Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Investigating the Efficacy of an Investigational Medication for COPD
Study Overview
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)
Study Details
Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Obstructive Pulmonary Disease
-
Age: 40 years - 80 years
-
Gender: All
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 patient 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 acute exacerbation of COPD (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 was contraindicated.
- Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter
at Visit 1.
Exclusion criteria:
- COPD diagnosis for less than 12 months prior to randomization.
- A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
- 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.
- Treatment with oxygen of more than 12 hours per day.
- 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. Patients who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program could be included).
- Diagnosis of α-1 anti-trypsin deficiency.
The above information was not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
This study investigates the effectiveness of an investigational medication given every two weeks to patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic lung disease that makes it hard to breathe and often involves symptoms like a persistent cough and shortness of breath. The study aims to see if the medication can reduce the number of acute COPD flare-ups, which are sudden worsening of symptoms.
Participants will undergo several procedures, including lung function tests to measure how much air they can exhale in one second (called FEV1). They will also complete questionnaires about their quality of life and have their lung health monitored over time. Some participants will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Who can participate: Adults who have been diagnosed with COPD for at least 12 months, are current or former smokers with a history of at least 10 pack-years, and have moderate to severe COPD may be eligible. They must have a history of chronic bronchitis and a high risk of exacerbations, with specific blood inflammation markers.
- Study details: Participants will receive either the investigational medication or a placebo every two weeks. They will continue their current COPD treatment and will be monitored for changes in lung function and quality of life. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study timelines: The study will last 68 weeks.
