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 - 85 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 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)

Key Dates

Start date

Jul 6, 2020

Status verified

May 2025

Primary completion

Feb 28, 2024

Completion

May 27, 2024

Study Design

Enrollment

935 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Participants received dupilumab 300 mg subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks
• Placebo Comparator: Placebo
  Participants received placebo matched to dupilumab 300 mg SC injection q2w up to 52 weeks

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 (92)

Find similar trials in Cullman, AL

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