AzTrials
AzTrials

Crohn's DiseasePhase 3NCT03105128

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 3 study testing risankizumab IV and risankizumab SC in people with Crohn's Disease, run by AbbVie at 475 sites in 44 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 purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD). Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
risankizumab IV and risankizumab SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
931 participants
Where
475 sitesin 44 countries
Study dates
10 May 2017to 14 Apr 2021
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 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
  • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
  • If female, participant must meet the contraception recommendations.

Who cannot join

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participants with unstable doses of concomitant Crohn's disease therapy.
  • Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
  • Prior exposure to p19 inhibitors (e.g., risankizumab).
  • Complications of Crohn's disease.
  • Having an ostomy or ileoanal pouch.
  • Known active Coronavirus Disease 2019 (COVID-19) infection.

Trial locations and contacts

475 sites in 44 countries.

475 sites in 44 countries

United States117 sites

  • University of Michigan Health Systems /ID# 157144

    Ann Arbor, Michigan, 48109

  • TX Clinical Research Institute /ID# 159410

    Arlington, Texas, 76012

  • Gastroenterology Associates LLC - Jefferson Hwy /ID# 161956

    Baton Rouge, Louisiana, 70809

  • Inquest Clinical Research /ID# 165695

    Baytown, Texas, 77521-2415

  • Washington Gastroenterology Associates /ID# 162120

    Bellevue, Washington, 98004

  • HP Clinical Research /ID# 162998

    Bountiful, Utah, 84010

  • Seffner Premier Health Care, PA /ID# 162265

    Brandon, Florida, 33510

  • NY Scientific /ID# 158418

    Brooklyn, New York, 11235

  • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 212036

    Burnt Hills, New York, 12027

  • Texas Digestive Disease Consultants /ID# 209596

    Cedar Park, Texas, 78613-5028

  • Texas Digestive Disease Consultants /ID# 209785

    Cedar Park, Texas, 78613-5028

  • Univ NC Chapel Hill /ID# 154840

    Chapel Hill, North Carolina, 27514-4220

  • Medical University of South Carolina /ID# 212579

    Charleston, South Carolina, 29425

  • Atrium Health Carolinas Medical Center /ID# 158481

    Charlotte, North Carolina, 28203

  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154839

    Chevy Chase, Maryland, 20815

  • Northwestern University Division of GI/Hepatology /ID# 158283

    Chicago, Illinois, 60611-2927

  • The University of Chicago Medical Center /ID# 157141

    Chicago, Illinois, 60637-1443

  • Tri-State Endoscopy /ID# 154933

    Cincinnati, Ohio, 45219

  • Clinical Research of West Florida, Inc /ID# 204859

    Clearwater, Florida, 33765

  • Clinical Research of West Florida, Inc /ID# 207450

    Clearwater, Florida, 33765

  • South Lake Pain Institute, Inc /ID# 162825

    Clermont, Florida, 34711

  • Cleveland Clinic Main Campus /ID# 208171

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 165834

    Colorado Springs, Colorado, 80907

  • Gastro Center of Maryland /ID# 165004

    Columbia, Maryland, 21045

  • The Ohio State University /ID# 164709

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 167901

    Columbus, Ohio, 43235

  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 201848

    Dallas, Texas, 75246

  • Western Connecticut Medical Group /ID# 165849

    Danbury, Connecticut, 06810-6000

  • Hometown Urgent Care and Resea /ID# 170453

    Dayton, Ohio, 45424

  • Universal Axon Clinical Research /ID# 165432

    Doral, Florida, 33166

  • NorthShore University HealthSystem /ID# 158287

    Evanston, Illinois, 60201

  • Plains Clinical Research Center, LLC /ID# 169715

    Fargo, North Dakota, 58104-5925

  • Intercity Advanced Gastroentertology Center /ID# 213399

    Fresh Meadows, New York, 11366

  • DHAT Research Institute /ID# 158217

    Garland, Texas, 75044-2208

  • Gastro One /ID# 154742

    Germantown, Tennessee, 38138

  • Duplicate_Long Island Clinical Research /ID# 154836

    Great Neck, New York, 11021-5343

  • Gastroenterology Associates, P.A. of Greenville /ID# 154911

    Greenville, South Carolina, 29615-3593

  • PennState Milton S.Hershey Med /ID# 154883

    Hershey, Pennsylvania, 17033

  • Clinical Trials America /ID# 158484

    Hickory, North Carolina, 28601

  • Houma Digestive Health Special /ID# 158286

    Houma, Louisiana, 70360

  • Vilo Research Group Inc /ID# 206130

    Houston, Texas, 77017-2337

  • CliniCore International, LLC /ID# 158209

    Houston, Texas, 77027-6812

  • Baylor College of Medicine - Baylor Medical Center /ID# 158212

    Houston, Texas, 77030-3411

  • Precision Research Institute, LLC /ID# 200503

    Houston, Texas, 77036

  • Centex Studies, Inc. - Houston /ID# 200720

    Houston, Texas, 77058

  • Newport Huntington Medica /ID# 213033

    Huntington Beach, California, 92648-5994

  • Nature Coast Clinical Research - Inverness /ID# 159414

    Inverness, Florida, 34452-4717

  • Southern Therapy and Advanced Research (STAR) LLC /ID# 162388

    Jackson, Mississippi, 39216

  • East Tennessee Research Institute /ID# 168737

    Johnson City, Tennessee, 37604

  • Vidant Multispecialty Clinic - Kinston /ID# 161111

    Kinston, North Carolina, 28501-1589

  • SIH Research Mumtaz, Inc /ID# 163082

