AzTrials
AzTrials

Ulcerative Colitis (UC)Phase 2/3NCT03398148

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2/3 study testing risankizumab IV and risankizumab SC in people with Ulcerative Colitis (UC), run by AbbVie at 430 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 objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. 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 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
1,558 participants
Where
430 sitesin 44 countries
Study dates
7 Mar 2018to 11 May 2023
Phase
Phase 2/3
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 at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
  • Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
  • Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
  • Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Who cannot join

  • Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Participant receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Participant with currently known complications of UC (e.g., megacolon).
  • No known active Coronavirus Disease - 2019 (COVID-19) infection.

Trial locations and contacts

430 sites in 44 countries.

430 sites in 44 countries

United States82 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524

    Ann Arbor, Michigan, 48109

  • Inquest Clinical Research /ID# 165685

    Baytown, Texas, 77521-2415

  • Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255

    Boston, Massachusetts, 02114

  • Texas Digestive Disease Consultants /ID# 209950

    Cedar Park, Texas, 78613-5028

  • GI Alliance /ID# 209798

    Cedar Park, Texas, 78613

  • Atrium Health Carolinas Medical Center /ID# 158512

    Charlotte, North Carolina, 28203

  • Clin Res Inst of Michigan, LLC /ID# 160327

    Chesterfield, Michigan, 48047

  • The University of Chicago Medical Center /ID# 160521

    Chicago, Illinois, 60637-1443

  • South Lake Pain Institute, Inc /ID# 162878

    Clermont, Florida, 34711

  • Cleveland Clinic Main Campus /ID# 209232

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 165841

    Colorado Springs, Colorado, 80907

  • The Ohio State University /ID# 164714

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 167113

    Columbus, Ohio, 43235

  • Gastro One /ID# 160418

    Cordova, Tennessee, 38018

  • Southern California Res. Ctr. /ID# 169660

    Coronado, California, 92118-1408

  • Plains Clinical Research Center, LLC /ID# 169732

    Fargo, North Dakota, 58104-5925

  • DHAT Research Institute /ID# 158226

    Garland, Texas, 75044-2208

  • Carolina Research /ID# 201090

    Greenville, North Carolina, 27834

  • Gastroenterology Associates, P.A. of Greenville /ID# 160472

    Greenville, South Carolina, 29607

  • Medical Research Center of CT /ID# 160311

    Hamden, Connecticut, 06518

  • Penn State Milton S. Hershey Medical Center /ID# 223563

    Hershey, Pennsylvania, 17033-2360

  • Houma Digestive Health Special /ID# 158317

    Houma, Louisiana, 70360

  • Vilo Research Group Inc /ID# 207656

    Houston, Texas, 77017-2337

  • CliniCore International, LLC /ID# 158218

    Houston, Texas, 77027-6812

  • Baylor College of Medicine - Baylor Medical Center /ID# 158221

    Houston, Texas, 77030-3411

  • Precision Research Institute, LLC /ID# 201351

    Houston, Texas, 77036

  • Centex Studies, Inc. - Houston /ID# 201222

    Houston, Texas, 77058

  • Indiana University /ID# 167252

    Indianapolis, Indiana, 46202

  • Hoag Memorial Hosp Presbyterian /ID# 218348

    Irvine, California, 92618

  • East Tennessee Research Institute /ID# 168747

    Johnson City, Tennessee, 37604

  • Univ Kansas Med Ctr /ID# 226602

    Kansas City, Kansas, 66160

  • UC San Diego Health System /ID# 160452

    La Jolla, California, 92037

  • Rocky Mountain Pediatric Gastroenterology /ID# 207174

    Lone Tree, Colorado, 80124-6798

  • United Medical Doctors /ID# 158528

    Los Alamitos, California, 90720-3309

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931

    Los Angeles, California, 90067-2001

  • Robley Rex VA Medical Center /ID# 218648

    Louisville, Kentucky, 40206

  • Caprock Gastro Research, LLC /ID# 215432

    Lubbock, Texas, 79424-3017

  • Gastroenterology Associates of Central Georgia, LLC /ID# 160523

    Macon, Georgia, 31201

  • Ctr for Advanced Gastroenterol /ID# 202811

    Maitland, Florida, 32751-6108

  • Great Lakes Gastroenterology Research, LLC /ID# 201777

    Mentor, Ohio, 44060-6211

  • University of Miami /ID# 160471

    Miami, Florida, 33136

  • Coral Research Clinic /ID# 158584

    Miami, Florida, 33186-4643

  • South Florida Research Ph I-IV, Inc. /ID# 161848

    Miami, Florida, 33193

  • Gastroenterology Group Naples /ID# 165212

    Naples, Florida, 34102

  • Vanderbilt University Medical Center /ID# 160580

    Nashville, Tennessee, 37232-0011

  • Yale Univ Digestive Diseases /ID# 213179

    New Haven, Connecticut, 06510

  • Delricht Research /ID# 206815

    New Orleans, Louisiana, 70115

  • Nola Research Works, LLC /ID# 161368

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 161938

    New Port Richey, Florida, 34653

  • Weill Cornell Medicine /ID# 165887

    New York, New York, 10022

  • Columbia Univ Medical Center /ID# 161934

    New York, New York, 10032-3725

  • Lenox Hill Hospital /ID# 168470

