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.

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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.

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• Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    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

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary 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 MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    The annualised rate of severe COPD exacerbationsTo 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 ExacerbationsTime 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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    References

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

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