    Kissimmee, Florida, 34741-4161

  • Las Vegas Medical Research /ID# 160172

    Las Vegas, Nevada, 89113

  • Revival Research Institute, Inc /ID# 210984

    Las Vegas, Nevada, 89128-3157

  • University of Kentucky Chandler Medical Center /ID# 157137

    Lexington, Kentucky, 40536

  • Alliance Medical Research /ID# 163840

    Lighthouse PT, Florida, 33064

  • Atria Clinical Research /ID# 164740

    Little Rock, Arkansas, 72209-7040

  • Rocky Mountain Pediatric Gastroenterology /ID# 207169

    Lone Tree, Colorado, 80124-6798

  • United Medical Doctors /ID# 207040

    Los Alamitos, California, 90720-3309

  • TLC Clinical Research Inc /ID# 212503

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162656

    Los Angeles, California, 90067-2001

  • University of Louisville /ID# 210521

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia, LLC /ID# 154857

    Macon, Georgia, 31201

  • Cfagi Llc /Id# 201571

    Maitland, Florida, 32751-6108

  • Duplicate_Clinical Neuroscience Solutions /ID# 164181

    Memphis, Tennessee, 38119-4823

  • Great Lakes Medical Research, LLC /ID# 201732

    Mentor, Ohio, 44060-6211

  • Vista Health Research, LLC /ID# 212664

    Miami, Florida, 33176-1032

  • ITB Research /ID# 161334

    Miami, Florida, 33176

  • Coral Research Clinic /ID# 158549

    Miami, Florida, 33186-4643

  • South Florida Research Ph I-IV, Inc. /ID# 161836

    Miami, Florida, 33193

  • WVU Medicine /ID# 167940

    Morgantown, West Virginia, 26506-1200

  • United Medical Doctors - Murrieta /ID# 158424

    Murrieta, California, 92563

  • Gastroenterology Group Naples /ID# 165206

    Naples, Florida, 34102

  • Vanderbilt University Medical Center /ID# 157138

    Nashville, Tennessee, 37232-0011

  • Digestive Disease Care /ID# 209619

    New Hyde Park, New York, 11040

  • North Shore University Hospital /ID# 168736

    New Hyde Park, New York, 11040

  • Delricht Research /ID# 206542

    New Orleans, Louisiana, 70115

  • Nola Research Works, LLC /ID# 161330

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 161959

    New Port Richey, Florida, 34653

  • NYU Langone Medical Center /ID# 160171

    New York, New York, 10016-6402

  • Columbia Univ Medical Center /ID# 161911

    New York, New York, 10032-3725

  • Lenox Hill Hospital /ID# 168465

    New York, New York, 10075

  • DiGiovanna Institute for Medical Education & Research /ID# 171118

    North Massapequa, New York, 11758

  • Southwest Gastroenterology /ID# 165002

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute /ID# 154914

    Ogden, Utah, 84403

  • Hightower Clinical /ID# 211938

    Oklahoma City, Oklahoma, 73102

  • Digestive Disease Specialists /ID# 170774

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center /ID# 210057

    Omaha, Nebraska, 68198-2000

  • Endoscopic Research, Inc. /ID# 205901

    Orlando, Florida, 32803

  • Omega Research Maitland, LLC /ID# 171081

    Orlando, Florida, 32810-2907

  • IMIC Inc. Medical Research /ID# 154943

    Palmetto Bay, Florida, 33157

  • Phoenix VA Health Care System /ID# 162267

    Phoenix, Arizona, 85012

  • Children's Hospital of Pittsburgh of UPMC /ID# 210920

    Pittsburgh, Pennsylvania, 15224-1334

  • Northwest Gastroenterology Clinic /ID# 158288

    Portland, Oregon, 97210

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154880

    Raleigh, North Carolina, 27612

  • Rapid City Medical Center - GI Research /ID# 163841

    Rapid City, South Dakota, 57701

  • McGuire DV AMC /ID# 159990

    Richmond, Virginia, 23249

  • Southern CA Research Ctr., Inc /ID# 167875

    Riverside, California, 92501

  • Mayo Clinic - Rochester /ID# 163085

    Rochester, Minnesota, 55905-0001

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 161336

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 168770

    San Antonio, Texas, 78229-5390

  • University of California, San Francisco /ID# 157143

    San Francisco, California, 94158

  • HonorHealth Research Institute - Shea /ID# 161783

    Scottsdale, Arizona, 85258

  • Virginia Mason - Seattle Orthapedics /ID# 155545

    Seattle, Washington, 98101

  • Louisana Research Center, LLC /ID# 162236

    Shreveport, Louisiana, 71105-6800

  • St. Louis University /ID# 161902

    St Louis, Missouri, 63104

  • Clinical Research Trials of Florida, Inc. /ID# 201014

    Tampa, Florida, 33607

  • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211883

    Tempe, Arizona, 85284-2604

  • Cotton-O'Neil Clinical Res Ctr /ID# 154738

    Topeka, Kansas, 66606

  • Center for Digestive Health /ID# 154690

    Troy, Michigan, 48098-6363

  • University of Arizona /ID# 158469

    Tucson, Arizona, 85724

  • Adult Gastroenterology Associates - Gen 1 Research /ID# 206125

    Tulsa, Oklahoma, 74136-7823

  • Tyler Research Institute, LLC /ID# 166796

    Tyler, Texas, 75701-4464

  • Gastro Health & Nutrition - Victoria /ID# 164296

    Victoria, Texas, 77904

  • Cedars-Sinai Medical Center-West Hollywood /ID# 163842

    West Hollywood, California, 90048

  • Velocity Clinical Research - Salt Lake City /ID# 161781

    West Jordan, Utah, 84088

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161328

    Wyoming, Michigan, 49519

  • Digestive Disease Associates, LTD /ID# 208847

    Wyomissing, Pennsylvania, 19610-2002

Other trials in United States

Japan45 sites

  • Tokatsu Tsujinaka Hospital /ID# 163362

    Abiko-shi, Chiba, 270-1168

  • Tokyo Medical And Dental University, Medical Hospital /ID# 160157

