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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 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 2,408-participant average among 104 other Crohn's Disease trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 2 states.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07184944
The ClinicalTrials.gov registry entry for NCT07184944 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 671 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,408-participant average among 104 other Crohn's Disease trials with a reported enrollment target (72% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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