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Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
NCT04456673 · View on ClinicalTrials.gov ↗
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 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)
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
- Helix Biomedics, LLC Site Number : 8400035 — Boynton Beach
- Pioneer Clinical Research Site Number : 8400043 — Boynton Beach
- Renaissance Research and Medical Group, Inc Site Number : 8400092 — Cape Coral
- St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020 — Clearwater
- Beautiful Minds Clinical Research Center Site Number : 8400081 — Cutler Bay
- Omega Research Consultants, LLC Site Number : 8400021 — DeBary
- Sciences Connections, LLC Site Number : 8400133 — Doral
California
- Kern Research, Inc Site Number : 8400031 — Bakersfield
- NewportNativeMD, Inc Site Number : 8400032 — Newport Beach
- Prospective Research Innovations, Inc. Site Number : 8400063 — Rancho Cucamonga
- ACRC Studies Site Number : 8400094 — San Diego
- Institute of HealthCare Assessment, Inc. Site Number : 8400015 — San Diego
- Allianz Research Institute Site Number : 8400007 — Westminster
Alabama
- Cullman Research Center, LLC Site Number : 8400095 — Cullman
- Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090 — Jasper
- Scottsboro Quick Care Clinic Site Number : 8400116 — Scottsboro
Arizona
- Phoenix Medical Group Site Number : 8400061 — Peoria
- Medical Advancement Center of Arizona Site Number : 8400107 — Tempe
Arkansas
- Asthma and Allergy Institute Site Number : 8400022 — Little Rock
Colorado
- Innovative Clinical Research Site Number : 8400018 — Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 935 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2024-05-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04456673
The ClinicalTrials.gov registry entry for NCT04456673 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 935 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04456673 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04456673 about?
NCT04456673 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 or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effec...
What is the current status of trial NCT04456673?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 935 participants. The study started on 2020-07-06. Estimated completion is 2024-05-27.
What conditions does trial NCT04456673 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04456673?
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04456673?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04456673 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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