    New York, New York, 10075

  • Manhattan Clinical Research, LLC /ID# 211805

    New York, New York, 10279

  • DiGiovanna Institute for Medical Education & Research /ID# 171129

    North Massapequa, New York, 11758

  • DM Clinical Research/Southwest /ID# 165012

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute /ID# 160480

    Ogden, Utah, 84403

  • Digestive Disease Specialists /ID# 170779

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research Inc. /ID# 167313

    Omaha, Nebraska, 68114-3723

  • Advent Health /ID# 160433

    Orlando, Florida, 32803

  • Endoscopic Research, Inc. /ID# 206711

    Orlando, Florida, 32803

  • Omega Research Group /ID# 203059

    Orlando, Florida, 32808

  • University of Pennsylvania /ID# 166266

    Philadelphia, Pennsylvania, 19104-5502

  • Gastroenterology Consultants of Southwest Virginia /ID# 218143

    Roanoke, Virginia, 24014-1372

  • Mayo Clinic - Rochester /ID# 200458

    Rochester, Minnesota, 55905-0001

  • University of Rochester Medical Center /ID# 161664

    Rochester, New York, 14642

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 161376

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 168776

    San Antonio, Texas, 78229-5390

  • UCSF Center for Colitis and Crohn's Disease /ID# 201210

    San Francisco, California, 94115-3011

  • Virginia Mason Medical Center /ID# 160466

    Seattle, Washington, 98101

  • Louisana Research Center, LLC /ID# 201204

    Shreveport, Louisiana, 71105-6800

  • Atlanta Gastroenterology Spec /ID# 161372

    Suwanee, Georgia, 30024

  • Lenus Research & Medical Group /ID# 169730

    Sweetwater, Florida, 33172

  • ProMedica Physicians Digestive Healthcare /ID# 215623

    Sylvania, Ohio, 43560-2767

  • Clinical Research Trials of Florida, Inc. /ID# 201783

    Tampa, Florida, 33607

  • AdventHealth Tampa /ID# 170503

    Tampa, Florida, 33613-4680

  • Baylor Scott & White Center for Diagnostic Medicine /ID# 204130

    Temple, Texas, 76508

  • Cotton-O'Neil Clinical Res Ctr /ID# 160412

    Topeka, Kansas, 66606

  • Adult Gastroenterology Associates - Gen 1 Research /ID# 208867

    Tulsa, Oklahoma, 74136-7823

  • Tyler Research Institute, LLC /ID# 166800

    Tyler, Texas, 75701-4464

  • Gastro Health & Nutrition - Victoria /ID# 164321

    Victoria, Texas, 77904

  • Cedars-Sinai Medical Center-West Hollywood /ID# 163851

    West Hollywood, California, 90048

  • Digestive Disease Associates, LTD /ID# 232407

    Wyomissing, Pennsylvania, 19610-2002

Other trials in United States

Japan60 sites

  • Tokatsu Tsujinaka Hospital /ID# 164438

    Abiko-shi, Chiba, 270-1168

  • Asahikawa Medical University Hospital /ID# 164433

    Asahikawa-shi, Hokkaido, 078-8510

  • Tokyo Medical And Dental University Hospital /ID# 164258

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital /ID# 209632

    Chiba, Chiba, 260-8677

  • Fukuoka University Chikushi Hospital /ID# 209055

    Chikushino-shi, Fukuoka, 818-8502

  • St.Luke's International Hospital /ID# 225822

    Chuo-ku, Tokyo, 104-8560

  • Saiseikai Fukuoka Genaral Hospital /ID# 225639

    Fukuoka, Fukuoka, 810-0001

  • Fukuoka University Hospital /ID# 226189

    Fukuoka, Fukuoka, 814-0180

  • NHO Fukuyama Medical Center /ID# 164439

    Fukuyama-shi, Hiroshima, 720-8520

  • Gifu University Hospital /ID# 208081

    Gifu, Gifu, 501-1194

  • Tokai University Hachioji Hospital /ID# 226899

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 226727

    Hamamatsu, Shizuoka, 431-3192

  • Matsuda Hospital /ID# 226616

    Hamamatsu, Shizuoka, 432-8061

  • National Hospital Organization Hirosaki General Medical Center /ID# 164252

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima University Hospital /ID# 164426

    Hiroshima, Hiroshima, 734-8551

  • Tokai University Hospital /ID# 209204

    Isehara-shi, Kanagawa, 259-1193

  • Teikyo University Hospital /ID# 225588

    Itabashi-ku, Tokyo, 173-8606

  • Sameshima Hospital /ID# 211181

    Kagoshima, Kagoshima-ken, 892-0846

  • Gokeikai Ofuna Chuo Hospital /ID# 169300

    Kamakura-shi, Kanagawa, 247-0056

  • Kanazawa University Hospital /ID# 169224

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital /ID# 169225

    Kashihara-shi, Nara, 634-8522

  • Tsujinaka Hospital Kashiwanoha /ID# 208964

    Kashiwa-shi, Chiba, 277-0871

  • St. Marianna University Hospital /ID# 226728

    Kawasaki-shi, Kanagawa, 216-8511

  • Aoyama Clinic /ID# 164425

    Kobe, Hyōgo, 650-0015

  • Kurume University Hospital /ID# 164427

    Kurume-shi, Fukuoka, 830-0011

  • The Jikei University Hospital /ID# 164434

    Minato-ku, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital /ID# 164256

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 164259

    Mitaka-shi, Tokyo, 181-8611

  • Aichi Medical University Hospital /ID# 164332

    Nagakute-shi, Aichi-ken, 480-1195

  • Nagasaki University Hospital /ID# 202674

    Nagasaki, Nagasaki, 852-8501

  • Daido Clinic /ID# 211479

    Nagoya, Aichi-ken, 457-8511

  • Nagoya University Hospital /ID# 164271

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 164331

    Nagoya, Aichi-ken, 467-8602

  • Hyogo Medical University Hospital /ID# 164424

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ogaki Municipal Hospital /ID# 226010

