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NCT06880744 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
A Phase 3 study of Ulcerative Colitis, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
- 20
- Study locations
NCT06880744: Recruiting Phase 3 study of Ulcerative Colitis, sponsored by AbbVie.
NCT06880744 is a Phase 3 study of Ulcerative Colitis that is actively recruiting participants, run by AbbVie. The registered enrollment target is 530 participants, below the 2,053-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06880744, a Phase 3 study of Ulcerative Colitis, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
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 |
What NCT06880744 shows while recruiting
NCT06880744 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 2,053-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (74% lower).
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.
NCT06880744 names 20 study sites across 5 states, led by Florida, California, Alabama.
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.
What interventions are being tested in trial NCT06880744?
The interventions under investigation include: Vedolizumab (DRUG), Risankizumab (DRUG).
Who is sponsoring clinical trial NCT06880744?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06880744's enrollment target sits among peer trials
530 21st of 122 higher than 102 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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