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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,713
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
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.
Annualised rate of severe COPD exacerbations in former smokers.
The primary efficacy endpoint is the rate of severe COPD exacerbations.
Time frame: Up to 104 weeks.
The annualised rate of severe COPD exacerbations
To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers.
Time frame: Up to 104 weeks.
Time to First Severe COPD Exacerbations
Time to first severe COPD exacerbation over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.
Time frame: Up to 104 weeks.
Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.
To evaluate the long-term effect of Tozorakimab as an add on to SoC compared to with SoC plus placebo on COPD related health care utilisation. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.
Time frame: Up to 104 weeks.
Time to first moderate-to-severe COPD exacerbation.
To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.
Time frame: Up to 104 weeks.
Annualised rate of moderate to severe COPD exacerbations.
To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations.
Time frame: Up to 104 weeks.
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Research Site
Sheffield, Alabama, United States
Research Site
Tempe, Arizona, United States
Research Site
Lincoln, California, United States
Research Site
Newport Beach, California, United States
Research Site
Northridge, California, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Cape Coral, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Pensacola, Florida, United States
Research Site
Plantation, Florida, United States
...and 325 more locations
Time to all-cause death.
To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.
Time frame: Up to 104 weeks.
Trough serum concentrations of Tozorakimab over the treatment period.
Pharmacokinetics: concentrations of Tozorakimab in trough serum.
Time frame: Up to 104 weeks.
Incidence of anti-drug antibodies.
Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.
Time frame: Up to 104 weeks.