Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Public ClinicalTrials.gov record NCT05326412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a, Open-label, Two-part Study to Evaluate the Mechanism of Action of Itepekimab (Anti-IL-33 mAb) on Airway Inflammation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05326412
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2022
- Primary completion
- Mar 4, 2025
- Completion
- Jul 24, 2025
- Last update posted
- Aug 30, 2026
2022 – 2025
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center - Harbor- Site Number : 8400006 | Torrance | California | 90509 | — |
| National Jewish Health Medical Center- Site Number : 8400012 | Denver | Colorado | 80206 | — |
| University of Miami UHealth Tower- Site Number : 8400015 | Miami | Florida | 33125 | — |
| University of Kansas Medical Center- Site Number : 8400004 | Kansas City | Missouri | 66160 | — |
| Allergy, Asthma and Clinical Research- Site Number : 8400010 | Oklahoma City | Oklahoma | 73120 | — |
| Clinical Research Associates of Central PA - Dubois- Site Number : 8400011 | DuBois | Pennsylvania | 15801 | — |
| University of Texas - Southwestern Medical Center- Site Number : 8400014 | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05326412, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2026 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05326412 live on ClinicalTrials.gov.