access - Gilroy

    Gilroy, California, 95020

  • Woodholme Gastroenterology Associates - Glen Burnie

    Glen Burnie, Maryland, 21061

  • Infusion Associates

    Grand Rapids, Michigan, 49525

  • Medication Management

    Greensboro, North Carolina, 27405

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • Inpatient Research Clinic

    Hialeah, Florida, 33013

  • Doral Medical Research

    Hialeah, Florida, 33016

  • Peters Medical Research

    High Point, North Carolina, 27262

  • CroNola LLC

    Houma, Louisiana, 70360

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas Health Services Center - Houston

    Houston, Texas, 77030

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Marshall Medical Center

    Huntington, West Virginia, 25701

  • Newport Huntington Med Grp

    Huntington Beach, California, 92648

  • Grand Teton Research Group

    Idaho Falls, Idaho, 83404

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • University of Mississippi School of Medicine

    Jackson, Mississippi, 39216-4500

  • Southern Therapy and Advanced Research (STAR) LLC

    Jackson, Mississippi, 39216

  • C2 Research Center, LLC

    Jacksonville, Florida, 32204

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Katy Gastro Health & Nutrition

    Katy, Texas, 77494

  • Care Access Research-Kinston

    Kinston, North Carolina, 28501

  • I.H.S. Health, LLC

    Kissimmee, Florida, 34741

  • Central Florida Gastro Research

    Kissimmee, Florida, 34744

  • GIA Clinical Trials, LLC

    Knoxville, Tennessee, 37909

  • NYU Langone Long Island Clinical Research Associates

    Lake Success, New York, 11042

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Om Research, LLC

    Lancaster, California, 93534

  • Advanced Biomedical Research of America - South Eastern Avenue

    Las Vegas, Nevada, 89123

  • Care Access - Las Vegas

    Las Vegas, Nevada, 89148

  • Wellness Clinical Research

    Lehigh Acres, Florida, 33936

  • BVL Research

    Liberty, Missouri, 64068

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • GastroIntestinal Biosciences Clinical Trials

    Los Angeles, California, 90067

  • Robley Rex VA Medical Center

    Louisville, Kentucky, 40206

  • Caprock Gastro Research, LLC

    Lubbock, Texas, 79424

  • Care Access Research-Lumberton

    Lumberton, North Carolina, 28358

  • Connecticut Gastroenterology

    Manchester, Connecticut, 06040

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503

  • Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125

  • Infinite Clinical Research

    Miami, Florida, 33133

  • Nickalus Children's Hospital Research Institute

    Miami, Florida, 33155

  • Research Associates of South Florida, LLC

    Miami, Florida, 33156

  • SaludMax Medical Corp

    Miami, Florida, 33165

  • Ezy Medical Research

    Miami, Florida, 33175

  • Coral Research Clinic Corp

    Miami, Florida, 33186

  • Goji Group - Research Trials Group

    Miami Lakes, Florida, 33016

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • Delta Research Partners LLC

    Monroe, Louisiana, 71201

  • Strand GI

    Myrtle Beach, South Carolina, 29572

  • Nola Research Works, LLC

    New Orleans, Louisiana, 70125

  • Children's Specialty Group, PPLC

    Norfolk, Virginia, 23507

  • California Medical Research Associates

    Northridge, California, 91324

  • Care Access Research LLC - Salt Lake City

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of California Irvine

    Orange, California, 92868

  • Gastroenterology Associates of Orangeburg

    Orangeburg, South Carolina, 29118

  • Center for Interventional Endoscopy

    Orlando, Florida, 32803

  • Endoscopic Research Inc

    Orlando, Florida, 32803

  • Orlando Health, Inc

    Orlando, Florida, 32806

  • Clintheory Healthcare

    Orlando, Florida, 32819

  • Care Access Research - Orlando

    Orlando, Florida, 32825

  • Digestive and Liver Center of Florida

    Orlando, Florida, 32825

  • inSite Digestive Health Care

    Pasadena, California, 91105

  • Digestive System Healthcare

    Pasadena, Texas, 77505

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503

  • The Center for Gastrointestinal Health

    Petersburg, Virginia, 23805

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85037

  • Synexus Clinical Research US, Inc.

    Pinellas Park, Florida, 33781

  • MNGI Digestive Health, P.A.

    Plymouth, Minnesota, 55446

  • Care Access Research LLC

    Pottsville, Pennsylvania, 17901

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • Velocity Clinical Research/Gut Whisperer

    Riverton, Utah, 84065

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • Capital Digestive Care

    Rockville, Maryland, 20850

  • Kalo Clinical Research

    Salt Lake City, Utah, 84102

  • Care Access Research LLC - Salt Lake City

    Salt Lake City, Utah, 84124

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

  • VIP Trials

    San Antonio, Texas, 78230

  • Care Access Research - San Jose

    San Jose, California, 95124

  • Wolverine Clinical Trials, LLC

    Santa Ana, California, 92705

  • Reliance Research

    Scottsdale, Arizona, 85260

  • Care Access Research - Scranton

    Scranton, Pennsylvania, 18508

  • Louisiana Clinical Research, LLC

    Shreveport, Louisiana, 71105

  • USPA Advance Concept Medical Research Group LLC.

