Save

Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

PHASE3RECRUITING

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.

Simpliy with AI

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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.

Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.

FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.

Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.

Capable of giving signed informed consent.

Exclusion criteria

Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.

Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.

Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.

Known history of:

Severe allergic reaction to any monoclonal and polyclonal antibody.

Allergy or reaction to any component of the IP formulation.

Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.

Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).

Participants who are not able to comply with the study requirements, procedures, and restrictions.

Simplify with AI

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)

Image related to Chronic Obstructive Pulmonary Disease (COPD)

Condition: Chronic Obstructive Pulmonary Disease (COPD)
COMBINATION_PRODUCT: Tozorakimab 1 and other drugs
Macquarie University, Not Specified, Australia and more
Sponsor: AstraZeneca

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 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.

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.

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).