Status:
RECRUITING
A Maintenance 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 multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcera...
Eligibility Criteria
Inclusion
- Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development)
- Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Exclusion
- Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
- Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
- 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 :
January 7 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2033
Estimated Enrollment :
671 Patients enrolled
Trial Details
Trial ID
NCT07185009
Start Date
January 7 2026
End Date
April 28 2033
Last Update
October 2 2025
Active Locations (2)
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1
Precision Clinical Research
Coral Springs, Florida, United States, 33065
2
Correa Research Center
Miami, Florida, United States, 33186