AzTrials
AzTrials

Crohn's DiseasePhase 3NCT03104413

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

A Phase 3 study testing risankizumab SC and risankizumab IV in people with Crohn's Disease, run by AbbVie at 403 sites in 43 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 objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD. Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
risankizumab SC and risankizumab IV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
618 participants
Where
403 sitesin 43 countries
Study dates
18 Dec 2017to 19 May 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
  • Demonstrated intolerance or inadequate response to biologic therapy for CD.
  • If female, participant must meet the contraception recommendations.

Who cannot join

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

Trial locations and contacts

403 sites in 43 countries.

403 sites in 43 countries

United States114 sites

  • TX Clinical Research Institute /ID# 159396

    Arlington, Texas, 76012

  • Atlanta Gastro Assoc /ID# 154755

    Atlanta, Georgia, 30342

  • Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970

    Baton Rouge, Louisiana, 70809

  • Inquest Clinical Research /ID# 165696

    Baytown, Texas, 77521-2415

  • Washington Gastroenterology Associates /ID# 162101

    Bellevue, Washington, 98004

  • HP Clinical Research /ID# 162992

    Bountiful, Utah, 84010

  • Seffner Premier Health Care, PA /ID# 162259

    Brandon, Florida, 33510

  • NY Scientific /ID# 158272

    Brooklyn, New York, 11235

  • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446

    Burnt Hills, New York, 12027

  • Texas Digestive Disease Consultants /ID# 209781

    Cedar Park, Texas, 78613-5028

  • Texas Digestive Disease Consultants /ID# 209945

    Cedar Park, Texas, 78613-5028

  • Medical University of South Carolina /ID# 212859

    Charleston, South Carolina, 29425

  • Atrium Health Carolinas Medical Center /ID# 158364

    Charlotte, North Carolina, 28203

  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846

    Chevy Chase, Maryland, 20815

  • Northwestern University Division of GI/Hepatology /ID# 158250

    Chicago, Illinois, 60611-2927

  • The University of Chicago Medical Center /ID# 157113

    Chicago, Illinois, 60637-1443

  • Tri-State Endoscopy /ID# 154939

    Cincinnati, Ohio, 45219

  • Clinical Research of West Florida, Inc /ID# 205864

    Clearwater, Florida, 33765

  • Clinical Research of West Florida, Inc /ID# 208127

    Clearwater, Florida, 33765

  • South Lake Pain Institute, Inc /ID# 162798

    Clermont, Florida, 34711

  • Cleveland Clinic Main Campus /ID# 209225

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 165832

    Colorado Springs, Colorado, 80907

  • Gastro Center of Maryland /ID# 164766

    Columbia, Maryland, 21045

  • The Ohio State University /ID# 164706

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 167877

    Columbus, Ohio, 43235

  • Southern California Res. Ctr. /ID# 211989

    Coronado, California, 92118-1408

  • Western Connecticut Medical Group /ID# 165874

    Danbury, Connecticut, 06810-6000

  • Hometown Urgent Care and Resea /ID# 170447

    Dayton, Ohio, 45424

  • Omega Research Maitland, LLC /ID# 171080

    DeBary, Florida, 32713-2260

  • Universal Axon Clinical Research /ID# 165426

    Doral, Florida, 33166

  • NorthShore University HealthSystem /ID# 158254

    Evanston, Illinois, 60201

  • Plains Clinical Research Center, LLC /ID# 169712

    Fargo, North Dakota, 58104-5925

  • Intercity Advanced Gastroentertology Center /ID# 215204

    Fresh Meadows, New York, 11366

  • DHAT Research Institute /ID# 158199

    Garland, Texas, 75044-2208

  • Gastro One /ID# 154757

    Germantown, Tennessee, 38138

  • Duplicate_Long Island Clinical Research /ID# 154843

    Great Neck, New York, 11021-5343

  • Gastroenterology Associates, P.A. of Greenville /ID# 154919

    Greenville, South Carolina, 29615-3593

  • PennState Milton S.Hershey Med /ID# 154894

