Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
NCT ID: NCT02573233
Last Updated: 2022-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2016-01-27
2018-01-03
Brief Summary
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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.
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Detailed Description
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Participants who completed the treatment period could be eligible to participate in an open-label extension study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
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.
Placebo
Pharmaceutical form:solution Route of administration: subcutaneous
fluticasone propionate and salmeterol
Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled
budesonide and formoterol
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
mometasone furoate and formoterol
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
Dupilumab
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.
Dupilumab SAR231893/REGN668
Pharmaceutical form:solution Route of administration: subcutaneous
fluticasone propionate and salmeterol
Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled
budesonide and formoterol
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
mometasone furoate and formoterol
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
Interventions
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Placebo
Pharmaceutical form:solution Route of administration: subcutaneous
Dupilumab SAR231893/REGN668
Pharmaceutical form:solution Route of administration: subcutaneous
fluticasone propionate and salmeterol
Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled
budesonide and formoterol
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
mometasone furoate and formoterol
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001572-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1170-7168
Identifier Type: OTHER
Identifier Source: secondary_id
PDY14192
Identifier Type: -
Identifier Source: org_study_id
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