A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT06073093. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety Study of SAR441566 Plus Methotrexate in Adults With ModeratetoSevere Rheumatoid Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06073093
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 264 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2023 (Actual)
- Primary completion
- Jun 18, 2025 (Actual)
- Completion
- Jul 2, 2025 (Actual)
- Last update posted
- Jul 11, 2025
2023 – 2025
United States locations
- U.S. sites
- 17
- U.S. states
- 8
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400023 | Northridge | California | 91324 | — |
| Inland Rheumatology & Osteoporosis Medical Group- Site Number : 8400004 | Upland | California | 91786 | — |
| UF Health Deerwood Park- Site Number : 8400020 | Jacksonville | Florida | 32256 | — |
| Life Clinical Trials- Site Number : 8400028 | Margate | Florida | 33063 | — |
| Future Care Solution - Miami- Site Number : 8400019 | Miami | Florida | 33142 | — |
| Innovia Research Center, Inc- Site Number : 8400026 | Miramar | Florida | 33027 | — |
| Integral Rheumatology and Immunology Specialists- Site Number : 8400010 | Plantation | Florida | 33324 | — |
| Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8400017 | Tampa | Florida | 33606 | — |
| Inspire Santa Fe Medical Group- Site Number : 8400029 | Santa Fe | New Mexico | 87505 | — |
| Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400012 | Charlotte | North Carolina | 28207 | — |
| Carolina Specialty Care- Site Number : 8400007 | Statesville | North Carolina | 28625 | — |
| Altoona Center for Clinical Research- Site Number : 8400002 | Duncansville | Pennsylvania | 16635 | — |
| Low Country Rheumatology- Site Number : 8400018 | Summerville | South Carolina | 29486 | — |
| American Indian Clinical Trials Research Network - Rapid City- Site Number : 8400022 | Rapid City | South Dakota | 57701 | — |
| Prolato Clinical Research Center- Site Number : 8400021 | Houston | Texas | 77054 | — |
| AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400031 | Irving | Texas | 75039 | — |
| Perceptive Pharma Research- Site Number : 8400009 | Richmond | Texas | 77407 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 85 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06073093, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 11, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06073093 live on ClinicalTrials.gov.