A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.
Secondary Objectives:
The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.
Inclusion criteria:
-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:
a) 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, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.
i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).
ii) Participants 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.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Caba, 1120, Argentina
Caba, C1414AIF, Argentina
Caba, C1425BEN, Argentina
Caba, C1425FVH, Argentina
Caba, C1426ABP, Argentina
Capital Federal, C1425DUC, Argentina
Gödöllö, 2100, Hungary
Akashi-Shi, Japan
Asahikawa-Shi, Japan
Chiyoda-Ku, Japan
Fukuyama-Shi, Japan
Habikino-Shi, Japan
Higashiosaka-Shi, Japan
Himeji-Shi, Japan
Iizuka-Shi, Japan
Isesaki-Shi, Japan
Itabashi-Ku, Japan
Kasuga-Shi, Japan
Kawaguchi-Shi, Japan
Kishiwada-Shi, Japan
Kodaira-Shi, Japan
Kokubunji-Shi, Japan
Koshi-Shi, Japan
Koshigaya-Shi, Japan
Kurashiki-Shi, Japan
Machida-Shi, Japan
Mizunami-Shi, Japan
Muroran-Shi, Japan
Nagakute-Shi, Japan
Naka-Gun, Japan
Naruto-Shi, Japan
Obihiro-Shi, Japan
Ome-Shi, Japan
Osaka Sayama-Shi, Japan
Osaka Sayama-Shi, Japan
Osaki-Shi, Japan
Ota-Shi, Japan
Oura-Gun, Japan
Sagamihara-Shi, Japan
Seto-Shi, Japan
Shibuya-Ku, Japan
Shinagawa-Ku, Japan
Shinagawa-Ku, Japan
Shinjuku-Ku, Japan
Sumida-Ku, Japan
Tachikawa-Shi, Japan
Tachikawa-Shi, Japan
Tomakomai-Shi, Japan
Uozu-Shi, Japan
Urasoe-Shi, Japan
Yonago-Shi, Japan
Zaporizhia, 69076, Ukraine