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.
Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients
with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
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The total study duration for each patient is 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. Patients who complete the treatment period may be eligible to participate in an open-label
extension study.
Phase 2
Sorry, this information is not available
Interventional
Drug : dupilumab SAR231893/REGN668, Drug : placebo, Drug : fluticasone propionate and salmeterol, Drug : budesonide and formoterol, Drug : mometasone furoate and formoterol
Study Arm Groups : Dupilumab, Placebo, Dupilumab, Placebo, Dupilumab, Placebo, Dupilumab, Placebo
See Interventions above
Change from baseline in number of inflammatory cells in the bronchial submucosa per square millimeter; At 12 weeks; Change from baseline in mucin-stained area in the bronchial submucosa per square millimeter; At 12 weeks
Absolute change from baseline in exhaled nitric oxide; At 12 weeks; Proportion of patients with antidrug antibodies; Up to 24 weeks; Proportion of patients with adverse events; Up to 24 weeks
Sorry, this information is not available
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.
All
18 Years - 65 Years
Patients
Sorry, this information is not available
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 is allowed. - Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal. Exclusion criteria: - Patients <18 years or >65 years. - Fractional exhaled nitric oxide (FeNO) <26 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 may impair lung function. - A patient who experiences an asthma exacerbation that results in emergency treatment,
hospitalization due to asthma, or treatment with systemic steroids at any time from 1
month prior to Visit 1. - A patient who has 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 (eg, 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 is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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.
An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma
Not available for this trial
- Regeneron Pharmaceuticals
PDY14192
Sanofi
