Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Completed · Phase 2 · NCT05326412
Conditions: Chronic Obstructive Pulmonary Disease
At a glance
- Research payments reported, 2025
- $304,380
- U.S. investigators named
- 9
- Sites paid
- 10
- Planned or actual enrollment
- 49
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab SAR440340 (drug)
- Dates
- Started 2022-05-19; completion 2025-07-25
- Results posted
- Yes
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…
From ClinicalTrials.gov, last updated 2026-08-31. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $304,380 in research payments for this study in 2025 (37 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- David Hsia, M.D. Critical Care Medicine · Denver, CO
- Steven E. Lommatzsch, M.D. Pulmonology · Denver, CO
- Trishul Siddharthan, MD Pulmonology · Miami, FL
- Mario Castro, MD Pulmonology · Kansas City, KS
- Benjamin D. Medoff, MD Critical Care Medicine · Boston, MA
- Martha M. Tarpay, MD Allergy & Immunology · Oklahoma City, OK
- Sandeep Bansal, MD Pulmonology · Du Bois, PA
- Kevin Ma, M.D. Critical Care Medicine · Philadelphia, PA
- William J. Calhoun, MD Pulmonology · Galveston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Clinical Research Associates of Central PA LLC $177,737
- University of Kansas Hospital $38,152
- Massachusetts General Hospital Attn Research Finance Attn 2021a $23,555
- University of Miami Office of Research Administration Ora $16,492
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical C $13,500
- Martha Tarpay MD Allergy Asthma and Clinical Researc Center $11,319
- Hospital of Univ of Pennsylvania, PA $10,550
- National Jewish Medical and Research Center $9,700
- University of Texas Medical Branch Galveston, TX $3,225
- University of Kansas Medical Center Research Institute Inc Kumc Research Institute $150
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.