Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
Evaluating the Efficacy of an Investigational Medication in COPD Patients
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 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)
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 - 85 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 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 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.
- 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.
This study investigates the effects of an investigational medication given every two weeks on patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic lung disease that makes it hard to breathe. The main goal is to see if the medication can reduce the rate of acute COPD flare-ups, which are sudden worsening of symptoms.
Participants will undergo various procedures, including lung function tests and quality of life assessments. Lung function is measured by how much air a person can forcefully exhale in one second, known as FEV1. The study will also compare these results to those of a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Who can participate: Adults with moderate to severe COPD who are current or former smokers with a history of at least 10 pack-years can participate. They must have a history of COPD exacerbations and be on stable COPD medication. Participants should not have other significant pulmonary diseases or a current diagnosis of asthma.
- Study details: Participants will receive the investigational medication or a placebo every two weeks. They will have regular lung function tests and health assessments to monitor lung function and overall health. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study Timelines: The study will last approximately 68 weeks.
