Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
SEQUENCE
A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
3 other identifiers
interventional
527
30 countries
295
Brief Summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Longer than P75 for phase_3
295 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedStudy Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
April 13, 2026
April 1, 2026
7.3 years
August 20, 2020
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Achieving Clinical Remission at Week 24
Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
Week 24
Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
Week 48
Number of Participants Reporting Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. 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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Up to 220 Weeks
Secondary Outcomes (5)
Percentage of Participants Achieving Clinical Remission at Week 48
Week 48
Percentage of Participants Achieving Endoscopic Response at Week 48
Week 48
Percentage of Participants Achieving Endoscopic Response at Week 24
Week 24
Percentage of Participants Achieving Steroid-Free Endoscopic Remission
Week 48
Percentage of Participants Achieving Steroid-Free Clinical Remission
Week 48
Study Arms (2)
Risankizumab Dose A Followed by Dose B
EXPERIMENTALParticipants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.
Ustekinumab
ACTIVE COMPARATORParticipants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
Interventions
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of Crohn's disease (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 Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
- Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.
You may not qualify if:
- Current diagnosis of ulcerative colitis or indeterminate colitis.
- Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
- Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
- Currently know complications of CD (strictures, short bowel, etc).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (300)
Advanced Gastroenterology, P.C /ID# 224396
Chandler, Arizona, 85224-1636, United States
Southern California Res. Ctr. /ID# 223484
Coronado, California, 92118-1408, United States
Hoag Memorial Hosp Presbyterian /ID# 224373
Irvine, California, 92618, United States
United Medical Doctors /ID# 223486
Los Alamitos, California, 90720-3309, United States
TLC Clinical Research Inc /ID# 223467
Los Angeles, California, 90048, United States
Duplicate_UC Davis Medical Center /ID# 225700
Sacramento, California, 95817, United States
Duplicate_University of California, San Francisco /ID# 223621
San Francisco, California, 94158, United States
Duplicate_Western Connecticut Medical Group /ID# 223478
Danbury, Connecticut, 06810, United States
Duplicate_Medical Research Center of CT /ID# 223540
Hamden, Connecticut, 06518, United States
Yale Univ Digestive Diseases /ID# 224463
New Haven, Connecticut, 06510, United States
Omega Research Maitland, LLC /ID# 223463
DeBary, Florida, 32713-2260, United States
Nature Coast Clinical Research - Inverness /ID# 223600
Inverness, Florida, 34452-4717, United States
University of Miami /ID# 223496
Miami, Florida, 33136, United States
Gastroenterology Group Naples /ID# 223516
Naples, Florida, 34102, United States
Advanced Research Institute, Inc /ID# 223470
New Port Richey, Florida, 34653, United States
Endoscopic Research, Inc. /ID# 223505
Orlando, Florida, 32803, United States
Duplicate_University of South Florida /ID# 224733
Tampa, Florida, 33612, United States
Atlanta Gastro Assoc /ID# 223537
Atlanta, Georgia, 30342, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 223525
Macon, Georgia, 31201, United States
Duplicate_The University of Chicago DCAM /ID# 223520
Chicago, Illinois, 60637, United States
NorthShore University-Endeavor Health Evanston Hospital /ID# 223538
Evanston, Illinois, 60201, United States
Southwest Gastroenterology /ID# 223509
