AzTrials
AzTrials

Ulcerative Colitis (UC)Phase 3COMMANDNCT03398135

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

A Phase 3 study testing risankizumab in people with Ulcerative Colitis (UC), run by AbbVie at 426 sites in 43 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,242 participants
Where
426 sitesin 43 countries
Study dates
28 Aug 2018to Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Who cannot join

  • Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

Trial locations and contacts

426 sites in 43 countries.

426 sites in 43 countries

United States78 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 159430

    Ann Arbor, Michigan, 48109

  • Inquest Clinical Research /ID# 165686

    Baytown, Texas, 77521-2415

  • Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164257

    Boston, Massachusetts, 02114

  • Texas Digestive Disease Consultants /ID# 209951

    Cedar Park, Texas, 78613-5028

  • GI Alliance /ID# 209799

    Cedar Park, Texas, 78613

  • Atrium Health Carolinas Medical Center /ID# 158543

    Charlotte, North Carolina, 28203

  • Clin Res Inst of Michigan, LLC /ID# 160300

    Chesterfield, Michigan, 48047

  • The University of Chicago Medical Center /ID# 160511

    Chicago, Illinois, 60637-1443

  • South Lake Pain Institute, Inc /ID# 162859

    Clermont, Florida, 34711

  • Cleveland Clinic Main Campus /ID# 209235

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 165838

    Colorado Springs, Colorado, 80907

  • The Ohio State University /ID# 164713

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 167112

    Columbus, Ohio, 43235

  • Gastro One /ID# 160373

    Cordova, Tennessee, 38018

  • Southern California Res. Ctr. /ID# 169659

    Coronado, California, 92118-1408

  • Plains Clinical Research Center, LLC /ID# 169729

    Fargo, North Dakota, 58104-5925

  • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 158235

    Garland, Texas, 75044

  • Gastroenterology Associates, P.A. of Greenville /ID# 160457

    Greenville, South Carolina, 29607

  • Duplicate_Medical Research Center of CT /ID# 160287

    Hamden, Connecticut, 06518

  • Penn State Milton S. Hershey Medical Center /ID# 230474

    Hershey, Pennsylvania, 17033-2360

  • Houma Digestive Health Special /ID# 158377

    Houma, Louisiana, 70360

  • Vilo Research Group Inc /ID# 207657

    Houston, Texas, 77017-2337

  • Baylor College of Medicine /ID# 158230

    Houston, Texas, 77030

  • Centex Studies, Inc. - Houston /ID# 201221

    Houston, Texas, 77058

  • Indiana University /ID# 167250

    Indianapolis, Indiana, 46202

  • Hoag Memorial Hosp Presbyterian /ID# 218347

    Irvine, California, 92618

  • Duplicate_East Tennessee Research Institute /ID# 168744

    Johnson City, Tennessee, 37604

  • Univ Kansas Med Ctr /ID# 226601

    Kansas City, Kansas, 66160

  • UC San Diego Health System /ID# 160430

    La Jolla, California, 92037

  • Rocky Mountain Pediatric Gastroenterology /ID# 207173

    Lone Tree, Colorado, 80124-6798

  • United Medical Doctors /ID# 158574

    Los Alamitos, California, 90720-3309

  • Cedars-Sinai Medical Center /ID# 163848

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934

    Los Angeles, California, 90067-2001

  • Duplicate_Robley Rex VA Medical Center /ID# 218647

    Louisville, Kentucky, 40206

  • Duplicate_Caprock Gastro Research, LLC /ID# 215433

    Lubbock, Texas, 79424-3017

  • Gastroenterology Associates of Central Georgia, LLC /ID# 160513

    Macon, Georgia, 31201

  • Ctr for Advanced Gastroenterol /ID# 202820

    Maitland, Florida, 32751-6108

  • Great Lakes Gastroenterology Research, LLC /ID# 201778

    Mentor, Ohio, 44060-6211

  • University of Miami /ID# 160456

    Miami, Florida, 33136

  • Coral Research Clinic /ID# 158608

    Miami, Florida, 33186-4643

  • South Florida Research Ph I-IV, Inc. /ID# 161844

    Miami, Florida, 33193

  • Gastroenterology Group Naples /ID# 165210

    Naples, Florida, 34102

  • Vanderbilt University Medical Center /ID# 160567

    Nashville, Tennessee, 37232-0011

  • Yale Univ Digestive Diseases /ID# 213265

    New Haven, Connecticut, 06510

  • Delricht Research /ID# 206817

    New Orleans, Louisiana, 70115

  • Nola Research Works, LLC /ID# 161356

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 161945

    New Port Richey, Florida, 34653

  • Weill Cornell Medicine /ID# 165884

    New York, New York, 10022

  • Columbia Univ Medical Center /ID# 161929

    New York, New York, 10032-3725

  • Lenox Hill Hospital /ID# 168469

    New York, New York, 10075

  • Manhattan Clinical Research, LLC /ID# 211803

    New York, New York, 10279

  • Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171128

    North Massapequa, New York, 11758

  • DM Clinical Research/Southwest /ID# 165009

