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Tolebrutininb · URSA

Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis

Ensayo de Sanofi en Myasthenia Gravis (del registro, en inglés).

Fase

Fase 3

Estado

Interrumpido

Participantes

6

previstos

Centros

22

Fin del objetivo primario

feb 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en dic 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «For strategic reasons the Tolebrutinib MG study has been terminated».

Qué mide

DB Period: Change From Baseline in Myasthenia Gravis-activities of Daily Living (MG-ADL) Total Score at Week 26 (Baseline (Day 1), Week 26) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tolebrutinib compared with placebo in adult participants aged 18 to 85 years old with moderate-to-severe generalized myasthenia gravis (gMG), who received Standard of Care (SoC). The double-blind (DB) treatment period of 26 weeks comprised of 7 site visits followed by a 2-year open label extension (OLE) period with quarterly visits. The efficacy of tolebrutinib versus placebo during the DB period was assessed by clinical evaluations, including scales based on physician examination or direct participant feedback i.e., patient reported outcomes (PROs). These evaluations continued during the OLE to measure long term efficacy and safety.

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Ficha completa en ClinicalTrials.gov (NCT05132569), actualizada en sep 2025.