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NCT03930732 · ClinicalTrials.gov registry record · Phase 3
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
A Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 939
- Enrollment target
- 20
- Study locations
NCT03930732 is a Phase 3 study of Chronic Obstructive Pulmonary Disease that has completed, run by Sanofi. The registered enrollment target is 939 participants, below the 1,743-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT03930732, a Phase 3 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 939 participants
- Enrollment target
- 20
- Study locations
Study Summary
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)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab SAR231893
- DRUG Inhaled Corticosteroid
- DRUG Inhaled Long-Acting Beta Agonist
- DRUG Inhaled Long-Acting Muscarinic Antagonist
Study Locations (20)
Florida
- Clinical Research Of West Florida Inc-Site Number:8400010 - Clearwater
- Finlay Medical Research-Site Number:8400014 - Greenacres City
- Project 4 research, Inc.-Site Number:8400023 - Miami
- Finlay Medical Research-Site Number:8400062 - Miami
- Renstar Medical Research-Site Number:8400051 - Ocala
- Florida Institute for Clinical Research, LLC-Site Number:8400029 - Orlando
- Emerald Coast Research Associates-Site Number:8400032 - Panama City
- Sarasota Clinical Research-Site Number:8400026 - Sarasota
Alabama
- SEC Clinical Research, LLC-Site Number:8400030 - Andalusia
- Clinical Research Center of Alabama, LLC-Site Number:8400041 - Birmingham
- UAB Lung Health Center-Site Number:8400013 - Birmingham
- SEC Clinical Research, LLC-Site Number:8400059 - Dothan
- Pulmonary Associates of Mobile, P.C.-Site Number:8400057 - Mobile
Georgia
- VitaLink research-Hamilton Mill-Site Number:8400055 - Dacula
- DC Research Works-Site Number:8400016 - Marietta
- North Georgia Clinical Research-Site Number:8400025 - Woodstock
Maryland
- Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012 - Baltimore
- Asthma Allergy & Sinus Center-Site Number:8400038 - White Marsh
Colorado
- Asthma and Allergy Associates, PC-Site Number:8400034 - Colorado Springs
Michigan
- Michigan Medicine (University of Michigan)-Site Number:8400050 - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 939 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03930732
The ClinicalTrials.gov registry entry for NCT03930732 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 939 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,743-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (46% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03930732 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, Alabama, Georgia.
Frequently Asked Questions
What is clinical trial NCT03930732 about?
NCT03930732 is a clinical study titled "Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation". 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 effe...
What is the current status of trial NCT03930732?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 939 participants. The study started on 2019-04-15. Estimated completion is 2023-05-02.
What conditions does trial NCT03930732 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT03930732?
The interventions under investigation include: Placebo (DRUG), Dupilumab SAR231893 (DRUG), Inhaled Corticosteroid (DRUG), Inhaled Long-Acting Beta Agonist (DRUG), Inhaled Long-Acting Muscarinic Antagonist (DRUG).
Who is sponsoring clinical trial NCT03930732?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03930732 being conducted?
This trial has 20 study locations across Alabama, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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