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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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 facts

Study ID

NCT06073093

Run by

Sanofi

People needed

264

Starts

2023-11-07

Expected to finish

2025-07-02

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration
• Moderate-to-severely active RA, defined as:
• persistently active disease >= 6 tender and >= 6 swollen joints
• high sensitivity C-reactive protein ≥ 4 mg/L
• Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit
• MTX - 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs) and folic/folinic acid (as part of MTX regimen)
• Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards
• BMI within the range [18 - 35] kg/m\^2 (inclusive)

You may not qualify if…

• Immunologic disorder other than RA, with the exception of secondary Sjogren's syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigator's judgement
• Any condition (other than RA) requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy
• Uncontrolled polymyalgia rheumatica or fibromyalgia
• History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1
• Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
• History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol
• History of solid organ transplant
• History of alcohol or drug abuse within the past 2 years
• History of diagnosis of demyelinating disease such as but not limited to:
• Multiple Sclerosis
• Acute Disseminated Encephalomyelitis
• Balo's Disease (Concentric Sclerosis)
• Charcot-Marie-Tooth Disease
• Guillain-Barre Syndrome
• human T-lymphotropic virus 1 Associated Myelopathy
• Neuromyelitis Optica (Devic's Disease)
• Planned surgery during the treatment period
• Participants who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
• Vaccination with live or live-attenuated virus vaccine within 3 months prior to screening or plan to receive one during the trial including at least 3 months after the last dose of study drug
• Any non-live vaccine (eg, COVID-19) within 14 days prior to randomization or plan to receive one during the trial
• Participant with personal or family history of long QT syndrome
• Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin
• Previous or current use of biologic therapy or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD - such as JAK inhibitors) for RA
• Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to screening. The dose of oral glucocorticoid must remain stable.
• Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screening

Where it is running

• Inland Rheumatology & Osteoporosis Medical Group- Site Number : 8400004 — Upland, California, United States
• UF Health Deerwood Park- Site Number : 8400020 — Jacksonville, Florida, United States
• Life Clinical Trials- Site Number : 8400028 — Margate, Florida, United States
• Future Care Solution - Miami- Site Number : 8400019 — Miami, Florida, United States
• Innovia Research Center, Inc- Site Number : 8400026 — Miramar, Florida, United States
• Integral Rheumatology and Immunology Specialists- Site Number : 8400010 — Plantation, Florida, United States
• Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8400017 — Tampa, Florida, United States
• Inspire Santa Fe Medical Group- Site Number : 8400029 — Santa Fe, New Mexico, United States
• Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400012 — Charlotte, North Carolina, United States
• Carolina Specialty Care- Site Number : 8400007 — Statesville, North Carolina, United States
• Altoona Center for Clinical Research- Site Number : 8400002 — Duncansville, Pennsylvania, United States
• Low Country Rheumatology- Site Number : 8400018 — Summerville, South Carolina, United States
• American Indian Clinical Trials Research Network - Rapid City- Site Number : 8400022 — Rapid City, South Dakota, United States
• Prolato Clinical Research Center- Site Number : 8400021 — Houston, Texas, United States
• AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400031 — Irving, Texas, United States
• Perceptive Pharma Research- Site Number : 8400009 — Richmond, Texas, United States
• Investigational Site Number : 0320005 — Berazategui, Buenos Aires, Argentina
• Investigational Site Number : 0320004 — Buenos Aires, Buenos Aires F.D., Argentina
• Investigational Site Number : 0320001 — Buenos Aires, Buenos Aires F.D., Argentina
• Investigational Site Number : 0320003 — Buenos Aires, Argentina
• Investigational Site Number : 0320007 — Buenos Aires, Argentina
• Investigational Site Number : 0320006 — Mar del Plata, Argentina
• Investigational Site Number : 0320002 — San Miguel de Tucumán, Argentina
• Investigational Site Number : 0320002 — San Miguel de Tucumán, Argentina
• Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400023 — Northridge, California, United States

Full record on ClinicalTrials.gov

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