Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Last updated: July 7, 2023
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Obstructive Pulmonary Disease (Copd)

Copd (Chronic Obstructive Pulmonary Disease)

Treatment

N/A

Clinical Study ID

TX312873
  • Ages 40-85
  • All Genders

Study Summary

This is a Phase 3, Randomized, Double-Blind, Placebo-Controlled study to assess the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations and pulmonary function in former smokers with moderate to severe COPD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

*

Exclusion

Exclusion Criteria:

*

Study Design

Study Start date:
December 16, 2020
Estimated Completion Date:
November 28, 2025

Study Description

This is a Phase 3, Randomized, Double-Blind, Placebo-Controlled study looking for patients from 40 - 85 years old with a diagnosis of moderate-to-severe COPD for at least 1 year. Participants must have a 10 pack-year history, but must not be currently smoking. Smoking cessation must have occurred 6 or more months prior to Screening visit for the study. The primary objective is to evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations.

Connect with a study center

  • Alpine Clinical Research Center

    Boulder, Colorado 80301
    United States

    Active - Recruiting

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