Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of
action of Itepekimab and its impact on airway inflammation in former and current smokers with
COPD, aged 40 to 70 years.
This study consists of participants who have been on a standard-of-care (SoC) triple (inhaled
corticosteroid [ICS] + long-acting β2-agonist [LABA] + long-acting muscarinic antagonist
[LAMA] or double (ICS + LABA) 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 will 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).
The total study duration for each part (Part A and Part B) is approximately 36 weeks:
- 4-week screening period
- 12-week treatment period
- 20-week followup period