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Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 40 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-03-06
Primary completion: 2026-06-16
Study completion finish: 2026-08-17
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05742802
Intervention or treatment
COMBINATION_PRODUCT: Tozorakimab 1
COMBINATION_PRODUCT: Tozorakimab 2
COMBINATION_PRODUCT: Placebo
Conditions
- • Chronic Obstructive Pulmonary Disease (COPD)
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Macquarie University, Not Specified, Australia
Research Site
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Tozorakimab Dose 1
| COMBINATION_PRODUCT: Tozorakimab 1
|
EXPERIMENTAL: Tozorakimab Dose 2
| COMBINATION_PRODUCT: Tozorakimab 2
|
PLACEBO_COMPARATOR: Placebo
| COMBINATION_PRODUCT: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Annualised rate of severe COPD exacerbations in former smokers. | The primary efficacy endpoint is the rate of severe COPD exacerbations. | Up to 104 weeks. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
The annualised rate of severe COPD exacerbations | To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers. | 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. | 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. | 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. | Up to 104 weeks. |
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. | Up to 104 weeks. |
Trough serum concentrations of tozorakimab over the treatment period. | Pharmacokinetics: concentrations of Tozorakimab in trough serum. | Up to 104 weeks. |
Incidence of anti-drug antibodies. | Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum. | Up to 104 weeks. |
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