A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (OBERON)
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (OBERON)
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.
Inclusion Criteria:
Exclusion Criteria:
CABA, C1425BEN, Argentina
Ciudad de Buenos Aires, C1414AIF, Argentina
Nyíregyháza-Sóstóhegy, 4481, Hungary
Asahikawa-shi, 078-8510, Japan
Fujieda-shi, 426-8677, Japan
Iizuka-shi, 820-8505, Japan
Itabashi-ku, 173-8610, Japan
Iwata-shi, 438-8550, Japan
Joyo-shi, 610-0113, Japan
Kawachinagano-shi, 586-8521, Japan
Kitakyusyu-shi, 806-8501, Japan
Koga-shi, 811-3195, Japan
Kokubunji-shi, 185-0014, Japan
Matsusaka-shi, 515-8544, Japan
Mizunami-shi, 509-6134, Japan
Nagaoka-shi, 940-8621, Japan
Shinjuku-ku, 162-8655, Japan
Toshima-ku, 170-0003, Japan
Toyonaka-shi, 560-8552, Japan
Yanagawa-shi, 832-0059, Japan
Lørenskog, 1478, Norway