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital /ID# 217532

    Chiba, Chiba, 260-8677

  • Fukuoka University Hospital /ID# 217792

    Fukuoka, Fukuoka, 814-0180

  • NHO Fukuyama Medical Center /ID# 163578

    Fukuyama-shi, Hiroshima, 720-8520

  • Duplicate_Tokai University Hachioji Hospital /ID# 160160

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 205689

    Hamamatsu, Shizuoka, 431-3192

  • National Hospital Organization Mito Medical Center /ID# 160154

    Higashi Ibaraki-gun, Ibaraki, 311-3193

  • Hiroshima University Hospital /ID# 160139

    Hiroshima, Hiroshima, 734-8551

  • Gokeikai Ofuna Chuo Hospital /ID# 171070

    Kamakura-shi, Kanagawa, 247-0056

  • Kanazawa University Hospital /ID# 201766

    Kanazawa, Ishikawa-ken, 920-8641

  • Tsujinaka Hospital Kashiwanoha /ID# 213847

    Kashiwa-shi, Chiba, 277-0871

  • The Jikei University Kashiwa Hospital /ID# 200007

    Kashiwa-shi, Chiba, 277-8567

  • Saitama Medical Center /ID# 160155

    Kawagoe-shi, Saitama, 350-8550

  • Yamanashi Prefectural Central Hospital /ID# 160156

    Kofu, Yamanashi, 400-8506

  • Kurume University Hospital /ID# 160138

    Kurume-shi, Fukuoka, 830-0011

  • Asahikawa Medical University Hospital /ID# 162844

    Midorigaokahiga-shi, Hokkaido, 078-8510

  • The Jikei University Hospital /ID# 163190

    Minato-ku, Tokyo, 105-8471

  • Duplicate_Kitasato University Kitasato Institute Hospital /ID# 160144

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 160149

    Mitaka-shi, Tokyo, 181-8611

  • Aichi Medical University Hospital /ID# 160159

    Nagakute-shi, Aichi-ken, 480-1195

  • Daido Clinic /ID# 211477

    Nagoya, Aichi-ken, 457-0818

  • Nagoya University Hospital /ID# 160150

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 160162

    Nagoya, Aichi-ken, 467-8602

  • Nishinomiya Munic Central Hospital /ID# 210104

    Nishinomiya-shi, Hyōgo, 663-8014

  • Hyogo College of Medicine College Hospital /Id# 160164

    Nishinomiya-shi, Hyōgo, 663-8501

  • Osaka City University Hospital /ID# 160146

    Osaka, Osaka, 545-8586

  • Shiga University of Medical Science Hospital /ID# 164022

    Ōtsu, Shiga, 520-2192

  • Kitasato University Hospital /ID# 171071

    Sagamihara-shi, Kanagawa, 252-0375

  • Tokitokai Tokito clinic /ID# 160145

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 160161

    Sakura-shi, Chiba, 285-8741

  • Sapporo Tokushukai Hospital /ID# 213493

    Sapporo, Hokkaido, 004-0041

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160158

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 163028

    Sapporo, Hokkaido, 060-8543

  • Tohoku University Hospital /ID# 162843

    Sendai, Miyagi, 9808574

  • Duplicate_Tohoku Rosai Hospital /ID# 163189

    Sendai, Miyagi, 981-8563

  • Tokyo Women's Medical University Hospital /ID# 205973

    Shinjuku-ku, Tokyo, 162-8666

  • NHO Shizuoka Medical Center /ID# 163029

    Sunto-gun, Shizuoka, 411-8611

  • Fujita Health University Hospital /ID# 163214

    Toyoake-shi, Aichi-ken, 470-1192

  • Mie University Hospital /ID# 203639

    Tsu, Mie-ken, 514-8507

  • Wakayama Medical University Hospital /ID# 200183

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital /ID# 200154

    Yamagata, Yamagata, 990-9585

  • Yokkaichi Hazu Medical Center /ID# 163741

    Yokkaichi-shi, Mie-ken, 510-0016

  • Yokohama City University Medical Center /ID# 163906

    Yokohama, Kanagawa, 232-0024

  • Yokohama Municipal Citizen's Hospital /ID# 204126

    Yokohama, Kanagawa, 240-8555

Other trials in Japan

Germany31 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212219

    Berlin, 10117

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212893

    Berlin, 10117

  • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211972

    Berlin, 10787

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159322

    Berlin, 10825

  • DRK Kliniken Berlin Westend /ID# 166146

    Berlin, 14050

  • Krankenhaus Waldfriede /ID# 212728

    Berlin-Zehlendorf, 14163

  • Stadtisches Klinikum Braunschweig /ID# 163666

    Braunschweig, 38126

  • Universitaetsklinikum Koeln /ID# 164985

    Cologne, North Rhine-Westphalia, 50937

  • Evangelisches Krankenhaus Kalk /ID# 212725

    Cologne, North Rhine-Westphalia, 51103

  • Medizinisches Versorgunszentrum Dachau /ID# 211557

    Dachau, 85221

  • Universitaetsklinikum Erlangen /ID# 159315

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Frankfurt /ID# 212978

    Frankfurt am Main, Hesse, 60590

  • Agaplesion Markus Krankenhaus /ID# 159317

    Frankfurt am Main, 60431

  • Universitaetsklinikum Freiburg /ID# 162019

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Praxiszentrum fuer Gastroenterologie /ID# 211964

    Grevenbroich, North Rhine-Westphalia, 41515

  • Asklepios Westklinikum Hamburg /ID# 159319

    Hamburg, 22559

  • Medizinische Hochschule Hannover /ID# 162021

    Hanover, 30625

  • Praxis fuer Gastroenterologie /ID# 166145

    Heidelberg, Baden-Wurttemberg, 69121

  • Universitaetsklinikum Jena /ID# 159323

    Jena, Thuringia, 07747

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159321

    Kiel, Schleswig-Holstein, 24105

  • EUGASTRO GmbH /ID# 212076

    Leipzig, 04103

  • Klinikum Lueneburg /ID# 163664

    Lüneburg, 21339

  • Universitaetsklinikum Magdeburg /ID# 211847

    Magdeburg, 39120

  • Universitatsklinikum Mannheim /ID# 162020

    Mannheim, Baden-Wurttemberg, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162018

