Calendario›SNY›Itepekimab
Itepekimab
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
Ensayo de Sanofi en Bronchiectasis (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 312
- Centros
- 138
- Fin del objetivo primario
- sep 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en feb 2024.
Qué mide
Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period (Baseline up to End of Treatment (EOT) (24-52 weeks)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06280391), actualizada en feb 2026.