    Ogaki-shi, Gifu, 503-8502

  • Kinshukai Infusion Clinic /ID# 226747

    Osaka, Osaka, 530-0011

  • Shiga University of Medical Science Hospital /ID# 164440

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital /ID# 209396

    Saga, Saga-ken, 849-8501

  • Kitasato University Hospital /ID# 169226

    Sagamihara-shi, Kanagawa, 252-0375

  • Tokitokai Tokito clinic /ID# 164253

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 164254

    Sakura-shi, Chiba, 285-8741

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 164432

    Sapporo, Hokkaido, 060-8543

  • Sapporo IBD Clinic /ID# 225923

    Sapporo, Hokkaido, 064-0919

  • Sapporo Higashi Tokushukai Hospital /ID# 208488

    Sapporo, Hokkaido, 065-0033

  • Tohoku University Hospital /ID# 164430

    Sendai, Miyagi, 9808574

  • NTT Medical Center Tokyo /ID# 225587

    Shinagawa-ku, Tokyo, 141-8625

  • Keio University Hospital /ID# 203629

    Shinjuku-ku, Tokyo, 160-8582

  • Tokuyama Central Hospital /ID# 226011

    Shunan-shi, Yamaguchi, 745-8522

  • NHO Shizuoka Medical Center /ID# 164435

    Sunto-gun, Shizuoka, 411-8611

  • National Hospital Organization Takasaki General Medical Center /ID# 164437

    Takasaki-shi, Gunma, 370-0829

  • Osaka Medical and Pharmaceutical University Hospital /ID# 226035

    Takatsuki-shi, Osaka, 569-8686

  • Fujita Health University Hospital /ID# 164261

    Toyoake-shi, Aichi-ken, 470-1192

  • Mie University Hospital /ID# 203633

    Tsu, Mie-ken, 514-8507

  • Japanese Red Cross Wakayama Medical Center /ID# 171195

    Wakayama, Wakayama, 640-8558

  • Wakayama Medical University Hospital /ID# 169487

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital /ID# 171474

    Yamagata, Yamagata, 990-9585

  • Yokkaichi Hazu Medical Center /ID# 164441

    Yokkaichi-shi, Mie-ken, 510-0016

  • Colo-proctology Center Matsushima Clinic /ID# 225914

    Yokohama, Kanagawa, 220-0045

  • Showa University Fujigaoka Hospital /ID# 209555

    Yokohama, Kanagawa, 227-8501

Other trials in Japan

China25 sites

  • Beijing Friendship Hospital /ID# 211066

    Beijing, Beijing Municipality, 100032

  • The First Hospital of Jilin University /ID# 212278

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University /ID# 211198

    Changsha, 410011

  • West China Hospital, Sichuan University /ID# 211276

    Chengdu, Sichuan, 610041

  • The Sixth Affiliated Hosp Sun /ID# 211231

    Guangzhou, Guangdong, 510655

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211025

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211064

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Anhui Medical University /ID# 211228

    Hefei, Anhui, 230022

  • Huai'an First People's Hospital /ID# 239196

    Huaian, Jiangsu, 223399

  • The First Affiliated Hospital of Nanchang University /ID# 212183

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 227439

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital /ID# 211232

    Nanjing, Jiangsu, 210029

  • Shanghai East Hospital /ID# 218791

    Pudong New District, Shanghai Municipality, 200136

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210962

    Shanghai, Shanghai Municipality, 200065

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211233

    Shanghai, Shanghai Municipality, 200127

  • Shanghai General Hospital /ID# 226190

    Shanghai, Shanghai Municipality, 201600

  • Shengjing Hospital of China Medical University /ID# 211646

    Shenyang, 110022

  • The Second Hospital of Hebei Medical University /ID# 213018

    Shijiazhuang, Hebei, 050000

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211071

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST /ID# 211072

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University /ID# 212868

    Wuhan, Hubei, 430060

  • Wuxi People's Hospital /ID# 218798

    Wuxi, Jiangsu, 214023

  • Xijing Hospital /ID# 211639

    Xi'an, Shaanxi, 710032

  • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215504

    Xi'an, Shaanxi, 710038

  • General Hospital of Ningxia Medical University /ID# 213911

    Yinchuan, Ningxia, 750000

Other trials in China

Germany20 sites

  • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219145

    Berlin, 10787

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159361

    Berlin, 10825

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210510

    Berlin, 12203

  • DRK Kliniken Berlin Westend /ID# 166153

    Berlin, 14050

  • Stadtisches Klinikum Braunschweig /ID# 163687

    Braunschweig, 38126

  • Universitaetsklinikum Koeln /ID# 164991

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Erlangen /ID# 159354

    Erlangen, Bavaria, 91054

  • Agaplesion Markus Krankenhaus /ID# 159356

    Frankfurt am Main, 60431

  • Universitaetsklinikum Freiburg /ID# 162034

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Praxiszentrum fuer Gastroenterologie /ID# 219069

