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Rilzabrutinib

Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma

Ensayo de Sanofi en Asma.

Más ensayos de: Asma.

Fase

Fase 2

Estado

Completado

Participantes

196

previstos

Centros

51

Fin del objetivo primario

feb 2024

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Proportion of participants with an LOAC event during the treatment period (Until Week 12) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib in adult participants (aged 18-70 years) with moderate-to-severe asthma who are not well controlled on ICS/LABA therapy. Study treatment includes investigational medicinal product (IMP) (rilzabrutinib or placebo) added-on to a background therapy of ICS/LABA (fluticasone/salmeterol \[non-investigational medicinal product\], standardized at screening). Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below: * Screening period (4 weeks) * Randomized IMP treatment period (12 weeks ± 3 days) * Background therapy stabilization phase (4 weeks) * Background therapy withdrawal phase (4-5 weeks) * No background therapy phase (3-4 weeks) * Post IMP treatment safety follow-up period (4 weeks ± 3 days)

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05104892), actualizada en mar 2024.