    South Miami, Florida, 33143

  • Advanced Clinical Research-Spokane Gastroenterology

    Spokane, Washington, 99202

  • Virginia Gastroenterology Institute

    Suffolk, Virginia, 23434

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Washington Gastroenterology, PLLC

    Tacoma, Washington, 98405

  • Advanced Research

    Tamarac, Florida, 33321

  • University of South Florida

    Tampa, Florida, 33612

  • Alliance Clinical Research, LLC

    Tampa, Florida, 33615

  • Synexus Site Network

    Tempe, Arizona, 85282

  • Care Access Research - Terre Haute

    Terre Haute, Indiana, 47802

  • Fomat Medical Research, Inc.

    Thousand Oaks, California, 91360

  • Digestive Health Specialists

    Tupelo, Mississippi, 38801

  • Care Access Research - Tuscaloosa

    Tuscaloosa, Alabama, 35406

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

  • TPMG Clinical Research Williamsburg

    Williamsburg, Virginia, 23188

  • Gastroenterology Associates of the Piedmont

    Winston-Salem, North Carolina, 27103

  • Care Access Research - Yonkers

    Yonkers, New York, 10701

Other trials in United States

Japan45 sites

  • Asahikawa Medical College Hospital

    Asahikawa, Hokkaido, 078-8510

  • Tokyo Medical and Dental University Hospital

    Bunkyō, Tokyo, 113-8519

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    Chuo-ku, Sapporo-shi, Hokkaido, 060-0033

  • Fukuoka University Hospital

    Fukuoka, Jonan-Ku, Fukuoka, 814-0180

  • National Hospital Organization Fukuyama Medical Center

    Fukuyama, Hiroshima, 720-0825

  • Matsuda Hospital

    Hamamatsu, Shizuoka, 4328061

  • National Hospital Organization Hirosaki General Medical Center

    Hirosaki, Aomori, 036-8545

  • Isesakishimin Hospital

    Isesaki, Gunma, 372-0817

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Sameshima Hospital

    Kagoshima, 892-0846

  • Ofuna Central Hospital

    Kamakura, Kanagawa, 247-0056

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Ibaraki Prefectural Central Hospital

    Kasama, Ibaraki, 890-8520

  • Tsujinaka Hospital

    Kashiwa, Chiba, 277 0871

  • Kiryu Kosei Hospital

    Kiryū, Gunma, 376 0024

  • Hoshi General Hospital

    Kōriyama, Fukushima, 963-8501

  • Showa University Koto Toyosu Hospital

    Koto-ku, Tokyo, 135 8577

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto Furitsu Medical University Hospital

    Kyoto, 602-8566

  • Maebashi Red Cross Hospital

    Maebashi, Gunma, 371 0811

  • Nagasaki Harbor Medical Center

    Nagasaki, Nagasaki, 850-0842

  • Kojunkai Daido Clinic

    Nagoya, Aichi-ken, 4570818

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo, 663-8501

  • Okayama Saiseikai General Hospital Outpatient Center

    Okayama, 700-0013

  • Okayama University Hospital

    Okayama, 700-8558

  • Infusion Clinic

    Osaka, Osaka, 530-0011

  • Saga-Ken Medical Center Koseikan

    Saga, Saga-ken, 840 8571

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • Tokitokai Tokito Clinic

    Saitama, 336-0963

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, Hokkaido, 004 0041

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido, 065-0033

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido

  • IMS Meirikai Sendai General Hospital

    Sendai, Miyagi, 980-0021

  • Takagi Clinic - Sendai

    Sendai, Miyagi, 981-3213

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

  • National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo, 162-8655

  • JHCO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550

  • Fujita Health University

    Toyoake, Aichi-ken, 470-1192

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Matsushima Cinic

    Yokohama, Kanagawa, 220-0045

  • Tottori University Hospital

    Yonago, Tottori, 683-8504

Other trials in Japan

China40 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 400014

  • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA

    Chongqing, Chongqing Municipality, 400037

  • The First Hospital Affiliated to AMU (Southwest Hospital)

    Chongqing, Chongqing Municipality, 400038

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

  • The First Affiliated Hospital of Fujian Medical University

    Fujian, Fuzhou, 350005

  • First affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • The Sixth Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • First Affiliated Hosp of College of Med, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650034

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210029

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Shanghai East Hospital

    Shanghai, Pudong District, 200120

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai 6th people's hospital

    Shanghai, Shanghai Municipality

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215066

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

    Wenzhou, Zhejiang, 310015

  • Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

    Wuhan, Hubei, 430030

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000

Other trials in China

Poland28 sites

  • Nova Reuma Społka Partnerska

    Bialystok, Podlaskie Voivodeship, 15-707

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Medyczne SYNEXUS

    Częstochowa, Silesian Voivodeship, 42-202

  • NZOZ "Twoje Zdrowie EL" Sp. z o.o.

    Elblag, 82-300

  • Synexus Polska Gdansku

    Gdansk, Pomeranian Voivodeship, 80-382

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, Pomeranian Voivodeship, 81-537

  • MED-ROZ

    Karwiany, Lower Silesian Voivodeship, 52-200

  • Synexus Polska - Katowicach

    Katowice, Silesian Voivodeship, 40040

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Knurów, 44-190

  • Topolowa Medicenter

    Krakow, Lesser Poland Voivodeship, 31-506

  • Synexus Polska Oddział w Lodzi

    Lodz, 90-127

  • ZOZ Gastromed

    Lublin, Lublin Voivodeship, 20-582

  • Medicenter Nowy Targ

    Nowy Targ, Lesser Poland Voivodeship, 34-400

  • Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-702

  • Private Practice - Dr. Korczowski Bartosz

    Rzeszów, Podkarpackie Voivodeship, 35-302

  • Centrum Medyczne Medyk

    Rzeszów, Subcarpathian, 35-326

  • Endoskopia Sp. z.o.o.

