AzTrials
AzTrials

Crohn's DiseasePhase 3FORTIFYNCT03105102

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

A Phase 3 study testing Risankizumab IV, Risankizumab SC and Risankizumab On-Body Injector (OBI) in people with Crohn's Disease, run by AbbVie at 496 sites in 47 countries.

Active, not recruiting

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

Official record

Search all trials

Trial summary

The study consists of 4 sub-studies, as follows: Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab… Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
Risankizumab IV, Risankizumab SC and Risankizumab On-Body Injector (OBI)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,336 participants
Where
496 sitesin 47 countries
Study dates
9 Apr 2018to Feb 2029
Phase
Phase 3

Key requirements

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

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

Who may be able to join

  • Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.
  • Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
  • Sub-Study 4:
  • Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
  • Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).

Who cannot join

  • Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.
  • Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
  • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
  • Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.

Trial locations and contacts

496 sites in 47 countries.

496 sites in 47 countries

United States111 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126

    Ann Arbor, Michigan, 48109

  • TX Clinical Research Institute /ID# 159404

    Arlington, Texas, 76012

  • Atlanta Gastro Assoc /ID# 154724

    Atlanta, Georgia, 30342

  • GI Alliance /ID# 161963

    Baton Rouge, Louisiana, 70809

  • Inquest Clinical Research /ID# 165694

    Baytown, Texas, 77521-2415

  • Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262

    Brandon, Florida, 33510-3107

  • NY Scientific /ID# 158294

    Brooklyn, New York, 11235

  • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447

    Burnt Hills, New York, 12027

  • GI Alliance /ID# 209797

    Cedar Park, Texas, 78613

  • Univ NC Chapel Hill /ID# 154833

    Chapel Hill, North Carolina, 27514-4220

  • Medical University of South Carolina /ID# 212858

    Charleston, South Carolina, 29425

  • Atrium Health Carolinas Medical Center /ID# 158428

    Charlotte, North Carolina, 28203

  • Clin Res Inst of Michigan, LLC /ID# 169179

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group - Chevy Chase /ID# 154832

    Chevy Chase, Maryland, 20815

  • Duplicate_Northwestern University /ID# 158261

    Chicago, Illinois, 60611-2927

  • The University of Chicago Medical Center /ID# 157124

    Chicago, Illinois, 60637-1443

  • Tri-State Endoscopy Center /ID# 154927

    Cincinnati, Ohio, 45219

  • South Lake Pain Institute, Inc /ID# 162808

    Clermont, Florida, 34711

  • Cleveland Clinic Main Campus /ID# 209226

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 165843

    Colorado Springs, Colorado, 80907

  • Gastro Center of Maryland /ID# 165001

    Columbia, Maryland, 21045

  • The Ohio State University /ID# 164708

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 167887

    Columbus, Ohio, 43235

  • Gastro One /ID# 154726

    Cordova, Tennessee, 38018

  • Southern California Res. Ctr. /ID# 211991

    Coronado, California, 92118-1408

  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406

    Dallas, Texas, 75246

  • Duplicate_Western Connecticut Medical Group /ID# 165879

    Danbury, Connecticut, 06810

  • Hometown Urgent Care and Resea /ID# 170464

    Dayton, Ohio, 45424

  • Universal Axon Clinical Research /ID# 165428

    Doral, Florida, 33166

  • NorthShore University-Endeavor Health Evanston Hospital /ID# 158265

    Evanston, Illinois, 60201

  • Plains Clinical Research Center, LLC /ID# 169718

    Fargo, North Dakota, 58104-5925

  • Intercity Advanced Gastroentertology Center /ID# 215205

    Fresh Meadows, New York, 11366

  • Duplicate_DHAT Research Institute /ID# 158208

    Garland, Texas, 75044-2208

  • Northwell Health - Great Neck /ID# 168738

    Great Neck, New York, 11021

  • Gastroenterology Associates, P.A. of Greenville /ID# 154904

    Greenville, South Carolina, 29607

  • Houma Digestive Health Special /ID# 158264

    Houma, Louisiana, 70360

  • Vilo Research Group Inc /ID# 207655

    Houston, Texas, 77017-2337

  • Baylor College of Medicine /ID# 158203

    Houston, Texas, 77030

  • Centex Studies, Inc. - Houston /ID# 201219

    Houston, Texas, 77058

  • Duplicate_Newport Huntington Medical Group /ID# 213035

    Huntington Beach, California, 92648

  • Nature Coast Clinical Research - Inverness /ID# 159408

    Inverness, Florida, 34452-4717

  • East Tennessee Research Institute /ID# 168739

    Johnson City, Tennessee, 37604

  • SIH Research Mumtaz, Inc /ID# 163083

    Kissimmee, Florida, 34741-4161

  • UC San Diego Health Systems /ID# 155555

    La Jolla, California, 92093

  • Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 154829

    Lake Success, New York, 11042

  • Revival Research Institute - Las Vegas /ID# 210985

    Las Vegas, Nevada, 89128-3157

  • Vector Clinical Trials /ID# 160170

    Las Vegas, Nevada, 89128

  • Duplicate_University of Kentucky Chandler Medical Center /ID# 157120

    Lexington, Kentucky, 40536

  • Alliance Medical Research /ID# 163837

    Lighthouse PT, Florida, 33064

  • Atria Clinical Research /ID# 164505

    Little Rock, Arkansas, 72209-7040

  • Rocky Mountain Pediatric Gastroenterology /ID# 207170

    Lone Tree, Colorado, 80124-6798

  • United Medical Doctors /ID# 207888

    Los Alamitos, California, 90720-3309

  • TLC Clinical Research Inc /ID# 212719

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences Clinical Trials /ID# 162657

