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

  • STATUS
    Recruiting
  • End date
    Sep 2, 2022
  • participants needed
    924
  • sponsor
    Sanofi
Updated on 2 December 2020
Investigator
For site information, send an email with site number to
Primary Contact
Investigational Site Number 1560011 (2.0 mi away) Contact
+441 other location
antibiotics
corticosteroids
pulmonary function test
bronchitis
dyspnea
cough
bronchodilator
forced expiratory volume
eosinophil count
muscarinic antagonists
severe chronic obstructive pulmonary disease
copd exacerbation

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 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)

Description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.

Details
Treatment Placebo, Inhaled Corticosteroid, Dupilumab SAR231893, Inhaled Long-Acting Beta Agonist, Inhaled Long-Acting Muscarinic Agonist, Inhaled Long-Acting Muscarinic Antagonist
Clinical Study IdentifierNCT03930732
SponsorSanofi
Last Modified on2 December 2020

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Eligibility

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Inclusion Criteria

Is your age between 40 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Obstructive Lung Disease or COPD (Chronic Obstructive Pulmonary Disease)?
Do you have any of these conditions: COPD or chronic obstructive pulmonary disease (copd) or COPD (Chronic Obstructive Pulmonary Disease) or Chronic Obstructive Lung Disease or chronic ob...?
Do you have any of these conditions: COPD (Chronic Obstructive Pulmonary Disease) or Chronic Obstructive Lung Disease or chronic obstructive pulmonary disease or chronic obstructive pulmo...?
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
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