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute /ID# 160465

    Ogden, Utah, 84405

  • Digestive Disease Specialists /ID# 170777

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research Inc. /ID# 167312

    Omaha, Nebraska, 68114-3723

  • Advent Health /ID# 160393

    Orlando, Florida, 32803

  • Endoscopic Research, Inc. /ID# 206709

    Orlando, Florida, 32803

  • Omega Research Group /ID# 203105

    Orlando, Florida, 32808

  • University of Pennsylvania /ID# 166262

    Philadelphia, Pennsylvania, 19104-5502

  • Gastroenterology Consultants of Southwest Virginia /ID# 218142

    Roanoke, Virginia, 24014-1372

  • Mayo Clinic - Rochester /ID# 200455

    Rochester, Minnesota, 55905-0001

  • Duplicate_University of Rochester Medical Center /ID# 161660

    Rochester, New York, 14642

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 161364

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 168774

    San Antonio, Texas, 78229-5390

  • UCSF Medical Center - Mount Zion /ID# 201209

    San Francisco, California, 94115

  • Virginia Mason Hospital & Medical Center /ID# 160432

    Seattle, Washington, 98101

  • Louisiana Research Center, LLC /ID# 201205

    Shreveport, Louisiana, 71105-6800

  • Duplicate_Lenus Research & Medical Group /ID# 169727

    Sweetwater, Florida, 33172

  • ProMedica Physicians Digestive Healthcare /ID# 215622

    Sylvania, Ohio, 43560-2767

  • Clinical Research Trials of Florida, Inc. /ID# 201794

    Tampa, Florida, 33607

  • Duplicate_AdventHealth Tampa /ID# 170482

    Tampa, Florida, 33613-4680

  • Baylor Scott & White Center for Diagnostic Medicine /ID# 204132

    Temple, Texas, 76508

  • Cotton O'Neil Clinical Research Center, Digestive Health /ID# 160367

    Topeka, Kansas, 66606

  • Adult Gastroenterology Associates - Gen 1 Research /ID# 208873

    Tulsa, Oklahoma, 74136-7823

  • Tyler Research Institute, LLC /ID# 166799

    Tyler, Texas, 75701

  • Gastro Health & Nutrition - Victoria /ID# 164308

    Victoria, Texas, 77904

  • Digestive Disease Associates, LTD - Wyomissing /ID# 232406

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan61 sites

  • Tokatsu Tsujinaka Hospital /ID# 164310

    Abiko-shi, Chiba, 270-1168

  • Duplicate_Asahikawa Medical University Hospital /ID# 164324

    Asahikawa-shi, Hokkaido, 078-8510

  • Institute of Science Tokyo Hospital /ID# 164225

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital /ID# 209633

    Chiba, Chiba, 260-8677

  • Fukuoka University Chikushi Hospital /ID# 209056

    Chikushino-shi, Fukuoka, 818-8502

  • St. Lukes International Hospital /ID# 225969

    Chuo-ku, Tokyo, 104-8560

  • Saiseikai Fukuoka Genaral Hospital /ID# 225640

    Fukuoka, Fukuoka, 810-0001

  • Fukuoka University Hospital /ID# 226723

    Fukuoka, Fukuoka, 814-0180

  • National Hospital Organization Fukuyama Medical Center /ID# 164315

    Fukuyama-shi, Hiroshima, 720-8520

  • Gifu University Hospital /ID# 208490

    Gifu, Gifu, 501-1194

  • Tokai University Hachioji Hospital /ID# 227102

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 226729

    Hamamatsu, Shizuoka, 431-3192

  • Matsuda Hospital - Hamamatsu /ID# 226831

    Hamamatsu, Shizuoka, 432-8061

  • National Hospital Organization Hirosaki General Medical Center /ID# 164216

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima University Hospital /ID# 164240

    Hiroshima, Hiroshima, 734-8551

  • Tokai University Hospital /ID# 209207

    Isehara, Kanagawa, 259-1193

  • Sameshima Hospital /ID# 211182

    Kagoshima, Kagoshima-ken, 892-0846

  • Gokeikai Ofuna Chuo Hospital /ID# 169296

    Kamakura-shi, Kanagawa, 247-0056

  • Kanazawa University Hospital /ID# 169221

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital /ID# 169222

    Kashihara-shi, Nara, 634-8522

  • Tsujinaka Hospital - Kashiwanoha /ID# 225968

    Kashiwa-shi, Chiba, 277-0871

  • St Marianna University School Of Medicine /ID# 226730

    Kawasaki-shi, Kanagawa, 216-8511

  • Aoyama Clinic /ID# 164236

    Kobe, Hyōgo, 650-0015

  • Kurume University Hospital /ID# 164237

    Kurume-shi, Fukuoka, 830-0011

  • Kitasato University Kitasato Institute Hospital /ID# 164222

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 164226

    Mitaka-shi, Tokyo, 181-8611

  • Aichi Medical University Hospital /ID# 164227

    Nagakute, Aichi-ken, 480-1195

  • Duplicate_Nagasaki University Hospital /ID# 205326

    Nagasaki, Nagasaki, 852-8501

  • Daido Clinic - Nagoya /ID# 211478

    Nagoya, Aichi-ken, 457-8511

  • Duplicate_Nagoya University Hospital /ID# 164230

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 164229

    Nagoya, Aichi-ken, 467-8602

  • Hyogo Medical University Hospital /ID# 164238

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ogaki Municipal Hospital /ID# 226009