    Los Angeles, California, 90067-2001

  • University of Louisville Hospital /ID# 210525

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia, LLC /ID# 154850

    Macon, Georgia, 31201

  • Cfagi Llc /Id# 202479

    Maitland, Florida, 32751-6108

  • Clinical Neuroscience Solutions /ID# 164180

    Memphis, Tennessee, 38119

  • Great Lakes Gastroenterology Research, LLC /ID# 201770

    Mentor, Ohio, 44060-6211

  • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884

    Mesa, Arizona, 85206

  • Sylvester Comprehensive Cancer Center /ID# 155007

    Miami, Florida, 33136-1002

  • Coral Research Clinic /ID# 158456

    Miami, Florida, 33186-4643

  • South Florida Research Ph I-IV, Inc. /ID# 161832

    Miami, Florida, 33193

  • West Virginia University Hospitals /ID# 167941

    Morgantown, West Virginia, 26506

  • United Medical Doctors - Murrieta /ID# 158300

    Murrieta, California, 92563

  • Gastroenterology Group Naples /ID# 165204

    Naples, Florida, 34102

  • Vanderbilt University Medical Center /ID# 157121

    Nashville, Tennessee, 37232-0011

  • Digestive Disease Care /ID# 211777

    New Hyde Park, New York, 11040

  • Delricht Research - Prytania Street - New Orleans /ID# 206644

    New Orleans, Louisiana, 70115

  • Nola Research Works, LLC /ID# 161317

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 161966

    New Port Richey, Florida, 34653

  • NYU Langone Medical Center /ID# 160169

    New York, New York, 10016-6402

  • Weill Cornell Medicine /ID# 165878

    New York, New York, 10022

  • Icahn School of Medicine at Mount Sinai /ID# 165612

    New York, New York, 10029

  • Columbia Univ Medical Center /ID# 161899

    New York, New York, 10032-3725

  • Lenox Hill Hospital /ID# 168467

    New York, New York, 10075

  • Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171126

    North Massapequa, New York, 11758

  • Southwest Gastroenterology /ID# 164781

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute /ID# 154907

    Ogden, Utah, 84405

  • Hightower Clinical /ID# 211993

    Oklahoma City, Oklahoma, 73102

  • Digestive Disease Specialists /ID# 170775

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center /ID# 210058

    Omaha, Nebraska, 68198-2000

  • Endoscopic Research, Inc. /ID# 205906

    Orlando, Florida, 32803

  • Omega Research - Orlando /ID# 171082

    Orlando, Florida, 32808

  • IMIC Inc. Medical Research /ID# 154942

    Palmetto Bay, Florida, 33157

  • Phoenix VA Health Care System /ID# 162264

    Phoenix, Arizona, 85012

  • Children's Hospital of Pittsburgh of UPMC /ID# 212544

    Pittsburgh, Pennsylvania, 15224-1334

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873

    Raleigh, North Carolina, 27612

  • Rapid City Medical Center - GI Research /ID# 163838

    Rapid City, South Dakota, 57701

  • Richmond VA Medical Center /ID# 159988

    Richmond, Virginia, 23249

  • Mayo Clinic - Rochester /ID# 163086

    Rochester, Minnesota, 55905-0001

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 161323

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 168773

    San Antonio, Texas, 78229-5390

  • University of California San Francisco - Mission Bay /ID# 157127

    San Francisco, California, 94158

  • Duplicate_Virginia Mason Medical Center /ID# 155556

    Seattle, Washington, 98101

  • Louisiana Research Center, LLC /ID# 162237

    Shreveport, Louisiana, 71105-6800

  • St. Louis University /ID# 161883

    St Louis, Missouri, 63104

  • Duplicate_Clinical Research of West Florida, Inc /ID# 208125

    Tampa, Florida, 33606-1246

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 205865

    Tampa, Florida, 33606

  • Baylor Scott & White Center for Diagnostic Medicine /ID# 204131

    Temple, Texas, 76508

  • Cotton O'Neil Clinical Research Center, Digestive Health /ID# 154722

    Topeka, Kansas, 66606

  • Center For Digestive Health - Troy /ID# 154683

    Troy, Michigan, 48098

  • Banner - University Medical Center Tucson /ID# 158502

    Tucson, Arizona, 85719

  • Adult Gastroenterology Associates - Gen 1 Research /ID# 208864

    Tulsa, Oklahoma, 74136-7823

  • Tyler Research Institute /ID# 166797

    Tyler, Texas, 75701

  • Gastro Health & Nutrition - Victoria /ID# 164290

    Victoria, Texas, 77904

  • Texas Digestive Disease Consultants /ID# 209946

    Webster, Texas, 77598

  • Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 163839

    West Hollywood, California, 90048

  • Velocity Clinical Research - Salt Lake City /ID# 161778

    West Jordan, Utah, 84088

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313

    Wyoming, Michigan, 49519

  • Digestive Disease Associates, LTD - Wyomissing /ID# 208297

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan45 sites

  • Tokatsu Tsujinaka Hospital /ID# 163352

    Abiko-shi, Chiba, 270-1168

  • Duplicate_Asahikawa Medical University Hospital /ID# 162848

    Asahikawa-shi, Hokkaido, 078-8510

  • Institute of Science Tokyo Hospital /ID# 160095

    Bunkyo-ku, Tokyo, 113-8519

  • Duplicate_Chiba University Hospital /ID# 217533

    Chiba, Chiba, 260-8677

  • Fukuoka University Hospital /ID# 217793

    Fukuoka, Fukuoka, 814-0180

  • National Hospital Organization Fukuyama Medical Center /ID# 163577

    Fukuyama-shi, Hiroshima, 720-8520

  • Tokai University Hachioji Hospital /ID# 160098

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 205690

    Hamamatsu, Shizuoka, 431-3192

  • NHO Mito Medical Center /ID# 160092

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Hiroshima University Hospital /ID# 160109

