Status:
COMPLETED
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2024
Estimated Enrollment :
935 Patients enrolled
Trial Details
Trial ID
NCT04456673
Start Date
July 6 2020
End Date
May 27 2024
Last Update
May 29 2025
Active Locations (334)
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1
Cullman Research Center, LLC Site Number : 8400095
Cullman, Alabama, United States, 35055
2
Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090
Jasper, Alabama, United States, 35501
3
Scottsboro Quick Care Clinic Site Number : 8400116
Scottsboro, Alabama, United States, 35768
4
Phoenix Medical Group Site Number : 8400061
Peoria, Arizona, United States, 85381