Trials / Recruiting
RecruitingNCT07184931
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 980 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 16 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duvakitug | Pharmaceutical form:Injection solution Route of administration:SC injection |
| DRUG | Placebo | Pharmaceutical form:Injection solution Route of administration:SC injection |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2029-05-14
- Completion
- 2029-05-14
- First posted
- 2025-09-22
- Last updated
- 2026-03-31
Locations
130 sites across 10 countries: United States, Canada, Georgia, Japan, Moldova, Puerto Rico, South Africa, Switzerland, Taiwan, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07184931. Inclusion in this directory is not an endorsement.