Status:
RECRUITING
A Maintenance 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 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 Croh...
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 STARSCAPE-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 29 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2034
Estimated Enrollment :
671 Patients enrolled
Trial Details
Trial ID
NCT07184944
Start Date
January 29 2026
End Date
March 20 2034
Last Update
October 2 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Precision Clinical Research-Site Number: 8400059
Coral Springs, Florida, United States, 33065
2
Regis Clinical Research, LLC-Site Number: 8400041
Miami, Florida, United States, 33126
3
Correa Research Center-Site Number: 8400010
Miami, Florida, United States, 33186