Risankizumab Versus Vedolizumab for Subjects with Ulcerative Colitis Naïve to Targeted Therapies
Research type
Research Study
Full title
A 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.
IRAS ID
1011557
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2024-518998-33
Clinicaltrials.gov Identifier
Research summary
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.REC name
Wales REC 3
REC reference
25/WA/0184
Date of REC Opinion
7 Jul 2025
REC opinion
Further Information Favourable Opinion