    Minden, 32423

  • Universitaetsklinikum Muenster /ID# 159316

    Münster, North Rhine-Westphalia, 48149

  • Universitaetsklinikum Regensburg /ID# 163665

    Regensburg, 93042

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210529

    Saarbrücken, Saarland, 66111

  • Universitaetsklinikum Tuebingen /ID# 159324

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm /ID# 164986

    Ulm, Baden-Wurttemberg, 89081

  • Duplicate_Gastro-Praxis Wiesbaden /ID# 159318

    Wiesbaden, 65189

Other trials in Germany

Canada19 sites

  • University of Calgary - Heritage Medical Research Clinic /ID# 157152

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 169761

    Edmonton, Alberta, T5R 1W2

  • University of Alberta - Zeidler Ledcor Centre /ID# 157098

    Edmonton, Alberta, T6G 2X8

  • Covenant Health /ID# 161617

    Edmonton, Alberta, T6K 4B2

  • Medicor Research Inc /ID# 157149

    Greater Sudbury, Ontario, P3A 1W8

  • CISSS de la Monteregie /ID# 161615

    Greenfield Park, Quebec, J4V 2H1

  • QEII - Health Sciences Centre /ID# 157087

    Halifax, Nova Scotia, B3H 2Y9

  • IWK Health Center /ID# 165900

    Halifax, Nova Scotia, B3K 6R8

  • CHAU- Hotel-Dieu de Levis /ID# 214375

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Center /ID# 157160

    London, Ontario, N6A 5W9

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159054

    Montreal, Quebec, H1T 2M4

  • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167066

    Montreal, Quebec, H2X 3E4

  • Montreal General Hospital - McGill University Health Center /ID# 157084

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc /ID# 159053

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 165903

    North Bay, Ontario, P1B 2H3

  • Mount Sinai Hospital /ID# 169762

    Toronto, Ontario, M5G 1X5

  • GIRI Gastrointestinal Research Institute /ID# 157095

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Asso /ID# 157157

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 161616

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Italy18 sites

  • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155635

    Bologna, 40138

  • A.O. Per L'Emergenza Cannizzaro /ID# 161306

    Catania, 95126

  • University of Catanzaro /ID# 212012

    Catanzaro, Calabria, 88100

  • Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168051

    Florence, Tuscany, 50139

  • Ospedale Policlinico San Martino /ID# 162430

    Genova, 16132

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155633

    Milan, 20122

  • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155631

    Milan, 20157

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212019

    Modena, Emilia-Romagna, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161305

    Negrar, Verona, 37024

  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155637

    Palermo, 90146

  • Duplicate_Fondazione IRCCS Policlinico San Matteo /ID# 212029

    Pavia, 27100

  • Policlinico Universitario Campus Bio-Medico /ID# 162429

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini /ID# 155636

    Rome, Lazio, 00152

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166911

    Rome, Lazio, 00161

  • Fondazione PTV Policlinico Tor Vergata /ID# 158021

    Rome, Roma, 00133

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155632

    Rome, Roma, 00168

  • Istituto Clinico Humanitas /ID# 155634

    Rozzano, Milano, 20089

  • Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162427

    Torrette, Ancona, 60123

Other trials in Italy

China16 sites

  • The Second Hospital Central South University /ID# 211696

    Changsha, 410011

  • West China Hospital, Sichuan University /ID# 210889

    Chengdu, 610041

  • Guangdong Provincial People's Hospital /ID# 212948

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hosp Sun /ID# 210785

    Guangzhou, Guangdong, 510655

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210725

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210624

    Hangzhou, Zhejiang, 310020

  • Jinhua Municipal Central Hospital /ID# 215626

    Jinhua, Zhejiang, 321000

  • The First Affiliated Hospital of Nanchang University /ID# 211034

    Nanchang, Jiangxi, 330006

  • Shanghai East Hospital /ID# 212683

    Pudong New District, 200136

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210841

    Shanghai, Shanghai Municipality, 200065

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210707

    Shanghai, Shanghai Municipality, 200127

  • The Second Hospital of Hebei Medical University /ID# 212740

    Shijiazhuang, Hebei, 050000

  • Tianjin Medical University General Hospital /ID# 210927

    Tianjin, 300052

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210856

    Wuhan, Hubei, 430022

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211038

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University /ID# 214873

    Wuhan, Hubei, 430060

Other trials in China

Poland15 sites

  • Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212081

    Chojnice, Pomeranian Voivodeship, 89-600

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212297

    Lodz, Łódź Voivodeship, 90-153

  • 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209985

    Lublin, Lublin Voivodeship, 20-049

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209981

    Lublin, Lublin Voivodeship, 20-954

  • Wojewodzki Szpital Specjalistyczny /ID# 212402

    Olsztyn, Warmian-Masurian Voivodeship, 10-561

  • Duplicate_SOLUMED Sp. z o.o., Sp.k. /ID# 160793

    Poznan, 60-529

  • Centrum Medyczne Medyk /ID# 212889

    Rzeszów, Podkarpackie Voivodeship, 35-326

  • Gastromed /Id# 212099

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • H-T. Centrum Medyczne - Endoterapia /ID# 212459

