A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.
Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.
Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Inclusion Criteria:
Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
Participant meets the following disease activity criteria:
Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.
Exclusion Criteria:
Covina, California 91723, United States
San Francisco, California 94158, United States
Danbury, Connecticut 06810, United States
Coral Gables, Florida 33134-2442, United States
Orlando, Florida 32804-5505, United States
Topeka, Kansas 66606, United States
Portland, Maine 04102, United States
Wyoming, Michigan 49519, United States
Englewood, New Jersey 07631-4152, United States
Garland, Texas 75044, United States
North Richland Hills, Texas 76180, United States
San Antonio, Texas 78212, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires 1280, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1115, Argentina
Córdoba, 5016, Argentina
Ribeirão Preto, São Paulo 14049-900, Brazil
Halifax, Nova Scotia B3H 2Y9, Canada
Montreal, Quebec H4A 3J1, Canada
Providencia, Region Metropolitana Santiago 7510086, Chile
Santiago, Region Metropolitana Santiago 8331150, Chile
Santiago, Region Metropolitana Santiago 8360156, Chile
Guangzhou, Guangdong 510655, China
Shanghai, Shanghai Municipality 200127, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310018, China
Luoyang, 471000, China
Gamagori-shi, Aichi-ken 443-8501, Japan
Kashiwa-shi, Chiba 277-0871, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Sunto-gun, Shizuoka 411-8611, Japan
Kaunas, 50161, Lithuania
San Juan, 00935, Puerto Rico
Daejeon, Daejeon Gwang Yeogsi 34943, South Korea
Suwon, Gyeonggido 16247, South Korea
Taipei City, Taipei 100, Taiwan
Dilovası, Kocaeli 41455, Turkey (Türkiye)
London, Greater London SW17 0QT, United Kingdom