    Hiroshima, Hiroshima, 734-8551

  • Gokeikai Ofuna Chuo Hospital /ID# 171066

    Kamakura-shi, Kanagawa, 247-0056

  • Kanazawa University Hospital /ID# 202258

    Kanazawa, Ishikawa-ken, 920-8641

  • Tsujinaka Hospital - Kashiwanoha /ID# 213848

    Kashiwa-shi, Chiba, 277-0871

  • The Jikei University Kashiwa Hospital /ID# 200030

    Kashiwa-shi, Chiba, 277-8567

  • Saitama Medical Center /ID# 160093

    Kawagoe, Saitama, 350-8550

  • Yamanashi Prefectural Central Hospital /ID# 160094

    Kofu, Yamanashi, 400-8506

  • Kurume University Hospital /ID# 160106

    Kurume-shi, Fukuoka, 830-0011

  • Duplicate_The Jikei University Hospital /ID# 163209

    Minato-ku, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital /ID# 160105

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 160114

    Mitaka-shi, Tokyo, 181-8611

  • Aichi Medical University Hospital /ID# 160097

    Nagakute, Aichi-ken, 480-1195

  • Daido Clinic - Nagoya /ID# 211476

    Nagoya, Aichi-ken, 457-8511

  • Nagoya University Hospital /ID# 160116

    Nagoya, Aichi-ken, 466-8560

  • Nagoya City University Hospital /ID# 160100

    Nagoya, Aichi-ken, 467-8602

  • Nishinomiya Municipal Central Hospital /ID# 210103

    Nishinomiya-shi, Hyōgo, 663-8014

  • Hyogo Medical University Hospital /ID# 160107

    Nishinomiya-shi, Hyōgo, 663-8501

  • Osaka Metropolitan University Hospital /ID# 160117

    Osaka, Osaka, 545-8586

  • Shiga University of Medical Science Hospital /ID# 164025

    Ōtsu, Shiga, 520-2192

  • Kitasato University Hospital /ID# 171065

    Sagamihara-shi, Kanagawa, 252-0375

  • Tokitokai Tokito clinic /ID# 160110

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 160099

    Sakura-shi, Chiba, 285-8741

  • Sapporo Tokushukai Hospital /ID# 213492

    Sapporo, Hokkaido, 004-0041

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 163056

    Sapporo, Hokkaido, 060-8543

  • Tohoku University Hospital /ID# 162847

    Sendai, Miyagi, 9808574

  • Tohoku Rosai Hospital /ID# 163229

    Sendai, Miyagi, 981-8563

  • Tokyo Women's Medical University Hospital /ID# 205974

    Shinjuku-ku, Tokyo, 162-8666

  • NHO Shizuoka Medical Center /ID# 163057

    Sunto-gun, Shizuoka, 411-8611

  • Duplicate_Fujita Health University Hospital /ID# 163234

    Toyoake-shi, Aichi-ken, 470-1192

  • Mie University Hospital /ID# 203640

    Tsu, Mie-ken, 514-8507

  • Wakayama Medical University Hospital /ID# 202561

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital /ID# 200159

    Yamagata, Yamagata, 990-9585

  • Yokkaichi Hazu Medical Center /ID# 163764

    Yokkaichi-shi, Mie-ken, 510-0016

  • Duplicate_Yokohama Municipal Citizen's Hospital /ID# 207161

    Yokohama, Kanagawa, 221-0855

  • Duplicate_Yokohama City University Medical Center /ID# 163907

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Germany28 sites

  • Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220

    Berlin, 10117

  • Dr. med. Thomas Brunk Gastroenterology Berlin /ID# 211974

    Berlin, 10318

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350

    Berlin, 10825

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 212894

    Berlin, 13353

  • DRK Kliniken Berlin Westend /ID# 166151

    Berlin, 14050

  • Krankenhaus Waldfriede /ID# 212727

    Berlin-Zehlendorf, 14163

  • Stadtisches Klinikum Braunschweig /ID# 163680

    Braunschweig, 38126

  • Universitaetsklinikum Koeln /ID# 164989

    Cologne, North Rhine-Westphalia, 50937

  • Evangelisches Krankenhaus Kalk /ID# 212726

    Cologne, North Rhine-Westphalia, 51103

  • Medizinisches Versorgunszentrum Dachau /ID# 211555

    Dachau, Bavaria, 85221

  • Universitaetsklinikum Erlangen /ID# 159343

    Erlangen, Bavaria, 91054

  • Duplicate_Agaplesion Markus Krankenhaus /ID# 159345

    Frankfurt am Main, Hesse, 60431

  • Universitaetsklinikum Frankfurt /ID# 212979

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg /ID# 162030

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Praxiszentrum fuer Gastroenterologie /ID# 211966

    Grevenbroich, North Rhine-Westphalia, 41515

  • Medizinische Hochschule Hannover /ID# 162032

    Hanover, Lower Saxony, 30625

  • Praxis fuer Gastroenterologie - Heidelberg /ID# 166150

    Heidelberg, Baden-Wurttemberg, 69121

  • Universitaetsklinikum Jena /ID# 159351

    Jena, Thuringia, 07747

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349

    Kiel, Schleswig-Holstein, 24105

  • Eugastro /ID# 212078

    Leipzig, Saxony, 04103

  • Klinikum Lueneburg /ID# 163678

    Lüneburg, Lower Saxony, 21339

  • Universitaetsklinikum Magdeburg /ID# 211843

    Magdeburg, 39120

  • Universitatsklinikum Mannheim /ID# 162031

    Mannheim, Baden-Wurttemberg, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029

    Minden, North Rhine-Westphalia, 32423

  • Universitaetsklinikum Muenster - Albert Schweitzer Campus /ID# 159344

    Münster, North Rhine-Westphalia, 48149

  • Universitaetsklinikum Regensburg /ID# 163813

    Regensburg, Bavaria, 93042

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528

    Saarbrücken, Saarland, 66111

  • Universitaetsklinikum Ulm /ID# 164990

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Canada19 sites

  • University of Calgary /ID# 157155

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 169763

    Edmonton, Alberta, T5R 1W2

  • University of Alberta Hospital /ID# 157099

    Edmonton, Alberta, T6G 2B7

  • Covenant Health /ID# 161632

    Edmonton, Alberta, T6K 4B2

  • Medicor Research Inc /ID# 157150

    Greater Sudbury, Ontario, P3A 1W8

  • CISSS de la Monteregie Centre - Hopital Charles Le Moyne /ID# 161630

    Greenfield Park, J4V 2H1

  • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 157088

    Halifax, Nova Scotia, B3H 2Y9

  • IWK Health Center /ID# 165905

    Halifax, Nova Scotia, B3K 6R8

  • Duplicate_Hamilton Health Sciences -McMaster University Medical Centre /ID# 157184

    Hamilton, Ontario, L8S 4K1

  • Hotel Dieu de Levis /ID# 214377

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Center- University Hospital /ID# 157161