    Hershey, Pennsylvania, 17033

  • Houma Digestive Health Special /ID# 158253

    Houma, Louisiana, 70360

  • Vilo Research Group Inc /ID# 207654

    Houston, Texas, 77017-2337

  • CliniCore International, LLC /ID# 158191

    Houston, Texas, 77027-6812

  • Baylor College of Medicine - Baylor Medical Center /ID# 158194

    Houston, Texas, 77030-3411

  • Precision Research Institute, LLC /ID# 201072

    Houston, Texas, 77036

  • Centex Studies, Inc. - Houston /ID# 201218

    Houston, Texas, 77058

  • Newport Huntington Medica /ID# 213034

    Huntington Beach, California, 92648-5994

  • East Tennessee Research Institute /ID# 168735

    Johnson City, Tennessee, 37604

  • Vidant Multispecialty Clinic - Kinston /ID# 161109

    Kinston, North Carolina, 28501-1589

  • SIH Research Mumtaz, Inc /ID# 163081

    Kissimmee, Florida, 34741-4161

  • UC San Diego Health Systems /ID# 155576

    La Jolla, California, 92093

  • Las Vegas Medical Research /ID# 160167

    Las Vegas, Nevada, 89113

  • Revival Research Institute, Inc /ID# 210986

    Las Vegas, Nevada, 89128-3157

  • University of Kentucky Chandler Medical Center /ID# 157109

    Lexington, Kentucky, 40536

  • Alliance Medical Research /ID# 163834

    Lighthouse PT, Florida, 33064

  • Duplicate_Atria Clinical Research /ID# 164504

    Little Rock, Arkansas, 72209-7040

  • Rocky Mountain Pediatric Gastroenterology /ID# 207171

    Lone Tree, Colorado, 80124-6798

  • United Medical Doctors /ID# 207887

    Los Alamitos, California, 90720-3309

  • TLC Clinical Research Inc /ID# 212501

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655

    Los Angeles, California, 90067-2001

  • University of Louisville /ID# 210523

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia, LLC /ID# 154865

    Macon, Georgia, 31201

  • Cfagi Llc /Id# 202482

    Maitland, Florida, 32751-6108

  • Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179

    Memphis, Tennessee, 38119

  • Great Lakes Medical Research, LLC /ID# 201774

    Mentor, Ohio, 44060-6211

  • University of Miami /ID# 155011

    Miami, Florida, 33136

  • Vista Health Research, LLC /ID# 212828

    Miami, Florida, 33176-1032

  • ITB Research /ID# 161278

    Miami, Florida, 33176

  • Coral Research Clinic /ID# 158330

    Miami, Florida, 33186-4643

  • South Florida Research Ph I-IV, Inc. /ID# 161825

    Miami, Florida, 33193

  • WVU Medicine /ID# 167942

    Morgantown, West Virginia, 26506-1200

  • United Medical Doctors - Murrieta /ID# 158278

    Murrieta, California, 92563

  • Gastroenterology Group Naples /ID# 165192

    Naples, Florida, 34102

  • Vanderbilt University Medical Center /ID# 157110

    Nashville, Tennessee, 37232-0011

  • Digestive Disease Care /ID# 211776

    New Hyde Park, New York, 11040

  • North Shore University Hospital /ID# 168734

    New Hyde Park, New York, 11040

  • Delricht Research /ID# 206567

    New Orleans, Louisiana, 70115

  • Nola Research Works, LLC /ID# 161271

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 161973

    New Port Richey, Florida, 34653

  • NYU Langone Medical Center /ID# 160166

    New York, New York, 10016-6402

  • Weill Cornell Medicine /ID# 165856

    New York, New York, 10022

  • Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610

    New York, New York, 10029

  • Columbia Univ Medical Center /ID# 167545

    New York, New York, 10032-3725

  • Lenox Hill Hospital /ID# 168466

    New York, New York, 10075

  • DiGiovanna Institute for Medical Education & Research /ID# 171130

    North Massapequa, New York, 11758

  • Southwest Gastroenterology /ID# 164764

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute /ID# 154922

    Ogden, Utah, 84403

  • Hightower Clinical /ID# 211992

    Oklahoma City, Oklahoma, 73102

  • Digestive Disease Specialists /ID# 170772

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center /ID# 210056

    Omaha, Nebraska, 68198-2000

  • Endoscopic Research, Inc. /ID# 205903