Oak Lawn, Illinois, 60453, United States
University of Louisville Hospital /ID# 223471
Louisville, Kentucky, 40202, United States
GI Alliance /ID# 223508
Baton Rouge, Louisiana, 70809, United States
Nola Research Works, LLC /ID# 223489
New Orleans, Louisiana, 70115, United States
Louisiana Research Center, LLC /ID# 223503
Shreveport, Louisiana, 71105-6800, United States
Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland /ID# 223518
Columbia, Maryland, 21045, United States
Massachusetts General Hospital /Id# 224335
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center /ID# 228094
Boston, Massachusetts, 02215-5400, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597
Ann Arbor, Michigan, 48109, United States
AA Medical Research Center - Flint /ID# 224384
Flint, Michigan, 48504, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465
Wyoming, Michigan, 49519, United States
Mayo Clinic - Rochester /ID# 223506
Rochester, Minnesota, 55905-0001, United States
Las Vegas Medical Research /ID# 223533
Las Vegas, Nevada, 89113, United States
Univ New Mexico /ID# 223515
Albuquerque, New Mexico, 87131, United States
NY Scientific /ID# 223479
Brooklyn, New York, 11235, United States
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048
Burnt Hills, New York, 12027, United States
Intercity Advanced Gastroentertology Center /ID# 224313
Fresh Meadows, New York, 11366, United States
North Shore University Hospital /ID# 224356
New Hyde Park, New York, 11040, United States
The Mount Sinai Hospital /ID# 223687
New York, New York, 10029, United States
Columbia Univ Medical Center /ID# 224215
New York, New York, 10032-3725, United States
Lenox Hill Hospital /ID# 223534
New York, New York, 10075, United States
Univ NC Chapel Hill /ID# 224405
Chapel Hill, North Carolina, 27514-4220, United States
Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 224406
Winston-Salem, North Carolina, 27157-0001, United States
Plains Clinical Research Center, LLC /ID# 223522
Fargo, North Dakota, 58104-5925, United States
University of Cincinnati Medical Center /ID# 224614
Cincinnati, Ohio, 45219-2364, United States
Cleveland Clinic Main Campus /ID# 223691
Cleveland, Ohio, 44195, United States
DSI Research, LLC /ID# 234116
Springboro, Ohio, 45066-1615, United States
Hightower Clinical /ID# 223566
Oklahoma City, Oklahoma, 73102, United States
Digestive Disease Specialists /ID# 223528
Oklahoma City, Oklahoma, 73112, United States
Penn State Milton S. Hershey Medical Center /ID# 224216
Hershey, Pennsylvania, 17033-2360, United States
Guthrie Medical Group, PC /ID# 223910
Sayre, Pennsylvania, 18840, United States
Digestive Disease Associates, LTD - Wyomissing /ID# 223462
Wyomissing, Pennsylvania, 19610, United States
Medical University of South Carolina /ID# 223485
Charleston, South Carolina, 29425, United States
Consultants in Gastroenterology - Columbia NE /ID# 224263
Columbia, South Carolina, 29203-8902, United States
Gastroenterology Associates, P.A. of Greenville /ID# 223497
Greenville, South Carolina, 29607, United States
Gastro One /ID# 223539
Cordova, Tennessee, 38018, United States
Vanderbilt University Medical Center /ID# 224610
Nashville, Tennessee, 37232-0011, United States
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512
Dallas, Texas, 75246, United States
Duplicate_DHAT Research Institute /ID# 223521
Garland, Texas, 75044-2208, United States
Vilo Research Group Inc /ID# 223513
Houston, Texas, 77017-2337, United States
Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488
Houston, Texas, 77030-3411, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 223510
San Antonio, Texas, 78212, United States
Southern Star Research Institute, LLC /ID# 223598
San Antonio, Texas, 78229-5390, United States
Texas Digestive Disease Consultants - Southlake /ID# 224264
Southlake, Texas, 76092, United States
Tyler Research Institute, LLC /ID# 223469
Tyler, Texas, 75701, United States
University of Vermont Medical Center /ID# 224047