    London, Ontario, N6A 5W9

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056

    Montreal, Quebec, H1T 2M4

  • Montreal General Hospital- McGill University Health Center /ID# 157085

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc /ID# 159055

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 165906

    North Bay, Ontario, P1B 2H3

  • Mount Sinai Hospital /ID# 169764

    Toronto, Ontario, M5G 1X5

  • Giri Gi Research Institute - Vancouver /ID# 157096

    Vancouver, British Columbia, V5Z 2K5

  • Toronto Digestive Disease Associates /ID# 157158

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 161631

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Italy19 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 155643

    Bologna, 40138

  • Ospedale Cannizzaro /ID# 161300

    Catania, 95126

  • Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 212016

    Catanzaro, 88100

  • Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992

    Florence, Tuscany, 50139

  • Duplicate_Ospedale Policlinico San Martino /ID# 162439

    Genoa, Genova, 16132

  • ASST Fatebenefratelli Sacco /ID# 155639

    Milan, Milano, 20157

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155641

    Milan, 20122

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028

    Modena, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299

    Negrar, Verona, 37024

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 155645

    Palermo, 90146

  • Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031

    Pavia, 27100

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227

    Rho, Milano, 20017

  • Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438

    Rome, Roma, 00128

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158022

    Rome, Roma, 00133

  • Azienda Ospedaliera San Camillo Forlanini /ID# 155644

    Rome, Roma, 00149

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912

    Rome, Roma, 00161

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 155642

    Rozzano, Lombardy, 20089

  • Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436

    Torrette, Ancona, 60123

Other trials in Italy

China16 sites

  • The Second Xiangya Hospital Of Central South University /ID# 211700

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University /ID# 210890

    Chengdu, Sichuan, 610041

  • Guangdong Provincial Peoples Hospital /ID# 212949

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 210784

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 210724

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625

    Hangzhou, Zhejiang, 310020

  • Jinhua Municipal Central Hospital /ID# 215628

    Jinhua, Zhejiang, 321000

  • The First Affiliated Hospital of Nanchang University /ID# 211036

    Nanchang, Jiangxi, 330006

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840

    Shanghai, Shanghai Municipality, 200065

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705

    Shanghai, Shanghai Municipality, 200127

  • Shanghai East Hospital /ID# 212684

    Shanghai, Shanghai Municipality, 200136

  • The Second Hospital of Hebei Medical University /ID# 212738

    Shijiazhuang, Hebei, 050000

  • Tianjin Medical University General Hospital /ID# 210926

    Tianjin, Tianjin Municipality, 300052

  • Duplicate_Union Hospital Tongji Medical College Huazhong University of Science a /ID# 211039

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST /ID# 210858

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University /ID# 214874

    Wuhan, Hubei, 430060

Other trials in China

United Kingdom16 sites

  • Barnsley Hospital NHS Foundation Trust /ID# 202773

    Barnsley, South Yorkshire, S75 2EP

  • University Hospitals Birmingham NHS Foundation Trust /ID# 157545

    Birmingham, B15 2TH

  • Addenbrookes Hospital /ID# 158034

    Cambridge, Cambridgeshire, CB2 2QQ

  • Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936

    Chertsey, Surrey, KT16 0PZ

  • Western General Hospital /ID# 207448

    Edinburgh, Edinburgh, City of, EH4 2XU

  • Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 157544

    Exeter, Devon, EX2 5DW

  • Gartnavel General Hospital /ID# 202568

    Glasgow, Glasgow City, G12 0YN

  • Calderdale and Huddersfield NHS Foundation Trust /ID# 209570

    Huddersfield, HX3 0PW

  • Hull University Teaching Hospitals NHS Trust /ID# 158761

    Hull, East Riding Of Yorkshire, HU3 2JZ

  • Leeds Teaching Hospitals NHS Trust /ID# 157550

    Leeds, West Yorkshire, LS9 7TF

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 163713

    London, Greater London, E1 2ES

  • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 157546

    London, Greater London, SE1 9RT

  • Kings College Hospital NHS Foundation Trust /ID# 158760

    London, Greater London, SE5 9RS

  • Fairfield General Hospital /ID# 207766

    Manchester, Lancashire, BL9 7TD

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708

    Newcastle upon Tyne, NE3 3HD

  • Oxford University Hospitals NHS Foundation Trust /ID# 158036

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

Poland15 sites

  • Centrum Medyczne Lukamed Sp. z o.o. /ID# 212478

    Chojnice, Pomeranian Voivodeship, 89-600

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477

    Lodz, Łódź Voivodeship, 90-153

  • 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940

    Lublin, Lublin Voivodeship, 20-049

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 210941

    Lublin, Lublin Voivodeship, 20-090

  • Wojewodzki Szpital Specjalistyczny W Olsztynie /ID# 212474

    Olsztyn, Warmian-Masurian Voivodeship, 10-561

  • Solumed Centrum Medyczne /ID# 163569

    Poznan, Greater Poland Voivodeship, 60-529

  • Centrum Medycznym Medyk /ID# 212891

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Gastromed Sp. z o.o /ID# 212476

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • H-T Centrum Medyczne Endoterapia /ID# 212475

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Zdrowia MDM /ID# 163570

    Warsaw, Masovian Voivodeship, 00-189

  • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 163582

    Warsaw, Masovian Voivodeship, 02-507

  • Vivamed Sp. z o.o. /ID# 202800

    Warsaw, Masovian Voivodeship, 03-580

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580

    Warsaw, Masovian Voivodeship, 04-730

  • Duplicate_Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocl /ID# 212601

    Wroclaw, Lower Silesian Voivodeship, 50-556

  • Planetmed Sp. z o.o. /ID# 202799

    Wroclaw, Lower Silesian Voivodeship, 52-210

Other trials in Poland

Spain14 sites

  • Hospital Clinic de Barcelona /ID# 157552

    Barcelona, 08036

  • Hospital Universitario Basurto /ID# 205190

    Bilbao, Vizcaya, 48013

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553

    Ferrol, A Coruna, 15405

  • Hospital Universitari de Bellvitge /ID# 208207

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital General Universitario Gregorio Maranon /ID# 161145

