NCT06073093

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety Study of SAR441566 Plus Methotrexate in Adults With ModeratetoSevere Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (4 to 6 weeks) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

Detailed description

The overall study duration for each participant will be approximately up to 149 days.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SAR441566	Tablet
DRUG	Placebo	Tablet

Timeline

• Start date: 2023-11-07
• Primary completion: 2025-06-18
• Completion: 2025-07-02
• First posted: 2023-10-10
• Last updated: 2025-07-11

Locations

102 sites across 19 countries: United States, Argentina, Brazil, Canada, Chile, China, Czechia, Georgia, Germany, Greece, India, Japan, Mauritius, Mexico, Poland, Puerto Rico, Slovakia, South Africa, Spain

Regulatory

• FDA-regulated drug study