    Sopot, Pomeranian Voivodeship, 81-756

  • Kiepury Clinic

    Sosnowiec, Silesian, 41-200

  • Dc-Med. Sp. z o.o.

    Swidnica, Lower Silesian Voivodeship, 58-100

  • Sonomed Sp. z o.o.

    Szczecin, West Pomeranian Voivodeship, 71-685

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • NZOZ Formed

    Wadowice, Lesser Poland Voivodeship, 34-100

  • NZOZ Vivamed

    Warsaw, Masovian Voivodeship, 03-580

  • Instytut Pomnik-Centrum Zdrowia Dziecka

    Warsaw, Woj Mazowieckie, 04-730

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • M. Sklodowskiej-Curie 12

    Wroclaw, Lower Silesian Voivodeship, 50-381

  • Melita Medical

    Wroclaw, Lower Silesian Voivodeship, 50-449

  • ETG Zamość

    Zamość, 22-400

Other trials in Poland

Brazil26 sites

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais, 30110-934

  • Faculdade de Medicina de Botucatu

    Botucatu, São Paulo, 18618-687

  • L2IP - Instituto de Pesquisas Clinicas Ltda.

    Brasília, Federal District, 70200-730

  • Chronos Pesquisa Clínica

    Brasília, Federal District, 72145-450

  • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

    Campinas, São Paulo, 13060-904

  • Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Associacao Paranaense de Cultura - PUCPR

    Curitiba, Paraná, 80230-130

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, Ceará, 60430-370

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

    Goiânia, Goiás, 74535-170

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-093

  • Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560-030

  • Hospital Gloria Dor

    Rio de Janeiro, 22211-230

  • Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao

    Salvador, Estado de Bahia, 41500-300

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-870

  • Pesquisare

    Santo André, São Paulo, 09080-110

  • Praxis Pesquisa Medica

    Santo André, São Paulo, 09790790

  • CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

    São Bernardo do Campo, São Paulo, 09715-090

  • Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

    São Paulo, São Paulo, 04039-004

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

  • Hospital Sírio Libanês

    São Paulo, 01308-050

  • Clinica Onco Star

    São Paulo, 04543-000

  • Hepatogastro

    São Paulo, 04543-001

  • Eurolatino Pesquisas Medicas Ltda.

    Uberlândia, Minas Gerais, 38411-186

Other trials in Brazil

Russia26 sites

  • Multidisciplinary Medical Clinic "Anthurium"

    Barnaul, 656043

  • LLC Evimed

    Chelyabinsk, 454048

  • Medical and Sanitary Division of Severstal

    Cherepovets, 162600

  • Scientific Centre of Reconstructive and Restorative Surgery

    Irkutsk, Irkutsk Oblast, 664079

  • Clinical Trials Center of Medical Institute

    Kaliningrad, 236035

  • Kazan State Medical University

    Kazan', 420029

  • SIH Kemerovo Regional Clinical Hosptial

    Kemerovo, 650066

  • Olla-Med

    Moscow, Moscow, 105554

  • LLC ?Medsanchast No 14?

    Moscow, 123022

  • State Scientific Centre of Coloproctology

    Moscow, 123423

  • Nizhny Novgorod Regional Hospital N.A. Semashko

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126

  • Novosibirski Gastrocenter

    Novosibirsk, Novosibirsk Oblast, 630007

  • LLC "Medicine Center SibNovoMed"

    Novosibirsk, 630005

  • The University Clinic of OSMU

    Omsk, 644050

  • Karelia Republican Hospital V.A. Baranova

    Petrozavodsk, Kareliya, Respublika, 185019

  • Rostov State Medical University

    Rostov-on-Don, Rostov Oblast, 344091

  • LLC Medical Center Reavita Med SPb

    Saint Petersburg, Sankt-Peterburg, 194354

  • Scientific research center ECO-security

    Saint Petersburg, Sankt-Peterburg, 196143

  • Pokrovskaya Municipal Hospital

    Saint Petersburg, 195067

  • Saint-Petersburg City Hospital of Saint Elizabeth

    Saint Petersburg, 195257

  • Academician I.P. Pavlov First St-Petersburg State Medical University

    Saint Petersburg, 197022

  • LLC Gastroenterology Centre Expert

    Saint Petersburg, 197110

  • SBIH City Clinical Hospital #31

    Saint Petersburg, 197110

  • SPb SBIH "City Polyclinic # 106"

    Saint Petersburg, 198328

  • NonState Healthcare Institution Central Clinical Hospital

    Samara, 443029

  • LLC MA New Hospital

    Yekaterinburg, 620109

Other trials in Russia

Ukraine22 sites

  • RCI Chernivtsi Regional Clinical Hospital

    Chernivtsi, 58002

  • Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

    Dnipro, 49038

  • Ivano-Frankivsk State Medical University

    Ivano-Frankivsk, 76018

  • City Clinical Hospital No. 2

    Kharkiv, Kharkiv Oblast, 61037

  • Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058

  • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

    Kiev, Kyiv Oblast, 4050

  • Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV

    Kyiv, 01030

  • International Institute of Clinical Trials LLC

    Kyiv, 02091

  • LLC Medbud-Clinic Medical Center

    Kyiv, 03037

  • Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway

    Kyiv, 03049

  • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

    Kyiv, 04078

  • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

    Kyiv, 04107

  • Lviv Railway Clinical Hospital

    Lviv, Lviv Oblast, 79000

  • Lviv Regional Endocrinology Dispensary

    Lviv, Lviv Oblast, 79000

  • Communal Enterprise "Odesa Regional Clinical Hospital"