    Orlando, Florida, 32803

  • IMIC Inc. Medical Research /ID# 154944

    Palmetto Bay, Florida, 33157

  • Phoenix VA Health Care System /ID# 162261

    Phoenix, Arizona, 85012

  • Children's Hospital of Pittsburgh of UPMC /ID# 212543

    Pittsburgh, Pennsylvania, 15224-1334

  • Northwest Gastroenterology Clinic /ID# 158255

    Portland, Oregon, 97210

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891

    Raleigh, North Carolina, 27612

  • Rapid City Medical Center - GI Research /ID# 163835

    Rapid City, South Dakota, 57701

  • Hunter Holmes McGuire VA Medical Center /ID# 159977

    Richmond, Virginia, 23249

  • Mayo Clinic - Rochester /ID# 163084

    Rochester, Minnesota, 55905-0001

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 161307

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 168772

    San Antonio, Texas, 78229-5390

  • HonorHealth Research Institute - Shea /ID# 165825

    Scottsdale, Arizona, 85258

  • Virginia Mason - Seattle Orthapedics /ID# 155577

    Seattle, Washington, 98101

  • Louisana Research Center, LLC /ID# 162239

    Shreveport, Louisiana, 71105-6800

  • Clinical Research Trials of Florida, Inc. /ID# 201606

    Tampa, Florida, 33607

  • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882

    Tempe, Arizona, 85284-2604

  • Baylor Scott & White Medical Center- Temple /ID# 204129

    Temple, Texas, 76508-0001

  • Cotton-O'Neil Clinical Res Ctr /ID# 154753

    Topeka, Kansas, 66606

  • Center for Digestive Health /ID# 154697

    Troy, Michigan, 48098-6363

  • University of Arizona /ID# 158305

    Tucson, Arizona, 85724

  • Adult Gastroenterology Associates - Gen 1 Research /ID# 208857

    Tulsa, Oklahoma, 74136-7823

  • Tyler Research Institute, LLC /ID# 166795

    Tyler, Texas, 75701-4464

  • Gastro Health & Nutrition - Victoria /ID# 164284

    Victoria, Texas, 77904

  • Velocity Clinical Research - Salt Lake City /ID# 161775

    West Jordan, Utah, 84088

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267

    Wyoming, Michigan, 49519

  • Digestive Disease Associates, LTD /ID# 208296

    Wyomissing, Pennsylvania, 19610-2002

Other trials in United States

Germany30 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218

    Berlin, 10117

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212892

    Berlin, 10117

  • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211976

    Berlin, 10787

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339

    Berlin, 10825

  • DRK Kliniken Berlin Westend /ID# 166149

    Berlin, 14050

  • Krankenhaus Waldfriede /ID# 212729

    Berlin-Zehlendorf, 14163

  • Stadtisches Klinikum Braunschweig /ID# 163673

    Braunschweig, 38126

  • Universitaetsklinikum Koeln /ID# 164987

    Cologne, North Rhine-Westphalia, 50937

  • Evangelisches Krankenhaus Kalk /ID# 212724

    Cologne, North Rhine-Westphalia, 51103

  • Medizinisches Versorgunszentrum Dachau /ID# 211550

    Dachau, 85221

  • Universitaetsklinikum Erlangen /ID# 159332

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Frankfurt /ID# 212977

    Frankfurt am Main, Hesse, 60590

  • Agaplesion Markus Krankenhaus /ID# 159334

    Frankfurt am Main, 60431

  • Duplicate_Universitaetsklinikum Freiburg /ID# 162025

    Freiburg im Breisgau, 79106

  • Praxiszentrum fuer Gastroenterologie /ID# 211965

    Grevenbroich, North Rhine-Westphalia, 41515

  • Asklepios Westklinikum Hamburg /ID# 159336

    Hamburg, 22559

  • Medizinische Hochschule Hannover /ID# 162027

    Hanover, 30625

  • Praxis fuer Gastroenterologie /ID# 166148

    Heidelberg, Baden-Wurttemberg, 69121

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338

    Kiel, Schleswig-Holstein, 24105

  • EUGASTRO GmbH /ID# 212077

    Leipzig, 04103

  • Klinikum Lueneburg /ID# 163671

    Lüneburg, 21339

  • Universitaetsklinikum Magdeburg /ID# 211840

    Magdeburg, 39120

  • Universitatsklinikum Mannheim /ID# 162026

    Mannheim, Baden-Wurttemberg, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024

