Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

Key facts

Study ID

NCT02573233

Run by

Sanofi

People needed

42

Starts

2016-01-27

Expected to finish

2018-01-03

Last updated by the study team

2022-04-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Participants <18 years or >65 years.
• Fractional exhaled nitric oxide (FeNO) <26 parts per billion (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 could impair lung function.
• A participant who experienced an asthma exacerbation that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
• A participant who had 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 (e.g., 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840402 — Tucson, Arizona, United States
• Investigational Site Number 840403 — Denver, Colorado, United States
• Investigational Site Number 840401 — Boston, Massachusetts, United States
• Investigational Site Number 840002 — St Louis, Missouri, United States
• Investigational Site Number 840404 — Winston-Salem, North Carolina, United States
• Investigational Site Number 840028 — Pittsburgh, Pennsylvania, United States
• Investigational Site Number 124012 — Montreal, Canada
• Investigational Site Number 124018 — Sainte-Foy, Canada
• Investigational Site Number 208002 — Hvidovre, Denmark
• Investigational Site Number 208001 — København NV, Denmark
• Investigational Site Number 276013 — Frankfurt am Main, Germany
• Investigational Site Number 276011 — Großhansdorf, Germany
• Investigational Site Number 276012 — Hanover, Germany
• Investigational Site Number 752001 — Lund, Sweden
• Investigational Site Number 826010 — London, United Kingdom
• Investigational Site Number 826009 — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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