ClinicalTrials.gov record
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
ClinicalTrials.gov ID: NCT04456673
Public ClinicalTrials.gov record NCT04456673. 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 Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by * Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo * Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) * Pre-bronchodilator FEV1 over 52 weeks compared to placebo * Lung function assessments * Moderate and severe COPD exacerbations * To evaluate safety and tolerability * To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)
Study identification
- NCT ID
- NCT04456673
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 935 participants
Conditions and interventions
Conditions
Interventions
- Dupilumab SAR231893 Drug
- Inhaled Corticosteroid Drug
- Inhaled Long-Acting Beta Agonist Drug
- Inhaled Long-Acting Muscarinic Antagonist Drug
- Placebo Drug
Drug
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
- Jul 5, 2020
- Primary completion
- Feb 27, 2024
- Completion
- May 26, 2024
- Last update posted
- May 28, 2025
2020 – 2024
United States locations
- U.S. sites
- 92
- U.S. states
- 24
- U.S. cities
- 82
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cullman Research Center, LLC Site Number : 8400095 | Cullman | Alabama | 35055 | — |
| Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090 | Jasper | Alabama | 35501 | — |
| Scottsboro Quick Care Clinic Site Number : 8400116 | Scottsboro | Alabama | 35768 | — |
| Phoenix Medical Group Site Number : 8400061 | Peoria | Arizona | 85381 | — |
| Medical Advancement Center of Arizona Site Number : 8400107 | Tempe | Arizona | 85283 | — |
| Asthma and Allergy Institute Site Number : 8400022 | Little Rock | Arkansas | 72209 | — |
| Kern Research, Inc Site Number : 8400031 | Bakersfield | California | 93301 | — |
| NewportNativeMD, Inc Site Number : 8400032 | Newport Beach | California | 92663 | — |
| Prospective Research Innovations, Inc. Site Number : 8400063 | Rancho Cucamonga | California | 91730 | — |
| ACRC Studies Site Number : 8400094 | San Diego | California | 92119 | — |
| Institute of HealthCare Assessment, Inc. Site Number : 8400015 | San Diego | California | 92120 | — |
| Allianz Research Institute Site Number : 8400007 | Westminster | California | 92683 | — |
| Innovative Clinical Research Site Number : 8400018 | Lafayette | Colorado | 80026 | — |
| Helix Biomedics, LLC Site Number : 8400035 | Boynton Beach | Florida | 33435 | — |
| Pioneer Clinical Research Site Number : 8400043 | Boynton Beach | Florida | 33437 | — |
| Renaissance Research and Medical Group, Inc Site Number : 8400092 | Cape Coral | Florida | 33991 | — |
| St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020 | Clearwater | Florida | 33765 | — |
| Beautiful Minds Clinical Research Center Site Number : 8400081 | Cutler Bay | Florida | 33157 | — |
| Omega Research Consultants, LLC Site Number : 8400021 | DeBary | Florida | 32713 | — |
| Sciences Connections, LLC Site Number : 8400133 | Doral | Florida | 33178 | — |
| InvesClinic, LLC Site Number : 8400039 | Fort Lauderdale | Florida | 33308 | — |
| Finlay Medical Research Site Number : 8400071 | Greenacres City | Florida | 33467 | — |
| Direct Helpers Medical Center Inc Site Number : 8400079 | Hialeah | Florida | 33012 | — |
| DL Research Solutions Inc Site Number : 8400089 | Miami | Florida | 33155 | — |
| Phoenix Medical Research, LLC Site Number : 8400012 | Miami | Florida | 33165 | — |
| Columbus Clinical Services Site Number : 8400062 | Miami | Florida | 33174 | — |
| Reed Medical Research Site Number : 8400123 | Miami | Florida | 33176 | — |
| De La Cruz Research Center, LLC Site Number : 8400075 | Miami | Florida | 33184 | — |
| Florida Institute for Clinical Research Site Number : 8400129 | Orlando | Florida | 32825-4454 | — |
| Central Florida Pulmonary Group, PA Site Number : 8400101 | Orlando | Florida | 32825 | — |
| Innovation Medical Research Center Site Number : 8400114 | Palmetto Bay | Florida | 33157 | — |
| Family Medical Specialists of Florida, PA Site Number : 8400077 | Plant City | Florida | 33563 | — |
| Coastal Pulmonary And Critical Care Site Number : 8400013 | St. Petersburg | Florida | 33704 | — |
| Florida Pulmonary Research Center Site Number : 8400001 | Winter Park | Florida | 32789 | — |
| Appalachian Clinical Research Site Number : 8400048 | Adairsville | Georgia | 30103 | — |
| Northlake Medical Group Site Number : 8400099 | Atlanta | Georgia | 30345 | — |
| River Birch Research, LLC Site Number : 8400045 | Blue Ridge | Georgia | 30513 | — |
| Medical Centre of Conyers Site Number : 8400064 | Conyers | Georgia | 30094 | — |
| David Kavtaradze MD, Inc. Site Number : 8400135 | Cordele | Georgia | 31015 | — |
| Gwinnett Biomedical Research Site Number : 8400052 | Lawrenceville | Georgia | 30046 | — |
| Southeast Lung Associates Site Number : 8400003 | Rincon | Georgia | 31326 | — |
| Herman Clinical Research LLC Site Number : 8400078 | Suwanee | Georgia | 30024 | — |
| Avant Research Associates LLC Site Number : 8400118 | Crowley | Louisiana | 70526 | — |
| Genesis Clinical Research & Consulting Site Number : 8400050 | Fall River | Massachusetts | 02723 | — |