    Minden, 32423

  • Universitaetsklinikum Muenster /ID# 159333

    Münster, North Rhine-Westphalia, 48149

  • Universitaetsklinikum Regensburg /ID# 163812

    Regensburg, 93042

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527

    Saarbrücken, Saarland, 66111

  • Universitaetsklinikum Tuebingen /ID# 159341

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm /ID# 164988

    Ulm, Baden-Wurttemberg, 89081

  • Duplicate_Gastro-Praxis Wiesbaden /ID# 159335

    Wiesbaden, 65189

Other trials in Germany

Italy18 sites

  • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659

    Bologna, 40138

  • A.O. Per L'Emergenza Cannizzaro /ID# 161303

    Catania, 95126

  • Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017

    Catanzaro, Calabria, 88100

  • Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168049

    Florence, Tuscany, 50139

  • Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434

    Genoa, Liguria, 16132

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155657

    Milan, 20122

  • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155655

    Milan, 20157

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018

    Modena, Emilia-Romagna, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302

    Negrar, Verona, 37024

  • Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212030

    Pavia, 27100

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211453

    Rho, Milano, 20017

  • Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini /ID# 155660

    Rome, Lazio, 00152

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910

    Rome, Lazio, 00161

  • Fondazione PTV Policlinico Tor Vergata /ID# 158023

    Rome, Roma, 00133

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656

    Rome, Roma, 00168

  • Istituto Clinico Humanitas /ID# 155658

    Rozzano, Milano, 20089

  • Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431

    Torrette, Ancona, 60123

Other trials in Italy

Canada17 sites

  • University of Calgary - Heritage Medical Research Clinic /ID# 157156

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 169766

    Edmonton, Alberta, T5R 1W2

  • University of Alberta - Zeidler Ledcor Centre /ID# 157100

    Edmonton, Alberta, T6G 2X8

  • Covenant Health /ID# 161636

    Edmonton, Alberta, T6K 4B2

  • Medicor Research Inc /ID# 157151

    Greater Sudbury, Ontario, P3A 1W8

  • CISSS de la Monteregie /ID# 161634

    Greenfield Park, Quebec, J4V 2H1

  • QEII - Health Sciences Centre /ID# 157089

    Halifax, Nova Scotia, B3H 2Y9

  • IWK Health Center /ID# 165909

    Halifax, Nova Scotia, B3K 6R8

  • London Health Sciences Center /ID# 157162

    London, Ontario, N6A 5W9

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058

    Montreal, Quebec, H1T 2M4

  • CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070

    Montreal, Quebec, H2X 3E4

  • Montreal General Hospital - McGill University Health Center /ID# 157086

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc /ID# 159057

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 165910

    North Bay, Ontario, P1B 2H3

  • GIRI Gastrointestinal Research Institute /ID# 157097

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Asso /ID# 157159

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 161635

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Poland13 sites

  • Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079

    Chojnice, Pomeranian Voivodeship, 89-600

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212290

    Lodz, Łódź Voivodeship, 90-153

  • 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984

    Lublin, Lublin Voivodeship, 20-049

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980

    Lublin, Lublin Voivodeship, 20-954

  • Wojewodzki Szpital Specjalistyczny /ID# 212400

    Olsztyn, Warmian-Masurian Voivodeship, 10-561

  • Centrum Medyczne Medyk /ID# 212888

    Rzeszów, Podkarpackie Voivodeship, 35-326

  • H-T. Centrum Medyczne - Endoterapia /ID# 212458

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Zdrowia MDM /ID# 163602

    Warsaw, Masovian Voivodeship, 00-635

  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604

    Warsaw, Masovian Voivodeship, 02-507

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578

    Warsaw, Masovian Voivodeship, 04-730

  • Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434

    Warsaw, 03-580

  • Planetmed Sp. z o.o. /ID# 205159

    Wroclaw, Lower Silesian Voivodeship, 52-210

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534

    Wroclaw, 50-556

Other trials in Poland

France11 sites

  • CHU Amiens-Picardie Site Sud /ID# 165056

    Amiens, Somme, 80054

  • Hapital Beaujon /ID# 166287

    Clichy, Île-de-France Region, 92110

  • CHU Grenoble - Hopital Michallon /ID# 211980

    La Tronche, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 162547

    Lille, Hauts-de-France, 59037

  • CHU Montpellier - Hôpital Saint Eloi /ID# 215146

    Montpellier, Herault, 34295

  • Chu de Nice-Hopital L'Archet Ii /Id# 162545

    Nice, Alpes-Maritimes, 06200

  • CHU Bordeaux - Hopital Haut Lévêque /ID# 162546

    Pessac, Gironde, 33604

  • HCL - Hôpital Lyon Sud /ID# 162548

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Hospital Pontchaillou /ID# 213207