    Ogaki-shi, Gifu, 503-8502

  • Kinshukai Infusion Clinic /ID# 226992

    Osaka, Osaka, 530-0011

  • Shiga University of Medical Science Hospital /ID# 164323

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital /ID# 209273

    Saga, Saga-ken, 849-8501

  • Kitasato University Hospital /ID# 169223

    Sagamihara-shi, Kanagawa, 252-0375

  • Tokitokai Tokito clinic /ID# 164218

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 164219

    Sakura-shi, Chiba, 285-8741

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164215

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 164278

    Sapporo, Hokkaido, 060-8543

  • Sapporo IBD Clinic /ID# 225967

    Sapporo, Hokkaido, 064-0919

  • Sapporo Higashi Tokushukai Hospital /ID# 208493

    Sapporo, Hokkaido, 065-0033

  • Tohoku University Hospital /ID# 164276

    Sendai, Miyagi, 9808574

  • NTT Medical Center Tokyo /ID# 225595

    Shinagawa-ku, Tokyo, 141-8625

  • Keio University Hospital /ID# 203630

    Shinjuku-ku, Tokyo, 160-8582

  • Tokuyama Central Hospital /ID# 226857

    Shunan-shi, Yamaguchi, 745-8522

  • NHO Shizuoka Medical Center /ID# 164314

    Sunto-gun, Shizuoka, 411-8611

  • National Hospital Organization Takasaki General Medical Center /ID# 164312

    Takasaki-shi, Gunma, 370-0829

  • Osaka Medical and Pharmaceutical University Hospital /ID# 226036

    Takatsuki-shi, Osaka, 569-8686

  • The Jikei University Hospital /ID# 164279

    Tokyo, 105-8461

  • Teikyo University Hospital /ID# 225594

    Tokyo, 173-8605

  • Fujita Health University Hospital /ID# 164313

    Toyoake, Aichi-ken, 470-1192

  • Mie University Hospital /ID# 203635

    Tsu, Mie-ken, 514-8507

  • Japanese Red Cross Wakayama Medical Center /ID# 171196

    Wakayama, Wakayama, 640-8558

  • Wakayama Medical University Hospital /ID# 169485

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital /ID# 171481

    Yamagata, Yamagata, 990-9585

  • Yokkaichi Hazu Medical Center /ID# 164316

    Yokkaichi-shi, Mie-ken, 510-0016

  • Matsushima Hospital /ID# 254448

    Yokohama, Kanagawa, 220-0041

  • Colo-proctology Center Matsushima Clinic /ID# 225915

    Yokohama, Kanagawa, 220-0045

  • SHOWA Medical University Fujigaoka Hospital /ID# 209606

    Yokohama, Kanagawa, 227-8501

Other trials in Japan

China25 sites

  • Beijing Friendship Hospital /ID# 211061

    Beijing, Beijing Municipality, 100032

  • The First Hospital of Jilin University /ID# 212277

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital Of Central South University /ID# 211196

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University /ID# 211275

    Chengdu, Sichuan, 610041

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 211229

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 211024

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211062

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Anhui Medical University /ID# 211227

    Hefei, Anhui, 230022

  • Huai'an First People's Hospital /ID# 239197

    Huaian, Jiangsu, 223399

  • The First Affiliated Hospital of Nanchang University /ID# 212182

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 227438

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital /ID# 211234

    Nanjing, Jiangsu, 210029

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210960

    Shanghai, Shanghai Municipality, 200065

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211230

    Shanghai, Shanghai Municipality, 200127

  • Shanghai East Hospital /ID# 218796

    Shanghai, Shanghai Municipality, 200136

  • Shanghai General Hospital /ID# 226652

    Shanghai, Shanghai Municipality, 201600

  • Shengjing Hospital of China Medical University /ID# 211643

    Shenyang, Liaoning, 110022

  • The Second Hospital of Hebei Medical University /ID# 213019

    Shijiazhuang, Hebei, 050000

  • Tongji Hospital Tongji Medical College of HUST /ID# 211069

    Wuhan, Hubei, 430030

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211070

    Wuhan, Hubei, 430048

  • Renmin Hospital of Wuhan University /ID# 212867

    Wuhan, Hubei, 430060

  • Wuxi People's Hospital /ID# 218797

    Wuxi, Jiangsu, 214023

  • Xijing Hospital /ID# 210708

    Xi'an, Shaanxi, 710032

  • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215505

    Xi’an, Shanxi, 710038

  • General Hospital of Ningxia Medical University /ID# 213912

    Yinchuan, Ningxia, 750000

Other trials in China

Germany20 sites

  • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219146

    Berlin, 10787

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159380

    Berlin, 10825

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210508

    Berlin, 12203

  • DRK Kliniken Berlin Westend /ID# 166155

    Berlin, 14050

  • Stadtisches Klinikum Braunschweig /ID# 163694

    Braunschweig, 38126

  • Universitaetsklinikum Koeln /ID# 164993

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Erlangen /ID# 159373

    Erlangen, Bavaria, 91054

  • Duplicate_Agaplesion Markus Krankenhaus /ID# 159375

    Frankfurt am Main, Hesse, 60431

  • Universitaetsklinikum Freiburg /ID# 162038

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Praxiszentrum fuer Gastroenterologie /ID# 219072

    Grevenbroich, North Rhine-Westphalia, 41515

  • Praxis fuer Gastroenterologie /ID# 166154

    Heidelberg, Baden-Wurttemberg, 69121

  • Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 163690

    Kassel, Hesse, 34117

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159379

    Kiel, Schleswig-Holstein, 24105

  • Eugastro /ID# 219071

    Leipzig, Saxony, 04103

  • Klinikum Lueneburg /ID# 163692

    Lüneburg, Lower Saxony, 21339

  • Universitatsklinikum Mannheim /ID# 162039

    Mannheim, Baden-Wurttemberg, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162037