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Zdrowia MDM /ID# 160794

    Warsaw, Masovian Voivodeship, 00-635

  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 160797

    Warsaw, Masovian Voivodeship, 02-507

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213579

    Warsaw, Masovian Voivodeship, 04-730

  • Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 205160

    Warsaw, 03-580

  • Planetmed Sp. z o.o. /ID# 202798

    Wroclaw, Lower Silesian Voivodeship, 52-210

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212602

    Wroclaw, 50-556

Other trials in Poland

United Kingdom13 sites

  • Cambridge University Hospitals NHS Foundation Trust /ID# 158031

    Cambridge, CB2 0QQ

  • Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207937

    Chertsey, Surrey, KT16 0PZ

  • NHS Lothian /ID# 207447

    Edinburgh, EH3 9HE

  • Royal Devon and Exeter NHS Trust Hospital /ID# 157517

    Exeter, Devon, EX2 5DW

  • Calderdale and Huddersfield NHS Foundation Trust /ID# 209569

    Huddersfield, HX3 0PW

  • Hull University Teaching Hospitals NHS Trust /ID# 158757

    Hull, HU3 2JZ

  • Leeds Teaching Hospitals NHS Trust /ID# 157523

    Leeds, LS9 7TF

  • Barts Health NHS Trust /ID# 163710

    London, London, City of, E1 2ES

  • Guy's and St Thomas' NHS Foundation Trust /ID# 157519

    London, London, City of, SE1 9RT

  • Duplicate_King's College Hospital NHS Foundation Trusts /ID# 158756

    London, SE5 9RS

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163709

    Newcastle upon Tyne, NE7 7DN

  • Oxford University Hospitals NHS Foundation Trust /ID# 158033

    Oxford, OX3 9DU

  • Duplicate_Northern Care Alliance NHS Group /ID# 207764

    Salford, M6 8HD

Other trials in United Kingdom

Spain12 sites

  • Hospital Clinic de Barcelona /ID# 157526

    Barcelona, 08036

  • Hospital Universitario Basurto /ID# 205189

    Bilbao, Vizcaya, 48013

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157527

    Ferrol, A Coruna, 15405

  • Hospital General Universitario Gregorio Maranon /ID# 161435

    Madrid, 28007

  • Hospital Universitario La Paz /ID# 159228

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157575

    Majadahonda, Madrid, 28222

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159230

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca /ID# 157532

    Salamanca, 37007

  • Hospital Universitario Virgen Macarena /ID# 160819

    Seville, 41009

  • Hospital Universitario y Politecnico La Fe /ID# 157530

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa /ID# 212523

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet /ID# 157531

    Zaragoza, 50009

Other trials in Spain

Ukraine12 sites

  • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165649

    Kharkiv, 61037

  • Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212050

    Kherson, 73000

  • Kyiv Municipal Clinical Hospital #18 /ID# 162521

    Kyiv, 01030

  • International Institute of Clinical Research LLC /ID# 211997

    Kyiv, 02091

  • Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165651

    Kyiv, 02232

  • Medical Center of LLC Medbud-Clinic /ID# 216929

    Kyiv, 03037

  • Kyiv Railway Clinical Hosp No.2 /ID# 217330

    Kyiv, 03049

  • Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 206788

    Lutsk, 43005

  • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165650

    Lviv, 79000

  • Duplicate_Transcarpathian Regional Clin. /ID# 168419

    Uzhhorod, 88000

  • Scientific Research Institute of Invalid Rehabilitation /ID# 211516

    Vinnytsia, Vinnytsia Oblast, 21029

  • MNPE Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrohov /ID# 216265

    Vinnytsia, 21018

Other trials in Ukraine

Portugal11 sites

  • Hospital Garcia de Orta, EPE /ID# 160747

    Almada, 2805-267

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160715

    Faro, 8000-386

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160739

    Guimarães, Braga District, 4835-044

  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160675

    Lisbon, 1169-050

  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167749

    Lisbon, 1349-019

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160694

    Lisbon, 1649-035

  • Hospital Beatriz Ângelo /ID# 207757

    Loures, 2674-514

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167750

    Portimão, Faro District, 8500-338

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160695

    Porto, 4200-319

  • Centro Hospitalar de Entre Douro e Vouga /ID# 160674

    Santa Maria DA Feira, Porto District, 4520-211

  • Centro Hosp de Tondela-Viseu /ID# 160697

    Viseu, 3504-509

Other trials in Portugal

Russia11 sites

  • Alliance Biomedical Ural Group /ID# 156950

    Izhevsk, Udmurtiya Republic, 426061

  • Kuzbass Regional Clinical Hospital /ID# 161310

    Kemerovo, Kemerovo Oblast, 650099

  • State Scientific Ctr Coloproct /ID# 204809

    Moscow, 123423

  • Novosibirski Gastrocenter /ID# 217554

    Novosibirsk, 630007

  • Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207440

    Perm, Permskiy Kray, 614990

  • Duplicate_St. Petersburg State Pediatric Medical University /ID# 211977

    Saint Petersburg, Sankt-Peterburg, 194100

  • City Clinical Hospital No. 31 /ID# 208866

    Saint Petersburg, 197110

  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 156949

    Stavropol, Stavropol Kray, 355012

  • Tver Regional Clinical Hospital /ID# 205925

    Tver', Tver Oblast, 170036

  • Regional Clinical Hospital #1 /ID# 163453

    Tyumen, Tyumen Oblast, 625023

  • Duplicate_Ulyanovsk State clinical hospi /ID# 156946

    Ulyanovsk, 432063

Other trials in Russia

South Korea11 sites

  • Dong-A University Hospital /ID# 158675

    Busan, 49201

  • Pusan National University Hospital /ID# 158677

    Busan, 49241

  • Yeungnam University Medical Center /ID# 158680

    Daegu, 42415

  • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213552

    Daejeon, 34943

  • Hanyang University Guri Hospital /ID# 158673