    Odesa, 65117

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, 88000

  • Medical Center "Health Clinic" LLC

    Vinnitsa, 21009

  • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

    Vinnytsia, 21005

  • Vinnytsya Regional Clinical Hospital

    Vinnytsia, 21018

  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

    Vinnytsia, 21029

  • Zaporozhye City Clinical Hospital #6

    Zaporizhzhya, 69000

  • Diacenter LLC

    Zaporizhzhya, 69076

Other trials in Ukraine

Germany21 sites

  • Charité Campus Virchow-Klinikum

    Berlin, 12200

  • Synexus Clinical Research GmbH

    Berlin, 12627

  • Knappschaftskrankenhaus Bottrop

    Bottrop, North Rhine-Westphalia, 46242

  • Florence-Nightingale-Krankenhaus

    Düsseldorf, 40489

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Synexus Clinical Research GmbH

    Frankfurt am Main, Hesse, 60313

  • Practice Dr.med. Denger and Dr.med. Pfitzner

    Friedrichsthal, Saarland, 66299

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle, Saxony-Anhalt, 06108

  • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

    Hamburg, 20251

  • Medizinische Hochschule Hanover

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Krankenhaus Eichhof

    Lauterbach, Hesse, 36341

  • Synexus Clinical Research GmbH-Leipzig Research Centre

    Leipzig, Saxony-Anhalt, 04103

  • St. Marienkrankenhaus-Medizinische Klinik I

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067

  • Gastroenterologische Gemeinschaftspraxis Mainz

    Mainz, 55122

  • Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin

    Neuss, North Rhine-Westphalia, 41462

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin

    Pforzheim, Baden-Wurttemberg, 75179

  • Tumorzentrum Nordthüringen

    Uslar, 99734

  • Gemeinschaftspraxis Jakobeit

    Wipperfürth, North Rhine-Westphalia, 51688

  • Universitätsklinikum Würzburg A. ö. R.

    Würzburg, Bavaria, 97080

Other trials in Germany

South Korea20 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Dong-A University Hospital

    Busan, 49201

  • Kyung Pook National University Hospital

    Daegu, Korea, 41944

  • Kyungpook National University Medical Center Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • The Catholic University of Korea, Daejeon St. Mary's Hospital

    Daejeon, Taejǒn-Kwangyǒkshi, 34943

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, Gangwon-do, 26426

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggido, 11923

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • Yeungnam Univeristy Medical Center

    Gyeongsan-si, Kyǒngsangbuk-do, 42415

  • Kyung Hee University Hospital

    Seoul, Korea, 02447

  • Seoul St. Mary's Hospital

    Seoul, Korea, 06591

  • Kyunghee University Hospital at Gangdong

    Seoul, Korea, 134727

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Samsung Medical Center

    Seoul, 06351

  • Chungang University Hospital

    Seoul, 06973

  • Seoul National University Hospital

    Seoul, 3080

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Turkey (Türkiye)20 sites

  • Hacettepe University Faculty of Medicine

    Ankara, 06100

  • Ankara City Hospital

    Ankara, 06800

  • Gazi University Faculty of Medicine

    Ankara

  • Uludag Universitesi

    Bursa, 16059

  • Trakya University

    Edirne, 22030

  • Eskisehir Osmangazi University Gastroenterology

    Eskişehir, 26040

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

  • Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi

    Hatay, 31040

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 34340

  • Medicana Kadiköy Hastanesi

    Istanbul, 34724

  • Fulya Acıbadem

    Istanbul

  • Dokuz Eylül Üniversitesi

    Izmir, 35340

  • Kocaeli University Medical Faculty Hospital

    İzmit, 41380

  • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi

    Kadıköy, Istanbul, 34734

  • Erciyes University Hospital

    Kayseri, 38039

  • Antalya Egitim ve Arastırma Hastanesi

    Kocaeli, Antalya, 7100

  • Konya Necmettin Erbakan Gastroenterology

    Konya, 42080

  • Inonu Universitesi Turgut Ozal Tıp Merkezi

    Malatya, 44280

  • Mersin University Medical Faculty

    Yenişehir, Mersin, 33343

Other trials in Turkey (Türkiye)

Italy18 sites

  • Azienda Ospedaliera Policlinico Consorziale

    Bari, 70124

  • Università degli Studi c/o Spedali Civili

    Brescia, 25100

  • Azienda Ospedaliera Giuseppe Brotzu

    Cagliari, 09134

  • Azienda Ospedaliera Saverio De Bellis

    Castellana Grotte, Bari, 70013

  • Azienda ospedaliero-universitaria Mater Domini

    Germaneto, Catanzaro, 88100

  • Istituto Mangiagalli

    Milan, MI, 20122

  • Ospedale Luigi Sacco

    Milan, 20157

  • Azienda Ospedaliera Universitaria Policlinico de Modena

    Modena, 41124

  • Università di Cagliari - Presidio Policlinico Monserrato

    Monserrato, Cagliari, 09042

  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli

    Naples, 80131

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • Presidio di Rho

    Rho, Milano, 20017

  • Polic.Umberto I -Univ. La Sapienza

    Roma, 00161

  • Policlinico Gemelli - Università Cattolica del Sacro Cuore

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Ospedale Clinicizzato San Donato

    San Donato Milanese, Milan, 20097

  • Azienda Ospedaliera Santa Maria Della Misericordia

    Udine, 33100

Other trials in Italy

Czechia16 sites

  • Vojenská Nemocnice Brno

    Brno, Brno-město, 636 00

  • Fakultni Nemocnice U svate Anny

    Brno, 65691

  • Hepato-Gastroenterologie HK

    Hradec Králové, Hradec Králové, 500 12

  • Oblastni nemocnice Nachod-Endoskopicke centrum

    Náchod

  • MUDr. Gregar, s.r.o.

