Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Public ClinicalTrials.gov record NCT03930732. 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 and 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 anti-drug antibodies (ADA)
Study identification
- NCT ID
- NCT03930732
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 939 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 80 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
- Apr 15, 2019 (Actual)
- Primary completion
- Feb 8, 2023 (Actual)
- Completion
- May 2, 2023 (Actual)
- Last update posted
- Feb 28, 2024
2019 – 2023
United States locations
- U.S. sites
- 51
- U.S. states
- 20
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SEC Clinical Research, LLC-Site Number:8400030 | Andalusia | Alabama | 36420 | — |
| Clinical Research Center of Alabama, LLC-Site Number:8400041 | Birmingham | Alabama | 35209-6802 | — |
| UAB Lung Health Center-Site Number:8400013 | Birmingham | Alabama | 35294 | — |
| SEC Clinical Research, LLC-Site Number:8400059 | Dothan | Alabama | 36303 | — |
| Pulmonary Associates of Mobile, P.C.-Site Number:8400057 | Mobile | Alabama | 36608 | — |
| Asthma and Allergy Associates, PC-Site Number:8400034 | Colorado Springs | Colorado | 80907 | — |
| Clinical Research Of West Florida Inc-Site Number:8400010 | Clearwater | Florida | 33765 | — |
| Finlay Medical Research-Site Number:8400014 | Greenacres City | Florida | 33467 | — |
| Project 4 research, Inc.-Site Number:8400023 | Miami | Florida | 33125 | — |
| Finlay Medical Research-Site Number:8400062 | Miami | Florida | 33126 | — |
| Renstar Medical Research-Site Number:8400051 | Ocala | Florida | 34470 | — |
| Florida Institute for Clinical Research, LLC-Site Number:8400029 | Orlando | Florida | 32825 | — |
| Emerald Coast Research Associates-Site Number:8400032 | Panama City | Florida | 32405 | — |
| Sarasota Clinical Research-Site Number:8400026 | Sarasota | Florida | 34239 | — |
| VitaLink research-Hamilton Mill-Site Number:8400055 | Dacula | Georgia | 30019 | — |
| DC Research Works-Site Number:8400016 | Marietta | Georgia | 30060 | — |
| North Georgia Clinical Research-Site Number:8400025 | Woodstock | Georgia | 30189 | — |
| Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012 | Baltimore | Maryland | 21224 | — |
| Asthma Allergy & Sinus Center-Site Number:8400038 | White Marsh | Maryland | 21162 | — |
| Michigan Medicine (University of Michigan)-Site Number:8400050 | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic Lanmark Center 2-46-Site Number:8400065 | Rochester | Minnesota | 55905 | — |
| Midwest Chest Consultants, P.C.-Site Number:8400011 | Saint Charles | Missouri | 63301 | — |
| Washington University School of Medicine-Site Number:8400004 | St Louis | Missouri | 63104 | — |
| Sierra Clinical Research-Site Number:8400035 | Las Vegas | Nevada | 89106 | — |
| Va Western New York Healthcare-Site Number:8400067 | Buffalo | New York | 14215 | — |
| IMA Clinical Research, LLC-Site Number:8400070 | New York | New York | 10036 | — |
| The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019 | Chapel Hill | North Carolina | 27514 | — |
| American Health Research-Site Number:8400061 | Charlotte | North Carolina | 28277 | — |
| Duke Asthma, Allergy and Airway Center-Site Number:8400064 | Durham | North Carolina | 27705 | — |
| Accellacare-Site Number:8400052 | Wilmington | North Carolina | 28401 | — |
| Southeastern Research Center-Site Number:8400060 | Winston-Salem | North Carolina | 27103-4027 | — |
| Midwest Pulmonary and Sleep Research Center-Site Number:8400040 | Dayton | Ohio | 45459 | — |
| Aventiv Research, Inc-Site Number:8400024 | Dublin | Ohio | 43016 | — |
| OK Clinical Research-Site Number:8400005 | Edmond | Oklahoma | 73034 | — |
| Velocity Clinical Research, Medford-Site Number:8400001 | Medford | Oregon | 97504 | — |
| Jefferson Associates in Internal Medicine-Site Number:8400037 | Clairton | Pennsylvania | 15025 | — |
| Temple University Hospital-Site Number:8400009 | Philadelphia | Pennsylvania | 19140 | — |
| Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033 | Pittsburgh | Pennsylvania | 15213 | — |
| Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063 | Wyomissing | Pennsylvania | 19610 | — |
| VitaLink Research-Easley-Site Number:8400022 | Easley | South Carolina | 29640 | — |
| VitaLink Research- Gaffney-Site Number:8400047 | Gaffney | South Carolina | 29340 | — |
| VitaLink Research-Greenville-Site Number:8400007 | Greenville | South Carolina | 29615 | — |
| Clinical Research of Charleston-Site Number:8400044 | Mt. Pleasant | South Carolina | 29464 | — |
| Clinical Research of Rock Hill-Site Number:8400046 | Rock Hill | South Carolina | 29732 | — |
| VitaLink Research - Spartanburg-Site Number:8400048 | Spartanburg | South Carolina | 29303 | — |
| Clinical Trials Center of Middle Tennessee-Site Number:8400073 | Franklin | Tennessee | 37067 | — |
| Bayer College of Medicine-Site Number:8400018 | Houston | Texas | 77030 | — |
| Metroplex Pulmonary and Sleep Center-Site Number:8400021 | McKinney | Texas | 75069 | — |
| Sherman Clinical Research-Site Number:8400027 | Sherman | Texas | 75092 | — |
| MultiCare Institute for Research and Innovation-Site Number:8400036 | Tacoma | Washington | 98405 | — |
| Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008 | 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 224 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03930732, 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 Feb 28, 2024 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03930732 live on ClinicalTrials.gov.