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)
Protocol Number: D9180C00012
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 administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.
https://clinicaltrials.gov/study/NCT06040086