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

• Status: Completed
• Trial end date: 2018-01-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Budesonide; Fluticasone; Formoterol Fumarate; Mometasone Furoate; Salmeterol Xinafoate; Xhance

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 was allowed.

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

Exclusion criteria:

• 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.