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NCT07184996 · ClinicalTrials.gov registry record · Phase 3
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 980
- Enrollment target
- 20
- Study locations
NCT07184996: Recruiting Phase 3 study of Ulcerative Colitis, sponsored by Sanofi.
NCT07184996 is a Phase 3 study of Ulcerative Colitis that is actively recruiting participants, run by Sanofi. The registered enrollment target is 980 participants, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07184996, a Phase 3 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 980 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
Primary Outcome
Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Duvakitug
Study Locations (20)
California
- FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027 - Arcadia
- Alliance Research Institute - Site Number: 8400008 - Canoga Park
- Southern California GI & Liver Centers - Site Number: 8400062 - Coronado
- GMC Clinical Research, LLC - Site Number: 8400113 - Folsom
- TLC Clinical Research Inc. - Site Number: 8400030 - Los Angeles
- United Medical Doctors CA - Site Number: 8400044 - Murrieta
- Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025 - Santa Maria
- Valiance Clinical Research - Tarzana - Site Number: 8400023 - Tarzana
- Clinical Trials Management Services - Site Number: 8400047 - Thousand Oaks
- Amicis Research Center-Valencia -Site Number: 8400064 - Valencia
- Om Research, LLC - Victorville - Site Number: 8400022 - Victorville
Florida
- Precision Clinical Research-Site Number: 8400059 - Coral Springs
- Sarkis Clinical Trials-Ocala - Site Number: 8400048 - Gainesville
- Clinical Research of Osceola - Site Number: 8400013 - Kissimmee
- Columbus Clinical Services LLc - Site Number: 8400038 - Miami
Arizona
- Onyx Clinical Research - Site Number: 8400021 - Peoria
- One of a Kind Clinical Research Center LLC - Site Number: 8400061 - Scottsdale
- Del Sol Research Management, LLC - Site Number: 8400012 - Tucson
Arkansas
- Preferred Research Partners - Site Number: 8400018 - Little Rock
Colorado
- Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 980 participants |
| Start Date | 2025-10-08 |
| Est. Completion | 2028-05-09 |
| Phase | Phase 3 |
What NCT07184996 shows while recruiting
NCT07184996 is an interventional study that assigns participants to a tested intervention. The registered 980 participants enrollment target is mid-sized for trials with a published cap, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07184996 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT07184996 about?
NCT07184996 is a clinical study titled "An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis". This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks wi...
What is the current status of trial NCT07184996?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 980 participants. The study started on 2025-10-08. Estimated completion is 2028-05-09.
What conditions does trial NCT07184996 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT07184996?
The interventions under investigation include: Placebo (DRUG), Duvakitug (DRUG).
Who is sponsoring clinical trial NCT07184996?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07184996 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07184996's enrollment target sits among peer trials
980 14th of 122 higher than 109 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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