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

NCT05742802
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,713
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Lead sponsor
AstraZeneca
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Start date
2023-03-06
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Number of sites
335
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Summary
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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Acronym
PROSPERO
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Short title
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
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Official 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).
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-05-27
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First posted
2023-02-24
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Registry last updated
2026-06-25
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Primary completion date
2026-02-26
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Start date
2023-03-06
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Actual participants
1,713
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Participants
1,713
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Participant count basis
Actual
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Protocol amendments
11
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Number of sites
335
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05742802
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ClinicalTrials.gov ID
NCT05742802
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Up to 104 weeks.

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

  1. The annualised rate of severe COPD exacerbations

    Timeframe: 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

    Timeframe: 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.

    Timeframe: 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.

    Timeframe: 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.

    Timeframe: 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.

    Timeframe: 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.

    Timeframe: Up to 104 weeks.

    Pharmacokinetics: concentrations of Tozorakimab in trough serum.

  8. Incidence of anti-drug antibodies.

    Timeframe: Up to 104 weeks.

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
130 Years
Healthy volunteers
No

  1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
  2. 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.
  3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
  4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
  5. Capable of giving signed informed consent.

  1. 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.

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

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

  4. Known history of:

    1. Severe allergic reaction to any monoclonal and polyclonal antibody.
    2. Allergy or reaction to any component of the IP formulation.

  5. 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.

  6. 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).

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

Sources for eligibility
clinicaltrials.gov

  • Research SiteSheffield, United States
  • Research SiteTempe, United States
  • Research SiteLincoln, United States
  • Research SiteNewport Beach, United States
  • Research SiteNorthridge, United States
  • Research SiteBoynton Beach, United States
  • Research SiteCape Coral, United States
  • Research SiteOrmond Beach, United States
  • Research SitePensacola, United States
  • Research SitePlantation, United States
  • Research SiteTampa, United States
  • Research SiteWinter Park, United States
  • Research SiteEvergreen Park, United States
  • Research SiteNormal, United States
  • Research SiteGreenwood, United States
  • Research SiteKansas City, United States
  • Research SiteBowling Green, United States
  • Research SiteBaton Rouge, United States
  • Research SiteZachary, United States
  • Research SiteBaltimore, United States
  • Research SiteWhite Marsh, United States
  • Research SiteNorth Dartmouth, United States
  • Research SiteFarmington Hills, United States
  • Research SiteGrand Rapids, United States
  • Research SiteRochester, United States

And 310 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-501063-41-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)