Burlington, Vermont, 05401-1473, United States
Richmond VA Medical Center /ID# 223586
Richmond, Virginia, 23249, United States
Virginia Mason Hospital & Medical Center /ID# 224253
Seattle, Washington, 98101, United States
Harborview Medical Center /ID# 224464
Seattle, Washington, 98104-2420, United States
West Virginia University Hospitals /ID# 223501
Morgantown, West Virginia, 26506, United States
Hospital Britanico de Buenos Aires /ID# 223432
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280, Argentina
Hospital Italiano de Buenos Aires /ID# 224550
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1199, Argentina
CINME Centro de Investigaciones Metabolicas /ID# 223447
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1027, Argentina
Gedyt /ID# 224698
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1115, Argentina
Duplicate_CEMIC /ID# 223670
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1431, Argentina
Duplicate_Sanatorio 9 de Julio /ID# 226086
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 223433
Córdoba, 5016, Argentina
Wollongong Hospital /ID# 224688
Wollongong, New South Wales, 2500, Australia
Mater Misericordiae Limited /ID# 223642
South Brisbane, Queensland, 4101, Australia
Griffith University /ID# 223641
Southport, Queensland, 4222, Australia
Lyell McEwin Hospital /ID# 223643
Elizabeth Vale, South Australia, 5112, Australia
Monash Health - Monash Medical Centre /ID# 224599
Clayton, Victoria, 3168, Australia
Universitaetsklinikum St. Poelten /ID# 223437
Sankt Pölten, Lower Austria, 3100, Austria
Medizinische Universitaet Wien /ID# 223438
Vienna, State of Vienna, 1090, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440
Linz, Upper Austria, 4010, Austria
ZAS Palfijn /ID# 223907
Merksem, Antwerpen, 2170, Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 223902
Anderlecht, Brussels Capital, 1070, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 223900
Brussels, Brussels Capital, 1200, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 223898
Liège, Liege, 4000, Belgium
Duplicate_CHU UCL Namur - site Godinne /ID# 223905
Godinne, Namur, 5530, Belgium
UZ Gent /ID# 223899
Ghent, Oost-Vlaanderen, 9000, Belgium
Vitaz /Id# 224511
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Universitair Ziekenhuis Leuven /ID# 223901
Leuven, Vlaams-Brabant, 3000, Belgium
AZ-Delta. /ID# 223896
Roeselare, West-Vlaanderen, 8800, Belgium
AZ Maria Middelares /ID# 223908
Ghent, 9000, Belgium
Duplicate_CHU de Liege /ID# 223904
Liège, 4000, Belgium
Faculdade de Medicina do ABC /ID# 223231
Santo André, La Spezia, 09060-870, Brazil
Upeclin Fmb - Unesp /Id# 223234
Botucatu, São Paulo, 18618-686, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 223233
Ribeirão Preto, São Paulo, 14049-900, Brazil
Kaiser Clinica e Hospital Dia /ID# 223232
São José do Rio Preto, São Paulo, 15015-110, Brazil
Hospital Tsaritsa Yoanna /ID# 223822
Sofiya, Sofia, 1527, Bulgaria
Umbal Kaspela /ID# 223415
Plovdiv, 4001, Bulgaria
MHAT Knyaginya Klementina /ID# 223425
Sofia, 1233, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757
Sofia, 1407, Bulgaria
Duplicate_University of Calgary /ID# 223750
Calgary, Alberta, T2N 4Z6, Canada
Allen Whey Khye Lim Professional Corporation /ID# 223755
Edmonton, Alberta, T5R 1W2, Canada
Covenant Health /ID# 223753
Edmonton, Alberta, T6K 4B2, Canada
Fraser Clinical Trials Inc /ID# 223742
New Westminster, British Columbia, V3L 3W4, Canada
Percuro Clinical Research, Ltd /ID# 223747
Victoria, British Columbia, V8V 3M9, Canada
QEII - Health Sciences Centre /ID# 223748
Halifax, Nova Scotia, B3H 2Y9, Canada
London Health Sciences Centre - University Hospital /ID# 223741
London, Ontario, N6A 5A5, Canada
Scott Shulman Medicine Professional Corporation /ID# 223754
North Bay, Ontario, P1B 2H3, Canada
Mount Sinai Hospital /ID# 223752
Toronto, Ontario, M5G 1X5, Canada
Axler, Toronto, ON. Canada /ID# 223740
Toronto, Ontario, M9V 0A9, Canada
CISSS de la Monteregie /ID# 224399
