NCT07184996

An Induction 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, Induction 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: 980 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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 active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Duvakitug	Pharmaceutical form:Solution for Injection-Route of administration:SC injection
DRUG	Placebo	Pharmaceutical form:Solution for injection-Route of administration:SC injection

Timeline

• Start date: 2025-10-08
• Primary completion: 2028-05-09
• Completion: 2028-05-09
• First posted: 2025-09-22
• Last updated: 2026-03-30

Locations

140 sites across 11 countries: United States, Canada, Georgia, Japan, Moldova, Poland, Puerto Rico, Serbia, Switzerland, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study