A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab (NCT06880744)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Gastro Health Research - St. Vincent'S East /ID# 275089 — Birmingham, Alabama
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (270 Sites)
Showing the first 25 of 270 sites.
- Gastro Health Research - St. Vincent'S East /ID# 275089 — Birmingham, Alabama
- Digestive Health Specialists /ID# 274785 — Dothan, Alabama
- East View Medical Research /ID# 276222 — Mobile, Alabama
- Arizona Health Research /ID# 274366 — Chandler, Arizona
- UC San Diego Health System /ID# 273538 — La Jolla, California
- Gastro Care Institute /ID# 274873 — Lancaster, California
- UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827 — Los Angeles, California
- Hoag Memorial Hospital Presbyterian /ID# 274364 — Newport Beach, California
- California Medical Research Associates /ID# 274787 — Northridge, California
- uc davis medical center - patient support services building /ID# 274251 — Sacramento, California
- Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527 — San Diego, California
- Danbury Hospital, Western Connecticut Health Network /ID# 275277 — Danbury, Connecticut
- Novum Research /ID# 273587 — Clermont, Florida
- Hillcrest Medical Research /ID# 273593 — DeLand, Florida
- Florida Research Institute /ID# 275196 — Lakewood Rch, Florida
- Sanchez Clinical Research /ID# 273727 — Miami, Florida
- Medical Professional Clinical Research /ID# 275208 — Miami, Florida
- Sarkis Clinical Trials - Ocala /ID# 273595 — Ocala, Florida
- Endoscopic Research, Inc. /ID# 273548 — Orlando, Florida
- Digestive And Liver Center Of Florida - Orlando /ID# 276432 — Orlando, Florida
- Emory University School Of Medicine - Atlanta /ID# 273522 — Atlanta, Georgia
- Gi Alliance - Glenview /ID# 274270 — Glenview, Illinois
- Illinois Gastroenterology Group /ID# 274280 — Gurnee, Illinois
- Southwest Gastroenterology - Oak Lawn /ID# 273596 — Oak Lawn, Illinois
- OSF St. Francis Medical Center /ID# 274391 — Peoria, Illinois
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis
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- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
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Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.