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A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
Condition: Ulcerative Colitis · Sponsor: AbbVie
About this study
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…
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (270)
| Gastro Health Research - St. Vincent'S East /ID# 275089 | Birmingham, Alabama, United States | — |
| Digestive Health Specialists /ID# 274785 | Dothan, Alabama, United States | — |
| East View Medical Research /ID# 276222 | Mobile, Alabama, United States | — |
| Arizona Health Research /ID# 274366 | Chandler, Arizona, United States | — |
| UC San Diego Health System /ID# 273538 | La Jolla, California, United States | — |
| Gastro Care Institute /ID# 274873 | Lancaster, California, United States | — |
| UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827 | Los Angeles, California, United States | — |
| Hoag Memorial Hospital Presbyterian /ID# 274364 | Newport Beach, California, United States | — |
| California Medical Research Associates /ID# 274787 | Northridge, California, United States | — |
| uc davis medical center - patient support services building /ID# 274251 | Sacramento, California, United States | — |
| Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527 | San Diego, California, United States | — |
| Danbury Hospital, Western Connecticut Health Network /ID# 275277 | Danbury, Connecticut, United States | — |
+ 258 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06880744