A study to investigate the efficacy and safety of SAR442970 in participants with ulcerative colitis
Research type
Research Study
Full title
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
IRAS ID
1012001
Contact name
Global Regulatory Submissions
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Research summary
This is a Phase 2b, multi-national, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study followed by an OL-LTE period to evaluate the efficacy and safety of SAR442970 in participants from 18 to 75 years of age with moderate to severe UC
This study will consist of the following study periods:
• Screening period: 4 weeks (+7 calendar days as needed).
• Induction period: 16 weeks, randomized, double-blind, placebo-controlled.
• Maintenance period: 36 weeks, double-blind, placebo-controlled, with Open-Label Treatment (OL) option for eligible participants.
• Open-Label Long-Term Extension Open-Label (OL-LTE) period: optional, up to 104 weeks.
• Post-Treatment Follow-Up period 8-week.
Approximately 99 participants will be randomly assigned in a ratio of 1:1:1 to one of the three (3) study arms by using an IRT:
1. SAR442970 150 mg SC Q2W, or
2. SAR442970 150 mg SC Q4W and Placebo 1mL SC Q4W two weeks apart, or
3. Placebo SC Q2W. Approximately 99 participants who meet the Inclusion/Exclusion criteria will be randomized in a 1:1:1 ratio to one of the 3 study treatment arms
The primary objective of this study is to assess the efficacy of SAR442970 150 mg Q2W or 150 mg Q4W in inducing clinical remission based on the difference in proportion of participants who achieve clinical remission at the end of the Week 16 Induction period by mMS between SAR442970 and placebo.
The secondary endpoints include endoscopic improvement, endoscopic response, endoscopic remission, clinical response/remission by mMS, clinical response/remission by total MS, change from baseline in PRO2 total score (SF and RB), mMS (SF, RB, and mMES), PMS (SF, RB, and PGA), histological improvement, histological remission, HEMI, PK, immunogenicity, safety and tolerability, improvement in disease-specific QOL and participant-reported disease-related signs and symptoms, either at the end of the Week 16 Induction period or Week 52 of the Maintenance period.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
25/EM/0091
Date of REC Opinion
28 May 2025
REC opinion
Further Information Favourable Opinion