Status:
RECRUITING
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D LLC
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely...
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 UC for at least 3 months prior to Baseline
- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies
Exclusion
- Participants with Crohn's Disease (CD), indeterminate colitis
- Current diagnosis of Ulcerative Proctitis
- Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \>3 bowel resections
- Prior or current high-grade gastrointestinal (GI) dysplasia
- Participants on treatment with but not on stable doses of conventional therapies prior to baseline
- Participants with prohibited medications or therapies prior to baseline
- 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 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 9 2028
Estimated Enrollment :
980 Patients enrolled
Trial Details
Trial ID
NCT07184996
Start Date
October 8 2025
End Date
May 9 2028
Last Update
December 11 2025
Active Locations (29)
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1
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia, California, United States, 91006
2
GMC Clinical Research, LLC - Site Number: 8400113
Folsom, California, United States, 95630
3
TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles, California, United States, 90048
4
United Medical Doctors CA - Site Number: 8400044
Murrieta, California, United States, 92563