    Guri-si, Gyeonggido, 11923

  • Duplicate_CHA bundang medical center CHA University /ID# 158672

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 158676

    Seoul, Seoul Teugbyeolsi, 03181

  • Severance Hospital /ID# 158671

    Seoul, Seoul Teugbyeolsi, 03722

  • Asan Medical Center /ID# 158678

    Seoul, 05505

  • Samsung Medical Center /ID# 158674

    Seoul, 06351

  • Duplicate_The Catholic University of Korea, ST. Vincent's Hospital /ID# 158681

    Suwon, Gyeonggido, 16247

Other trials in South Korea

Belgium9 sites

  • Imelda Ziekenhuis /ID# 157392

    Bonheiden, 2820

  • ULB Hospital Erasme /ID# 157397

    Brussels, Brussels Capital, 1070

  • UZ Gent /ID# 157394

    Ghent, Oost-Vlaanderen, 9000

  • CHU UCL Namur - site Godinne /ID# 157401

    Godinne, Namur, 5530

  • Universitair Ziekenhuis Leuven /ID# 157396

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 157398

    Liège, 4000

  • Groupe Sante CHC - Clinique du MontLegia /ID# 157393

    Liège, 4000

  • AZ-Delta /ID# 157391

    Roeselare, 8800

  • UCL Saint-Luc /ID# 157395

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Czechia9 sites

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 163134

    Hradec Králové, 500 12

  • CTCenter MaVe s.r.o. /ID# 163149

    Olomouc, 779 00

  • Nemocnice Pardubickeho kraje, a.s. /ID# 163182

    Pardubice, 530 03

  • Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165463

    Prague, Praha 4, 140 00

  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211305

    Prague, 118 33

  • Axon Clinical, s.r.o. /ID# 163176

    Prague, 140 00

  • Thomayerova nemocnice /ID# 162940

    Prague, 140 59

  • ResTrial s.r.o. /ID# 211075

    Prague, 143 00

  • NH Hospital a.s. /ID# 211076

    Prague, 155 00

Other trials in Czechia

Israel9 sites

  • Soroka University Medical Center /ID# 157798

    Beersheba, Southern District, 8443901

  • Duplicate_Rambam Medical Center /ID# 171072

    Haifa, 3109601

  • The Edith Wolfson Medical Center /ID# 217329

    Holon, 5822000

  • Shaare Zedek Medical Center /ID# 163540

    Jerusalem, 91031

  • Shaare Zedek Medical Center /ID# 171073

    Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 165913

    Jerusalem, 91120

  • Sheba Medical Center /ID# 157797

    Ramat Gan, Tel Aviv, 5239424

  • Sheba Medical Center /ID# 171074

    Ramat Gan, Tel Aviv, 5239424

  • Tel Aviv Sourasky Medical Center /ID# 157796

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Serbia9 sites

  • Clinical Hosp Center Zvezdara /ID# 156978

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 156979

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 156973

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 156976

    Belgrade, Beograd, 11080

  • University Children's Hospital 'Tirsova' /ID# 211481

    Belgrade, 11000

  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212797

    Belgrade, 11040

  • University Clinical Center Kragujevac /ID# 156975

    Kragujevac, Sumadijski Okrug, 34000

  • General Hospital Leskovac /ID# 209574

    Leskovac, 16000

  • Clinical Center Vojvodina /ID# 156972

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

Bulgaria8 sites

  • UMHAT Dr Georgi Stranski EAD /ID# 203977

    Pleven, 5800

  • University Multiprofile Hospit /ID# 158644

    Plovdiv, 4001

  • Second Multiprofile Hospital f /ID# 158646

    Sofia, 1202

  • Duplicate_Tokuda Hospital Sofia /ID# 158645

    Sofia, 1407

  • UMHAT Sveti Ivan Rilski /ID# 204714

    Sofia, 1431

  • UMHAT Tsaritsa Joanna - ISUL /ID# 211240

    Sofia, 1527

  • MHAT Trakia /ID# 201672

    Stara Zagora, 6004

  • University Multiprofile Hospit /ID# 167575

    Varna, 9010

Other trials in Bulgaria

Brazil7 sites

  • Upeclin Fmb - Unesp /Id# 157688

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 157646

    Curitiba, Paraná, 80810-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157672

    Goiânia, Goiás, 74535-170

  • Hospital de Clinicas de Porto Alegre /ID# 157653

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157649

    Ribeirão Preto, São Paulo, 14051-140

  • Faculdade de Medicina do ABC /ID# 159672

    Santo André, São Paulo, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 157656

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

Other trials in Brazil

Greece7 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 171077

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157428

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 157427

    Heraklion, Crete, 71307

  • University General Hospital of Ioannina /ID# 157425

    Ioannina, 45500

  • Tzaneio general hospital of Piraeus /ID# 206445

    Piraeus, Attica, 18536

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157429

    Pireaus, 18454

  • Theageneio Anticancer Hospital /ID# 163921

    Thessaloniki, 54639

Other trials in Greece

Sweden7 sites

  • Sahlgrenska University Hospital /ID# 157879

    Gothenburg, Västra Götaland County, 413 45

  • Skane University hospital /ID# 211235

    Malmö, Skåne County, 214 28

  • Duplicate_SU Molndal. /ID# 157880

    Mölndal, 431 80

  • Duplicate_Karolinska Univ Sjukhuset /ID# 209966

    Solna, 171 64

  • Duplicate_GHP Stockholm Gastro Center /ID# 210479

    Stockholm, Stockholm County, 114 28

  • Ersta diakoni /ID# 157878

    Stockholm, Stockholm County, 116 91

  • Danderyd Hospital /ID# 202136

    Stockholm, Stockholm County, 182 88

Other trials in Sweden

Australia5 sites

  • Emeritus Research /ID# 213511

    Camberwell, Victoria, 3124

  • Lyell McEwin Hospital /ID# 211363

    Elizabeth Vale, South Australia, 5112

  • Footscray Hospital /ID# 211361

    Footscray, Victoria, 3011

  • Duplicate_Mater Hospital /ID# 167990

    South Brisbane, Queensland, 4101

  • Griffith University /ID# 212627

    Southport, Queensland, 4222

Other trials in Australia

Croatia5 sites

  • UHC Osijek /ID# 157564

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki bolnicki centar Split /ID# 157567

