Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT04751487. 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
Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: Primary population (former smokers cohort): \- Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): * Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD * Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD * Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD * Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) * Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD * Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD * Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD * Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD * Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Study identification
- NCT ID
- NCT04751487
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,234 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 85 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
- Feb 12, 2021 (Actual)
- Primary completion
- Apr 21, 2025 (Actual)
- Completion
- Aug 28, 2025 (Actual)
- Last update posted
- Oct 9, 2026
2021 – 2025
United States locations
- U.S. sites
- 59
- U.S. states
- 21
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333 | Phoenix | Arizona | 85020 | — |
| UCSF Fresno - Site Number : 8400030 | Fresno | California | 93701 | — |
| Palmtree Clinical Research Site Number : 8400184 | Palm Springs | California | 92262 | — |
| Allianz Research Institute Colorado Site Number : 8400061 | Denver | Colorado | 80219 | — |
| Helix Biomedics, LLC - Site Number : 8400049 | Boynton Beach | Florida | 33435 | — |
| Innovative Research of West Florida, Inc- Site Number : 8400041 | Clearwater | Florida | 33756 | — |
| Beautiful Minds Clinical Research Center Site Number : 8400352 | Cutler Bay | Florida | 33157 | — |
| Omega Research - Site Number : 8400031 | DeBary | Florida | 32713 | — |
| Sciences Connections, LLC Site Number : 8400045 | Doral | Florida | 33178 | — |
| North Florida/South Georgia Veterans Health System Site Number : 8400176 | Gainesville | Florida | 32608 | — |
| Finlay Medical Research- Site Number : 8400011 | Greenacres City | Florida | 33467 | — |
| Direct Helpers Medical Center Inc- Site Number : 8400065 | Hialeah | Florida | 33012 | — |
| Multi-Specialty Research Associates, Inc- Site Number : 8400044 | Lake City | Florida | 32055 | — |
| Advanced Pulmonary Research Institute Site Number : 8400018 | Loxahatchee Groves | Florida | 33470 | — |
| Columbus Clinical Services- Site Number : 8400054 | Miami | Florida | 33125 | — |
| Finlay Medical Research Site Number : 8400007 | Miami | Florida | 33126 | — |
| MCR Research Site Number : 8400425 | Miami | Florida | 33126 | — |
| Y and L Advance Health Care, Inc D/B/A Elite Clinical Res- Site Number : 8400009 | Miami | Florida | 33144 | — |
| My Community Research Center Site Number : 8400060 | Miami | Florida | 33155 | — |
| Phoenix Medical Research- Site Number : 8400019 | Miami | Florida | 33165 | — |
| Renstar Medical Research- Site Number : 8400015 | Ocala | Florida | 34470 | — |
| Central Florida Pulmonary Group, PA- Site Number : 8400192 | Orlando | Florida | 32803 | — |
| Oviedo Medical Research Site Number : 8400026 | Oviedo | Florida | 32765 | — |
| Innovation Medical Research Center- Site Number : 8400067 | Palmetto Bay | Florida | 33157 | — |
| Pines Care Research Center LLC- Site Number : 8400056 | Pembroke Pines | Florida | 33025 | — |
| Sarasota Memorial Health Care System Clinical ResearchCenter- Site Number : 8400178 | Sarasota | Florida | 34239 | — |
| Genesis Clinical Research, LLC Site Number : 8400182 | Tampa | Florida | 33603 | — |
| Clinical Research of West Florida, Inc- Site Number : 8400008 | Tampa | Florida | 33606 | — |
| Medster Research, LLC Site Number : 8400051 | Valdosta | Georgia | 31605 | — |
| North Georgia Clinical Research Site Number : 8400013 | Woodstock | Georgia | 30189 | — |
| Care Access Fairview Heights Site Number : 8400033 | Fairview Heights | Illinois | 62208 | — |
| Captain James A. Lovell Federal Health Care Center Site Number : 8400032 | North Chicago | Illinois | 60064 | — |
| Illinois Lung Institute- Site Number : 8400024 | Peoria | Illinois | 61605 | — |
| The Iowa Clinic Site Number : 8400034 | West Des Moines | Iowa | 50266 | — |
| Cotton O'Neil Garfield- Site Number : 8400063 | Topeka | Kansas | 66606 | — |
| Pulmonary & Critical Care Site Number : 8400047 | Shreveport | Louisiana | 71105 | — |
| Johns Hopkins Asthma and Allergy Center- Site Number : 8400055 | Baltimore | Maryland | 21224 | — |
| Care Access Site Number : 8400276 | Boston | Massachusetts | 02110 | — |
| Care Access Site Number : 8400281 | Boston | Massachusetts | 02110 | — |
| Revive Research Institute Site Number : 8400186 | Lathrup Village | Michigan | 48076 | — |
| Washington University School of Medicine- Site Number : 8400035 | St Louis | Missouri | 63110 | — |
| Smart Medical Research Site Number : 8400191 | Brooklyn | New York | 11230 | — |
| VA Western New York Healthcare System Site Number : 8400050 | Buffalo | New York | 14215 | — |
| New York - Presbyterian Queens- Site Number : 8400028 | Flushing | New York | 11355 | — |
| Schenectady Pulmonary and Critical Care Associates- Site Number : 8400029 | Schenectady | New York | 12308 | — |
| Advanced Respiratory and Sleep Medicine- Site Number : 8400022 | Huntersville | North Carolina | 28078 | — |
| University of Cincinnati- Site Number : 8400042 | Cincinnati | Ohio | 45267 | — |
| Toledo Institute of Clinical Research- Site Number : 8400014 | Toledo | Ohio | 43617 | — |
| St. Luke's University Health Network- Site Number : 8400187 | Bethlehem | Pennsylvania | 18015 | — |
| Temple University Hospital Site Number : 8400062 | Philadelphia | Pennsylvania | 19140-5103 | — |
| Allegheny Health Network- Site Number : 8400058 | Pittsburgh | Pennsylvania | 15212 | — |
| Lowcountry Lung & Critical Care- Site Number : 8400175 | Charleston | South Carolina | 29406 | — |
| Medtrial, LLC Site Number : 8400048 | Columbia | South Carolina | 29204 | — |
| TTS Research- Site Number : 8400012 | Boerne | Texas | 78006 | — |
| United Memorial Medical Center (UMMC)- Site Number : 8400193 | Houston | Texas | 77091 | — |
| Radiance Clinical Research- Site Number : 8400037 | Lampasas | Texas | 76550-1820 | — |
| Sun Research Institute - Site Number : 8400183 | San Antonio | Texas | 78215 | — |
| AES Salt Lake City- Site Number : 8400332 | Murray | Utah | 84123 | — |
| The Rheumatology and Pulmonary Clinic- Site Number : 8400053 | Beckley | West Virginia | 25801 | — |
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 179 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04751487, 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 Oct 9, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04751487 live on ClinicalTrials.gov.