    Olomouc, Olomouc Region, 779 00

  • PreventaMed, s.r.o.

    Olomouc, 77900

  • MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance

    Ostrava - Muglinov, 712 00

  • A-Shine, s.r.o.

    Pilsen, 301 00

  • Institut Klinicke a Experimentalni Mediciny

    Prague, Prague, 14021

  • Synexus Czech

    Prague, Praha 2, 120 00

  • Thomayerova nemocnice

    Prague, Praha 4, 14059

  • AXON Clinical

    Prague, 150 00

  • Mediendo, s.r.o.

    Prague, 18600

  • ISCARE Clinical Centre

    Prague, 19000

  • Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem

    Ústí nad Labem, Czech Republic, 40113

  • Nemocnice Tomase Bati ve Zline

    Zlín, Zlín, 762 75

Other trials in Czechia

France14 sites

  • CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie

    Amiens, 80054

  • Hôpital Beaujon

    Clichy, Paris, 92110

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Paris, 94270

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • CHRU de Montpellier-Hopital St Eloi

    Montpellier, 34295

  • Hôpital Saint Antoine

    Paris, Cedex 12, 75012

  • GH Necker - Enfants Malades

    Paris, 75015

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -

    Pierre-Bénite, Rhone, 69495

  • CHU de Poitiers- Service d'Hépato-gastro-entérologie,

    Poitiers, 86021

  • CHU Charles Nicolle in Rouen

    Rouen, 76036

  • CHU St Etienne Hopital Nord

    Saint-Etienne, 42055

  • Hopital de Hautepierre - Service d'Hépatogastroentérolgie

    Strasbourg, Bas Rhin, 67098

  • CHRU de Nancy

    Vand?uvre-lès-Nancy, 54511

Other trials in France

India14 sites

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012

  • Apollo Speciality Hospital - Teynampet

    Chennai, Tamil Nadu, 600035

  • Asian Institute of Gastroenterology

    Hyderabad, Telangana, 500032

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302006

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Midas Multispeciality Hospital Pvt.Ltd.

    Nagpur, Maharashtra, 440010

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Aakash Healthcare Super Speciality Hospital

    New Delhi, 110075

  • Ruby Hall Clinic and Grant Medical Foundation

    Pune, Maharashtra, 411001

  • Gujarat Hospital - Gastro and Vascular Centre

    Surat, Gujarat, 395009

  • Gandhi Hospital

    Telangana, 500003

  • Yashoda Super Speciality Hospital

    Telangana, 500003

  • International Gastro Institute

    Vadodara, Gujarat, 390007

Other trials in India

Romania14 sites

  • SC Med Life SA

    Bucharest, 010719

  • Spitalul Clinic CF 2 Bucuresti

    Bucharest, 011464

  • S.C. Centrul Medical Medicum SRL

    Bucharest, 012015

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Universitar de Urgență București

    Bucharest, 050098

  • Spitalul Clinic Colentina

    Bucharest, 21155

  • CCBR Clinical Research

    Bucharest, 30463

  • Spitalul Euroclinic

    Bucureti, Bucharest, 014461

  • Sc Tvm Med Serv

    Cluj-Napoca, Cluj, 400132

  • Gastromed S.R.L.

    Constanța, 900168

  • Affidea Medical Research Center

    Constanța, 900591

  • Spitalul Pelican

    Oradea, Bihor County, 410450

  • Spitalul Clinic Judetean Targu Mures

    Târgu Mureş, 540103

  • S.C. Materna Care S.R.L.

    Timișoara, 300645

Other trials in Romania

Spain12 sites

  • Complexo Hospitalario Universitario A Coruña, CHUAC

    A Coruña, 15006

  • Instituto de Ciencias Médicas

    Alicante, 3004

  • Centro Medico Teknon - DIGESTIVO

    Barcelona, 8022

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, Barcelona, 17007

  • Hospital De Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35010

  • Hospital La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC

    Pamplona, Navarre, 31008

  • Hospital Universitario Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, 38010

  • Clínica Gaias - Santiago

    Santiago de Compostela, A Coruña [La Coruña], 15702

Other trials in Spain

Australia11 sites

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St. Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Northern Hospital

    Epping, Victoria, 3076

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Coastal Digestive Health

    Maroochydore, Queensland, 4558

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Coral Sea Clinical Research Institute

    North Mackay, Queensland, 4740

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Hungary11 sites

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, EU, 8230

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

    Békéscsaba, 5600

  • Clinexpert SMO

    Budapest, 1033

  • Synexus Magyarorszag Kft.

    Budapest, 1036

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Bugát Pál Kórház

    Gyöngyös, 3200

  • Synexus Gyula

    Gyula, Bekes County, 5700

  • Endomedix Diagnosztikai Központ - Miskolc

    Miskolc, 3526

  • SZTE AOK Belgyogyaszati Klinika

    Szeged, Csongrád megye, 6725

  • CLINFAN Szolgáltató Kft

    Szekszárd, 7100

  • Clinexpert Tatabánya Ltd.