    Minden, North Rhine-Westphalia, 32423

  • Duplicate_LMU Klinikum Campus Grosshadern /ID# 210484

    Munich, Bavaria, 81377

  • Universitaetsklinikum Regensburg /ID# 163693

    Regensburg, 93042

  • Universitaetsklinikum Ulm /ID# 164994

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Russia17 sites

  • Interdisctrict Multidisciplinary Hospital /ID# 204921

    Anzorey, Kabardino-Balkarskaya Respublika, 361350

  • Clinic of New Technologies of Medicine /ID# 204926

    Dzerzhinskiy, 140091

  • Immanuel Kant Baltic Federal University /ID# 204920

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kuzbass Regional Clinical Hospital /ID# 165759

    Kemerovo, Kemerovo Oblast, 650099

  • Arsvita Clinic /ID# 208947

    Korolyov, Moscow Oblast, 141077

  • First Moscow State Medical University n.a I.M. Sechenov /ID# 204981

    Moscow, 119992

  • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203513

    Moscow, 123423

  • Central Clinical Hospital RZHD Medicine /ID# 204922

    Moscow, 129128

  • GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233974

    Nal'chik, Kabardino-Balkarskaya Respublika, 360001

  • Novosibirski Gastrocenter /ID# 229852

    Novosibirsk, Novosibirsk Oblast, 630007

  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227456

    Perm, Permskiy Kray, 614109

  • Euromedservice /ID# 204918

    Pushkin, 196603

  • Uninova Medical Center /ID# 229786

    Saint Petersburg, Leningradskaya Oblast', 198218

  • International Medical Center SOGAZ /ID# 206832

    Saint Petersburg, 191186

  • City Clinical Hospital #40 /ID# 204927

    Sestroretsk, Sankt-Peterburg, 197706

  • Regional Clinical Hospital #1 /ID# 165763

    Tyumen, Tyumen Oblast, 625023

  • Ulyanovsk Regional Clinical Hospital /ID# 204923

    Ulyanovsk, 432017

Other trials in Russia

Italy15 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 155627

    Bologna, 40138

  • Ospedale Cannizzaro /ID# 164039

    Catania, 95126

  • Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 200124

    Catanzaro, 88100

  • Ospedale San Martino /ID# 164030

    Genoa, Genova, 16132

  • ASST Fatebenefratelli Sacco /ID# 155623

    Milan, Milano, 20157

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 170959

    Milan, Milano, 20162

  • Azienda Ospedaliero-Universitaria di Modena /ID# 201818

    Modena, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164029

    Negrar, Verona, 37024

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211450

    Rho, Milano, 20017

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 163994

    Roma, 00128

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158020

    Rome, Roma, 00133

  • Azienda Ospedaliera San Camillo Forlanini /ID# 155628

    Rome, Roma, 00149

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171223

    Rome, Roma, 00161

  • UOC Medicina Interna e Gastroe /ID# 155624

    Rome, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 155626

    Rozzano, Lombardy, 20089

Other trials in Italy

Poland12 sites

  • Vitamed Galaj i Cichomski Sp.j. /ID# 213358

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • NZOZ All-Medicus /ID# 170282

    Katowice, Silesian Voivodeship, 40-659

  • Centrum Medyczne Plejady /ID# 170635

    Krakow, Lesser Poland Voivodeship, 30-363

  • Endoskopia Sp. z o.o. /ID# 170284

    Sopot, Pomeranian Voivodeship, 81-756

  • Gastromed Sp. z o.o /ID# 231065

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • H-T Centrum Medyczne Endoterapia /ID# 231501

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Zdrowia MDM /ID# 170283

    Warsaw, Masovian Voivodeship, 00-189

  • Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 216103

    Warsaw, Masovian Voivodeship, 00-728

  • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 170286

    Warsaw, Masovian Voivodeship, 02-507

  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie Panstwowy Instytut Bada /ID# 170285

    Warsaw, Masovian Voivodeship, 02-781

  • Vivamed Sp. z o.o. /ID# 216308

    Warsaw, Masovian Voivodeship, 03-580

  • Vistamed /ID# 210106

    Wroclaw, Lower Silesian Voivodeship, 53-149

Other trials in Poland

Spain12 sites

  • Hospital Clinic de Barcelona /ID# 159462

    Barcelona, 08036

  • Duplicate_Hospital Universitario Reina Sofia /ID# 167062

    Córdoba, 14004

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159463

    Ferrol, A Coruna, 15405

  • Hospital Universitario de Cabuenes /ID# 170745

    Gijón, Principality of Asturias, 33394

  • Hospital Universitario La Paz /ID# 159471

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 159466

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario Universitario de Pontevedra /ID# 216183

    Pontevedra, 36071

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159473

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Salamanca /ID# 159469

    Salamanca, 37711

  • Hospital Universitario Virgen Macarena /ID# 159969

    Seville, 41009

  • Hospital Alvaro Cunqueiro CHUVI /ID# 167359

    Vigo, Pontevedra, 36213

  • Hospital Universitario Miguel Servet /ID# 159468

    Zaragoza, 50009

Other trials in Spain

Canada11 sites

  • Duplicate_University of Calgary /ID# 169125

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 169770

    Edmonton, Alberta, T5R 1W2

  • Covenant Health /ID# 169128

    Edmonton, Alberta, T6K 4B2

  • Hotel Dieu de Levis /ID# 214379

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Center- University Hospital /ID# 169117

