Study identifier:D9180C00008
ClinicalTrials.gov identifier:NCT05742802
EudraCT identifier:N/A
CTIS identifier:2022-501063-41-00
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease (COPD) with a History of Exacerbations (PROSPERO).
Chronic obstructive pulmonary disease (COPD)
Phase 3
No
Tozorakimab 1, Tozorakimab 2, Placebo
All
1596
Interventional
40 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Tozorakimab Dose 1 Injection subcutaneously Tozorakimab via pre-filled syringe. | Combination Product: Tozorakimab 1 Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study. |
Experimental: Tozorakimab Dose 2 Injection subcutaneously Tozorakimab via pre-filled syringe. | Combination Product: Tozorakimab 2 Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study. |
Placebo Comparator: Placebo Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe. | Combination Product: Placebo Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo. |