Efficacy and safety of tozorakimab in symptomatic chronic obstructive pulmonary disease with a history of exacerbations (MIRANDA)
Efficacy and safety of tozorakimab in symptomatic chronic obstructive pulmonary disease with a history of exacerbations (MIRANDA)
ClinicalTrials.gov ID: NCT06040086
Sponsor: AstraZeneca
Information provided by: AstraZeneca (Responsible Party)
Last Update Posted: 2024-06-04
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.
Official 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)
Intervention / Treatment:
- Drug: Placebo
- Drug: Tozorakimab
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-09-22
|
| Primary Completion (Estimated) |
2026-09-10
|
| Study Completion (Estimated) |
2026-12-07
|
| Enrollment (Estimated) | 1240 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
D9180C00012
2023-505543-39 (EudraCT Number) |