    Grevenbroich, North Rhine-Westphalia, 41515

  • Praxis fuer Gastroenterologie /ID# 166152

    Heidelberg, Baden-Wurttemberg, 69121

  • Gastroenterologie Opernstrasse /ID# 163683

    Kassel, 34117

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159360

    Kiel, Schleswig-Holstein, 24105

  • EUGASTRO GmbH /ID# 219070

    Leipzig, 04103

  • Klinikum Lueneburg /ID# 163685

    Lüneburg, 21339

  • Universitatsklinikum Mannheim /ID# 162035

    Mannheim, Baden-Wurttemberg, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162033

    Minden, 32423

  • LMU Klinikum Campus Grosshadern /ID# 210481

    München, 81377

  • Universitaetsklinikum Regensburg /ID# 163686

    Regensburg, 93042

  • Universitaetsklinikum Ulm /ID# 164992

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Russia17 sites

  • Interdisctrict Multidisciplinary Hospital /ID# 203335

    Anzorey, Kabardino-Balkarskaya Respublika, 361350

  • Clinic of New Technologies of Medicine /ID# 203369

    Dzerzhinskiy, 140091

  • Immanuel Kant Baltic Federal University /ID# 204888

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kuzbass Regional Clinical Hospital /ID# 165750

    Kemerovo, Kemerovo Oblast, 650099

  • Arsvita Clinic /ID# 208946

    Korolyov, Moscow Oblast, 141077

  • First Moscow State Medical University n.a I.M. Sechenov /ID# 204978

    Moscow, 119992

  • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203512

    Moscow, 123423

  • Central Clinical Hospital RZHD Medicine /ID# 204917

    Moscow, 129128

  • GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233973

    Nal'chik, Kabardino-Balkarskaya Respublika, 360001

  • Novosibirski Gastrocenter /ID# 229855

    Novosibirsk, 630007

  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227457

    Perm, Permskiy Kray, 614109

  • Euromedservice /ID# 204892

    Pushkin, 196603

  • Uninova Medical Center /ID# 229216

    Saint Petersburg, Leningradskaya Oblast', 198218

  • International Medical Center SOGAZ /ID# 206727

    Saint Petersburg, 191186

  • City Clinical Hospital #40 /ID# 203370

    Sestroretsk, Sankt-Peterburg, 197706

  • Regional Clinical Hospital #1 /ID# 165754

    Tyumen, Tyumen Oblast, 625023

  • Ulyanovsk Regional Clinical Hospital /ID# 203368

    Ulyanovsk, 432017

Other trials in Russia

Italy15 sites

  • Ospedale Sant Orsola Malpighi /ID# 155611

    Bologna, Emilia-Romagna, 40138

  • A.O. Per L'Emergenza Cannizzaro /ID# 164036

    Catania, 95126

  • University of Catanzaro /ID# 200125

    Catanzaro, Calabria, 88100

  • Ospedale Policlinico San Martino /ID# 164031

    Genoa, Genova, 16132

  • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155607

    Milan, 20157

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 170947

    Milan, 20162

  • Azienda Ospedaliero-Universitaria di Modena /ID# 201819

    Modena, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164041

    Negrar, Verona, 37024

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211449

    Rho, Milano, 20017

  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 163992

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini /ID# 155612

    Rome, Lazio, 00152

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171226

    Rome, Lazio, 00161

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158018

    Rome, Roma, 00133

  • UOC Medicina Interna e Gastroe /ID# 155608

    Rome, 00168

  • Istituto Clinico Humanitas /ID# 155610

    Rozzano, Milano, 20089

Other trials in Italy

Poland12 sites

  • Vitamed Gałaj i Cichomski Sp.j. /ID# 213283

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • NZOZ All-Medicus /ID# 170596

    Katowice, Silesian Voivodeship, 40-659

  • Centrum Medyczne Plejady /ID# 170633

    Krakow, Lesser Poland Voivodeship, 30-363

  • Endoskopia Sp. z o.o. /ID# 170598

    Sopot, Pomeranian Voivodeship, 81-756

  • Gastromed Sp. z o.o /ID# 230978

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • H-T. Centrum Medyczne - Endoterapia /ID# 230979

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Zdrowia MDM /ID# 170597

    Warsaw, Masovian Voivodeship, 00-635

  • WIP Warsaw IBD Point Profesor Kierkus /ID# 216102

    Warsaw, Masovian Voivodeship, 00-728

  • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 170601

    Warsaw, Masovian Voivodeship, 02-507

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170600

    Warsaw, Masovian Voivodeship, 02-781

  • NZOZ Vivamed Jadwiga Miecz /ID# 216307

    Warsaw, Masovian Voivodeship, 03-580

  • Vistamed /ID# 210105

    Wroclaw, Lower Silesian Voivodeship, 53-149

Other trials in Poland

Spain12 sites

  • Hospital Clinic de Barcelona /ID# 159439

    Barcelona, 08036

  • Hospital Universitario Reina Sofia /ID# 167058

    Córdoba, 14004

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159440

    Ferrol, A Coruna, 15405

  • Hospital de Cabuenes /ID# 170748

    Gijón, Principality of Asturias, 33394

  • Hospital Universitario La Paz /ID# 159459

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159443

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario Universitario de Pontevedra /ID# 216182

    Pontevedra, 36071

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159461

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Salamanca /ID# 159446

    Salamanca, 37711

  • Hospital Universitario Virgen Macarena /ID# 159968

    Seville, 41009

  • Hospital Alvaro Cunqueiro CHUVI /ID# 167360

    Vigo, Pontevedra, 36213

  • Hospital Universitario Miguel Servet /ID# 159445

    Zaragoza, 50009

Other trials in Spain

Canada11 sites

  • University of Calgary /ID# 169111

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 169767

    Edmonton, Alberta, T5R 1W2

  • Covenant Health /ID# 169114

    Edmonton, Alberta, T6K 4B2

  • Hotel Dieu de Levis /ID# 214378

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Center- University Hospital /ID# 169103