    Madrid, 28007

  • Hospital Universitario La Paz /ID# 159235

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157573

    Majadahonda, Madrid, 28222

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Salamanca /ID# 157558

    Salamanca, 37711

  • Hospital Universitario Virgen Macarena /ID# 159967

    Seville, 41009

  • Hospital Clinico Universitario de Valencia /ID# 209700

    Valencia, 46010

  • Hospital Universitario y Politecnico La Fe /ID# 157556

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa /ID# 212525

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet /ID# 157557

    Zaragoza, 50009

Other trials in Spain

Belgium13 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 157408

    Anderlecht, Brussels Capital, 1070

  • Imelda Ziekenhuis /ID# 157403

    Bonheiden, Antwerpen, 2820

  • Cliniques Universitaires UCL Saint-Luc /ID# 157406

    Brussels, Brussels Capital, 1200

  • UZ Gent /ID# 157405

    Ghent, Oost-Vlaanderen, 9000

  • AZ Maria Middelares /ID# 213532

    Ghent, 9000

  • AZ Groeninge /ID# 211513

    Kortrijk, 8500

  • Universitair Ziekenhuis Leuven /ID# 157407

    Leuven, Vlaams-Brabant, 3000

  • Groupe Sante CHC - Clinique du MontLegia /ID# 157404

    Liège, Liege, 4000

  • CHU de Liege /ID# 157409

    Liège, 4000

  • AZ Sint-Maarten /ID# 212876

    Mechelen, Antwerpen, 2800

  • ZAS Palfijn /ID# 212877

    Merksem, Antwerpen, 2170

  • AZ-Delta. /ID# 157402

    Roeselare, West-Vlaanderen, 8800

  • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 157412

    Yvoir, Namur, 5530

Other trials in Belgium

France12 sites

  • CHU Amiens-Picardie Site Sud /ID# 165058

    Amiens, Somme, 80054

  • Hopital Beaujon /ID# 166284

    Clichy, Île-de-France Region, 92110

  • Duplicate_CHU Grenoble - Hopital Michallon /ID# 212834

    La Tronche, Isere, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 162559

    Lille, Nord, 59037

  • CHU Montpellier - Hopital Saint Eloi /ID# 215147

    Montpellier, Herault, 34295

  • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249858

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

  • Chu de Nice-Hopital Larchet Ii /Id# 162557

    Nice, Alpes-Maritimes, 06202

  • Centre Hospitalier Universitaire de Bordeaux /ID# 162558

    Pessac, New Aquitaine, 33604

  • HCL - Hopital Lyon Sud /ID# 162560

    Pierre-Bénite, Rhone, 69495

  • CHRU Pontchaillou /ID# 213209

    Rennes, 35033

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 162562

    St-Priest-en-Jarez, Pays de la Loire Region, 42270

  • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 162561

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

Other trials in France

South Korea12 sites

  • Inje University Haeundae Hospital /ID# 202518

    Busan, Busan Gwang Yeogsi, 48108

  • Dong-A University Medical Center /ID# 158699

    Busan, Busan Gwang Yeogsi, 49201

  • Pusan National University Hospital /ID# 158695

    Busan, Busan Gwang Yeogsi, 49241

  • Yeungnam University Medical Center - Daegu /ID# 158691

    Daegu, Daegu Gwang Yeogsi, 42415

  • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 213554

    Daejeon, Daejeon Gwang Yeogsi, 34943

  • Hanyang University Guri Hospital /ID# 158690

    Guri-si, Gyeonggido, 11923

  • Duplicate_CHA University Bundang Medical Center /ID# 158698

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 158694

    Seoul, Seoul Teugbyeolsi, 03181

  • Asan Medical Center /ID# 158696

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 158692

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 158689

    Seoul, 03722

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 158693

    Suwon, Gyeonggido, 16247

Other trials in South Korea

Ukraine12 sites

  • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657

    Kharkiv, 61037

  • Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399

    Kherson, 73000

  • Kyiv City Clinical Hospital No.18 /ID# 162531

    Kyiv, 01030

  • Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 211998

    Kyiv, 02091

  • Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659

    Kyiv, 02232

  • Medical Center of LLC Medbud-Clinic /ID# 216998

    Kyiv, 03037

  • Kyiv Railway Clinical Hosp No.2 /ID# 217366

    Kyiv, 03049

  • ME Volyn Regional Clinical Hospital of Volyn Regional Council /ID# 206789

    Lutsk, Volyn Oblast, 43005

  • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658

    Lviv, Lviv Oblast, 79000

  • Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960

    Uzhhorod, Zakarpattia Oblast, 88018

  • Centre of Gastroenterology and Dietetics /ID# 216474

    Vinnytsia, Vinnytsia Oblast, 21018

  • University Hospital of M.I. Pyrogov VNMU /ID# 212000

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

Portugal11 sites

  • Duplicate_Hospital Garcia de Orta, EPE /ID# 160745

    Almada, Setúbal District, 2805-267

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713

    Faro, 8000-386

  • Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737

    Guimarães, Braga District, 4835-044

  • Centro Hospitalar de Lisboa Central - Lisbon /ID# 160673

    Lisbon, Lisbon District, 1169-050

  • Centro Hospitalar De Lisboa Ocidental - Hospital De Egas Moniz /ID# 167751

    Lisbon, Lisbon District, 1349-019

  • Unidade Local de Saude de Santa Maria /ID# 160692