    Split, Split-Dalmatia County, 21000

  • Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157565

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 157721

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 157566

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Romania5 sites

  • Tvm Med Serv Srl /Id# 166294

    Cluj-Napoca, 400132

  • Institutul Clinic Fundeni /ID# 163046

    Sector 2, Bucharest, 022328

  • Institutul Clinic Fundeni /ID# 163264

    Sector 2, Bucharest, 022328

  • Cabinet Particular Policlinic Algomed /ID# 163047

    Timișoara, 300002

  • Duplicate_Centrul Medical Tuculanu SRL /ID# 166295

    Timișoara, 300168

Other trials in Romania

South Africa5 sites

  • Kingsbury Hospital /ID# 163116

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 163115

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 158117

    CAPE TOWN Milnerton, Western Cape, 7441

  • Clinresco Centers /ID# 163864

    Johannesburg, Gauteng, 1619

  • Wits Clinical Research Site /ID# 158115

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Austria4 sites

  • Medizinische Universitaet Graz /ID# 158137

    Graz, Styria, 8036

  • Universitaetsklinikum St. Poelten /ID# 166425

    Sankt Pölten, Lower Austria, 3100

  • Krankenhaus der Barmherzigen Brueder Wien /ID# 212059

    Vienna, State of Vienna, 1020

  • Duplicate_Medical University of Vienna /ID# 158138

    Vienna, State of Vienna, 1090

Other trials in Austria

Chile4 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 210759

    Concepción, 4070038

  • Complejo Asistencial Dr. Sotero del Rio /ID# 169382

    Santiago, Santiago Metropolitan, 8207257

  • Hospital Las Higueras /ID# 167090

    Talcahuano, 1740000

  • Centro de Investigaciones Clínicas Viña del Mar /ID# 203589

    Viña del Mar, Valparaiso, 2540488

Other trials in Chile

Colombia4 sites

  • Hospital Univ San Ignacio /ID# 158733

    Bogota, Cundinamarca, 110231

  • Instituto de Coloproctologia /ID# 158741

    Medellín, Antioquia, 050024

  • Hospital Pablo Tobon Uribe /ID# 158735

    Medellín, Antioquia, 50034

  • Hospital Universitario San Vic /ID# 171487

    Medellín, 50010

Other trials in Colombia

Mexico4 sites

  • JM Research SC /ID# 161733

    Cuernavaca, Morelos, 62290

  • Health Pharma Professional Research S.A de C.V /ID# 161734

    Del. Benito Juárez, 03810

  • Unidad de Atencion Medica e Investigacion en Salud /ID# 163624

    Mérida, Yucatán, 97000

  • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 167648

    Zapopan, Jalisco, 45070

Other trials in Mexico

Norway4 sites

  • Helse More og Romsdal HF, Alesund sjukehus /ID# 212811

    Ålesund, 6017

  • Vestre viken - Baerum Sykehus /ID# 157886

    Gjettum, 1346

  • Sykehuset Levanger Helse NT /ID# 157885

    Levanger, 7601

  • Akershus universitetssykehus /ID# 169378

    Nordbyhagen, Akershus, 1474

Other trials in Norway

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156465

    Banská Bystrica, 975 17

  • Univerzitna nemocnica Martin /ID# 163200

    Martin, 036 01

  • KM Management, spol. s.r.o. /ID# 206763

    Nitra, 949 01

  • GASTRO I., s.r.o. /ID# 156466

    Prešov, 080 01

Other trials in Slovakia

Belarus3 sites

  • Grodno city clinical hospital #2 /ID# 159499

    Grodno, 230011

  • Gomel Regional Clinical Hospital /ID# 159498

    Homyel, 246029

  • Vitebsk Regional Advanced Clin /ID# 159497

    Vitebsk, 210001

Other trials in Belarus

Bosnia and Herzegovina3 sites

  • University Clinical Centre of the Republic of Srpska /ID# 157717

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 164512

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 165134

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Estonia3 sites

  • East Tallinn Central Hospital /ID# 157076

    Tallinn, Harju, 10138

  • West Tallinn Central Hospital /ID# 157077

    Tallinn, 10617

  • North Estonia Medical Centre /ID# 163507

    Tallinn, 13419

Other trials in Estonia

Ireland3 sites

  • Beaumont Hospital /ID# 157515

    Beaumont, Dublin, D09 XR63

  • St Vincent's University Hospital /ID# 157512

    Elm Park, Dublin, D04 T6F4

  • University Hospital Galway /ID# 157513

    Galway, H91 YR71

Other trials in Ireland

Latvia3 sites

  • Pauls Stradins Clinical University Hospital /ID# 159614

    Riga, 1002

  • Digestive Disease Center Gastro /ID# 163105

    Riga, LV-1079

  • Riga East Clinical University Hospital /ID# 159613

    Riga, LV-1079

Other trials in Latvia

Malaysia3 sites

  • Queen Elizabeth Hospital /ID# 160654

    Division Pantai Barat Utara, Sabah, 88200

  • Universiti Sains Malaysia /ID# 160656

    Kelantan, Kelantan, 16150

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 163654

    Kuala Lumpur, Selangor, 56000

Other trials in Malaysia

New Zealand3 sites

  • Christchurch Hospital /ID# 163074

    Christchurch, Canterbury, 8011

  • Dunedin Hospital /ID# 167989

    Dunedin, Otago, 9016

  • Wellington Regional Hospital /ID# 167987

    Newtown Wellington, Wellington Region, 6021

Other trials in New Zealand

Singapore3 sites

  • National University Hospital /ID# 160658

    Singapore, 119074

  • Singapore General Hospital /ID# 160657

    Singapore, 169608

  • KL Ling Gastroenterology and Liver Clinic /ID# 205737

    Singapore, 228510

Other trials in Singapore

Switzerland3 sites

  • Duplicate_Universitaetsspital Basel /ID# 164555

    Basel, 4031

  • Inselspital, Universitätsspital Bern /ID# 163531

    Bern, 3010

  • Universitätsspital Zürich /ID# 163532

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Argentina2 sites

  • Hospital Privado Univesitario /ID# 161988

    Córdoba, 5016

  • Duplicate_HOSPITAL CENTENARIO /ID# 170883

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Hong Kong2 sites

  • Queen Mary Hospital /ID# 163902

    Hong Kong, 999077

  • Tuen Mun Hospital /ID# 163901

    Tuenmen

Other trials in Hong Kong

Lithuania2 sites

  • Duplicate_Hospital of lithuanian university of Health Science Kauno Klinikos /ID# 162582

    Kaunas, 50161

  • Duplicate_Vilnius University Hospital /ID# 162507

    Vilnius, LT-08661

Other trials in Lithuania

Netherlands2 sites

  • Academisch Medisch Centrum /ID# 157950

    Amsterdam, 1105 AZ

  • Elisabeth Tweesteden Ziekenhuis /ID# 163631

    Tilburg, 5022 GC

Other trials in Netherlands

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

Conditions
Crohn's Disease
Being tested
placebo for risankizumab, risankizumab IV, risankizumab SC
Keywords
Crohn's Disease (CD), Risankizumab, ABBV-066, BI 655066
Medical subject headings
Crohn Disease

What participants receive

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

  • placebo for risankizumabDrug

    Placebo for risankizumab administered by intravenous infusion

  • risankizumab IVDrug

    Also called ABBV-066 BI 655066, SKYRIZI

    Risankizumab administered by intravenous infusion

  • risankizumab SCDrug

    Also called ABBV-066 BI 655066, SKYRIZI

    Risankizumab administered by subcutaneous (SC) injection

Study groups in NCT03105128
Study groupRoleWhat they receive
Risankizumab Dose 1 (Period 1)ExperimentalParticipants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Receives: Drug: risankizumab IV
Risankizumab Dose 2 (Period 1)ExperimentalParticipants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Receives: Drug: risankizumab IV
Placebo (Period 1)Placebo comparatorParticipants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Receives: Drug: placebo for risankizumab
Risankizumab Dose 1 (Period 2)ExperimentalParticipants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Receives: Drug: risankizumab IV
Risankizumab Dose 2 (Period 2)ExperimentalParticipants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Receives: Drug: risankizumab SC
Risankizumab Dose 3 (Period 2)ExperimentalParticipants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Receives: Drug: risankizumab SC

What is being measured

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

  1. US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

    The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.

    Measured: Week 12

  2. US Specific: Percentage of Participants With Endoscopic Response

    The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).

    Measured: Week 12

  3. Global Outside of US: Percentage of Participants With Clinical Remission

    Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.

    Measured: Week 12

  4. Global Outside of US: Percentage of Participants With Endoscopic Response

    The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).