    Tatabánya, Komárom-Esztergom, H-2800

Other trials in Hungary

Canada10 sites

  • Milestone Clinical

    Dartmouth, Nova Scotia, B2W 6L4

  • Gastroenterology and internal medicine research institute

    Edmonton, Alberta, T5R 1W2

  • Viable Clinical Research

    Greater Sudbury, Ontario, P3C 5K6

  • K&M Medical

    Kentville, Nova Scotia, B4N 0A3

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Victoria Hospital

    London, Ontario, N6A 5W9

  • CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital

    Montreal, Quebec, H1T 2M4

  • Fraser Clinical Trials Inc

    New Westminster, British Columbia, V3L 3W4

  • The Medical Arts Health Research Group

    North Vancouver, British Columbia, V7L 4W8

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Israel9 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Galilee Medical Center Department of Internal Medicine A

    Nahariya, 22100

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Kaplan Medical Center

    Rehovot, 7610001

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

Mexico9 sites

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31203

  • Instituto de Investigaciones Clínicas para la Salud

    Durango, 34000

  • PanAmerican Clinical Research S.A.de C.V. Guadalajara

    Guadalajara, JA, 44670

  • Health Pharma Professional Research S.A. de C.V:

    Mexico City, Mexico City, 03100

  • Grupo Medico Camino Sc

    Mexico City, Mexico City, 03310

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

  • PanAmerican Clinical Research Mexico S.A. de C.V.

    Querétaro City, Querétaro, 76226

  • Centro de Alta Especialidad Reumatologia Inv del Potosi SC

    San Luis Potosí City, 78213

  • Sociedad de Metabolismo y Corazon

    Veracruz, 91900

Other trials in Mexico

United Kingdom9 sites

  • Synexus Midlands Clinical Research Center

    Birmingham, Wstmid, B15 2SQ

  • Addenbrookes Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Synexus Wales Clinical Research Centre

    Cardiff, South Glamorgan, CF15 9SS

  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

    Doncaster, DN2 5LT

  • Paediatric Clinical Research Facility Royal Hospital for Children and Young People

    Edinburgh, EH16 4TJ

  • Chelsea and Westminster Hospital

    Fulham, London, SW10 9NH

  • Synexus North East Clinical Research Centre

    Hexham, NE46 1QJ

  • Whipps Cross University Hospital

    London, England, E11 1NR

  • Synexus Manchester Clinical Research Centre

    Manchester, Greater Manchester, M15 6SE

Other trials in United Kingdom

Serbia8 sites

  • Clinical Hospital Center Zvezdara

    Belgrade, Beograd, 11000

  • University Medical Center "Bezanijska kosa"

    Belgrade, NAP, 11080

  • Clinical Center " Dr Dragisa Misovic Dedinje"

    Belgrade, 11000

  • Clinical Center Kragujevac Gastroenterohepatology Clinic

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, Nišavski Okrug, 18000

  • Sremska Mitrovica Health Centre

    Sremska Mitrovica, Vojvodina, 22000

  • Zemun Medical Centre

    Zemun, Beograd, 11080

  • General Hospital "Djordje Joanovic"

    Zrenjanin, Vojvodina, 23000

Other trials in Serbia

Argentina7 sites

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1027AAP

  • DOM- Centro de Reumatologia

    CABA, Buenos Aires, 1111

  • Mautalen Salud e Investigación

    CABA, Buenos Aires, C1128AAF

  • CEMIC- Servicio de Reumatología

    CABA, Buenos Aires, C1431FWO

  • CIPREC

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, C1119ACN

  • Instituto Medico Elsa Perez SRL (IMEP)

    Ciudadela, Buenos Aires, 1702

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

Other trials in Argentina

Slovakia6 sites

  • FNsP FDRoosevelta Banska Bystrica

    Banská Bystrica, 97517

  • CLINIQ, s.r.o

    Bratislava, 811 09

  • Gastromedic

    Nové Zámky, 94002

  • Gastro

    Prešov, Presov, 080 01

  • Gastro LM s.r.o.

    Prešov, 08001

  • Endomed, s.r.o.

    Vranov N. Toplou, Presov, 093 01

Other trials in Slovakia

Belgium5 sites

  • Imelda General Hospital

    Bonheiden, Antwerpen, 2820

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • UZ Brussel

    Brussels, 1090

  • AZ Groeninge

    Kortrijk, 8500

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Austria4 sites

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Universitätsklinikum Salzburg

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Schwestern Wien

    Vienna, 1060

  • AKH

    Vienna, 1090

Other trials in Austria

Puerto Rico4 sites

  • Caguas Gastroenterology and Hepatology Center, LLC

    Caguas, 00726-4980

  • Pan American Center for Oncology Trials

    Rio Piedras, 00935

  • Latin Clinical Trial Center

    San Juan, 00909

  • Wellness clinical Research Vega Baja

    Vega Baja, 00694

Other trials in Puerto Rico

Switzerland3 sites

  • Inselspital Bern

    Bern, 3010

  • Gastroenterologische Praxis Balsiger, Seibold & Partner

    Bern, CH-3012

  • Cantonal Hospital St.Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Croatia2 sites

  • Clinical Medical Centre Osijek

    Osijek, 31000

  • CHC Zagreb

    Zagreb, 10000

Other trials in Croatia

Denmark2 sites

  • Aalborg Hospital

    Aalborg, 9100

  • Aarhus Universitetshospital, Skejby

    Aarhus, Central Jutland, 8200

Other trials in Denmark

Netherlands2 sites

  • ETZ Elisabeth Tilburg

    Tilburg, North Brabant, 5022 GC

  • Bernhoven Uden

    Uden, 5406 PT

Other trials in Netherlands

Latvia1 site

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, Riga, LV-1002

Other trials in Latvia

Lithuania1 site

  • Hospital of Lithuanian University of Health Sciences Kaunas

    Kaunas, 50009

Other trials in Lithuania

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Conditions
Crohn's Disease
Being tested
Mirikizumab, Ustekinumab, 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.

