Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT04701983. 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: 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: * 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
Study identification
- NCT ID
- NCT04701983
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,127 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
- Dec 16, 2020 (Actual)
- Primary completion
- Apr 11, 2025 (Actual)
- Completion
- Aug 27, 2025 (Actual)
- Last update posted
- Oct 15, 2026
2020 – 2025
United States locations
- U.S. sites
- 75
- U.S. states
- 18
- U.S. cities
- 59
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Site Number : 8400012 | Birmingham | Alabama | 34294 | — |
| Jasper Summit Research Site Number : 8400178 | Jasper | Alabama | 35501 | — |
| Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034 | Chandler | Arizona | 85286 | — |
| Pulmonary Associates Site Number : 8400392 | Phoenix | Arizona | 85027 | — |
| Noble Clinical Research Site Number : 8400182 | Tucson | Arizona | 85704-7876 | — |
| Tucson Clinical Research Institute Site Number : 8400431 | Tucson | Arizona | 85712 | — |
| California Research Institute Site Number : 8400400 | Huntington Park | California | 90255 | — |
| Modena Allergy + Asthma Site Number : 8400036 | La Jolla | California | 92037 | — |
| Imax Clinical Trials LLC 1 Site Number : 8400419 | La Palma | California | 90623 | — |
| Downtown LA Research Center Inc. Site Number : 8400027 | Los Angeles | California | 90017 | — |
| MACRO Trials Site Number : 8400030 | Los Angeles | California | 90048 | — |
| Antelope Valley Clinical Trials Site Number : 8400003 | Northridge | California | 91325 | — |
| ~Alpine Clinical Research Center Site Number : 8400180 | Boulder | Colorado | 80301 | — |
| Innovative Clinical Research Site Number : 8400017 | Lafayette | Colorado | 80026 | — |
| Clin Research W Florida Site Number : 8400004 | Clearwater | Florida | 33765 | — |
| Beautiful Minds Clinical Research Center Site Number : 8400037 | Cutler Bay | Florida | 33157 | — |
| Indago Research and Health Center Site Number : 8400187 | Hialeah | Florida | 33012 | — |
| Advanced Clinical Research Site Number : 8400409 | Kendall | Florida | 33156 | — |
| Advanced Pulmonary Research Institute Site Number : 8400455 | Loxahatchee Groves | Florida | 33470 | — |
| University of Miami/Miami VA Medical Center Site Number : 8400026 | Miami | Florida | 33125 | — |
| DL Research Solutions Inc Site Number : 8400033 | Miami | Florida | 33155 | — |
| Reliant Medical Research Site Number : 8400397 | Miami | Florida | 33165 | — |
| Research Institute of South Florida,Inc Site Number : 8400006 | Miami | Florida | 33173 | — |
| PROLIVE MEDICAL RESEARCH Site Number : 8400420 | Miami | Florida | 33175 | — |
| Reed Medical Research Site Number : 8400032 | Miami | Florida | 33176 | — |
| High Quality Research Site Number : 8400406 | Miami | Florida | 33184 | — |
| Deluxe Health Center Site Number : 8400188 | Miami Lakes | Florida | 33014 | — |
| Florida Institute for Clinical Research Site Number : 8400013 | Orlando | Florida | 32825-4454 | — |
| Tellabio International Research Services Site Number : 8400411 | Pembroke Pines | Florida | 33025 | — |
| Avanza Medical Research Center Site Number : 8400376 | Pensacola | Florida | 32503 | — |
| Broward Pulmonary and Sleep Specialists Site Number : 8400031 | Plantation | Florida | 33324 | — |
| Coastal Medical Research Institute Site Number : 8400044 | St. Petersburg | Florida | 33707 | — |
| Pasadena Center for Medical Research Site Number : 8400043 | St. Petersburg | Florida | 33710 | — |
| AdtreMed Site Number : 8400442 | Tampa | Florida | 33607 | — |
| Premier Medical Associates Site Number : 8400388 | The Villages | Florida | 32159 | — |
