Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies
Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90024, United States
Sacramento, California 95817, United States
San Diego, California 92103, United States
Danbury, Connecticut 06810, United States
Metairie, Louisiana 70006, United States
Flowood, Mississippi 39232, United States
New York, New York 10075, United States
Asheville, North Carolina 28801, United States
Charlotte, North Carolina 28207, United States
Greenville, North Carolina 27834, United States
Wyomissing, Pennsylvania 19610, United States
Orangeburg, South Carolina 29118, United States
Knoxville, Tennessee 37909, United States
Chesapeake, Virginia 23320, United States
Sofiya, Sofia 1527, Bulgaria
Sofiya, Sofia 1606, Bulgaria
Sofiya, Sofia 1784, Bulgaria
Edmonton, Alberta T5R 1W2, Canada
Beijing, Beijing Municipality 100730, China
Guangzhou, Guangdong 510655, China
Wuhan, Hubei 430022, China
Shanghai, Shanghai Municipality 200127, China
Hangzhou, Zhejiang 310009, China
Hangzhou, Zhejiang 310018, China
Grad Zagreb, City of Zagreb 10000, Croatia
St-Priest-en-Jarez, Pays de la Loire Region 42270, France
Minden, North Rhine-Westphalia 32423, Germany
Kiel, Schleswig-Holstein 24105, Germany
Monserrato, Cagliari 09042, Italy
Rome, Roma 00168, Italy
Kaunas, 50161, Lithuania
Dordrecht, South Holland 3318 AT, Netherlands
Rotterdam, South Holland 3045 PM, Netherlands
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-794, Poland
Szczecin, West Pomeranian Voivodeship 71-434, Poland
Riyadh, Riyadh Region 11426, Saudi Arabia
Riyadh, Riyadh Region 12713, Saudi Arabia
Banská Bystrica, Banská Bystrica Region 975 17, Slovakia
Šempeter Pri Gorici, Urban Municipality of Nova Gorica 5290, Slovenia
Daejeon, Daejeon Gwang Yeogsi 34943, South Korea
Suwon, Gyeonggido 16247, South Korea
Seoul, Seoul Teugbyeolsi 03722, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Las Palmas de Gran Canaria, Las Palmas 35010, Spain
London, Greater London E1 1BB, United Kingdom
Glasgow, Lanarkshire G51 4TF, United Kingdom