Clinical trial NCT02573233: Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Official title: An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2015-10-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12
timeFrame: Baseline, Week 12
measure: Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12
timeFrame: From Baseline to Week 6 through Week 12
measure: Number of Participants With Antidrug Antibodies (ADA)
timeFrame: From Baseline up to 24 weeks
measure: Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration
timeFrame: Week 0, Week 2, 6, 8, 12, 18, End of study (Week 24)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Investigational Site Number 840402
state: Arizona
city: Denver
country: United States
facility: Investigational Site Number 840403
state: Colorado
city: Boston
country: United States
facility: Investigational Site Number 840401
state: Massachusetts
city: Saint Louis
country: United States
facility: Investigational Site Number 840002
state: Missouri
city: Winston-Salem
country: United States
facility: Investigational Site Number 840404
state: North Carolina
city: Pittsburgh
country: United States
facility: Investigational Site Number 840028
state: Pennsylvania
city: Montreal
country: Canada
facility: Investigational Site Number 124012
city: Sainte Foy
country: Canada
facility: Investigational Site Number 124018
city: Hvidovre
country: Denmark
facility: Investigational Site Number 208002
city: København Nv
country: Denmark
facility: Investigational Site Number 208001
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 276013
city: Großhansdorf
country: Germany
facility: Investigational Site Number 276011
city: Hannover
country: Germany
facility: Investigational Site Number 276012
city: Lund
country: Sweden
facility: Investigational Site Number 752001
city: London
country: United Kingdom
facility: Investigational Site Number 826010
city: Oxford
country: United Kingdom
facility: Investigational Site Number 826009
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: