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Itepekimab · AERIFY-4

A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

Ensayo de Sanofi en EPOC.

Más ensayos de: EPOC.

Fase

Fase 3

Estado

Completado

Participantes

669

previstos

Centros

223

Fin del objetivo primario

sep 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en ene 2024.

Qué mide

Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation (Baseline up to Week 72) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: * The study duration will be up to 72 weeks * The treatment duration will be up to 52 weeks * A follow-up period of 20 weeks will be conducted * The number of on-site visits will be 7 and the number of phone contacts will be 5

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06208306), actualizada en sep 2026.