    London, Ontario, N6A 5W9

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108

    Montreal, Quebec, H1T 2M4

  • Royal Victoria Hospital / McGill University Health Centre /ID# 169104

    Montreal, Quebec, H4A 3J1

  • Fraser Clinical Trials Inc /ID# 169102

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 169113

    North Bay, Ontario, P1B 2H3

  • Toronto Digestive Disease Asso /ID# 169106

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 169109

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

South Korea11 sites

  • Inje University Haeundae Hospital /ID# 203028

    Busan, 48108

  • Dong-A University Hospital /ID# 158705

    Busan, 49201

  • Pusan National University Hospital /ID# 158711

    Busan, 49241

  • Yeungnam University Medical Center /ID# 158703

    Daegu, 42415

  • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242378

    Daejeon, 34943

  • Hanyang University Gurihospital /ID# 158702

    Guri-si, Gyeonggido, 11923

  • CHA University Bundang Medical Center /ID# 158710

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 158707

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 158701

    Seoul, Seoul Teugbyeolsi, 03722

  • Samsung Medical Center /ID# 158704

    Seoul, 06351

  • The Catholic University of Korea, ST. Vincent's Hospital /ID# 158706

    Suwon, Gyeonggido, 16247

Other trials in South Korea

France10 sites

  • CHU Amiens-Picardie Site Sud /ID# 171576

    Amiens, Somme, 80054

  • Hopital Beaujon /ID# 200092

    Clichy, Île-de-France Region, 92110

  • APHM - Hopital Nord /ID# 225825

    Marseille, Bouches-du-Rhone, 13015

  • CHU Montpellier - Hôpital Saint Eloi /ID# 223779

    Montpellier, Herault, 34295

  • Clinique Jules Verne /ID# 240976

    Nantes, 44300

  • Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249860

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

  • Chu de Nice-Hopital L'Archet Ii /Id# 171577

    Nice, Alpes-Maritimes, 06200

  • CHU Bordeaux - Hopital Haut Leveque /ID# 171579

    Pessac, Gironde, 33604

  • CHU de SAINT ETIENNE - Hopital Nord /ID# 171580

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

  • CHRU Nancy - Hopitaux de Brabois /ID# 200095

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

Other trials in France

United Kingdom10 sites

  • Barnsley Hospital NHS Foundation Trust /ID# 202770

    Barnsley, S75 2EP

  • Cambridge University Hospitals NHS Foundation Trust /ID# 158040

    Cambridge, CB2 0QQ

  • NHS Lothian /ID# 208802

    Edinburgh, EH3 9HE

  • Royal Devon University Healthcare NHS Foundation Trust /ID# 157587

    Exeter, Devon, EX2 5DW

  • Liverpool University Hospitals NHS Foundation Trust /ID# 203858

    Liverpool, L7 8XP

  • Barts Health NHS Trust /ID# 157590

    London, London, City of, E1 2ES

  • King's College Hospital NHS Foundation Trust /ID# 158766

    London, SE5 9RS

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041

    Newcastle upon Tyne, NE7 7DN

  • University Hospital Southampton NHS Foundation Trust /ID# 210813

    Southampton, Hampshire, SO16 6YD

  • St George's University Hospitals NHS Foundation Trust /ID# 208378

    Tooting, SW17 0QT

Other trials in United Kingdom

Turkey (Türkiye)9 sites

  • Ankara Univ Medical Faculty /ID# 167210

    Ankara, 06590

  • Inonu Universitesi Turgut Ozal /ID# 203981

    Battalgazi/malatya, 44280

  • Uludag University Medical Faculty /ID# 204182

    Bursa, 16059

  • Fırat University Medical Facul /ID# 171292

    Elâzığ, 23100

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207

    Istanbul, 34098

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293

    Istanbul, 34899

  • Acibadem Kozyatagi Hospital /ID# 213276

    Kadıköy, Istanbul, 34742

  • Erciyes University Medical Fac /ID# 171291

    Melikgazi, Kayseri, 38030

  • Sisli Etfal Train & Res Hosp /ID# 171409

    Şişli, 34371

Other trials in Turkey (Türkiye)

Belgium8 sites

  • Imelda Ziekenhuis /ID# 211100

    Bonheiden, 2820

  • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200252

    Brussels, Brussels Capital, 1070

  • CHU UCL Namur - site Godinne /ID# 200254

    Godinne, Namur, 5530

  • Universitair Ziekenhuis Leuven /ID# 170812

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 200253

    Liège, 4000

  • Groupe Sante CHC - Clinique du MontLegia /ID# 200250

    Liège, 4000

  • AZ-Delta /ID# 200040

    Roeselare, West-Vlaanderen, 8800

  • UCL Saint-Luc /ID# 200039

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Greece8 sites

  • General Hospital of Athens Ippokratio /ID# 229189

    Athens, Attica, 11527

  • General Hospital of Athens Laiko /ID# 206440

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217480

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 165216

    Heraklion, Crete, 71500

  • Tzaneio general hospital of Piraeus /ID# 206439

    Piraeus, Attica, 18536

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165218

    Pireaus, 18454

  • Theageneio Anticancer Hospital /ID# 165217

    Thessaloniki, 54639

Other trials in Greece

Portugal8 sites

  • Hospital Garcia de Orta, EPE /ID# 165583

    Almada, 2805-267

  • Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166054

    Coimbra, 3000-075

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165580

    Guimarães, Braga District, 4835-044

  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165582

    Lisbon, 1169-050

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166551

    Portimão, Faro District, 8500-338

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165581

    Porto, 4200-319

  • Centro Hospitalar de Entre Douro e Vouga /ID# 166052

    Santa Maria DA Feira, Porto District, 4520-211

  • Centro Hosp de Tondela-Viseu /ID# 166053

    Viseu, 3504-509

Other trials in Portugal

Brazil7 sites

  • Upeclin Fmb - Unesp /Id# 157690

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 157671

    Curitiba, Paraná, 80810-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157679

