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Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With A... | Completed
Evaluation of Dupilumab's Effects o... | Completed
Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
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Medical Conditions
  • Asthma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT02573233
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Placebo, Drug : Dupilumab SAR231893/REGN668, Drug : fluticasone propionate and salmeterol, Drug : budesonide and formoterol, Drug : mometasone furoate and formoterol

Study Arm Groups : Placebo, Dupilumab, Placebo, Dupilumab, Placebo, Dupilumab, Placebo, Dupilumab

Intervention Type
See Interventions above
Primary Outcome Measures
    Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12; Baseline, Week 12; Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12; Baseline, Week 12; Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12; Baseline, Week 12; Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12; Baseline, Week 12; Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12; Baseline, Week 12; Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12; Baseline, Week 12
Secondary Outcome Measures
    Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12; Baseline, Week 12; Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12; From Baseline to Week 6 through Week 12; Number of Participants With Antidrug Antibodies (ADA); From Baseline up to 24 weeks; Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration; Week 0, Week 2, 6, 8, 12, 18, End of study (Week 24); Number of Participants With Treatment Emergent Adverse Events (TEAEs); Baseline up to Week 24
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 65 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant 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 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
W2 1NY
Oxford
OX3 7LE
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Canada, Denmark, Germany, Sweden, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma
EudraCT Number
Not available for this trial
Funder(s)
  • Regeneron Pharmaceuticals
Other Study ID Numbers
PDY14192
Sponsor(s)
Sanofi
Key Dates

Recruitment Start Date

Jan 2016

Recruitment End Date

Jan 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

08 Oct 2015

Date updated in source

25 Jan 2019