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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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)

Key facts

Study ID

NCT04456673

Run by

Sanofi

People needed

935

Starts

2020-07-06

Expected to finish

2024-05-27

Last updated by the study team

2025-05-29

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
• 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).
• Diagnosis of α-1 anti-trypsin deficiency.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• 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
• Institute of HealthCare Assessment, Inc. Site Number : 8400015 — San Diego, California, United States
• Allianz Research Institute Site Number : 8400007 — Westminster, California, United States
• Innovative Clinical Research Site Number : 8400018 — Lafayette, Colorado, United States
• Helix Biomedics, LLC Site Number : 8400035 — Boynton Beach, Florida, United States
• Pioneer Clinical Research Site Number : 8400043 — Boynton Beach, Florida, United States
• Renaissance Research and Medical Group, Inc Site Number : 8400092 — Cape Coral, Florida, United States
• St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020 — Clearwater, Florida, United States
• Beautiful Minds Clinical Research Center Site Number : 8400081 — Cutler Bay, Florida, United States
• Omega Research Consultants, LLC Site Number : 8400021 — DeBary, Florida, United States
• Sciences Connections, LLC Site Number : 8400133 — Doral, Florida, United States
• InvesClinic, LLC Site Number : 8400039 — Fort Lauderdale, Florida, United States
• Finlay Medical Research Site Number : 8400071 — Greenacres City, Florida, United States
• Direct Helpers Medical Center Inc Site Number : 8400079 — Hialeah, Florida, United States
• DL Research Solutions Inc Site Number : 8400089 — Miami, Florida, United States
• Phoenix Medical Research, LLC Site Number : 8400012 — Miami, Florida, United States
• Cullman Research Center, LLC Site Number : 8400095 — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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