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Amlitelimab · TIDE-asthma
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
Ensayo de Sanofi en Asma.
Más ensayos de: Asma.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 437
- Centros
- 113
- Fin del objetivo primario
- oct 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2022.
Qué mide
Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks (Baseline (Day 1) to Week 48) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study was to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: * The study duration (per participant) was up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. * The randomized treatment duration was up to approximately 60 weeks. * The scheduled number of visits was 13.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05421598), actualizada en mar 2026.