Sponsor Name:
AstraZeneca AB
AstraZeneca K.K.
Protocol Title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing,
Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab
in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a
History of COPD Exacerbations (MIRANDA)
Regulatory Agency Identifier Number: EU CT Number: 2023-505543-39
Brief Summary: 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.