    Lisbon, 1649-035

  • Hospital de Loures, E.P.E /ID# 207759

    Loures, 2674-514

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752

    Portimão, Faro District, 8500-338

  • Unidade Local de Saude Sao Joao /ID# 160693

    Porto, 4200-319

  • Centro Hospitalar de Entre Douro e Vouga /ID# 160672

    Santa Maria DA Feira, Porto District, 4520-211

  • Centro Hosp de Tondela-Viseu /ID# 160699

    Viseu, 3504-509

Other trials in Portugal

Russia11 sites

  • Alliance Biomedical Ural Group /ID# 200972

    Izhevsk, Udmurtiya Republic, 426061

  • Kuzbass Regional Clinical Hospital /ID# 200962

    Kemerovo, Kemerovo Oblast, 650099

  • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808

    Moscow, 123423

  • Novosibirski Gastrocenter /ID# 217552

    Novosibirsk, Novosibirsk Oblast, 630007

  • Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439

    Perm, Permskiy Kray, 614990

  • Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978

    Saint Petersburg, Sankt-Peterburg, 194100

  • City Clinical Hospital No. 31 /ID# 208872

    Saint Petersburg, 197110

  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970

    Stavropol, Stavropol Kray, 355012

  • Tver Regional Clinical Hospital /ID# 206858

    Tver', Tver Oblast, 170036

  • Regional Clinical Hospital #1 /ID# 200973

    Tyumen, Tyumen Oblast, 625023

  • Ulyanovsk Regional Clinical Hospital /ID# 200964

    Ulyanovsk, 432017

Other trials in Russia

Czechia9 sites

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 163225

    Hradec Králové, 500 12

  • Nemocnice Pardubickeho kraje, a.s. /ID# 163226

    Pardubice, 530 03

  • Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465

    Prague, Praha 4, 140 00

  • ResTrial GastroEndo /ID# 211078

    Prague, Praha 4, 143 00

  • Iscare Klinicke Centrum /ID# 225794

    Prague, Praha 9, 190 00

  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306

    Prague, 118 33

  • Axon Clinical, s.r.o. /ID# 163223

    Prague, 140 00

  • Fakultni Thomayerova nemocnice /ID# 162941

    Prague, 140 59

  • Nemocnice Horovice - NH Hospital a.s /ID# 211077

    Prague, 155 00

Other trials in Czechia

Israel9 sites

  • Soroka University Medical Center /ID# 157794

    Beersheba, Southern District, 8443901

  • Duplicate_Rambam Medical Center /ID# 171067

    Haifa, 3109601

  • The Edith Wolfson Medical Center /ID# 217331

    Holon, Southern District, 5822000

  • Shaare Zedek Medical Center /ID# 163541

    Jerusalem, Jerusalem, 91031

  • Shaare Zedek Medical Center /ID# 171068

    Jerusalem, Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 165914

    Jerusalem, Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 157793

    Ramat Gan, Tel Aviv, 5265601

  • The Chaim Sheba Medical Center /ID# 171069

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 157792

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Serbia9 sites

  • Clinical Hosp Center Zvezdara /ID# 157052

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 157053

    Belgrade, Beograd, 11000

  • University Children's Hospital 'Tirsova' /ID# 211482

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 157047

    Belgrade, Beograd, 11000

  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799

    Belgrade, Beograd, 11040

  • Clin Hosp Ctr Bezanijska Kosa /ID# 157050

    Belgrade, Beograd, 11080

  • Duplicate_University Clinical Center Kragujevac /ID# 157049

    Kragujevac, Sumadijski Okrug, 34000

  • General Hospital Leskovac /ID# 209575

    Leskovac, Jablanicki Okrug, 16000

  • University Clinical Center Vojvodina /ID# 157046

    Novi Sad, 21000

Other trials in Serbia

Bulgaria7 sites

  • UMHAT Dr Georgi Stranski EAD /ID# 203976

    Pleven, 5800

  • Umbal Kaspela /ID# 165700

    Plovdiv, 4001

  • 2nd Mhat /ID# 165702

    Sofia, 1202

  • Tokuda Hospital Sofia /ID# 165701

    Sofia, 1407

  • UMHAT Sveti Ivan Rilski /ID# 204815

    Sofia, 1431

  • Duplicate_UMHAT Tsaritsa Joanna - ISUL /ID# 211242

    Sofia, 1527

  • MHAT Trakia /ID# 201668

    Stara Zagora, 6004

Other trials in Bulgaria

Greece7 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 157422

    Heraklion, Crete, 71500

  • University General Hospital of Ioannina /ID# 157420

    Ioannina, 45500

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 157424

    Nikaia, Attica, 18454

  • Tzaneio general hospital of Piraeus /ID# 206443

    Piraeus, Attica, 18536

  • Theageneio Anticancer Hospital /ID# 163897

    Thessaloniki, 54639

Other trials in Greece

Sweden7 sites

  • Duplicate_Sahlgrenska University Hospital /ID# 163792

    Gothenburg, Västra Götaland County, 413 45

  • Duplicate_Sahlgrenska University Hospital /ID# 163797

    Gothenburg, Västra Götaland County, 413 46

  • Skane University hospital /ID# 211745

    Malmö, Skåne County, 214 28

  • Karolinska University Hospital Solna /ID# 212025

    Solna, Stockholm County, 171 64

  • GHP Stockholm Gastro Center /ID# 211748

    Stockholm, Stockholm County, 114 28

  • Medicinkliniken, Gastroenheten /ID# 163744

    Stockholm, Stockholm County, 116 28

  • Danderyd Hospital /ID# 202138

    Stockholm, Stockholm County, 182 88

Other trials in Sweden

Croatia6 sites

  • Poliklinika Borzan d.o.o. /ID# 157559

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki Bolnicki Centar Split /ID# 157562

