A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis
Status:
Recruiting
Trial end date:
2025-08-08
Target enrollment:
Participant gender:
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 (6 weeks ± 3 days) 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.