NCT06975722

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Phase 2b, Multi-national, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Followed by a Long-term Extension to Evaluate the Efficacy and Safety of SAR442970 in Adult Participants With Moderate to Severe Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SAR442970	Route of administration: Subcutaneous
DRUG	Placebo	Route of administration: Subcutaneous

Timeline

• Start date: 2025-07-07
• Primary completion: 2026-12-17
• Completion: 2029-10-17
• First posted: 2025-05-16
• Last updated: 2026-03-27

Locations

66 sites across 12 countries: United States, Australia, China, Czechia, France, Germany, Hungary, Japan, Moldova, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study