    Goiânia, Goiás, 74535-170

  • Hospital de Clinicas de Porto Alegre /ID# 157662

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157660

    Ribeirão Preto, São Paulo, 14051-140

  • Faculdade de Medicina do ABC /ID# 163995

    Santo André, São Paulo, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 157680

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

Other trials in Brazil

Israel6 sites

  • Soroka University Medical Center /ID# 171100

    Beersheba, Southern District, 8443901

  • Rambam Health Care Campus /ID# 171103

    Haifa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 171099

    Jerusalem, Jerusalem, 91120

  • Shaare Zedek Medical Center /ID# 163544

    Jerusalem, 91031

  • Rabin Medical Center /ID# 167403

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 211278

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

New Zealand6 sites

  • Christchurch Hospital /ID# 205342

    Christchurch, Canterbury, 8011

  • Waikato Hospital /ID# 212789

    Hamilton, Waikato Region, 3240

  • Hutt Hospital /ID# 212786

    Lower Hutt, 5010

  • Wellington Regional Hospital /ID# 205343

    Newtown, Wellington Region, 6021

  • Dunedin Hospital /ID# 212790

    Otago, Otago, 9016

  • Tauranga Hospital /ID# 212792

    Tauranga South, Bay of Plenty, 3112

Other trials in New Zealand

Romania6 sites

  • Sana Monitoring /Id# 224166

    Bucharest, 011025

  • Fundeni Clinical Institute /ID# 171264

    Bucharest, 022328

  • Fundeni Clinical Institute /ID# 224168

    Bucharest, 022328

  • Clinica GASTRO MED SRL /ID# 224169

    Cluj-Napoca, Cluj, 400380

  • Cabinet Particular Policlinic Algomed /ID# 171266

    Timișoara, 300002

  • Duplicate_Centrul Medical Tuculanu SRL /ID# 171268

    Timișoara, 300168

Other trials in Romania

Serbia6 sites

  • Clinical Hosp Center Zvezdara /ID# 200151

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 200152

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 202059

    Belgrade, Beograd, 11080

  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224926

    Belgrade, 11040

  • General Hospital Leskovac /ID# 207226

    Leskovac, 16000

  • Clinical Center Vojvodina /ID# 156910

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa6 sites

  • Farmovs (Pty) Ltd /Id# 207537

    Bloemfontein, Free State, 9301

  • Allergy & Immunology (AIU) /ID# 171441

    Cape Town, Western Cape, 7700

  • Dr JP Wright /ID# 171138

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 171137

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 229905

    CAPE TOWN Milnerton, Western Cape, 7441

  • Clinresco Centers /ID# 239824

    Johannesburg, Gauteng, 1619

Other trials in South Africa

Taiwan6 sites

  • Chung Shan Medical University Hospital /ID# 163651

    Taichung, 40201

  • China Medical University Hospital /ID# 160189

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 163649

    Taichung, 40705

  • National Taiwan University Hospital /ID# 162187

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 163650

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital /ID# 222877

    Taoyuan City, 333

Other trials in Taiwan

Argentina5 sites

  • Gedyt /ID# 243423

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1115

  • Cemic /Id# 167782

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1431

  • Hospital Privado Univesitario /ID# 167779

    Córdoba, 5016

  • Hospital Provincial del Centenario /ID# 170898

    Rosario, Santa Fe Province, 2000

  • Sanatorio 9 de Julio /ID# 167780

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Austria5 sites

  • Medizinische Universitaet Graz /ID# 169053

    Graz, Styria, 8010

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 215320

    Linz, Upper Austria, 4010

  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200685

    Salzburg, 5020

  • Duplicate_Universitaetsklinikum St.Poelten /ID# 169048

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universitaet Wien /ID# 169050

    Vienna, State of Vienna, 1090

Other trials in Austria

Bulgaria5 sites

  • UMHAT Kaspela EOOD /ID# 200797

    Plovdiv, 4001

  • MHAT Hadzhi Dimitar /ID# 207945

    Sliven, 8800

  • Second MHAT Sofia /ID# 200799

    Sofia, 1202

  • UMHAT Sveti Ivan Rilski /ID# 210797

    Sofia, 1431

  • UMHAT Tsaritsa Joanna - ISUL /ID# 209977

    Sofia, 1527

Other trials in Bulgaria

Chile5 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 210761

    Concepción, 4070038

  • Complejo Asistencial Dr. Sotero del Rio /ID# 169385

    Santiago, Region Metropolitana Santiago, 8207257

  • Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125

    Santiago, Region Metropolitana Santiago, 8350488

  • Hospital Las Higueras /ID# 167093

    Talcahuano, 1740000

  • Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151

    Victoria, Araucania, 4720843

Other trials in Chile

Croatia5 sites

  • Klinicki bolnicki centar Osijek /ID# 157472

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki bolnicki centar Split /ID# 157473

