Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05326412 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD

Study acronym: AERIFY-3
StatusCompleted
PhasePhase 2
SponsorSanofi
Started2022-05-19
View on ClinicalTrials.gov ↗
This 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

Amendment history 1 change detected by DataLookout

2026-09-01
notable
Results posted: 2026-08-31
Trial Details
NCT Number NCT05326412
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 49 participants
Start Date 2022-05-19
Primary Completion 2025-03-05 (estimated)
Study Completion 2025-07-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-31