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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

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

NCT04456673•Sanofi

View on ClinicalTrials.gov

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)

Detailed Description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with a physician diagnosis of COPD who met the following criteria at screening:
•* Current or former smokers with a smoking history of ≥10 pack-years.
•* Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity \[FVC\] ratio \<0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%).
•* Medical Research Council (MRC) Dyspnea Scale grade ≥2.
•* Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
•* Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the participant was taking inhaled corticosteroid (ICS)/long-acting beta agonist (LABA)/long-acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations were recorded by the investigator and defined as AECOPD that required either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations had to require the use of systemic corticosteroids. Severe exacerbations were recorded by the investigator and defined as AECOPD requiring hospitalization or observation \> 24 hours in emergency department/urgent care facility.
•* Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
•Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/microliter at Visit 1.
•Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
•History of, or planned pneumonectomy or lung volume reduction surgery. Participants who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation \<4 weeks prior to screening (Note: participants in the maintenance phase of a rehabilitation program can be included).
+2 more criteria

Exclusion Criteria

•COPD diagnosis for less than 12 months prior to randomization.
•Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.
•Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
•Cor pulmonale, evidence of right cardiac failure.
•Long-term treatment with oxygen \>4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation \>88%
•Hypercapnia requiring Bi-level ventilation.

Locations (334)

Cullman Research Center, LLC Site Number : 8400095

Cullman, Alabama, United States

Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090

Jasper, Alabama, United States

Scottsboro Quick Care Clinic Site Number : 8400116

Scottsboro, Alabama, United States

Phoenix Medical Group Site Number : 8400061

Peoria, Arizona, United States

Medical Advancement Center of Arizona Site Number : 8400107

Tempe, Arizona, United States

Asthma and Allergy Institute Site Number : 8400022

Little Rock, Arkansas, United States

Kern Research, Inc Site Number : 8400031

Bakersfield, California, United States

NewportNativeMD, Inc Site Number : 8400032

Newport Beach, California, United States

Prospective Research Innovations, Inc. Site Number : 8400063

Rancho Cucamonga, California, United States

ACRC Studies Site Number : 8400094

San Diego, California, United States

Key Dates

Start Date

July 6, 2020

Primary Completion Date

February 28, 2024

Completion Date

May 27, 2024

Last Updated

May 29, 2025

Enrollment

935

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Dupilumab SAR231893

DRUG

Inhaled Corticosteroid

DRUG

Inhaled Long-Acting Beta Agonist

DRUG

Inhaled Long-Acting Muscarinic Antagonist

DRUG

Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

Inclusion Criteria

Exclusion Criteria

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