Greenfield Park, Quebec, J4V 2H1, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744
Lévis, Quebec, G6V 3Z1, Canada
Montreal General Hospital- McGill University Health Center /ID# 223743
Montreal, Quebec, H3G 1A4, Canada
Duplicate_Duplicate_CHUS - Hopital Fleurimont /ID# 224819
Sherbrooke, Quebec, J1H 5N4, Canada
Hospital Guillermo Grant Benavente de Concepción /ID# 223668
Concepción, Bio-Bio, 4070038, Chile
Hospital Las Higueras /ID# 223669
Talcahuano, Bio-Bio, 1740000, Chile
Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 224032
Providencia, Region Metropolitana Santiago, 7510086, Chile
Anhui Provincial Hospital /ID# 224832
Hefei, Anhui, 230001, China
Peking University Third Hospital /ID# 224479
Beijing, Beijing Municipality, 100191, China
Chongqing General Hospital /ID# 232305
Chongqing, Chongqing Municipality, 400013, China
Zhongshan Hospital Xiamen University /ID# 224663
Xiamen, Fujian, 361004, China
Zhujiang Hospital of Southern Medical University /ID# 224524
Guangzhou, Guangdong, 510280, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 224416
Guangzhou, Guangdong, 510655, China
The Second Affiliated Hospital of Zhengzhou University /ID# 224528
Zhengzhou, Henan, 450014, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College of HUST /ID# 224428
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University /ID# 224525
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital Of Central South University /ID# 224684
Changsha, Hunan, 410011, China
Duplicate_The Third Xiangya Hospital of Central South University /ID# 224754
Changsha, Hunan, 410013, China
Changzhou No.2 Peoples Hospital /ID# 238965
Changzhou, Jiangsu, 213000, China
Nanjing Drum Tower Hospital /ID# 224746
Nanjing, Jiangsu, 210008, China
Wuxi People's Hospital /ID# 224426
Wuxi, Jiangsu, 214023, China
The First Affiliated Hospital of Nanchang University /ID# 224507
Nanchang, Jiangxi, 330006, China
Shengjing Hospital of China Medical University /ID# 224478
Shenyang, Liaoning, 110022, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420
Shanghai, Shanghai Municipality, 200127, China
West China Hospital, Sichuan University /ID# 224786
Chengdu, Sichuan, 610041, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 224662
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421
Hangzhou, Zhejiang, 310018, China
Iscare Klinické Centrum /ID# 223279
Prague, Praha 9, 190 00, Czechia
Nemocnice Ceske Budejovice a.s. /ID# 224219
České Budějovice, 370 01, Czechia
Hepato-Gastroenterologie HK, s.r.o. /ID# 223277
Hradec Králové, 500 12, Czechia
Nemocnice Pardubickeho kraje, a.s. /ID# 223256
Pardubice, 530 03, Czechia
Axon Clinical, s.r.o. /ID# 223260
Prague, 140 00, Czechia
Nemocnice Horovice - NH Hospital a.s /ID# 223276
Prague, 155 00, Czechia
Chu de Nice-Hopital Larchet Ii /Id# 223763
Nice, Alpes-Maritimes, 06202, France
CHU Clermont-Ferrand /ID# 224529
Clermont, Auvergne-Rhône-Alpes, 63100, France
APHM - Hopital Nord /ID# 223869
Marseille, Bouches-du-Rhone, 13015, France
Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 223764
Pessac, Gironde, 33604, France
CHU Montpellier - Hopital Saint Eloi /ID# 223860
Montpellier, Herault, 34295, France
Duplicate_CHU Grenoble - Hopital Michallon /ID# 224091
La Tronche, Isere, 38700, France
CHU Reims - Hôpital Robert Debre /ID# 224530
Reims, Marne, 51092, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 223767
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
CHRU Lille - Hopital Claude Huriez /ID# 223765
Lille, Nord, 59037, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 241098
Nantes, Pays de la Loire Region, 44000, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 223768
St-Priest-en-Jarez, Pays de la Loire Region, 42270, France
Clinique Jules Verne /ID# 223870
Nantes, 44300, France
Polyclinique Grand Sud /ID# 224092
Nîmes, 30932, France
Hopital Universitaire Purpan Hopital Rangueil /ID# 224732
Toulouse, 31059, France
Hopital Beaujon /ID# 223863