    Split, Split-Dalmatia County, 21000

  • Zadar General Hospital /ID# 157563

    Zadar, 23000

  • Klinicka bolnica Dubrava Zagreb /ID# 157560

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 157728

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 157561

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Egypt6 sites

  • Zagazig University Hospitals /ID# 164539

    Al Sharqia, 44519

  • Alexandria University /ID# 157187

    Alexandria, Alexandria Governorate, 21131

  • Alexandria University /ID# 164540

    Alexandria, Alexandria Governorate, 21131

  • Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175

    Cairo, 11559

  • National Hepatology and Tropical Medicine Research Institute /ID# 157874

    Cairo, 11559

  • Duplicate_Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506

    Cairo, 11566

Other trials in Egypt

Denmark5 sites

  • Aarhus Universitetshospital - Skejby /ID# 155664

    Aarhus, Central Jutland, 8200

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530

    Hvidovre, Capital Region, 2650

  • Sygehusenheden Nyborg - OUH /ID# 161525

    Nyborg, Region Syddanmark, 5800

  • Odense University Hospital /ID# 155531

    Odense, Region Syddanmark, 5000

  • Roskilde Sygehus /ID# 155532

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Taiwan5 sites

  • China Medical University Hospital /ID# 160141

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 160140

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 160142

    Tainan, 704

  • National Taiwan University Hospital /ID# 162190

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 212712

    Taipei, 11217

Other trials in Taiwan

Argentina4 sites

  • Cemic /Id# 168078

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1431

  • Hospital Britanico de Buenos Aires /ID# 168077

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280

  • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 168076

    Córdoba, 5016

  • Hospital Provincial del Centenario /ID# 170886

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Australia4 sites

  • Emeritus Research /ID# 213512

    Camberwell, Victoria, 3124

  • Lyell McEwin Hospital /ID# 212215

    Elizabeth Vale, South Australia, 5112

  • Mater Misericordiae Limited /ID# 167220

    South Brisbane, Queensland, 4101

  • Griffith University /ID# 212635

    Southport, Queensland, 4222

Other trials in Australia

Austria4 sites

  • Medizinische Universitaet Graz /ID# 158140

    Graz, Styria, 8010

  • Universitaetsklinikum St. Poelten /ID# 166424

    Sankt Pölten, Lower Austria, 3100

  • Krankenhaus der Barmherzigen Brueder Wien /ID# 212060

    Vienna, State of Vienna, 1020

  • Medizinische Universitaet Wien /ID# 158141

    Vienna, State of Vienna, 1090

Other trials in Austria

Chile4 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 210760

    Concepción, Biobio, 4070038

  • Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122

    Santiago, Region Metropolitana Santiago, 8350488

  • Complejo Asistencial Dr. Sotero del Rio /ID# 169384

    Santiago, Santiago Metropolitan, 8207257

  • Hospital Las Higueras /ID# 167092

    Talcahuano, Biobio, 1740000

Other trials in Chile

Colombia4 sites

  • Hospital Univ San Ignacio /ID# 158734

    Bogota, Cundinamarca, 110231

  • Instituto de Coloproctologia ICO - Medellin /ID# 158743

    Medellín, Antioquia, 050024

  • Hospital Pablo Tobon Uribe /ID# 158730

    Medellín, Antioquia, 050034

  • Hospital Universitario San Vic /ID# 171486

    Medellín, Antioquia, 50010

Other trials in Colombia

Mexico4 sites

  • JM Research SC /ID# 170729

    Cuernavaca, Morelos, 62290

  • Health Pharma Professional Research S.A de C.V /ID# 170730

    Del. Benito Juárez, 03810

  • Unidad de Atencion Medica e Investigacion en Salud /ID# 170732

    Mérida, Yucatán, 97000

  • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734

    Zapopan, Jalisco, 45070

Other trials in Mexico

New Zealand4 sites

  • Christchurch Hospital. /ID# 167224

    Christchurch, Canterbury, 8011

  • Dunedin Hospital /ID# 167227

    Otago, Otago, 9016

  • Aotearoa Clinical Trials /ID# 167226

    Papatoetoe, Auckland, 2025

  • Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225

    Wellington, 6021

Other trials in New Zealand

Norway4 sites

  • Helse More og Romsdal HF, Alesund sjukehus /ID# 212810

    Ålesund, Møre og Romsdal, 6017

  • Duplicate_Vestre viken - Baerum Sykehus /ID# 212996

    Gjettum, Akershus, 1346

  • Sykehuset Levanger Helse NT /ID# 201669

    Levanger, Nord-Trondelag, 7601

  • Akershus Universitetssykehus /ID# 169379

    Nordbyhagen, Akershus, 1474

Other trials in Norway

Romania4 sites

  • Fundeni Clinical Institute /ID# 170899

    Bucharest, 022328

  • Tvm Med Serv Srl /Id# 170902

    Cluj-Napoca, 400132

  • Cabinet Particular Policlinic Algomed /ID# 170900

    Timișoara, 300002

  • Duplicate_Centrul Medical Tuculanu SRL /ID# 170903

    Timișoara, 300168

Other trials in Romania

South Africa4 sites

  • Private Practice Dr MN Rajabally /ID# 163112

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 158116

    CAPE TOWN Milnerton, Western Cape, 7441

  • Clinresco Centers /ID# 163865

    Johannesburg, Gauteng, 1619

  • Wits Clinical Research /ID# 158114

    Johannesburg, Gauteng, 1864

Other trials in South Africa

Belarus3 sites

  • Gomel Regional Clinical Hospital /ID# 205112

    Homyel, 246029

  • Grodno city clinical hospital #2 /ID# 205113

    Hrodna, Grodnenskaya, 230011

  • Vitebsk Regional Advanced Clin /ID# 206778

    Vitebsk, 210001

Other trials in Belarus

Estonia3 sites

  • North Estonia Medical Centre /ID# 164326

    Mustamäe, Harju, 13419

  • West Tallinn Central Hospital /ID# 157075

    Tallinn, Harju, 10617

  • East Tallinn Central Hospital /ID# 157074

    Tallinn, 10138

Other trials in Estonia

Ireland3 sites

  • Duplicate_Beaumont Hospital /ID# 157543

    Beaumont, Dublin, D09 XR63

  • St Vincents University Hospital /ID# 157540

    Elm Park, Dublin, D04 T6F4

  • University Hospital Galway /ID# 157541

    Galway, H91 YR71

Other trials in Ireland

Latvia3 sites

  • VCA Polyclinic Aura /ID# 159611

    Riga, 1035

  • Pauls Stradins Clinical University Hospital /ID# 159612

    Riga, LV-1002

  • Duplicate_Digestive Disease Center Gastro /ID# 163107

    Riga, LV-1079

Other trials in Latvia

Malaysia3 sites

  • Queen Elizabeth Hospital /ID# 160664

    Division Pantai Barat Utara, Sabah, 88200

  • Universiti Sains Malaysia /ID# 160666

    Kelantan, Kelantan, 16150

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363

    Kuala Lumpur, Selangor, 56000

Other trials in Malaysia

Singapore3 sites

  • Mount Elizabeth Hospital /ID# 205741

    Singapore, Central Singapore, 228510

  • National University Hospital /ID# 160667

    Singapore, 119074

  • Singapore General Hospital /ID# 160668

    Singapore, 169608

Other trials in Singapore

Slovakia3 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468

    Banská Bystrica, Banská Bystrica Region, 975 17

  • KM Management, spol. s.r.o. /ID# 206764

    Nitra, Nitra Region, 949 01

  • Gastro I., s.r.o. /ID# 156469

    Prešov, Presov, 080 01

Other trials in Slovakia

Switzerland3 sites

  • University Hospital Basel /ID# 164554

    Basel Town, Canton of Basel-City, 4031

  • Inselspital, Universitaetsspital Bern /ID# 163535

    Bern, 3010

  • University Hospital Zurich /ID# 163536

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Bosnia and Herzegovina2 sites

