A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 1060 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.
Inclusion Criteria:
Exclusion Criteria:
CABA, C1056ABJ, Argentina
CABA, C1425BEN, Argentina
Ciudad de Buenos Aires, 1425, Argentina
Edogawa-ku, 134-0083, Japan
Fujieda-shi, 426-8677, Japan
Habikino-shi, 583-8588, Japan
Higashiibaraki-gun, 311-3193, Japan
Himeji-shi, 672-8064, Japan
Hitachi-shi, 317-0077, Japan
Itabashi-ku, 173-0003, Japan
Itabashi-ku, 173-8610, Japan
Kasuga-shi, 816-0813, Japan
Kishiwada-shi, 596-8501, Japan
Koga-shi, 811-3195, Japan
Matsusaka-shi, 515-8544, Japan
Meguro-ku, 152-0021, Japan
Meguro-ku, 152-8621, Japan
Mizunami-shi, 509-6134, Japan
Nagaoka-shi, 940-2085, Japan
Ogaki-shi, 503-8502, Japan
Ohota-ku, 145-0063, Japan
Omuta-shi, 837-0911, Japan
Sagamihara-shi, 228-0815, Japan
Setagaya-ku, 157-0072, Japan
Shibuya-ku, 150-0013, Japan
Shinagawa-ku, 140-8522, Japan
Shinagawa-ku, 142-8666, Japan
Shinjuku-ku, 162-8655, Japan
Shinjuku-ku, 162-8666, Japan
Sumida-ku, 130-0015, Japan
Toshima-ku, 170-0003, Japan
Toshima-ku, 171-0014, Japan
Yokkaichi-shi, 510-8567, Japan
Yoshida-gun, 910-1193, Japan
Lenasia Ext8, 1820, South Africa
Kaohsiung Hsien, TAIWAN, Taiwan
Kharkiv Region, 61075, Ukraine