| Appalachian Clinical Research Site Number : 8400024 | Adairsville | Georgia | 30103 | — |
| Covenant Pulmonary Critical Care Site Number : 8400183 | Atlanta | Georgia | 30344 | — |
| David Kavtaradze MD, Inc. Site Number : 8400029 | Cordele | Georgia | 31015 | — |
| Alpha Clinical Research Georgia Site Number : 8400190 | Dunwoody | Georgia | 30350 | — |
| Gwinnett Biomedical Research Site Number : 8400007 | Lawrenceville | Georgia | 30046 | — |
| Benchmark Research Site Number : 8400193 | Covington | Louisiana | 70433 | — |
| Paul Shapero, PC Site Number : 8400016 | Bangor | Maine | 04401 | — |
| Care Access Site Number : 8400276 | Boston | Massachusetts | 02110 | — |
| Care Access Site Number : 8400277 | Boston | Massachusetts | 02110 | — |
| Care Access Site Number : 8400278 | Boston | Massachusetts | 02110 | — |
| Care Access Site Number : 8400280 | Boston | Massachusetts | 02110 | — |
| Care Access Site Number : 8400281 | Boston | Massachusetts | 02110 | — |
| Revival Research Institute, LLC Site Number : 8400191 | Dearborn | Michigan | 48126 | — |
| Advanced Pulmonary Research Institute of Michigan Site Number : 8400403 | Warren | Michigan | 48088 | — |
| Hannibal Clinic Site Number : 8400383 | Hannibal | Missouri | 63401 | — |
| Midwest Chest Consultants, P.C. Site Number : 8400002 | Saint Charles | Missouri | 63301 | — |
| Hendeson Clinical Trials Site Number : 8400365 | Henderson | Nevada | 89052 | — |
| Northwell Health Site Number : 8400019 | Mount Kisco | New York | 10549 | — |
| Gastonia Pharmaceutical Research Site Number : 8400010 | Gastonia | North Carolina | 28054 | — |
| East Carolina University Brody School Of Medicine Site Number : 8400022 | Greenville | North Carolina | 27834 | — |
| Carolina Research Center Site Number : 8400005 | Shelby | North Carolina | 28150 | — |
| Accellacare Site Number : 8400001 | Wilmington | North Carolina | 28401 | — |
| Southeastern Research Center Site Number : 8400011 | Winston-Salem | North Carolina | 27103 | — |
| Bernstein Clinical Research Center Site Number : 8400014 | Cincinnati | Ohio | 45236 | — |
| WellNow Urgent Care and Research Site Number : 8400039 | Springdale | Ohio | 45215 | — |
| Clinical Research of Central PA Site Number : 8400023 | DuBois | Pennsylvania | 15801 | — |
| Bogan Sleep Consultants Site Number : 8400181 | Columbia | South Carolina | 29201 | — |
| Clinical Research of Rock Hill Site Number : 8400008 | Rock Hill | South Carolina | 29732 | — |
| REX Clinical Trials Site Number : 8400371 | Beaumont | Texas | 77701 | — |
| Clinrx Research Site Number : 8400021 | Carrollton | Texas | 75007 | — |
| Corsicana Medical Research, LLC Site Number : 8400018 | Corsicana | Texas | 75110 | — |
| Texas Tech University Health Sciences Center Site Number : 8400189 | El Paso | Texas | 79911 | — |
| The Methodist Hospital Research Institute Site Number : 8400194 | Houston | Texas | 77030 | — |
| Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038 | Houston | Texas | 77043-2742 | — |
| Santa Clara Family Clinic Site Number : 8400398 | Houston | Texas | 77087 | — |
| Metroplex Pulmonary and Sleep Center Site Number : 8400015 | McKinney | Texas | 75069 | — |
| Advance Lung and Sleep Center Site Number : 8400040 | Sherman | Texas | 75092 | — |
| Sherman Clinical Research Site Number : 8400009 | Sherman | Texas | 75092 | — |
| DM Clinical Research Site Number : 8400179 | Tomball | Texas | 77375 | — |
| Clearlake Specialties Site Number : 8400025 | Webster | Texas | 77598 | — |
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 157 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04701983, 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 15, 2026 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04701983 live on ClinicalTrials.gov.