    London, Ontario, N6A 5W9

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169122

    Montreal, Quebec, H1T 2M4

  • Montreal General Hospital- McGill University Health Center /ID# 169118

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc /ID# 169116

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 169127

    North Bay, Ontario, P1B 2H3

  • Toronto Digestive Disease Associates /ID# 169120

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 169123

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

South Korea11 sites

  • Inje University Haeundae Hospital /ID# 203027

    Busan, Busan Gwang Yeogsi, 48108

  • Dong-A University Medical Center /ID# 158665

    Busan, Busan Gwang Yeogsi, 49201

  • Duplicate_Pusan National University Hospital /ID# 158670

    Busan, Busan Gwang Yeogsi, 49241

  • Yeungnam University Medical Center /ID# 158662

    Daegu, 42415

  • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 242379

    Daejeon, Daejeon Gwang Yeogsi, 34943

  • Duplicate_Hanyang University Gurihospital /ID# 158661

    Guri-si, Gyeonggido, 11923

  • CHA Bundang Medical Center /ID# 158669

    Seongnam, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 158666

    Seoul, Seoul Teugbyeolsi, 03181

  • Samsung Medical Center /ID# 158663

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 158660

    Seoul, 03722

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 158664

    Suwon, Gyeonggido, 16247

Other trials in South Korea

France10 sites

  • Duplicate_CHU Amiens-Picardie Site Sud /ID# 207880

    Amiens, Somme, 80054

  • Hopital Beaujon /ID# 207876

    Clichy, Île-de-France Region, 92110

  • APHM - Hopital Nord /ID# 225826

    Marseille, Bouches-du-Rhone, 13015

  • CHU Montpellier - Hopital Saint Eloi /ID# 223781

    Montpellier, Herault, 34295

  • Clinique Jules Verne /ID# 240977

    Nantes, 44300

  • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249861

    Neuilly-sur-Seine, Île-de-France Region, 92200

  • Chu de Nice-Hopital Larchet Ii /Id# 207881

    Nice, Alpes-Maritimes, 06202

  • Centre Hospitalier Universitaire de Bordeaux /ID# 207883

    Pessac, New Aquitaine, 33604

  • Duplicate_CHU de SAINT ETIENNE - Hopital Nord /ID# 207882

    Saint Priest EN Jarez, Pays de la Loire Region, 42270

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 207877

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

Other trials in France

United Kingdom10 sites

  • Barnsley Hospital NHS Foundation Trust /ID# 202771

    Barnsley, S75 2EP

  • Addenbrookes Hospital /ID# 158046

    Cambridge, Cambridgeshire, CB2 2QQ

  • Western General Hospital - NHS Lothian /ID# 208801

    Edinburgh, Edinburgh, City of, EH4 2XU

  • Royal Devon & Exeter Hospital /ID# 157614

    Exeter, Devon, EX2 5DW

  • Liverpool University Hospitals NHS Foundation Trust /ID# 203860

    Liverpool, L7 8XP

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 157617

    London, Greater London, E1 2ES

  • Kings College Hospital NHS Foundation Trust /ID# 158762

    London, Greater London, SE5 9RS

  • St George University Hospitals NHS Foundation Trust /ID# 208379

    London, Greater London, SW17 0QT

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158047

    Newcastle upon Tyne, NE3 3HD

  • University Hospital Southampton NHS Foundation Trust /ID# 210814

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Turkey (Türkiye)9 sites

  • Ankara Univ Medical Faculty /ID# 167205

    Ankara, 06590

  • Inonu Universitesi Turgut Ozal /ID# 203980

    Battalgazi/malatya, 44280

  • Uludag University Medical Faculty /ID# 204179

    Bursa, 16059

  • F?rat University Medical Facul /ID# 171285

    Elâzığ, 23100

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 167202

    Istanbul, 34098

  • Duplicate_Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171290

    Istanbul, 34899

  • Acibadem Kozyatagi Hospital /ID# 213277

    Kadıköy, Istanbul, 34742

  • Duplicate_Erciyes University Medical Fac /ID# 171283

    Melikgazi, Kayseri, 38030

  • Sisli Etfal Train & Res Hosp /ID# 171415

    Şişli, Istanbul, 34371

Other trials in Turkey (Türkiye)

