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SAR441566 · SPECIFI-RA

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

Ensayo de Sanofi en Artritis reumatoide.

Más ensayos de: Artritis reumatoide.

Fase

Fase 2

Estado

Completado

Participantes

264

previstos

Centros

102

Fin del objetivo primario

jun 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en nov 2023.

Qué mide

Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12 (del registro, en inglés) (del inicio a la semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06073093), actualizada en jul 2025.