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Completed

NCT Number: NCT05742802

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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• Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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

Treatment and study plan

Tozorakimab 1

Combination Product

Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.

Tozorakimab 2

Combination Product

Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.

Placebo

Combination Product

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.

Primary outcomes

  1. Annualised rate of severe COPD exacerbations in former smokers.

    Time frame: Up to 104 weeks.

    The primary efficacy endpoint is the rate of severe COPD exacerbations.

Secondary outcomes

  1. The annualised rate of severe COPD exacerbations

    Time frame: Up to 104 weeks.

    To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers.

  2. Time to First Severe COPD Exacerbations

    Time frame: Up to 104 weeks.

    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.

  3. Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.

    Time frame: Up to 104 weeks.

    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.

  4. Time to first moderate-to-severe COPD exacerbation.

    Time frame: Up to 104 weeks.

    To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.

  5. Annualised rate of moderate to severe COPD exacerbations.

    Time frame: Up to 104 weeks.

    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.

  6. Time to all-cause death.

    Time frame: Up to 104 weeks.

    To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.

  7. Trough serum concentrations of Tozorakimab over the treatment period.

    Time frame: Up to 104 weeks.

    Pharmacokinetics: concentrations of Tozorakimab in trough serum.

  8. Incidence of anti-drug antibodies.

    Time frame: Up to 104 weeks.

    Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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).

Acronym: PROSPERO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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