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NCT07184931 · ClinicalTrials.gov registry record · Phase 3
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 980
- Enrollment target
- 20
- Study locations
NCT07184931: Recruiting Phase 3 study of Crohn's Disease, sponsored by Sanofi.
NCT07184931 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 980 participants, below the 2,385-participant average among 105 other Crohn's Disease trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07184931, a Phase 3 study of Crohn's Disease, 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, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week 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). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
Primary Outcome
Clinical Remission by CDAI: CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Duvakitug
Study Locations (20)
California
- Kagoshima IBD Gastroenterology Clinic - 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.: 8400030 - Los Angeles
- United Medical Doctors CA-Site Number: 8400044 - Murrieta
- Prospective Research Innovations Inc.: 8400017 - Rancho Cucamonga
- Valiance Clinical Research - Tarzana: 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: 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
- Regis Clinical Research, LLC-Site Number: 8400041 - 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: 8400018 - Little Rock
Colorado
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 980 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2029-05-14 |
| Phase | Phase 3 |
What NCT07184931 shows while recruiting
NCT07184931 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 2,385-participant average among 105 other Crohn's Disease trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07184931 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT07184931 about?
NCT07184931 is a clinical study titled "An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease". This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 ...
What is the current status of trial NCT07184931?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 980 participants. The study started on 2025-10-01. Estimated completion is 2029-05-14.
What conditions does trial NCT07184931 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT07184931?
The interventions under investigation include: Placebo (DRUG), Duvakitug (DRUG).
Who is sponsoring clinical trial NCT07184931?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07184931 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 NCT07184931's enrollment target sits among peer trials
980 10th of 105 higher than 96 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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.
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