    Split, Split-Dalmatia County, 21000

  • Clinical Hospital Dubrava /ID# 157475

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 157471

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 201917

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Egypt5 sites

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226793

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226794

    Alexandria, 21131

  • Air Force Specialized Hospital /ID# 170986

    Cairo

  • National Liver Institute /ID# 171040

    Menoufiya, 35111

Other trials in Egypt

Ukraine5 sites

  • CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367

    Ivano-Frankivsk, 76018

  • Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350

    Kherson, 73000

  • Kyiv Municipal Clinical Hospital #18 /ID# 224348

    Kyiv, 01030

  • Medical Center "OK!Clinic+" /ID# 205482

    Kyiv, 02091

  • CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343

    Kyiv, 04073

Other trials in Ukraine

Czechia4 sites

  • Fakultni nemocnice u sv. Anny v Brne /ID# 239157

    Brno, 656 91

  • Nemocnice Ceske Budejovice a.s. /ID# 225226

    České Budějovice, 370 01

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 163395

    Hradec Králové, 500 12

  • Fakultni nemocnice Ostrava /ID# 225567

    Ostrava, 708 52

Other trials in Czechia

Denmark4 sites

  • Bispebjerg and Frederiksberg Hospital /ID# 208945

    Copenhagen NV, Capital Region, 2400

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202266

    Hvidovre, Capital Region, 2650

  • Odense University Hospital /ID# 205602

    Odense C, Region Syddanmark, 5000

  • Sjællands Universitetshospital /ID# 200033

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164347

    Banská Bystrica, 975 17

  • KM Management, spol. s.r.o. /ID# 206602

    Nitra, 949 01

  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224099

    Nové Zámky, 940 34

  • GASTRO I., s.r.o. /ID# 164346

    Prešov, 080 01

Other trials in Slovakia

Mexico3 sites

  • JM Research SC /ID# 203593

    Cuernavaca, Morelos, 62290

  • Health Pharma Professional Research S.A de C.V /ID# 203597

    Del. Benito Juárez, 03810

  • Unidad de Atencion Medica e Investigacion en Salud /ID# 203595

    Mérida, Yucatán, 97000

Other trials in Mexico

Puerto Rico3 sites

  • Ponce Medical School Foundation /ID# 221244

    Ponce, 00716-0377

  • San Jorge Children Hospital /ID# 166954

    San Juan, 00912-3310

  • VA Caribbean Healthcare System /ID# 221245

    San Juan, 00921-3201

Other trials in Puerto Rico

Sweden3 sites

  • Alingsas lasarett /ID# 202074

    Alingsås, Västra Götaland County, 441 33

  • Sahlgrenska University Hospital Molndal /ID# 202843

    Mölndal, Västra Götaland County, 431 80

  • Danderyds sjukhus AB /ID# 202035

    Stockholm, 182 88

Other trials in Sweden

Colombia2 sites

  • Hospital Universitario San Vic /ID# 171490

    Medellín, 50010

  • Oncomédica SAS /ID# 206937

    Montería, Departamento de Córdoba, 230003

Other trials in Colombia

Latvia2 sites

  • VCA Polyclinic Aura /ID# 163802

    Riga, 1035

  • Pauls Stradins Clinical University Hospital /ID# 163803

    Riga, LV- 1002

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 170714

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 170614

    Vilnius, 08661

Other trials in Lithuania

Netherlands2 sites

  • Academisch Medisch Centrum /ID# 157959

    Amsterdam, 1105 AZ

  • Elisabeth Tweesteden Ziekenhuis /ID# 163767

    Tilburg, 5022 GC

Other trials in Netherlands

Switzerland2 sites

  • Inselspital, Universitätsspital Bern /ID# 202911

    Bern, 3010

  • Universitatsspital Zurich /ID# 202910

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Malaysia1 site

  • Universiti Sains Malaysia /ID# 221971

    Kelantan, Kelantan, 16150

Other trials in Malaysia

Singapore1 site

  • KL Ling Gastroenterology and Liver Clinic /ID# 205738

    Singapore, 228510

Other trials in Singapore

Slovenia1 site

  • Univ Medical Ctr Ljubljana /ID# 210627

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Being tested
risankizumab IV, placebo for risankizumab, risankizumab SC
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.

  • risankizumab IVDrug

    Also called ABBV-066, BI 655066

    risankizumab intravenous (IV) infusion

  • placebo for risankizumabDrug

    placebo for risankizumab

  • risankizumab SCDrug

    Also called ABBV-066, BI 655066

    risankizumab subcutaneous (SC) injection

Study groups in NCT03398148
Study groupRoleWhat they receive
Substudy 1, Induction Period 1: Double-blind Placebo IVPlacebo comparatorParticipants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Receives: Drug: placebo for risankizumab
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IVExperimentalParticipants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
Receives: Drug: risankizumab IV
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IVExperimentalParticipants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Receives: Drug: risankizumab IV
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IVExperimentalParticipants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
Receives: Drug: risankizumab IV
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IVExperimentalParticipants receive risankizumab 1800mg administered by intravenous (IV) infusion.
Receives: Drug: risankizumab IV
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SCExperimentalParticipants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
Receives: Drug: risankizumab SC
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SCExperimentalParticipants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
Receives: Drug: risankizumab SC
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IVExperimentalParticipants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
Receives: Drug: risankizumab IV
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV PboExperimentalParticipants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
Receives: Drug: risankizumab IV
Substudy 2, Induction Period 1: Double-blind Placebo IVPlacebo comparatorParticipants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Receives: Drug: placebo for risankizumab
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IVExperimentalParticipants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
Receives: Drug: risankizumab IV
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SCExperimentalParticipants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
Receives: Drug: risankizumab SC
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SCExperimentalParticipants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
Receives: Drug: risankizumab SC
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IVExperimentalParticipants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
Receives: Drug: risankizumab IV
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV PboExperimentalParticipants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
Receives: Drug: risankizumab IV

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

    The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
    3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)

    The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

    For Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1.

