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

An exploratory, randomized, double-blind, placebo-controlled study of the effects of dupilumab on airway inflammation of adults with persistent asthma - EXPEDITION

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001572-22-DE

Enrollment

Registered

2015-08-07

Start date

2015-12-01

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 18.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: dupilumab Product Code: SAR231893 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Dupilumab Current Sponsor code: SAR231893 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients 65 years. • Fractional exhaled nitric oxide (FeNO) 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.

Design outcomes

Primary

Measure	Time frame
Main 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;Primary end point(s): 1 - Change from baseline in number of inflammatory cells in the bronchial submucosa per square millimeter 2 - Change from baseline in mucin-stained area in the bronchial submucosa per square millimeter;Timepoint(s) of evaluation of this end point: Baseline, 12 weeks	—

Measure

Time frame

Main 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;Primary end point(s): 1 - Change from baseline in number of inflammatory cells in the bronchial submucosa per square millimeter 2 - Change from baseline in mucin-stained area in the bronchial submucosa per square millimeter;Timepoint(s) of evaluation of this end point: Baseline, 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1 -Absolute change from baseline in exhaled nitric oxide 2 - Proportion of patients with antidrug antibodies 3 - Proportion of patients with adverse events;Timepoint(s) of evaluation of this end point: 1 - Baseline, 12 weeks 2 & 3 - Up to 24 weeks	—

Countries

Canada, Denmark, Germany, Sweden, United Kingdom, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026