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NCT07185009 · ClinicalTrials.gov registry record · Phase 3
A Maintenance 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
- 671
- Enrollment target
- 5
- Study locations
NCT07185009: Recruiting Phase 3 study of Ulcerative Colitis, sponsored by Sanofi.
NCT07185009 is a Phase 3 study of Ulcerative Colitis that is actively recruiting participants, run by Sanofi. The registered enrollment target is 671 participants, below the 2,052-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (67% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07185009, a Phase 3 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 671 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.
Primary Outcome
Mayo Score is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. Clinical remission is defined as mMS score of 0 to 2, including SFS of 0 or 1, RBS of 0, and mMES of 0 or 1 (score of 1 modified to exclude friability)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Duvakitug
Study Locations (5)
Florida
- Royal Palm Clinical Research - Site Number: 8400065 - Fort Myers
- Clinical Research of Osceola - Site Number: 8400013 - Kissimmee
Louisiana
- Delta Research Partners - Site Number: 8400087 - Monroe
Missouri
- BVL Clinical Research - Site Number: 8400005 - Liberty
Texas
- Tyler Research Institute, LLC - Site Number: 8400095 - Tyler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 671 participants |
| Start Date | 2026-01-16 |
| Est. Completion | 2033-04-28 |
| Phase | Phase 3 |
What NCT07185009 shows while recruiting
NCT07185009 is an interventional study that assigns participants to a tested intervention. The registered 671 participants enrollment target is mid-sized for trials with a published cap, below the 2,052-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (67% 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.
NCT07185009 lists 5 locations in 4 states (Florida, Louisiana, Missouri).
Frequently Asked Questions
What is clinical trial NCT07185009 about?
NCT07185009 is a clinical study titled "A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis". This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 286 weeks including: * ...
What is the current status of trial NCT07185009?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 671 participants. The study started on 2026-01-16. Estimated completion is 2033-04-28.
What conditions does trial NCT07185009 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT07185009?
The interventions under investigation include: Placebo (DRUG), Duvakitug (DRUG).
Who is sponsoring clinical trial NCT07185009?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07185009 being conducted?
This trial has 5 study locations across Florida, Louisiana, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07185009's enrollment target sits among peer trials
671 17th of 122 higher than 106 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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