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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SAR441566 — DRUG
  Tablet
• Placebo — DRUG
  Tablet

Study Details

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.

Key Dates

First listed

Oct 10, 2023

Start date

Nov 7, 2023

Status verified

Jul 2025

Primary completion

Jun 18, 2025

Completion

Jul 2, 2025

Study Design

Enrollment

264 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SAR441566 dose regimen A
  Participant will receive dose regimen A of SAR441566 for 12 weeks
• Experimental: SAR441566 dose regimen B
  Participant will receive dose regimen B of SAR441566 for 12 weeks
• Experimental: SAR441566 dose regimen C
  Participant will receive dose regimen C of SAR441566 for 12 weeks
• Experimental: SAR441566 dose regimen D
  Participant will receive dose regimen D of SAR441566 for 12 weeks
• Placebo Comparator: Placebo
  Participant will receive SAR441566-matching placebo for 12 weeks

Primary Outcome Measure

Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12 [ Time Frame: Baseline to Week 12 ]

Locations (17)

Find similar trials in Northridge, CA

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