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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07184996
The ClinicalTrials.gov registry entry for NCT07184996 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 980 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (52% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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