NCT07185009

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 671 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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 Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.

Conditions

• Ulcerative Colitis

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: 2026-01-16
• Primary completion: 2028-09-21
• Completion: 2033-04-28
• First posted: 2025-09-22
• Last updated: 2026-04-03

Locations

10 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study