Study identifier:D9180C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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 (MEDI3506) in Participants with Chronic Obstructive Pulmonary Disease (COPD) with a History of Exacerbations.
Chronic obstructive pulmonary disease (COPD)
Phase 3
No
Tozorakimab, Placebo
All
2544
Interventional
40 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jan 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Tozorakimab Dose 1 Injection subcutaneously Tozorakimab or placebo via pre-filled syringe. | Combination Product: Tozorakimab Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and regimen in the PROSPERO study. |
Experimental: Tozorakimab Dose 2 Injection subcutaneously Tozorakimab via pre-filled syringe. | Combination Product: Tozorakimab Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and 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 reassigned to one of the active doses of Tozorakimab or placebo in a 1:1:2 ratio. |