Belgium8 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 200256

    Anderlecht, Brussels Capital, 1070

  • Imelda Ziekenhuis /ID# 211101

    Bonheiden, Antwerpen, 2820

  • Cliniques Universitaires UCL Saint-Luc /ID# 200260

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Leuven /ID# 170829

    Leuven, Vlaams-Brabant, 3000

  • Groupe Sante CHC - Clinique du MontLegia /ID# 200255

    Liège, Liege, 4000

  • CHU de Liege /ID# 200257

    Liège, 4000

  • AZ-Delta /ID# 200258

    Roeselare, West-Vlaanderen, 8800

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 200259

    Yvoir, Namur, 5530

Other trials in Belgium

Greece8 sites

  • General Hospital of Athens Ippokratio /ID# 229190

    Athens, Attica, 11527

  • General Hospital of Athens Laiko /ID# 206438

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170910

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217479

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 165327

    Heraklion, Crete, 71500

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 165313

    Nikaia, Attica, 18454

  • Tzaneio general hospital of Piraeus /ID# 206437

    Piraeus, Attica, 18536

  • Theageneio Anticancer Hospital /ID# 165329

    Thessaloniki, 54639

Other trials in Greece

Portugal8 sites

  • Duplicate_Hospital Garcia de Orta, EPE /ID# 165579

    Almada, Setúbal District, 2805-267

  • Unidade Local de Saude de Coimbra, EPE /ID# 166050

    Coimbra, 3000-075

  • Centro Hospitalar Do Alto Ave - Hospital Senhora Da Oliveira /ID# 165576

    Guimarães, Braga District, 4839-008

  • Duplicate_Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Cap /ID# 165578

    Lisbon, 1169-050

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166563

    Portimão, Faro District, 8500-338

  • Unidade Local de Saude Sao Joao, EPE /ID# 165577

    Porto, 4200-319

  • Centro Hospitalar de Entre Douro e Vouga /ID# 166048

    Santa Maria DA Feira, Porto District, 4520-211

  • Centro Hosp de Tondela-Viseu /ID# 166049

    Viseu, 3504-509

Other trials in Portugal

Brazil7 sites

  • Upeclin Fmb - Unesp /Id# 157691

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 157677

    Curitiba, Paraná, 80810-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157683

    Goiânia, Goiás, 74535-170

  • Hospital de Clinicas de Porto Alegre /ID# 157670

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 157668

    Ribeirão Preto, São Paulo, 14049-900

  • Faculdade de Medicina do ABC /ID# 163993

    Santo André, La Spezia, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 157686

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

Other trials in Brazil

Israel6 sites

  • Soroka University Medical Center /ID# 171093

    Beersheba, Southern District, 8443901

  • Rambam Health Care Campus /ID# 171096

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 163543

    Jerusalem, Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 171092

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center. /ID# 167402

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 211279

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

New Zealand6 sites

  • Christchurch Hospital. /ID# 205337

    Christchurch, Canterbury, 8011

  • Waikato Hospital /ID# 212788

    Hamilton, Waikato Region, 3240

  • Hutt Hospital /ID# 212787

    Lower Hutt, Wellington Region, 5010

  • Wellington Regional Hospital /ID# 205338

    Newtown, Wellington Region, 6021

  • Dunedin Hospital /ID# 212791

    Otago, Otago, 9016

  • Tauranga Hospital /ID# 212793

    Tauranga South, Bay of Plenty, 3112

Other trials in New Zealand

Romania6 sites

  • Sana Monitoring /Id# 224154

    Bucharest, 011025

  • Fundeni Clinical Institute /ID# 171259

    Bucharest, 022328

  • Fundeni Clinical Institute /ID# 224155

    Bucharest, 022328

  • Clinica Gastro Med SRL /ID# 224156

    Cluj-Napoca, Cluj, 400380

  • Cabinet Particular Policlinic Algomed /ID# 171260

    Timișoara, 300002

  • Duplicate_Centrul Medical Tuculanu SRL /ID# 171263

    Timișoara, 300168

Other trials in Romania

Serbia6 sites

  • Clinical Hosp Center Zvezdara /ID# 200150

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 200153

    Belgrade, Beograd, 11000

  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224927

    Belgrade, Beograd, 11040

  • Clin Hosp Ctr Bezanijska Kosa /ID# 202060

    Belgrade, Beograd, 11080

  • General Hospital Leskovac /ID# 224198

    Leskovac, Jablanicki Okrug, 16000

  • Duplicate_Clinical Center Vojvodina /ID# 156876

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa6 sites

  • Farmovs (Pty) Ltd /Id# 207538

    Bloemfontein, Free State, 9301

  • Allergy & Immunology (AIU) /ID# 171439

    Cape Town, Western Cape, 7700

  • Dr JP Wright /ID# 171142

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 171141

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 229906

    CAPE TOWN Milnerton, Western Cape, 7441

  • Clinresco Centers /ID# 239825

    Johannesburg, Gauteng, 1619

Other trials in South Africa

Taiwan6 sites

  • Chung Shan Medical University Hospital /ID# 171426

    Taichung, 402

  • China Medical University Hospital /ID# 160194

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 171433

    Taichung, 40705

  • Taipei Veterans General Hosp /ID# 171436

    Taipei, 11217

  • National Taiwan University Hospital /ID# 162188

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 222878

    Taoyuan City, 333

Other trials in Taiwan

Argentina5 sites

  • Cemic /Id# 167805

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1431

  • Gedyt /ID# 243424

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1115

  • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 167802

    Córdoba, 5016

  • Hospital Provincial del Centenario /ID# 170896

    Rosario, Santa Fe Province, 2000

  • Sanatorio 9 de Julio /ID# 167803

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Austria5 sites

  • Duplicate_Medizinische Universitaet Graz /ID# 169052

    Graz, Styria, 8010

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 216043

    Linz, Upper Austria, 4010

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 200686

    Salzburg, 5020

  • Duplicate_Universitaetsklinikum St.Poelten /ID# 169049

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universitaet Wien /ID# 169051

    Vienna, State of Vienna, 1090

Other trials in Austria

Bulgaria5 sites

  • Umbal Kaspela /ID# 200795

    Plovdiv, 4001

  • MHAT Hadzhi Dimitar /ID# 207947

    Sliven, 8800

  • Duplicate_Second MHAT Sofia /ID# 200794

    Sofia, 1202

  • UMHAT Sveti Ivan Rilski /ID# 210798

    Sofia, 1431

  • Hospital Tsaritsa Yoanna /ID# 209978

    Sofiya, Sofia, 1527

Other trials in Bulgaria

Croatia5 sites

  • Poliklinika Borzan d.o.o. /ID# 157595

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki Bolnicki Centar (KBC) Split /ID# 157596