Clichy, Île-de-France Region, 92110, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249859
Neuilly-sur-Seine, Île-de-France Region, 92200, France
Universitaetsklinikum Freiburg /ID# 223406
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitatsklinikum Mannheim /ID# 223410
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinikum Ulm /ID# 223400
Ulm, Baden-Wurttemberg, 89081, Germany
Universitaetsklinikum Erlangen /ID# 223404
Erlangen, Bavaria, 91054, Germany
Universitatsklinik Regensburg /ID# 223407
Regensburg, Bavaria, 93053, Germany
Duplicate_Agaplesion Markus Krankenhaus /ID# 223673
Frankfurt am Main, Hesse, 60431, Germany
Duplicate_Universitaetsklinikum Frankfurt /ID# 223396
Frankfurt am Main, Hesse, 60590, Germany
Medizinische Hochschule Hannover /ID# 223402
Hanover, Lower Saxony, 30625, Germany
Klinikum Lueneburg /ID# 223408
Lüneburg, Lower Saxony, 21339, Germany
Praxiszentrum fuer Gastroenterologie /ID# 223409
Grevenbroich, North Rhine-Westphalia, 41515, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482
Saarbrücken, Saarland, 66111, Germany
Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403
Dresden, Saxony, 01307, Germany
Eugastro /ID# 223401
Leipzig, Saxony, 04103, Germany
Otto-von-Guericke-Universitaet /ID# 223413
Magdeburg, Saxony-Anhalt, 39120, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395
Kiel, Schleswig-Holstein, 24105, Germany
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 229110
Berlin, 10318, Germany
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411
Berlin, 10825, Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 223405
Berlin, 13353, Germany
DRK Kliniken Berlin Westend /ID# 223412
Berlin, 14050, Germany
Krankenhaus Waldfriede /ID# 223397
Berlin-Zehlendorf, 14163, Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 224552
Münster, 48155, Germany
General Hospital of Athens Ippokratio /ID# 223344
Athens, Attica, 11527, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342
Athens, Attica, 11527, Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340
Nikaia, Attica, 18454, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 223336
Heraklion, Crete, 71500, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338
Athens, 10676, Greece
University General Hospital of Ioannina /ID# 223339
Ioannina, 45500, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 223887
Thessaloniki, 54642, Greece
Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
Szeged, Csongrád megye, 6725, Hungary
Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 223773
Debrecen, Hajdú-Bihar, 4032, Hungary
Duplicate_Clinfan Szolgaltato Kft. /ID# 224751
Szekszárd, Tolna County, 7100, Hungary
Clinexpert Kft /ID# 223775
Budapest, 1033, Hungary
Semmelweis Egyetem /ID# 223772
Budapest, 1085, Hungary
Yitzhak Shamir Medical Center /ID# 224686
Ẕerifin, Central District, 70300, Israel
Shaare Zedek Medical Center /ID# 223549
Jerusalem, Jerusalem, 91031, Israel
The Edith Wolfson Medical Center /ID# 227652
Ashkelon, Southern District, 5822000, Israel
Soroka University Medical Center /ID# 223556
Beersheba, Southern District, 8410101, Israel
The Chaim Sheba Medical Center /ID# 223557
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 223551
Tel Aviv, Tel Aviv, 6423906, Israel
Rabin Medical Center. /ID# 223558
Petah Tikva, 4941492, Israel
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 223330
Bologna, Emilia-Romagna, 40138, Italy
Duplicate_Ospedale Policlinico San Martino /ID# 223329
Genoa, Genova, 16132, Italy
Duplicate_Ospedale San Raffaele IRCCS /ID# 241167
Milan, Milano, 20132, Italy
ASST Fatebenefratelli Sacco /ID# 223322
Milan, Milano, 20157, Italy
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335
Rho, Milano, 20017, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332
Rome, Roma, 00133, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 223325
Rome, Roma, 00149, Italy
Duplicate_Policlinico Agostino Gemelli /ID# 223323
Rome, Roma, 00168, Italy
Duplicate_IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327