    Rennes, 35033

  • CHU de SAINT ETIENNE - Hopital Nord /ID# 162550

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

  • CHRU Nancy - Hôpitaux de Brabois /ID# 162549

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

Other trials in France

Portugal11 sites

  • Hospital Garcia de Orta, EPE /ID# 160688

    Almada, 2805-267

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732

    Faro, 8000-386

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691

    Guimarães, Braga District, 4835-044

  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677

    Lisbon, 1169-050

  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167753

    Lisbon, 1349-019

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160741

    Lisbon, 1649-035

  • Hospital Beatriz Ângelo /ID# 207758

    Loures, 2674-514

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754

    Portimão, Faro District, 8500-338

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742

    Porto, 4200-319

  • Centro Hospitalar de Entre Douro e Vouga /ID# 160676

    Santa Maria DA Feira, Porto District, 4520-211

  • Centro Hosp de Tondela-Viseu /ID# 160731

    Viseu, 3504-509

Other trials in Portugal

South Korea11 sites

  • Inje University Haeundae Hospital /ID# 202516

    Busan, 48108

  • Duplicate_Dong-A University Hospital /ID# 163370

    Busan, 49201

  • Pusan National University Hospital /ID# 163376

    Busan, 49241

  • Yeungnam University Medical Center /ID# 163366

    Daegu, 42415

  • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553

    Daejeon, 34943

  • Hanyang University Guri Hospital /ID# 163351

    Guri-si, Gyeonggido, 11923

  • CHA Bundang Medical center CHA University /ID# 163377

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 163354

    Seoul, Seoul Teugbyeolsi, 03181

  • Severance Hospital /ID# 163374

    Seoul, Seoul Teugbyeolsi, 03722

  • Samsung Medical Center /ID# 163426

    Seoul, 06351

  • The Catholic University of Korea, ST. Vincent's Hospital /ID# 163365

    Suwon, Gyeonggido, 16247

Other trials in South Korea

Spain11 sites

  • Hospital Clinic de Barcelona /ID# 157533

    Barcelona, 08036

  • Hospital Universitario Basurto /ID# 205188

    Bilbao, Vizcaya, 48013

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157534

    Ferrol, A Coruna, 15405

  • Hospital General Universitario Gregorio Maranon /ID# 161144

    Madrid, 28007

  • Hospital Universitario La Paz /ID# 159232

    Madrid, 28046

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca /ID# 157539

    Salamanca, 37007

  • Hospital Universitario Virgen Macarena /ID# 159966

    Seville, 41009

  • Hospital Clinico Universitario de Valencia /ID# 209699

    Valencia, 46010

  • Hospital Universitario y Politecnico La Fe /ID# 157537

    Valencia, 46026

  • Hospital Universitario Miguel Servet /ID# 157538

    Zaragoza, 50009

Other trials in Spain

United Kingdom11 sites

  • Barnsley Hospital NHS Foundation Trust /ID# 202772

    Barnsley, S75 2EP

  • University Hospitals Birmingham NHS Foundation Trust /ID# 157577

    Birmingham, B15 2TH

  • Cambridge University Hospitals NHS Foundation Trust /ID# 158037

    Cambridge, CB2 0QQ

  • Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938

    Chertsey, Surrey, KT16 0PZ

  • NHS Lothian /ID# 207446

    Edinburgh, EH3 9HE

  • NHS Greater Glasgow and Clyde /ID# 202314

    Glasgow, Scotland, G12 0XH

  • Hull University Teaching Hospitals NHS Trust /ID# 158759

    Hull, HU3 2JZ

  • King's College Hospital NHS Foundation Trusts /ID# 158758

    London, SE5 9RS

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889

    Newcastle upon Tyne, NE7 7DN

  • Oxford University Hospitals NHS Foundation Trust /ID# 158039

    Oxford, OX3 9DU

  • Duplicate_Northern Care Alliance NHS Group /ID# 207765

    Salford, M6 8HD

Other trials in United Kingdom

China10 sites

  • West China Hospital, Sichuan University /ID# 210888

    Chengdu, 610041

  • The Sixth Affiliated Hosp Sun /ID# 210783

    Guangzhou, Guangdong, 510655

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626

    Hangzhou, Zhejiang, 310020

  • The First Affiliated Hospital of Nanchang University /ID# 211035

    Nanchang, Jiangxi, 330006

  • Shanghai East Hospital /ID# 212671

    Pudong New District, 200136

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842

    Shanghai, Shanghai Municipality, 200065

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210706

    Shanghai, Shanghai Municipality, 200127

