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SAR443820

A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis

Ensayo de Sanofi en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

Fase 2

Estado

Interrumpido

Participantes

174

previstos

Centros

35

Fin del objetivo primario

nov 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was terminated as it did not meet its primary and key secondary endpoints».

Qué mide

Part A: Change From Baseline to Week 48 in Serum Neurofilament Light Chain (sNfL) Levels (Baseline (up to Day 1, pre-dose) and Week 48) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration was approximately 100 weeks and included the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B) The study was terminated prior to completion (of Week 96) as primary endpoint was not met. Therefore final duration was less than 96 weeks.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05630547), actualizada en sep 2025.