A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Persistent Asthma

Sanofi-aventis Recherche & Développement0 个研究点目标入组 1,638 人开始时间: 2015年4月9日最近更新: 2015年7月10日

适应症

试验速览

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•Adults and adolescent patients with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:
•- Existing treatment with medium to high dose ICS (=250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotrine receptor antagonist) for at least 3 months with a stable dose =1 month prior to Visit 1.
•- Note for Japan: for subjects aged 18 years and older, ICS must be on =200 mcg of fluticasone propionate twice daily or equivalent; for subjects aged 12 to 17 years, ICS must be =100 mcg of fluticasone propionate twice daily or equivalent).
•- Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose =1 month prior to Visit 1.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 84
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 254

•Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are =18 years of age).
•Weight is less than 30 kilograms.
•Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
•A subject who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
•Clinical evidence or imaging (eg, chest X-ray, computed tomography) within 12 months of Visit 1 consistent with lung disease(s) other than asthma.
•Current smoker or cessation of smoking within 6 months prior to Visit 1.
•Previous smoker with a smoking history >10 pack-years.
•Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

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