Negrar, Verona, 37024, Italy
Azienda Ospedaliera G. Brotzu /ID# 241165
Cagliari, 09121, Italy
Duplicate_Ospedale San Giovanni Di Dio - Cagliari /ID# 223474
Cagliari, 09124, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 223324
Milan, 20122, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 223333
Palermo, 90146, Italy
Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179
Mexicali, Estado de Baja California, 21200, Mexico
BRCR Global Mexico /ID# 223970
Guadalajara, Jalisco, 44600, Mexico
Centro Medico Zambrano Hellion /ID# 224025
San Pedro Garza García, Nuevo León, 66278, Mexico
Medical Care & Research SA de CV /ID# 223974
Mérida, Yucatán, 97070, Mexico
Faicic S de Rl de Cv /Id# 226990
Veracruz, 91900, Mexico
Radboud Universitair Medisch Centrum /ID# 233750
Nijmegen, Gelderland, 6525 GA, Netherlands
Elisabeth Tweesteden Ziekenhuis /ID# 223229
Tilburg, North Brabant, 5022 GC, Netherlands
Amsterdam UMC, locatie AMC /ID# 223228
Amsterdam, North Holland, 1105 AZ, Netherlands
Universitair Medisch Centrum Utrecht /ID# 223696
Utrecht, 3584 CX, Netherlands
Gastromed Sp. z o.o /ID# 223705
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Malopolskie Centrum Kliniczne /ID# 223708
Krakow, Lesser Poland Voivodeship, 30-149, Poland
Vivamed Sp. z o.o. /ID# 223706
Warsaw, Masovian Voivodeship, 03-580, Poland
Duplicate_Institutul Clinic Fundeni /ID# 223914
Bucharest, București, 022328, Romania
Duplicate_Univ Emergency Hosp Bucharest /ID# 223579
Bucharest, București, 050098, Romania
Sana Monitoring /Id# 223682
Bucharest, 011025, Romania
Spitalul Clinic Colentina /ID# 223680
Bucharest, 020121, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017
Târgu Mureş, 540136, Romania
Targu Mures Emergency Clinical County Hospital /ID# 223613
Târgu Mureş, 540136, Romania
Cabinet Particular Policlinic Algomed /ID# 223578
Timișoara, 300002, Romania
Immanuel Kant Baltic Federal University /ID# 224224
Kaliningrad, Kaliningrad Oblast, 236016, Russia
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222
Moscow, 123423, Russia
City Clinical Hospital No. 31 /ID# 224223
Saint Petersburg, 197110, Russia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302
Banská Bystrica, Banská Bystrica Region, 975 17, Slovakia
KM Management, spol. s.r.o. /ID# 223304
Nitra, Nitra Region, 949 01, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580
Nové Zámky, Nitra Region, 940 34, Slovakia
Duplicate_GASTRO I., s.r.o. /ID# 223303
Prešov, Presov, 080 01, Slovakia
Lenasia Clinical Trial Centre /ID# 224306
Johannesburg, Gauteng, 1820, South Africa
Dr MJ Prins /ID# 224304
Cape Town, Western Cape, 7500, South Africa
Private Practice Dr MN Rajabally /ID# 223805
Cape Town, Western Cape, 7800, South Africa
Spoke Research Inc /ID# 223803
CAPE TOWN Milnerton, Western Cape, 7441, South Africa
Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456
Junggu, Daejeon Gwang Yeogsi, 34943, South Korea
Duplicate_Dong-A University Hospital /ID# 223455
서구, Gyeongsangnam-do, 49201, South Korea
Duplicate_Kangbuk Samsung Hospital /ID# 223452
Seoul, Seoul Teugbyeolsi, 03181, South Korea
Samsung Medical Center /ID# 223453
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356
Ferrol, A Coruna, 15405, Spain
Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 226554
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitario Germans Trias i Pujol /ID# 223436
Badalona, Barcelona, 08916, Spain
Duplicate_Hospital Universitario de Bellvitge /ID# 225719
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario de Fuenlabrada /ID# 223371
Fuenlabrada, Madrid, 28942, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 223319
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Central de Asturias /ID# 223368
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario de Alicante Doctor Balmis /ID# 223552
Alicante, 03010, Spain
Hospital Clinic de Barcelona /ID# 223355
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Maranon /ID# 223317