    Split, Split-Dalmatia County, 21000

  • Clinical Hospital Dubrava /ID# 157598

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 157594

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 201915

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Czechia5 sites

  • Duplicate_Fakultni nemocnice u sv. Anny v Brne /ID# 239158

    Brno, Brno-mesto, 656 91

  • SurGal Clinic /ID# 252300

    Brno, South Moravian, 602 00

  • Nemocnice Ceske Budejovice a.s. /ID# 225228

    České Budějovice, 370 01

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 163389

    Hradec Králové, 500 12

  • Fakultni Nemocnice Ostrava /ID# 225568

    Ostrava, Ostrava-mesto, 708 52

Other trials in Czechia

Egypt5 sites

  • Alexandria University /ID# 226795

    Alexandria, Alexandria Governorate, 21131

  • Alexandria University /ID# 226796

    Alexandria, Alexandria Governorate, 21131

  • Duplicate_Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 201824

    Alexandria, 21131

  • Air Force Specialized Hospital /ID# 170984

    Cairo

  • National Liver Institute /ID# 171042

    Menoufiya, Monufia Governorate, 35111

Other trials in Egypt

Ukraine5 sites

  • CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203366

    Ivano-Frankivsk, 76018

  • Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224349

    Kherson, 73000

  • Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 205484

    Kyiv, 02091

  • CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224344

    Kyiv, 04073

  • Medical center of the private enterprise Sygma /ID# 224347

    Kyiv, 04116

Other trials in Ukraine

Chile4 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 210762

    Concepción, Biobio, 4070038

  • Complejo Asistencial Dr. Sotero del Rio /ID# 169386

    Santiago, Santiago Metropolitan, 8207257

  • Hospital Las Higueras /ID# 167094

    Talcahuano, Biobio, 1740000

  • Duplicate_Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213152

    Victoria, Araucania, 4720843

Other trials in Chile

Denmark4 sites

  • Bispebjerg and Frederiksberg Hospital /ID# 208953

    Copenhagen NV, Capital Region, 2400

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 205093

    Hvidovre, Capital Region, 2650

  • Duplicate_Odense Universitets Hospital /ID# 209502

    Odense C, Region Syddanmark, 5000

  • Duplicate_Sjællands Universitetshospital /ID# 200073

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164348

    Banská Bystrica, Banská Bystrica Region, 975 17

  • KM Management, spol. s.r.o. /ID# 206603

    Nitra, Nitra Region, 949 01

  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224100

    Nové Zámky, Nitra Region, 940 34

  • Gastro I., s.r.o. /ID# 164345

    Prešov, Presov, 080 01

Other trials in Slovakia

Colombia3 sites

  • Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 158736

    Bogota DC, Cundinamarca, 111221

  • Fundación Hospitalaria San Vicente de Paul /ID# 171488

    Medellín, Antioquia, 50010

  • Imat Oncomedica /ID# 207041

    Montería, Departamento de Córdoba, 230018

Other trials in Colombia

Mexico3 sites

  • JM Research SC /ID# 206518

    Cuernavaca, Morelos, 62290

  • Health Pharma Professional Research S.A de C.V /ID# 206516

    Del. Benito Juárez, 03810

  • Unidad de Atencion Medica e Investigacion en Salud /ID# 206515

    Mérida, Yucatán, 97000

Other trials in Mexico

Sweden3 sites

  • Alingsas lasarett /ID# 202075

    Alingsås, Västra Götaland County, 441 33

  • Sahlgrenska University Hospital Molndal /ID# 202841

    Mölndal, Västra Götaland County, 431 80

  • Danderyds sjukhus AB /ID# 202036

    Stockholm, 182 88

Other trials in Sweden

Latvia2 sites

  • VCA Polyclinic Aura /ID# 160204

    Riga, 1035

  • Pauls Stradins Clinical University Hospital /ID# 160205

    Riga, LV-1002

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 201142

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 201144

    Vilnius, 08661

Other trials in Lithuania

Netherlands2 sites

  • Amsterdam UMC, locatie AMC /ID# 157965

    Amsterdam, North Holland, 1105 AZ

  • Elisabeth Tweesteden Ziekenhuis /ID# 163738

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Puerto Rico2 sites

  • Ponce Medical School Foundation /ID# 222825

    Ponce, 00716-0377

  • VA Caribbean Healthcare System /ID# 222779

    San Juan, 00921-3201

Other trials in Puerto Rico

Switzerland2 sites

  • Inselspital, Universitaetsspital Bern /ID# 202909

    Bern, 3010

  • University Hospital Zurich /ID# 202908

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Singapore1 site

  • Mount Elizabeth Hospital /ID# 206563

    Singapore, Central Singapore, 228510

Other trials in Singapore

Slovenia1 site

  • Univ Medical Ctr Ljubljana /ID# 210628

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.