  • MirikizumabDrug

    Also called LY3074828

    Administered IV

  • MirikizumabDrug

    Also called LY3074828

    Administered SC

  • UstekinumabDrug

    Administered IV

  • UstekinumabDrug

    Administered SC

  • PlaceboDrug

    Administered IV

  • PlaceboDrug

    Administered SC

Study groups in NCT03926130
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.
Receives: Drug: Placebo
300 mg MirikizumabExperimentalParticipants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
Receives: Drug: Mirikizumab
90 mg UstekinumabActive comparatorParticipants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)
Receives: Drug: Ustekinumab
300 mg Mirikizumab (Adolescents)ExperimentalParticipants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W
Receives: Drug: Mirikizumab

What is being measured

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

  1. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab)

    Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).

    Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none=0; diameter 0.1-0.5 cm=1; 0.5-2 cm=2; >2 cm=3); extent of ulcerated surface (none=0; <10%=1; 10% to 30%=2; >30%=3); extent of affected surface (none=0; <50%=1; 50% to 75%=2; >75%=3); presence \& type of narrowing (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

    Measured: Week 12 to Week 52

  2. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab)

    Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).

    Clinical remission defined as Crohn's Disease Activity Index (CDAI) total score <150. The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]).. Total score range of 0 to 600 points.

    Measured: Week 12 to Week 52

Secondary outcomes (16)

  1. Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab)

    Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

    Measured: Week 12

  2. Percentage of Adult Participants Achieving Endoscopic Response at Week 52

    Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

    Measured: Week 52

  3. Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab)

    Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points.

    Measured: Week 12

  4. Percentage of Adult Participants Achieving Clinical Remission at Week 52

    Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points.

    Measured: Week 52

  5. Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab)

    Endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore >1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1.

    Measured: Week 12

  6. Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab)

    The Urgency NRS is a single patient-reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).

    Measured: Baseline, Week 12

  7. Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab)

    The Urgency NRS is a single patient-reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).

    Measured: Baseline, Week 52

  8. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab)

    Clinical Response by PRO defined as ≥30% decrease in SF and/or AP \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).

    Clinical Remission by PRO defined as SF≤3 and not worse than baseline (as per Bristol Stool Scale Category 6 or 7) and AP ≤1 and no worse than baseline.

    Measured: Week 12 to Week 52

  9. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 (Placebo and Mirikizumab)

    Clinical Response by PRO defined as ≥30% decrease in SF and/or AP \& neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 \& AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Endoscopic remission=SES-CD Total Score ≤4 \& at least 2-point reduction from baseline \& no subscore >1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments \& each of 20 individual variables scored 0-3: presence \& size of ulcers (none=0;diameter 0.1-0.5 cm=1;0.5-2 cm=2;>2 cm=3);extent of ulcerated surface (none=0;<10%=1;10% to 30%=2;>30%=3);extent of affected surface (none=0;<50%=1;50% to 75%=2;>75%=3);presence \& type of narrowing (none=0;single,can be passed=1;multiple,can be passed=2;cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56;higher scores indicating more severe disease. No subscore >1=no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1

    Measured: Week 12 to Week 52

  10. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Corticosteroid-free Clinical Remission at Week 52 (Placebo and Mirikizumab)

    Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).

    Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points.

    Corticosteroid-free clinical remission by CDAI is defined as achieving clinical remission by CDAI at Week 52 and being corticosteroid free from Week 40 to Week 52.

    Measured: Week 12 to Week 52

  11. Change From Baseline in C-Reactive Protein (CRP) at Week 52 in Adult Participants (Placebo and Mirikizumab)

    Change from baseline in CRP

    Measured: Baseline, Week 52

  12. Change From Baseline in Fecal Calprotectin at Week 52 in Adult Participants (Placebo and Mirikizumab)

    Change from baseline in Fecal Calprotectin

    Measured: Baseline, Week 52

  13. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Resolution of Baseline Extraintestinal Manifestations (EIMs) at Week 52 (Placebo and Mirikizumab)

    Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).

    Measured: Week 12 to Week 52

  14. Percentage of Adult Participants Achieving Clinical Response at Week 12 and ≥50% Reduction in Number of Draining Cutaneous Fistulae at Week 52 in Participants With Draining Cutaneous Fistulae at Baseline (Placebo and Mirikizumab)

    Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).

    Measured: Week 12 to Week 52

  15. Change From Baseline in Health Related Quality of Life at Week 52 in Adult Participants: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Placebo and Mirikizumab)

    The IBDQ is a 32-item patient completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." IBDQ total score is calculated as the sum of all questions. Scores range from 32 to 224; a higher score indicates a better quality of life.