  • Duplicate_Tianjin Med Univ General Hosp /ID# 210925

    Tianjin, 300052

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857

    Wuhan, Hubei, 430022

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211040

    Wuhan, Hubei, 430022

Other trials in China

Czechia9 sites

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 163218

    Hradec Králové, 500 12

  • CTCenter MaVe s.r.o. /ID# 163215

    Olomouc, 779 00

  • Nemocnice Pardubickeho kraje, a.s. /ID# 163219

    Pardubice, 530 03

  • Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165479

    Prague, Praha 4, 140 00

  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304

    Prague, 118 33

  • Axon Clinical, s.r.o. /ID# 163216

    Prague, 140 00

  • Thomayerova nemocnice /ID# 162942

    Prague, 140 59

  • ResTrial s.r.o. /ID# 211074

    Prague, 143 00

  • NH Hospital a.s. /ID# 211073

    Prague, 155 00

Other trials in Czechia

Russia9 sites

  • Alliance Biomedical Ural Group /ID# 200703

    Izhevsk, Udmurtiya Republic, 426061

  • Kuzbass Regional Clinical Hospital /ID# 200707

    Kemerovo, Kemerovo Oblast, 650099

  • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204806

    Moscow, 123423

  • Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207438

    Perm, Permskiy Kray, 614990

  • City Clinical Hospital No. 31 /ID# 208865

    Saint Petersburg, 197110

  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200701

    Stavropol, Stavropol Kray, 355012

  • Tver Regional Clinical Hospital /ID# 206586

    Tver', Tver Oblast, 170036

  • Regional Clinical Hospital #1 /ID# 200708

    Tyumen, Tyumen Oblast, 625023

  • Ulyanovsk Regional Clinical Hospital /ID# 200700

    Ulyanovsk, 432017

Other trials in Russia

Belgium8 sites

  • Imelda Ziekenhuis /ID# 157381

    Bonheiden, 2820

  • ULB Hospital Erasme /ID# 157386

    Brussels, Brussels Capital, 1070

  • UZ Gent /ID# 157383

    Ghent, Oost-Vlaanderen, 9000

  • AZ Maria Middelares /ID# 212871

    Ghent, 9000

  • AZ Groeninge /ID# 212571

    Kortrijk, 8500

  • AZ Sint-Maarten /ID# 212280

    Mechelen, Antwerpen, 2800

  • ZNA - Jan Palfijn /ID# 212822

    Merksem, 2170

  • UCL Saint-Luc /ID# 157384

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Bulgaria8 sites

  • UMHAT Dr Georgi Stranski EAD /ID# 203975

    Pleven, 5800

  • University Multiprofile Hospit /ID# 165697

    Plovdiv, 4001

  • Second Multiprofile Hospital f /ID# 165699

    Sofia, 1202

  • Acibadem City Clinic UMHAT Tokuda /ID# 165698

    Sofia, 1407

  • UMHAT Sveti Ivan Rilski /ID# 204713

    Sofia, 1431

  • UMHAT Tsaritsa Joanna - ISUL /ID# 211241

    Sofia, 1527

  • MHAT Trakia /ID# 201665

    Stara Zagora, 6004

  • University Multiprofile Hospit /ID# 167576

    Varna, 9010

Other trials in Bulgaria

Serbia8 sites

  • Clinical Hosp Center Zvezdara /ID# 156956

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 156963

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 156957

    Belgrade, Beograd, 11000

  • Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959

    Belgrade, Beograd, 11080

  • University Children's Hospital 'Tirsova' /ID# 211480

    Belgrade, 11000

  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798

    Belgrade, 11040

  • University Clinical Center Kragujevac /ID# 156961

    Kragujevac, Sumadijski Okrug, 34000

  • Clinical Center Vojvodina /ID# 156958

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

Greece7 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 157417

    Heraklion, Crete, 71307

  • University General Hospital of Ioannina /ID# 157415

    Ioannina, 45500

  • Tzaneio general hospital of Piraeus /ID# 206441

    Piraeus, Attica, 18536

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419

    Pireaus, 18454

  • Theageneio Anticancer Hospital /ID# 163922

    Thessaloniki, 54639

Other trials in Greece

Israel7 sites

  • Soroka University Medical Center /ID# 157789

    Beersheba, Southern District, 8443901

  • Duplicate_Rambam Medical Center /ID# 171056

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 163539

    Jerusalem, 91031

  • Shaare Zedek Medical Center /ID# 171055

    Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 171062

    Jerusalem, 91120

  • Sheba Medical Center /ID# 171059

    Ramat Gan, Tel Aviv, 5239424

  • Tel Aviv Sourasky Medical Center /ID# 157787

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Croatia6 sites

  • UHC Osijek /ID# 157704

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki bolnicki centar Split /ID# 157705