| Infinity Medical Research Site Number : 8400004 | South Dartmouth | Massachusetts | 02747 | — |
| Henry Ford Health System Site Number : 8400053 | Detroit | Michigan | 48202 | — |
| Revive Research Institute Site Number : 8400120 | Lathrup Village | Michigan | 48076 | — |
| Romedica, LLC Site Number : 8400034 | Rochester | Michigan | 48307 | — |
| Covenant Healthcare Site Number : 8400057 | Saginaw | Michigan | 48638 | — |
| Great Lakes Research Institute Site Number : 8400096 | Southfield | Michigan | 48075-5400 | — |
| Montana Medical Research Site Number : 8400019 | Missoula | Montana | 59808 | — |
| Somnos Clinical Research Site Number : 8400016 | Lincoln | Nebraska | 68510 | — |
| Quality Clinical Research, Inc. Site Number : 8400073 | Omaha | Nebraska | 68114 | — |
| Jersey City Breathing Center Site Number : 8400137 | Jersey City | New Jersey | 07304 | — |
| WellNow Urgent Care Site Number : 8400132 | East Amherst | New York | 14051 | — |
| Northwell Health Site Number : 8400054 | New Hyde Park | New York | 11040 | — |
| Mid Hudson Medical Research PLLC Site Number : 8400037 | New Windsor | New York | 12553-7754 | — |
| Great Lakes Medical Research Site Number : 8400044 | Westfield | New York | 14787 | — |
| Onsite Clinical Solutions LLC Site Number : 8400042 | Charlotte | North Carolina | 28277 | — |
| Clinical Research of Gastonia Site Number : 8400010 | Gastonia | North Carolina | 28054 | — |
| Monroe Biomedical Research Site Number : 8400087 | Monroe | North Carolina | 28112 | — |
| Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006 | Mooresville | North Carolina | 28117 | — |
| Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117 | Mooresville | North Carolina | 28117 | — |
| Coastal Carolina Health Care, P.A. Site Number : 8400025 | New Bern | North Carolina | 28562 | — |
| Southeastern Research Center Site Number : 8400068 | Winston-Salem | North Carolina | 27103 | — |
| Optimed Research, LTD Site Number : 8400082 | Columbus | Ohio | 43235 | — |
| Toledo Institute of Clinical Research Site Number : 8400024 | Toledo | Ohio | 43617 | — |
| Allergy, Asthma and Clinical Research Center Site Number : 8400127 | Oklahoma City | Oklahoma | 73120 | — |
| Clinical Research of Central PA Site Number : 8400009 | DuBois | Pennsylvania | 15801 | — |
| Frontier Clinical Research, LLC Site Number : 8400049 | Scottdale | Pennsylvania | 15683 | — |
| Carolina Medical Research, LLC Site Number : 8400026 | Clinton | South Carolina | 29325 | — |
| MD First Research Site Number : 8400105 | Lancaster | South Carolina | 29720 | — |
| LLM Research Site Number : 8400125 | Myrtle Beach | South Carolina | 29577 | — |
| Health Concepts Site Number : 8400027 | Rapid City | South Dakota | 57702 | — |
| Pulmonary & Sleep Specialists Site Number : 8400136 | Dickson | Tennessee | 37055 | — |
| Clinical Trials Center of Middle Tennessee Site Number : 8400066 | Franklin | Tennessee | 37067 | — |
| MultiSpecialty Clinical Research Site Number : 8400110 | Johnson City | Tennessee | 37601 | — |
| REX Clinical Trials Site Number : 8400143 | Beaumont | Texas | 77701 | — |
| Clinrx Research Site Number : 8400059 | Carrollton | Texas | 75007 | — |
| Houston Pulmonary and Sleep Associates Site Number : 8400011 | Cypress | Texas | 77429 | — |
| Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055 | Houston | Texas | 77043-2742 | — |
| Prolato Clinical Research Center Site Number : 8400128 | Houston | Texas | 77054 | — |
| Pioneer Research Solutions, Inc. Site Number : 8400070 | Houston | Texas | 77099 | — |
| Radiance Clinical Research Site Number : 8400029 | Lampasas | Texas | 76550-1820 | — |
| DCOL Center for Clinical Research Site Number : 8400028 | Longview | Texas | 75605 | — |
| Metroplex Pulmonary and Sleep Center Site Number : 8400131 | McKinney | Texas | 75069 | — |
| Clinrx Research, LLC Site Number : 8400069 | Plano | Texas | 75024 | — |
| Diagnostics Research Group Site Number : 8400038 | San Antonio | Texas | 78229 | — |
| Mt. Olympus Medical Research Site Number : 8400115 | Sugar Land | Texas | 77479 | — |
| Pulmonary Research of Abingdon, LLC Site Number : 8400030 | Abingdon | Virginia | 24210 | — |
| Clinical Research Partners Site Number : 8400040 | Richmond | Virginia | 23236 | — |
| Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088 | Greenfield | Wisconsin | 53228 | — |
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 242 non-U.S. sites.
Recently updated Chronic Obstructive Pulmonary Disease trials
Other public records listing Chronic Obstructive Pulmonary Disease. Sorted by last update posted; newest first. Not a recommendation.
- NCT07512687: Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia Recruiting
- NCT06390345: Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention Recruiting
- NCT05399056: Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling Recruiting
- NCT05237505: The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome) Recruiting
- NCT07053423: A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease. Recruiting
- NCT06208306: A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04456673, 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 May 28, 2025 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04456673 live on ClinicalTrials.gov.