NCT06867094

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate-to-severe Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

Conditions

• Colitis Ulcerative

Interventions

Type	Name	Description
DRUG	SAR441566	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	SAR441566 matching Placebo	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2025-03-28
• Primary completion: 2027-07-29
• Completion: 2028-05-11
• First posted: 2025-03-10
• Last updated: 2026-04-06

Locations

112 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Georgia, Germany, Greece, Hungary, India, Italy, Japan, Poland, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study