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NCT07184944 · ClinicalTrials.gov registry record · Phase 3
A Maintenance 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
- 671
- Enrollment target
- 2
- Study locations
NCT07184944: Recruiting Phase 3 study of Crohn's Disease, sponsored by Sanofi.
NCT07184944 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 671 participants, below the 2,388-participant average among 105 other Crohn's Disease trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07184944, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 671 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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 the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
Primary Outcome
Clinical Remission by Crohn's Disease Activity Index (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 (2)
Florida
- Clinical Research of Osceola-Site Number: 8400013 - Kissimmee
Texas
- Tyler Research Institute LLC-Site Number: 8400095 - Tyler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 671 participants |
| Start Date | 2026-01-22 |
| Est. Completion | 2034-03-20 |
| Phase | Phase 3 |
What NCT07184944 shows while recruiting
NCT07184944 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 2,388-participant average among 105 other Crohn's Disease trials with a reported enrollment target (72% 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.
NCT07184944 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT07184944 about?
NCT07184944 is a clinical study titled "A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease". This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40...
What is the current status of trial NCT07184944?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 671 participants. The study started on 2026-01-22. Estimated completion is 2034-03-20.
What conditions does trial NCT07184944 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT07184944?
The interventions under investigation include: Placebo (DRUG), Duvakitug (DRUG).
Who is sponsoring clinical trial NCT07184944?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07184944 being conducted?
This trial has 2 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07184944's enrollment target sits among peer trials
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