    Measured: Week 12

  2. Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score

    The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
    3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)

    The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

    For Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.

    Measured: Week 12

Secondary outcomes (28)

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

    Endoscopic improvement is defined as endoscopy subscore of 0 or 1.

    Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

    Measured: Week 12

  2. Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Full Mayo Score in Participants With a Full Mayo Score of 6 to 12 at Baseline

    The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement.

    Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.

    Measured: Week 12

  3. Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score

    The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
    3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)

    The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease.

    Clinical response per Adapted Mayo Score was defined as decrease from baseline in Adapted Mayo Score ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.

    Measured: Week 12

  4. Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score

    Clinical response per Partial Adapted Mayo Score (without endoscopy).

    The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)

    The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease.

    Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score >= 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.

    Measured: Week 4

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

    Endoscopic remission was defined as endoscopy subscore of 0.

    Measured: Week 12

  6. Sub-Study 1: Percentage of Participants With Hospitalization

    Participants with an event that results in admission to the hospital.

    Measured: Through Week 12

  7. Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)

    Mucosal healing defined as endoscopic and histologic remission.

    Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

    The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.

    Measured: Week 12

  8. Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)

    The US-SQ is a patient questionnaire to assess severity of Ulcerative Colitis (UC) related gastrointestinal symptoms (e.g., frequent bowel movements, abdominal pain, cramping) and non-gastrointestinal symptoms (e.g., joint pain and sleep difficulties).

    It consists of 17 questions and each question is answered on a scale from can be answered on a scale from 1 (Not at all/ never) to 5 (Very much/Always) with overall symptom score range from 17 to 85. A lower score indicates lower UC severity.

    Measured: Baseline Through Week 12

  9. 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.

    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: Baseline Through Week 12

  10. Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component

    The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.

    Measured: Baseline Through Week 12

  11. Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component

    The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.

    Measured: Baseline through Week 12

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

    The FACIT-Fatigue Scale is a validated self-administered 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.

    0 = not at all

    1. = a little bit
    2. = somewhat
    3. = quite a bit
    4. = very much

    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: Baseline Through Week 12

  13. Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries

    Participants who underwent surgery related to UC.

    Measured: Through Week 12

  14. Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score

    The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
    3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)

    The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease.

    Clinical Response is defined as a decrease from baseline in the Adapted Mayo Score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).

    Measured: Week 12

  15. Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement

    Endoscopic Improvement is defined as an endoscopic subscore of 0 or 1.

    Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

    Measured: Week 12

  16. Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)

    Histologic-Endoscopic Mucosal Improvement is defined as an endoscopic subscore of 0 or 1 without evidence of friability and a Geboes score ≤ 3.1.

    The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

    The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers).

    The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.

    Measured: Week 12

  17. Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission

    Endoscopic remission per endoscopy subscore.

    Endoscopic Remission: endoscopic subscore = 0.

    Measured: Week 12

  18. Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4

    Clinical response per Partial Adapted Mayo Score (without endoscopy).

    The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)

    The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease.

    Clinical Response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo Score ≥ 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.

    Measured: Week 4

  19. Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency

    Percentage of participants who reported no bowel urgency. Bowel urgency was assessed by participants in a subject diary completed once a day.

    Measured: Week 12

  20. Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain

    Percentage of participants who reported no abdominal pain. Abdominal pain was assessed by participants in a subject diary completed once a day.

    Measured: Week 12

  21. Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12

    Mucosal healing defined as endoscopic and histologic remission.

    Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

    The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.

    Measured: Week 12

  22. Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    The FACIT-Fatigue Scale is a validated self-administered 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.

    0 = not at all

    1. = a little bit
    2. = somewhat
    3. = quite a bit
    4. = very much

    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: Baseline to Week 12

  23. Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

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

    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: Baseline to Week 12

  24. Sub-Study 2: Occurrence of UC-related Hospitalizations

    Participants with an UC-related event that results in admission to the hospital.

    Measured: Baseline Through Week 12

  25. Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements

    Percentage of participants who reported no nocturnal bowel movements.

    Measured: Week 12

  26. Sub-Study 2: Percentage of Participants Achieving No Tenesmus

    Percentage of participants who reported no tenesmus.

    Measured: Week 12

  27. Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week

    Change in number of fecal incontinence episodes per week.

    Measured: Baseline to Week 12

  28. Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms

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

    Measured: Baseline to 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 posted12 Jan 2018
  2. Study start7 Mar 2018
  3. Primary completion9 Nov 2022
  4. Study completion11 May 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03398148
Sponsor's protocol ID
M16-067
Other IDs
2016-004677-40, 2016
Status last verified
Jan 2025
First submitted
8 Jan 2018
Last updated
16 Jan 2025
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, analyses plans, 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.

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 2/3 study testing risankizumab IV and risankizumab SC in people with Ulcerative Colitis (UC), run by AbbVie at 430 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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 430 sites in United States, Japan, China, Germany, Russia 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jan 2025). 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?

Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score (time frame: Week 12). 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 NCT03398148, 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 16 Jan 2025.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in