  • University Clinical Centre of the Republic of Srpska /ID# 164513

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 165139

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Hong Kong2 sites

  • Queen Mary Hospital /ID# 163923

    Hong Kong, 999077

  • Tuen Mun Hospital /ID# 163905

    Hong Kong

Other trials in Hong Kong

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 162514

    Vilnius, 08661

Other trials in Lithuania

Netherlands2 sites

  • Amsterdam University Medical Center /ID# 157956

    Amsterdam, North Holland, 1105 AZ

  • Elisabeth Tweesteden Ziekenhuis /ID# 163632

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

About this study

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

The study consists of 4 sub-studies, as follows:

  • Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
  • Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
  • Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
  • Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
  • OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
Conditions
Crohn's Disease
Being tested
Placebo for Risankizumab SC, Risankizumab IV, Placebo for Risankizumab IV, Risankizumab SC, Risankizumab On-Body Injector (OBI)
Keywords
Risankizumab, ABBV-066, BI 655066, SKYRIZI, Crohn's Disease (CD)
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 SCDrug

    Placebo for Risankizumab SC Subcutaneous (SC) Injection

  • Risankizumab IVDrug

    Also called ABBV-066, BI 655066, SKYRIZI

    Risankizumab IV Intravenous (IV) infusion

  • Placebo for Risankizumab IVDrug

    Placebo for Risankizumab IV Intravenous (IV) infusion

  • Risankizumab SCDrug

    Also called ABBV-066, BI 655066, SKYRIZI

    Risankizumab SC Subcutaneous (SC) injection

  • Risankizumab On-Body Injector (OBI)Drug

    Also called ABBV-066, BI 655066, SKYRIZI

    Subcutaneous (SC) injection; on-body injector (OBI)

Study groups in NCT03105102
Study groupRoleWhat they receive
Double-blind Placebo for Risankizumab (Sub-Study 1)Placebo comparatorParticipants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Receives: Drug: Placebo for Risankizumab SC
Double-blind Risankizumab Dose 1 (Sub-Study 1)ExperimentalParticipants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Receives: Drug: Risankizumab SC
Double-blind Risankizumab Dose 2 (Sub-Study 1)ExperimentalParticipants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Receives: Drug: Risankizumab SC
Maintenance Risankizumab Dose 1 (Sub-Study 2)ExperimentalParticipants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Receives: Drug: Placebo for Risankizumab IV; Drug: Risankizumab SC
Maintenance Risankizumab Dose 2 (Sub-Study 2)ExperimentalParticipants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Receives: Drug: Placebo for Risankizumab SC; Drug: Risankizumab IV; Drug: Risankizumab SC
Open-label Risankizumab (Sub-Study 3)ExperimentalParticipants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Receives: Drug: Risankizumab SC
Risankizumab On-Body Injector and Open Label (Sub-Study 4)ExperimentalParticipants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
Receives: Drug: Risankizumab SC; Drug: Risankizumab On-Body Injector (OBI)
CTE: Open Label Continuous Treatment ExtensionExperimentalParticipants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.
Receives: Drug: Risankizumab SC

What is being measured

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

  1. Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

    The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.

    Measured: Week 52

  2. Sub-Study 1: Percentage of Participants With Endoscopic Response

    Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

    Measured: Week 52

  3. Sub-Study 3: Number of Participants With Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

    Measured: Up to Week 220

  4. Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration

    Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.

    Measured: Up to Week 16

  5. Sub-Study 4: Percentage of Participants who had no Potential Hazards

    Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.

    Measured: Up to Week 16

  6. Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16

    SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment.

    Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.

    Measured: Up to Week 16

  7. Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16

    Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.

    Measured: Up to Week 16

Secondary outcomes (12)

  1. Sub-Study 1: Percentage of Participants With Clinical Remission

    Clinical remission per average daily stool frequency (SF) and average daily AP score.

    Measured: Week 52

  2. Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0

    The CDAI is used to evaluate disease activity in patients with Crohn's disease

    Measured: Week 52

  3. Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy

    Endoscopic healing was assessed using SES-CD.

    Measured: Week 52

  4. Sub-Study 1: Percentage of Participants With Endoscopic Remission

    Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer

    Measured: Week 52

  5. Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

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

    Measured: Week 52

  6. Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline

    Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.

    Measured: Week 52

  7. Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

    Measured: Week 52

  8. Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission

    SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.

    Measured: Week 52

  9. Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission

    AP Remission is defined by an average daily AP <= 1 and not worse than baseline.

    Measured: Week 52

  10. Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response

    The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from baseline of > 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

    Measured: Week 52

  11. Sub-Study 1: Percentage of Participants With Deep Remission

    Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).

    Measured: Week 52

  12. Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52

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

    Measured: Up to Week 52

Timeline

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

  1. First posted7 Apr 2017
  2. Study start9 Apr 2018
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03105102
Sponsor's protocol ID
M16-000
Other IDs
2023-506399-28-00, 2023
Acronym
FORTIFY
Status last verified
Aug 2026
First submitted
4 Apr 2017
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Expanded access
Available

Publications

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

    PubMed 39909280

  • 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

  • Ferrante M, Irving PM, Abreu MT, Axler J, Gao X, Cao Q, Fujii T, Rausch A, Torres J, Neimark E, Song A, Wallace K, Kligys K, Berg S, Liao X, Zhou Q, Kalabic J, Feagan B, Panaccione R. Maintenance Risankizumab Sustains Induction Response in Patients with Crohn's Disease in a Randomized Phase 3 Trial. J Crohns Colitis. 2024 Mar 1;18(3):416-423. doi: 10.1093/ecco-jcc/jjad168.

    PubMed 37797293

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

    PubMed 37368103

  • Loftus EV Jr, Griffith J, Neimark E, Song A, Wallace K, Nannapaneni S, Zhou J, Byrne R, Kligys K, Pang Y, Liao X, Kalabic J, Dubinsky M. Efficacy, Safety, Patient Experience, and Tolerability of Risankizumab Administered by On-Body Injector for Moderate to Severe Crohn's Disease. Adv Ther. 2023 May;40(5):2311-2325. doi: 10.1007/s12325-023-02477-2. Epub 2023 Mar 14.

    PubMed 36917429

  • Ferrante M, 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, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.

    PubMed 35644155

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