    Measured: Baseline, Week 52

  16. Adult Population Pharmacokinetics (PopPK): Area Under the Concentration Time Curve (AUC) of Mirikizumab

    PopPK: AUC of Mirikizumab

    Measured: 900 mg Mirikizumab: Week 4: Predose; Week 4, Day 1: Postdose; Week 8, 12: Predose 300 mg Mirikizumab: Week 16, 24, 36: Predose; Week 52

Timeline

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

  1. First posted24 Apr 2019
  2. Study start23 Jul 2019
  3. Primary completion23 Aug 2023
  4. Study completion2 Oct 2023

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926130
Sponsor's protocol ID
16590
Other IDs
I6T-MC-AMAM, 2018-004614-18, 2018
Acronym
VIVID-1
Status last verified
Dec 2024
First submitted
23 Apr 2019
Last updated
27 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Gao X, Cao Q, Liu X, Chen B, Liu W, Tang W, Wang Y, Zhong J, Li Z, Wang X, Sun Y, Gupta P, Yu J, Xu J, Chen M. Sustained Efficacy and Safety of Mirikizumab Through 152 Weeks in Chinese Patients with Moderately to Severely Active Crohn's Disease: A Subpopulation Analysis of the VIVID-1 and VIVID-2 Phase 3 Trials. BioDrugs. 2026 Oct 28. doi: 10.1007/s40259-026-00810-z. Online ahead of print.

    PubMed 42946942

  • Jairath V, Magro F, Protic M, De Hertogh G, Harpaz N, Hisamatsu T, D'Haens G, Pai R, Yu G, Morris N, Luo WT, Hon E, Escobar R, Biedermann L, Reinisch W; VIVID Study Group. Histologic and combined histologic-endoscopic outcomes with mirikizumab in Crohn's disease: VIVID-1 trial results. J Crohns Colitis. 2026 Jun 7;20(6):jjag077. doi: 10.1093/ecco-jcc/jjag077.

    PubMed 42309525

  • Chua L, Otani Y, Lin Z, Friedrich S, Durand F, Zhang XC. Mirikizumab Pharmacokinetics and Exposure-Response in Patients With Moderately-To-Severely Active Crohn's Disease: Results From Two Randomized Studies. Clin Transl Sci. 2025 Aug;18(8):e70320. doi: 10.1111/cts.70320.

    PubMed 40804779

  • Jairath V, D'Haens G, Sands BE, Travis S, Chaparro M, Peyrin-Biroulet L, Chen MH, Dubinsky M, Ferrante M, Schreiber S, McGinnis K, Vadhariya A, Appelmans S, Lin Z, Yu G, Protic M, Moses R, Ghosh S. Bowel Urgency in Crohn's Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study. Clin Gastroenterol Hepatol. 2026 Feb;24(2):463-473.e5. doi: 10.1016/j.cgh.2025.07.003. Epub 2025 Jul 14.

    PubMed 40669578

  • Regueiro M, Fischer M, Bossuyt P, Protic M, Traxler K, Yu G, Zang H, Vadhariya A, Hisamatsu T, Juillerat P, Armuzzi A, Gisbert JP, Walsh A. Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study. J Crohns Colitis. 2025 Jul 3;19(7):jjaf100. doi: 10.1093/ecco-jcc/jjaf100.

    PubMed 40491246

  • Lee SD, Vermeire S, Ungaro R, Vadhariya A, Durand F, Morris N, Yu G, Fisher DA, Traxler K, Long M. Mirikizumab Improves Quality of Life and Work Productivity in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 Study. Am J Gastroenterol. 2025 Mar 13;120(8):1809-1819. doi: 10.14309/ajg.0000000000003410.

    PubMed 40079470

  • Lewis JD, Vadhariya A, Su S, Zhou X, Durand F, Kawata AK, Stassek L, Clucas C, Schreiber S. A patient-reported outcome measure comprising the stool frequency and abdominal pain items from the Crohn's Disease Activity Index: psychometric evaluation in adults with Crohn's disease. J Patient Rep Outcomes. 2025 Feb 17;9(1):19. doi: 10.1186/s41687-025-00851-y.

    PubMed 39962027

  • Dubinsky M, Vadhariya A, Su S, Zhou X, Durand F, Clucas C, Stassek L, Kawata AK, Travis S. The Urgency Numeric Rating Scale: Psychometric Evaluation in Adults with Crohn's Disease. Adv Ther. 2025 Feb;42(2):1044-1060. doi: 10.1007/s12325-024-03081-8. Epub 2024 Dec 18.

    PubMed 39692838

  • Ferrante M, D'Haens G, Jairath V, Danese S, Chen M, Ghosh S, Hisamatsu T, Kierkus J, Siegmund B, Bragg SM, Crandall W, Durand F, Hon E, Lin Z, Lopes MU, Morris N, Protic M, Carlier H, Sands BE; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024 Dec 14;404(10470):2423-2436. doi: 10.1016/S0140-6736(24)01762-8. Epub 2024 Nov 21.

    PubMed 39581202

  • Regueiro M, Su S, Vadhariya A, Zhou X, Durand F, Stassek L, Kawata AK, Clucas C, Jairath V. Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease. Qual Life Res. 2025 Feb;34(2):509-521. doi: 10.1007/s11136-024-03829-3. Epub 2024 Nov 13.

    PubMed 39537976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirikizumab and Ustekinumab in people with Crohn's Disease, run by Eli Lilly and Company at 580 sites in 34 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 580 sites in United States, Japan, China, Poland, Brazil and 29 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?

Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) (time frame: Week 12 to Week 52). The study lists 2 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 NCT03926130, which also lists 10 linked publications.

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 27 Dec 2024.

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