Calendario›SNY›Itepekimab SAR440340 · AERIFY-3
Itepekimab SAR440340 · AERIFY-3
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Ensayo de Sanofi en EPOC.
Más ensayos de: EPOC.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 49
- Centros
- 23
- Fin del objetivo primario
- mar 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2022.
Qué mide
Change From Baseline in Itepekimab Pharmacodynamic Normalized Enrichment Score Derived From Former Smokers in Endobronchial Biopsies in Current Smokers With Chronic Obstructive Pulmonary Disease at Week 12 (Baseline (Week 0) and Week 12) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study was an exploratory, two-part, 12-week, Phase 2a study evaluated the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consisted of participants who had been on a standard-of-care (SoC) mono (long-acting β2-agonist \[LABA\]) or long-acting muscarinic antagonist \[LAMA\]), double (inhaled corticosteroid \[ICS\] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants would stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). Part A would consist of participants who were former smokers with COPD; Part B would consist of participants who were current smokers with COPD. The total study duration for each part (Part A and Part B) was approximately 36 weeks: * 4-week screening period * 12-week treatment period * 20-week followup period
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05326412), actualizada en ago 2026.