Last updated on February 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Obstructive Lung Disease | COPD (Chronic Obstructive Pulmonary Disease)
  • Age: Between 40 - 80 Years
  • Gender: Male or Female

Inclusion criteria:

  • Participants with a physician diagnosis of COPD who meet the following criteria:
  • Current or former smokers with a smoking history of 10 pack-years.
  • Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] 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 are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are 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: 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 are 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 can be included).
  • Diagnosis of -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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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