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.
The overall study duration for each participant will be approximately up to 149 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
264
Tablet
Tablet
Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400023
Northridge, California, United States
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
Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12
ACR20 response criteria is a dichotomous composite endpoint indicating the proportion of participants with at least 20 percent improvement in the number of tender and swollen joints, and in three out of the remaining five ACR core-set measures: patient pain (VAS, No pain to Severe Pain), Patient Global Assessment of disease activity (VAS, Very well to Very Poor), physician global assessment of disease activity (VAS, Very good to Very bad), physical functioning assessment (Health Assessment Questionnaire-Disability Index \[HAQ-DI\]), and acute phase reactants (ESR or CRP mg/dl; in this study CRP will be used). ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR20 is ≥ 20% improvement.
Time frame: Baseline to Week 12
Change from baseline in Disease activity score - C-reactive protein (DAS-28 CRP) at week 12
The DAS28-CRP is a composite endpoint. DAS28-CRP is comprised of clinical assessment of 28 swollen joint count (SJC)/ tender joint count (TJC), patient assessment of global disease activity and CRP mg/dL. It is a continuous measure allowing for measurement of absolute change in disease burden and percentage improvement. The DAS28 can be calculated using the following formula: DAS28 = 0.56 x 28TJC + 0.28 x 28SJC + 0.36 x Log(CRP+1) + 0.014 x GH + 0.96 The DAS28 provides a number indicating the current activity of the RA. A DAS28 above 5.1 means high disease activity, whereas a DAS28 below 3.2 indicates low disease activity and a DAS28 below 2.6 means disease remission.
Time frame: Baseline to Week 12
Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12
ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR50 is ≥ 50% improvement. ACR50 responders include ACR20 responders
Time frame: Baseline to week 12
Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
Incidence of TEAEs, SAEs, and AESIs
Time frame: Baseline to week 14
Plasma pre-dose concentrations of SAR441566
Time frame: Week 2 to week 12
Plasma post-dose concentrations of SAR441566
Time frame: Week 0 to week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 92 more locations