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
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
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.
Inclusion Criteria:
Exclusion Criteria:
San Francisco, California 94158, United States
Evanston, Illinois 60201, United States
Chevy Chase, Maryland 20815, United States
Ann Arbor, Michigan 48109, United States
Wyoming, Michigan 49519, United States
Burnt Hills, New York 12027, United States
Winston-Salem, North Carolina 27157-0001, United States
Hershey, Pennsylvania 17033-2360, United States
Wyomissing, Pennsylvania 19610, United States
Columbia, South Carolina 29203-8902, United States
Greenville, South Carolina 29607, United States
Dallas, Texas 75246, United States
Houston, Texas 77030-3411, United States
San Antonio, Texas 78212, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires 1280, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires F.D. 1199, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1027, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1115, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1431, Argentina
Córdoba, 5016, Argentina
Anderlecht, Brussels Capital 1070, Belgium
Ribeirão Preto, São Paulo 14049-900, Brazil
Sofiya, Sofia 1527, Bulgaria
Montreal, Quebec H3G 1A4, Canada
Providencia, Region Metropolitana Santiago 7510086, Chile
Guangzhou, Guangdong 510655, China
Wuhan, Hubei 430022, China
Changsha, Hunan 410013, China
Shanghai, Shanghai Municipality 200127, China
Hangzhou, Zhejiang 310009, China
Hangzhou, Zhejiang 310018, China
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
Nantes, Pays de la Loire Region 44000, France
St-Priest-en-Jarez, Pays de la Loire Region 42270, France
Neuilly-sur-Seine, Île-de-France Region 92200, France
Dresden, Saxony 01307, Germany
Kiel, Schleswig-Holstein 24105, Germany
Berlin-Zehlendorf, 14163, Germany
Athens, 10676, Greece
Szeged, Csongrád megye 6725, Hungary
Bologna, Emilia-Romagna 40138, Italy
Mexicali, Estado de Baja California 21200, Mexico
Moscow, 123423, Russia
Banská Bystrica, Banská Bystrica Region 975 17, Slovakia
CAPE TOWN Milnerton, Western Cape 7441, South Africa
Junggu, Daejeon Gwang Yeogsi 34943, South Korea
서구, Gyeongsangnam-do 49201, South Korea
Ferrol, A Coruna 15405, Spain
Santiago de Compostela, A Coruna 15706, Spain
L'Hospitalet de Llobregat, Barcelona 08907, Spain
Basel Town, Canton of Basel-City 4031, Switzerland
Istanbul, 34098, Turkey (Türkiye)
Edinburgh, Edinburgh, City of EH4 2XU, United Kingdom
London, Greater London E1 2ES, United Kingdom
London, Greater London SE1 7EH, United Kingdom
London, Greater London SE5 9RS, United Kingdom
London, Greater London SW17 0QT, United Kingdom
Southampton, Hampshire SO16 6YD, United Kingdom
Glasgow, Lanarkshire G51 4TF, United Kingdom
Nottingham, Nottinghamshire NG5 1PB, United Kingdom
Oxford, Oxfordshire OX3 9DU, United Kingdom
Newcastle upon Tyne, NE3 3HD, United Kingdom