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

NCT03930732 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 939

Last updated 2024-02-28

Study results available
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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)

Conditions

Interventions

DRUG

Dupilumab SAR231893

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DRUG

Inhaled Corticosteroid

Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

DRUG

Inhaled Long-Acting Beta Agonist

Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

DRUG

Inhaled Long-Acting Muscarinic Antagonist

Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2023-02-08
Completion
2023-05-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03930732 on ClinicalTrials.gov