    Measured: Week 12

Secondary outcomes (31)

  1. US Specific: Percentage of Participants With Clinical Remission

    Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.

    Measured: Week 12

  2. US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.

    Measured: Week 4

  3. US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.

    Measured: Week 12

  4. US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.

    Measured: Week 12

  5. US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.

    Measured: Week 4

  6. US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response

    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.

    Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).

    Measured: Week 12

  7. US Specific: Percentage of Participants With Stool Frequency (SF) Remission

    Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.

    Measured: Week 12

  8. US Specific: Percentage of Participants With Abdominal Pain (AP) Remission

    The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.

    Measured: Week 12

  9. US Specific: Percentage of Participants With Endoscopic Remission

    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable

    Measured: Week 12

  10. US Specific: Percentage of Participants With Enhanced Clinical Response

    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission

    Measured: Week 4

  11. US Specific: Percentage of Participants With Ulcer-Free Endoscopy

    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline

    Measured: Week 12

  12. US Specific: Percentage of Participants With Enhanced Clinical Response

    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission

    Measured: Week 12

  13. US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at

    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

    Measured: Week 12

  14. US Specific: Percentage of Participants With CD-Related Hospitalization

    Participants with at least one admission to the hospital due to Crohn's Disease.

    Measured: Week 12

  15. US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline

    Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.

    Measured: Week 12

  16. Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

    The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.

    Measured: Week 12

  17. Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.

    Measured: Week 4

  18. Global Outside of US: Percentage of Participants With Clinical Remission

    Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.

    Measured: Week 4

  19. Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.

    Measured: Week 12

  20. Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.

    Measured: Week 12

  21. Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

    The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.

    Measured: Week 12

  22. Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response

    Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).

    Measured: Week 12

  23. Global Outside of US: Percentage of Participants With Endoscopic Remission

    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable

    Measured: Week 12

  24. Global Outside of US: Percentage of Participants With Enhanced Clinical Response

    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission

    Measured: Week 4

  25. Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy

    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline

    Measured: Week 12

  26. Global Outside of US: Percentage of Participants With Enhanced Clinical Response

    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission

    Measured: Week 12

  27. Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline

    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

    Measured: Week 12

  28. Global Outside of US: Percentage of Participants With CD-Related Hospitalization

    Participants with at least one admission to the hospital due to Crohn's Disease.

    Measured: Week 12

  29. Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline

    Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.

    Measured: Week 12

  30. Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment

    WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

    Measured: Week 12

  31. Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score

    The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.

    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 posted7 Apr 2017
  2. Study start10 May 2017
  3. Primary completion9 Nov 2020
  4. Study completion14 Apr 2021

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
Double blind
Who is masked
Participant, Investigator
Enrolment
931 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03105128
Sponsor's protocol ID
M16-006
Other IDs
2016-003123-32, 2016
Status last verified
Jun 2022
First submitted
4 Apr 2017
Last updated
6 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Expanded access
Available

Publications

  • Panaccione R, Ferrante M, Dotan I, Panes J, Hisamatsu T, Bossuyt P, Danese S, Song A, Kalabic J, Joshi N, Zambrano J, Zhang Y, Duan WR, Kligys K, Dubinsky MC, Lindsay JO, Vermeire S, Siegmund B, Irving PM, D'Haens G. Extended Risankizumab Treatment in Patients With Crohn's Disease Who Did Not Achieve Clinical Response to Induction Treatment. Clin Gastroenterol Hepatol. 2025 Oct;23(11):2012-2022.e6. doi: 10.1016/j.cgh.2024.12.023. Epub 2025 Feb 3.

    PubMed 39909280

  • Atreya R, Ferrante M, Panaccione R, Feagan B, Shchukina O, Jairath V, Rieder F, Hisamatsu T, Siegmund B, Kligys K, Song A, Zambrano J, Mallick M, Zhang Y, Armuzzi A, D'Haens G. Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies. J Crohns Colitis. 2025 Apr 4;19(4):jjae164. doi: 10.1093/ecco-jcc/jjae164.

    PubMed 39485390

  • Peyrin-Biroulet L, Colombel JF, Louis E, Ferrante M, Motoya S, Panaccione R, Torres J, Ungaro RC, Kligys K, Kalabic J, Zambrano J, Zhang Y, D'Haens G. Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies. Gastro Hep Adv. 2024 Mar 7;3(4):539-550. doi: 10.1016/j.gastha.2024.02.008. eCollection 2024.

    PubMed 39131711

  • Louis E, Lee WJ, Litcher-Kelly L, Ollis S, Pranschke E, Fitzgerald K, Lacerda AP, Neimark E, Sanchez Gonzalez Y, Panes J. Content Validity and Psychometric Evaluation of the Crohn's Symptom Severity (CSS) Questionnaire in Patients with Moderately to Severely Active Crohn's Disease. Adv Ther. 2024 Sep;41(9):3678-3705. doi: 10.1007/s12325-024-02923-9. Epub 2024 Aug 6.

    PubMed 39105965

  • Schreiber S, Cross RK, Panaccione R, D'Haens G, Bossuyt P, Dotan I, Colombel JF, Louis E, Dubinsky MC, Kligys K, Neimark E, Song A, Zambrano J, Kalabic J, Cheng E, Zhang Y, Ferrante M. Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid-free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease. Aliment Pharmacol Ther. 2024 Oct;60(7):897-906. doi: 10.1111/apt.18184. Epub 2024 Jul 25.

    PubMed 39054592

  • Dubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27.

    PubMed 37368103

  • Loftus EV Jr, Ananthakrishnan AN, Lee WJ, Gonzalez YS, Fitzgerald KA, Wallace K, Zhou W, Litcher-Kelly L, Ollis SB, Su S, Danese S. Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis. Pharmacoecon Open. 2023 Sep;7(5):823-840. doi: 10.1007/s41669-023-00419-w. Epub 2023 Jun 9.

    PubMed 37296268

  • D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.

    PubMed 35644154

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risankizumab IV and risankizumab SC in people with Crohn's Disease, run by AbbVie at 475 sites in 44 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 5 inclusion and 7 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 475 sites in United States, Japan, Germany, Canada, Italy and 39 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 6 Jul 2022). 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?

US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (time frame: Week 12). The study lists 4 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 NCT03105128, which also lists 8 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 6 Jul 2022.

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