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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: budesonide and formoterol; Drug: Dupilumab SAR231893/REGN668; Drug: mometasone furoate and formoterol; Drug: Placebo; Drug: fluticasone propionate and salmeterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02573233

U1111-1170-7168 (Other Identifier)

2015-001572-22 (EudraCT Number)

PDY14192

Details and patient eligibility

About

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.

Full description

The total study duration for each participant was between approximately 29 and maximum of 30 weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a treatment period of 12 weeks, and a post-treatment period of 12 weeks.

Participants who completed the treatment period could be eligible to participate in an open-label extension study.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14, added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Treatment:

Drug: fluticasone propionate and salmeterol

Drug: mometasone furoate and formoterol

Drug: Placebo

Drug: budesonide and formoterol

Dupilumab

Experimental group

Description:

Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14, added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Treatment:

Drug: fluticasone propionate and salmeterol

Drug: Dupilumab SAR231893/REGN668

Drug: mometasone furoate and formoterol

Drug: budesonide and formoterol