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

Conditions

• Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab SAR231893 — DRUG
  Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
• Inhaled Corticosteroid — DRUG
  Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
• Inhaled Long-Acting Beta Agonist — DRUG
  Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
• Inhaled Long-Acting Muscarinic Antagonist — DRUG
  Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
• Placebo — DRUG
  Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Study Details

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)

Key Dates

Start date

Apr 15, 2019

Status verified

Jan 2024

Primary completion

Feb 8, 2023

Completion

May 2, 2023

Study Design

Enrollment

939 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).
• Placebo Comparator: Placebo
  Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment \[EOT\] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).

Primary Outcome Measure

Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-Week Treatment Period [ Time Frame: Baseline (Day 1) to Week 52 ]

Locations (51)

Find similar trials in Andalusia, AL

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