    Split, Split-Dalmatia County, 21000

  • Zadar General Hospital /ID# 157706

    Zadar, 23000

  • Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 157720

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 157703

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Denmark6 sites

  • Aalborg Universitets Hospital /ID# 160685

    Aalborg, 9000

  • Aarhus University Hospital /ID# 155534

    Aarhus N, Central Jutland, 8200

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535

    Hvidovre, Capital Region, 2650

  • Sygehusenheden Nyborg - OUH /ID# 161591

    Nyborg, Region Syddanmark, 5800

  • Odense Universitets Hospital /ID# 155536

    Odense C, 5000

  • Sjællands Universitetshospital, Roskilde /ID# 155537

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Egypt6 sites

  • Zagazig University Hospitals /ID# 164018

    Al Sharqia, 44519

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157176

    Cairo, 11559

  • National Hepatology and Tropical Medicine Research Institute /ID# 157875

    Cairo, 11559

  • Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630

    Cairo, 11566

Other trials in Egypt

Australia5 sites

  • Emeritus Research /ID# 213510

    Camberwell, Victoria, 3124

  • Lyell McEwin Hospital /ID# 211364

    Elizabeth Vale, South Australia, 5112

  • Footscray Hospital /ID# 211362

    Footscray, Victoria, 3011

  • Mater Misericordiae Limited /ID# 167216

    South Brisbane, Queensland, 4101

  • Griffith University /ID# 212631

    Southport, Queensland, 4222

Other trials in Australia

Chile5 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 210758

    Concepción, 4070038

  • Complejo Asistencial Dr. Sotero del Rio /ID# 169383

    Santiago, Santiago Metropolitan, 8207257

  • Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121

    Santiago, Santiago Metropolitan, 8350488

  • Hospital Las Higueras /ID# 167091

    Talcahuano, 1740000

  • Centro de Investigaciones Clínicas Viña del Mar /ID# 203585

    Viña del Mar, Valparaiso, 2540488

Other trials in Chile

Romania5 sites

  • Duplicate_Institutul Clinic Fundeni /ID# 170888

    Bucharest, 022328

  • Tvm Med Serv Srl /Id# 170891

    Cluj-Napoca, 400132

  • Institutul Clinic Fundeni /ID# 170890

    Sector 2, Bucharest, 022328

  • Cabinet Particular Policlinic Algomed /ID# 170889

    Timișoara, 300002

  • Duplicate_Centrul Medical Tuculanu SRL /ID# 170892

    Timișoara, 300168

Other trials in Romania

Taiwan5 sites

  • China Medical University Hosp /ID# 160130

    Taichung, 40447

  • Taichung Veterans General Hosp /ID# 160134

    Taichung, 407

  • National Cheng Kung University Hospital /ID# 160129

    Tainan, 70403

  • National Taiwan University Hospital /ID# 162189

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 212711

    Taipei, 11217

Other trials in Taiwan

Argentina4 sites

  • Hospital Britanico de Buenos Aires /ID# 168081

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1280

  • Cemic /Id# 168082

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

  • Hospital Privado Univesitario /ID# 168080

    Córdoba, 5016

  • Hospital Provincial del Centenario /ID# 170904

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Austria4 sites

  • Duplicate_LKH-Univ. Klinikum Graz /ID# 158134

    Graz, Styria, 8036

  • Universitaetsklinikum St. Poelten /ID# 166423

    Sankt Pölten, Lower Austria, 3100

  • Krankenhaus der Barmherzigen Brueder Wien /ID# 211418

    Vienna, State of Vienna, 1020

  • Duplicate_Medical University of Vienna /ID# 158135

    Vienna, State of Vienna, 1090

Other trials in Austria

Mexico4 sites

  • JM Research SC /ID# 170762

    Cuernavaca, Morelos, 62290

  • Health Pharma Professional Research S.A de C.V /ID# 170763

    Del. Benito Juárez, 03810

  • Unidad de Atencion Medica e Investigacion en Salud /ID# 170765

    Mérida, Yucatán, 97000

  • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766

    Zapopan, Jalisco, 45070

Other trials in Mexico

New Zealand4 sites

  • Middlemore Clinical Trials /ID# 167214

    Auckland, 2025

  • Christchurch Hospital /ID# 167212

    Christchurch, Canterbury, 8011

  • Dunedin Hospital /ID# 167215

    Dunedin, Otago, 9016

  • Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213

    Wellington, 6021

Other trials in New Zealand

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156453

    Banská Bystrica, 975 17

  • Univerzitna nemocnica Martin /ID# 163205

    Martin, 036 01

  • KM Management, spol. s.r.o. /ID# 206762

    Nitra, 949 01

  • GASTRO I., s.r.o. /ID# 156455

    Prešov, 080 01

Other trials in Slovakia

South Africa4 sites

  • Kingsbury Hospital /ID# 171158

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 171159

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 171172

    CAPE TOWN Milnerton, Western Cape, 7441

  • Wits Clinical Research Site /ID# 171169

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Bosnia and Herzegovina3 sites

