Status:
RECRUITING
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D LLC
Conditions:
Crohn's Disease
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief 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 participant...
Eligibility Criteria
Inclusion
- Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development
- Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline
- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
Exclusion
- Participants with Ulcerative Colitis (UC) or indeterminate colitis
- Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
- Prior or current high-grade gastrointestinal (GI) dysplasia
- Participants on treatment with but not on stable doses of conventional therapy prior to baseline
- Participants receiving prohibited medications or therapies
- Participants with previous exposure to anti-TL1A investigational therapy
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 14 2029
Estimated Enrollment :
980 Patients enrolled
Trial Details
Trial ID
NCT07184931
Start Date
October 1 2025
End Date
May 14 2029
Last Update
December 15 2025
Active Locations (30)
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1
GMC Clinical Research, LLC: 8400113
Folsom, California, United States, 95630
2
TLC Clinical Research Inc.: 8400030
Los Angeles, California, United States, 90048
3
United Medical Doctors CA: 8400044
Murrieta, California, United States, 92563
4
Prospective Research Innovations Inc.: 8400017
Rancho Cucamonga, California, United States, 91730