Madrid, 28007, Spain
Hospital Clinico San Carlos /ID# 223367
Madrid, 28040, Spain
Hospital Universitario La Paz /ID# 223318
Madrid, 28046, Spain
Hospital Universitario Virgen Macarena /ID# 223315
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio /ID# 223476
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia /ID# 223321
Valencia, 46010, Spain
Hospital Universitario y Politecnico La Fe /ID# 223314
Valencia, 46026, Spain
Karolinska University Hospital Solna /ID# 223423
Solna, Stockholm County, 171 64, Sweden
GHP Stockholm Gastro Center /ID# 223420
Stockholm, Stockholm County, 114 28, Sweden
Duplicate_Falu Lasarett /ID# 227222
Falun, 791 31, Sweden
Danderyds sjukhus AB /ID# 223363
Stockholm, 182 88, Sweden
University Hospital Basel /ID# 223711
Basel Town, Canton of Basel-City, 4031, Switzerland
Duplicate_Universitatsspital Zurich /ID# 223712
Zurich, Canton of Zurich, 8091, Switzerland
Inselspital, Universitaetsspital Bern /ID# 223590
Bern, 3010, Switzerland
Gazi Universitesi Tip Fakultes /ID# 223386
Yenimahalle, Ankara, 06560, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 223388
Ankara, 06590, Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 223387
Istanbul, 34098, Turkey (Türkiye)
Mersin University Medical /ID# 223385
Mersin, 33343, Turkey (Türkiye)
Lviv Regional Clinical Hospital /ID# 223661
Lviv, Lviv Oblast, 79010, Ukraine
Kyiv City Clinical Hospital No.18 /ID# 223700
Kyiv, 01030, Ukraine
Medical Center of LLC DIASERVIS /ID# 224249
Zaporizhzhia, 69076, Ukraine
Addenbrookes Hospital /ID# 223648
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Royal Devon & Exeter Hospital /ID# 223644
Exeter, Devon, EX2 5DW, United Kingdom
Western General Hospital - NHS Lothian /ID# 223646
Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 223651
London, Greater London, E1 2ES, United Kingdom
St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 223647
London, Greater London, SE1 7EH, United Kingdom
Kings College Hospital NHS Foundation Trust /ID# 223649
London, Greater London, SE5 9RS, United Kingdom
St George University Hospitals NHS Foundation Trust /ID# 223656
London, Greater London, SW17 0QT, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 224351
Southampton, Hampshire, SO16 6YD, United Kingdom
East and North Hertfordshire NHS Trust /ID# 224607
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 223653
Glasgow, Lanarkshire, G51 4TF, United Kingdom
Duplicate_Nottingham University Hospitals NHS Trust /ID# 224179
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 223645
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Belfast Health and Social Care Trust /ID# 224023
Belfast, BT9 7AB, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust /ID# 223654
Huddersfield, HX3 0PW, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655
Newcastle upon Tyne, NE3 3HD, United Kingdom
Northern Care Alliance NHS Group /ID# 223650
Salford, M6 8HD, United Kingdom
NHS Forth Valley /ID# 224657
Stirling, FK9 4SW, United Kingdom
Related Publications (3)
Peyrin-Biroulet L, Atreya R, Danese S, Lindsay JO, Chapman JC, Anschutz T, Huang X, Zambrano J, van Haaren S, Joshi N, Duan WR, Cross RK. Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study. J Crohns Colitis. 2025 Dec 23;19(12):jjaf213. doi: 10.1093/ecco-jcc/jjaf213.
PMID: 41344313DERIVEDHasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
PMID: 40357993DERIVEDPeyrin-Biroulet L, Chapman JC, Colombel JF, Caprioli F, D'Haens G, Ferrante M, Schreiber S, Atreya R, Danese S, Lindsay JO, Bossuyt P, Siegmund B, Irving PM, Panaccione R, Cao Q, Neimark E, Wallace K, Anschutz T, Kligys K, Duan WR, Pivorunas V, Huang X, Berg S, Shu L, Dubinsky M; SEQUENCE Study Group. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease. N Engl J Med. 2024 Jul 18;391(3):213-223. doi: 10.1056/NEJMoa2314585.
PMID: 39018531DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 24, 2020
Study Start
September 30, 2020
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.