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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
NCT06880744 · View on ClinicalTrials.gov ↗
Study 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. 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.
Conditions Studied
Interventions
- DRUG Vedolizumab
- DRUG Risankizumab
Study Locations (20)
Florida
- Novum Research /ID# 273587 — Clermont
- Hillcrest Medical Research /ID# 273593 — DeLand
- Florida Research Institute /ID# 275196 — Lakewood Rch
- Sanchez Clinical Research /ID# 273727 — Miami
- Medical Professional Clinical Research /ID# 275208 — Miami
- Sarkis Clinical Trials - Ocala /ID# 273595 — Ocala
- Endoscopic Research, Inc. /ID# 273548 — Orlando
- Digestive And Liver Center Of Florida - Orlando /ID# 276432 — Orlando
California
- UC San Diego Health System /ID# 273538 — La Jolla
- Gastro Care Institute /ID# 274873 — Lancaster
- UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827 — Los Angeles
- Hoag Memorial Hospital Presbyterian /ID# 274364 — Newport Beach
- California Medical Research Associates /ID# 274787 — Northridge
- uc davis medical center - patient support services building /ID# 274251 — Sacramento
- Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527 — San Diego
Alabama
- Gastro Health Research - St. Vincent'S East /ID# 275089 — Birmingham
- Digestive Health Specialists /ID# 274785 — Dothan
- East View Medical Research /ID# 276222 — Mobile
Arizona
- Arizona Health Research /ID# 274366 — Chandler
Connecticut
- Danbury Hospital, Western Connecticut Health Network /ID# 275277 — Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2025-06-17 |
| Est. Completion | 2028-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06880744
The ClinicalTrials.gov registry entry for NCT06880744 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Vedolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06880744 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06880744 about?
NCT06880744 is a clinical study titled "A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab". 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 seve...
What is the current status of trial NCT06880744?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2025-06-17. Estimated completion is 2028-09.
What conditions does trial NCT06880744 study?
This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06880744?
The interventions under investigation include: Vedolizumab (DRUG), Risankizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06880744?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06880744 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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