Being tested
risankizumab, placebo for risankizumab
Keywords
ABBV-066, BI 655066
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • risankizumabDrug

    Also called ABBV-066, BI 655066, SKYRIZI

    subcutaneous (SC) injection

  • placebo for risankizumabDrug

    subcutaneous (SC) injection

Study groups in NCT03398135
Study groupRoleWhat they receive
Substudy 1: Double-blind PlaceboPlacebo comparatorParticipants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
Receives: Drug: placebo for risankizumab
Substudy 1: Double-blind Risankizumab Dose 1ExperimentalParticipants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
Receives: Drug: risankizumab
Substudy 1: Double-blind Risankizumab Dose 2ExperimentalParticipants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
Receives: Drug: risankizumab
Substudy 2: Open-label (OL) Clinical Assessment RisankizumabExperimentalParticipants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
Receives: Drug: risankizumab
Substudy 2: OL Therapeutic Drug Monitoring RisankizumabExperimentalParticipants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
Receives: Drug: risankizumab
Substudy 3: OL Extension RisankizumabExperimentalParticipants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
Receives: Drug: risankizumab
OL Continuous Treatment Extension - Dose 1ExperimentalParticipants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.
Receives: Drug: risankizumab
OL Continuous Treatment Extension - Dose 2ExperimentalParticipants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.
Receives: Drug: risankizumab

What is being measured

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

  1. Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score

    Clinical remission per Adapted Mayo Score.

    Measured: Week 52

  2. Percentage of Participants with Adverse Events (AE)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Week 300

Secondary outcomes (17)

  1. Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement

    Endoscopic improvement per endoscopy subscore.

    Measured: Week 52

  2. Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement

    Percentage of participants achieving histologic-endoscopic mucosal improvement.

    Measured: Week 52

  3. Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission

    Endoscopic remission per endoscopy subscore.

    Measured: Week 52

  4. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days

    Clinical remission per Adapted Mayo Score.

    Measured: Week 52

  5. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0

    Clinical remission per Adapted Mayo Score.

    Measured: Week 52

  6. Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency

    Percentage of participants achieving no bowel urgency.

    Measured: Week 52

  7. Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain

    Percentage of participants achieving no abdominal pain.

    Measured: Week 52

  8. Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission

    Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.

    Measured: Week 52

  9. Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0

    Endoscopic improvement per endoscopy subscore.

    Measured: Week 52

  10. Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score

    Clinical response per Adapted Mayo Score.

    Measured: Week 52

  11. Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.

    Measured: Week 0 to Week 52

  12. Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

    Measured: Baseline (Week 0) to Week 52

  13. Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements

    Percentage of participants achieving no nocturnal bowel movements.

    Measured: Week 52

  14. Sub-Study 1: Percentage of Participants Achieving No Tenesmus

    Percentage of participants achieving no tenesmus.

    Measured: Week 52

  15. Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week

    Change in number of fecal incontinence episodes per week.

    Measured: Baseline (Week 0) to Week 52

  16. Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms

    Change in number of days per week with sleep interrupted due to UC symptoms.

    Measured: Baseline (Week 0) to Week 52

  17. Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization

    Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.

    Measured: Through 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 posted12 Jan 2018
  2. Study start28 Aug 2018
  3. Primary completionSep 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03398135
Sponsor's protocol ID
M16-066
Other IDs
2023-506994-36-00, 2023
Acronym
COMMAND
Status last verified
Jan 2026
First submitted
8 Jan 2018
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Panaccione R, Melmed GY, Drobne D, Kaur M, Danese S, Hisamatsu T, Kalabic J, Chen S, Cheng L, Duan WR, Shah S, Louis E. Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment. Clin Gastroenterol Hepatol. 2026 May;24(5):1424-1433. doi: 10.1016/j.cgh.2025.09.007. Epub 2025 Sep 13.

    PubMed 40953785

  • Reinisch W, Loftus EV Jr, Schreiber S, Rubin DT, Louis E, Hecht PM, Barrachina EM, Kalabic J, Vladea R, Sharma D, Duan WR, Zhang Y, Panaccione R. Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis. J Crohns Colitis. 2025 Apr 4;19(4):jjaf025. doi: 10.1093/ecco-jcc/jjaf025.

    PubMed 40168091

  • Panaccione R, Louis E, Colombel JF, D'Haens G, Peyrin-Biroulet L, Dubinsky M, Takeuchi K, Rubin DT, Kalabic J, Chien KB, Chen S, Cheng L, Zhang Y, Duan WR, Vladea R, Hecht PM, Morisset P, Schreiber S, Ferrante M. Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. J Crohns Colitis. 2025 Jan 11;19(1):jjaf005. doi: 10.1093/ecco-jcc/jjaf005.

    PubMed 39804294

  • Louis E, Schreiber S, Panaccione R, Bossuyt P, Biedermann L, Colombel JF, Parkes G, Peyrin-Biroulet L, D'Haens G, Hisamatsu T, Siegmund B, Wu K, Boland BS, Melmed GY, Armuzzi A, Levine P, Kalabic J, Chen S, Cheng L, Shu L, Duan WR, Pivorunas V, Sanchez Gonzalez Y, D'Cunha R, Neimark E, Wallace K, Atreya R, Ferrante M, Loftus EV Jr; INSPIRE and COMMAND Study Group. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024 Sep 17;332(11):881-897. doi: 10.1001/jama.2024.12414.

    PubMed 39037800

  • Thakre N, Goebel A, Winzenborg I, Suleiman AA, D'Cunha R, Mensing S, Liu W, Pang Y. Population Pharmacokinetic and Exposure-Response Modeling to Inform Risankizumab Dose Selection in Patients With Ulcerative Colitis. Clin Pharmacol Ther. 2024 Sep;116(3):847-857. doi: 10.1002/cpt.3330. Epub 2024 Jun 11.

    PubMed 38863178

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risankizumab in people with Ulcerative Colitis (UC), run by AbbVie at 426 sites in 43 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 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 426 sites in United States, Japan, China, Germany, Russia and 38 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

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

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

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

What does the primary outcome measure?

Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score (time frame: 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 NCT03398135, which also lists 5 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 20 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in