Clinical Trial Details

NCT ID: NCT02573233
Date Last Changed: October 10, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study to evaluate Asthma

Research Study Title

An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma

Purpose

Primary Objective:

To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients with persistent asthma.

Secondary Objective:

To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Sanofi
Duration
26 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 65 Years

Inclusion criteria:

  • Male and female adults with a physician diagnosis of persistent asthma for ≥12 months.

  • Existing treatment with medium to high dose inhaled corticosteroids in combination with a long-acting beta agonist for at least 3 months with a stable dose ≥1 month prior to Visit 1 (Screening Visit).

  • Treatment with a third asthma controller for at least 3 months with a stable dose ≥1 month prior to Visit 1 is allowed.

  • Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.

Exclusion criteria:

  • Patients < 18 years or > 65 years.

  • Fractional exhaled nitric oxide (FeNO) < 26 ppb at Visit 1 (Screening Visit).

  • Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis [Churg-Strauss Syndrome]) which may impair lung function.

  • A patient who experiences an asthma exacerbation that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.

  • A patient who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1.

  • Evidence of lung disease(s) other than asthma.

  • Previous smoker (smoking history > 10 pack-years) or current smoker (within 6 months prior to Visit 1).

  • Comorbid disease that might interfere with the evaluation of investigational medicinal product or conduct of study procedures (eg, bronchoscopy).

  • Anti-immunoglobulin E (IgE) therapy (omalizumab) or any other biologic therapy within 6 months of Visit 1.

  • Exposure to another investigative study medication within a time period prior to Visit 1 that is less than 5 half-lives of the study medication.

  • Treatment with systemic (oral or injectable) corticosteroids within 28 days of Visit 1.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Site Locations (16)

Country State City Zip Facility and Contact
United States Arizona Tucson 85724 Investigational Site Number 840402
United States Colorado Denver 80206 Investigational Site Number 840403
United States Massachusetts Boston 02115 Investigational Site Number 840401
United States Missouri Saint Louis 63110 Investigational Site Number 840002
United States North Carolina Winston-Salem 27157-1071 Investigational Site Number 840404
United States Pennsylvania Pittsburgh 15213 Investigational Site Number 840028
Canada Montreal H2X 2P4 Investigational Site Number 124012
Canada Sainte Foy G1V 4G5 Investigational Site Number 124018
Denmark Hvidovre 2650 Investigational Site Number 208002
Denmark København Nv 2400 Investigational Site Number 208001
Germany Frankfurt Am Main 60596 Investigational Site Number 276013
Germany Großhansdorf 22927 Investigational Site Number 276011
Germany Hannover 30625 Investigational Site Number 276012
United Kingdom Bristol BS10 5NB Investigational Site Number 826011
United Kingdom London W2 1NY Investigational Site Number 826010
United Kingdom Oxford OX3 7LE Investigational Site Number 826009

Contact

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