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
-
All
1869
Interventional
40 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.
Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations
Location
Status
Location
SASSARI, Italy, 07100
Status
Recruiting
Location
Vejle, Denmark, 7100
Status
Recruiting
Location
ZUTPHEN, Netherlands, 7207 AE
Status
Recruiting
Location
HEERLEN, Netherlands, 6419 PC
Status
Recruiting
Location
Sao Paulo, Brazil, 05403-000
Status
Recruiting
Location
Namur, Belgium, 5101
Status
Recruiting
Location
Gent, Belgium, 9000
Status
Recruiting
Location
Leuven, Belgium, 3000
Status
Recruiting
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. |
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