A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations. Approximately 770 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.
Inclusion Criteria:
Exclusion Criteria:
Praha 10 - Strasnice, 100 00, Czechia
Asahi-shi, 289-2511, Japan
Habikino-shi, 583-8588, Japan
Himeji-shi, 672-8064, Japan
Itabashi-ku, 173-8610, Japan
Izumo-shi, 693-8501, Japan
Kanuma-shi, 322-0036, Japan
Kasuga-shi, 816-0813, Japan
Kishiwada-shi, 596-8501, Japan
Matsusaka-shi, 515-8544, Japan
Meguro-ku, 153-8515, Japan
Nishinomiya-shi, 663-8501, Japan
Sagamihara-shi, 228-0815, Japan
Sakaide-shi, 762-8550, Japan
Sasebo-shi, 857-8511, Japan
Seto-shi, 489-8642, Japan
Shibuya-ku, 150-0013, Japan
Shinagawa-ku, 142-8666, Japan
Shinjuku-ku, 162-8655, Japan
Sumida-ku, 130-8587, Japan
Toshima-ku, 171-0014, Japan
Touon-shi, 791-0281, Japan
Tsukubo-gun, 701-0304, Japan
Uozu-shi, 937-0042, Japan
Kaohsiung Hsien, TAIWAN, Taiwan