  • University Clinical Centre of the Republic of Srpska /ID# 157710

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 165018

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 165132

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Colombia3 sites

  • Hospital Univ San Ignacio /ID# 158737

    Bogota, Cundinamarca, 110231

  • Instituto de Coloproctologia /ID# 158740

    Medellín, Antioquia, 050024

  • Hospital Pablo Tobon Uribe /ID# 158732

    Medellín, Antioquia, 50034

Other trials in Colombia

Ireland3 sites

  • Beaumont Hospital /ID# 157572

    Beaumont, Dublin, D09 XR63

  • St Vincent's University Hospital /ID# 157569

    Elm Park, Dublin, D04 T6F4

  • University Hospital Galway /ID# 157570

    Galway, H91 YR71

Other trials in Ireland

Malaysia3 sites

  • Queen Elizabeth Hospital /ID# 160659

    Division Pantai Barat Utara, Sabah, 88200

  • Universiti Sains Malaysia /ID# 160661

    Kelantan, Kelantan, 16150

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362

    Kuala Lumpur, Selangor, 56000

Other trials in Malaysia

Singapore3 sites

  • National University Hospital /ID# 160662

    Singapore, 119074

  • Singapore General Hospital /ID# 160663

    Singapore, 169608

  • KL Ling Gastroenterology and Liver Clinic /ID# 205736

    Singapore, 228510

Other trials in Singapore

Estonia2 sites

  • East Tallinn Central Hospital /ID# 157072

    Tallinn, Harju, 10138

  • West Tallinn Central Hospital /ID# 157073

    Tallinn, 10617

Other trials in Estonia

Latvia2 sites

  • Pauls Stradins Clinical University Hospital /ID# 159616

    Riga, 1002

  • Riga East Clinical University Hospital /ID# 159615

    Riga, LV-1079

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584

    Kaunas, 50161

  • Vinius University Hospital Santaros Klinikos /ID# 162524

    Vilnius, 08661

Other trials in Lithuania

Netherlands2 sites

  • Academisch Medisch Centrum /ID# 157953

    Amsterdam, 1105 AZ

  • Elisabeth Tweesteden Ziekenhuis /ID# 163620

    Tilburg, 5022 GC

Other trials in Netherlands

Switzerland2 sites

  • Universitätsspital Basel /ID# 166321

    Basel, Canton of Basel-City, 4031

  • Universitätsspital Zürich /ID# 163528

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Ukraine2 sites

  • Kyiv Municipal Clinical Hospital #18 /ID# 162527

    Kyiv, 01030

  • Duplicate_Transcarpathian Regional Clin. /ID# 167958

    Uzhhorod, 88000

Other trials in Ukraine

Belarus1 site

  • Vitebsk Regional Advanced Clin /ID# 204807

    Vitebsk, 210001

Other trials in Belarus

About this study

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

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

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

What participants receive

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

  • placebo for risankizumab IVDrug

    placebo for risankizumab administered as intravenous (IV) infusion.

  • risankizumab SCDrug

    Also called ABBV-066 BI 655066, SKYRIZI

    risankizumab administered by subcutaneous (SC) injection

  • risankizumab IVDrug

    Also called ABBV-066 BI 655066, SKYRIZI

    risankizumab administered as intravenous (IV) infusion.

Study groups in NCT03104413
Study groupRoleWhat they receive
Risankizumab Dose 1 (Induction Period 1)ExperimentalParticipants randomized to receive risankizumab dose 1 in Induction Period 1.
Receives: Drug: risankizumab IV
Risankizumab Dose 2 (Induction Period 1)ExperimentalParticipants randomized to receive risankizumab dose 2 in Induction Period 1.
Receives: Drug: risankizumab IV
Placebo (Induction Period 1)Placebo comparatorParticipants randomized to receive placebo for risankizumab in Induction Period 1.
Receives: Drug: placebo for risankizumab IV
Risankizumab Dose 1 (Induction Period 2)ExperimentalParticipants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Receives: Drug: risankizumab IV
Risankizumab Dose 2 (Induction Period 2)ExperimentalParticipants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Receives: Drug: risankizumab SC
Risankizumab Dose 3 (Induction period 2)ExperimentalParticipants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Receives: Drug: risankizumab SC

What is being measured

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

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

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

    Measured: Week 12

  2. US Specific: Percentage of Participants With Endoscopic Response

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

Secondary outcomes (31)

  1. US Specific: Percentage of Participants With Clinical Remission

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

    Measured: Week 12

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

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

    Measured: Week 4

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 4

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

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

  9. US Specific: Percentage of Participants With Endoscopic Remission

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

    Measured: Week 12

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

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

    Measured: Week 4

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Up to Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 4

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

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

    Measured: Week 4

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 4

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

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

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

    Measured: Week 12

Timeline

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

  1. First posted7 Apr 2017
  2. Study start18 Dec 2017
  3. Primary completion30 Nov 2020
  4. Study completion19 May 2021

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
618 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104413
Sponsor's protocol ID
M15-991
Other IDs
2016-003190-17, 2016
Status last verified
Aug 2021
First submitted
4 Apr 2017
Last updated
14 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Expanded access
Available

Publications

  • Feagan BG, Colombel JF, Panaccione R, Schreiber S, Ferrante M, Kamikozuru K, Ma C, Lee WJ, Griffith J, Joshi N, Kligys K, Kalabic J, Xuan S, Dubinsky M. Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease. Gastro Hep Adv. 2024 Sep 5;4(1):100544. doi: 10.1016/j.gastha.2024.08.022. eCollection 2025.

    PubMed 39802486

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

    PubMed 39485390

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

    PubMed 39131711

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

    PubMed 39054592

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

    PubMed 37368103

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

    PubMed 35644154

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risankizumab SC and risankizumab IV in people with Crohn's Disease, run by AbbVie at 403 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 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 403 sites in United States, Germany, Italy, Canada, Poland 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?

Yes. Results are posted in the registry (first posted 14 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (time frame: Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03104413, which also lists 6 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 14 Jun 2022.

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