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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05742802
Recruitment Status : Recruiting
First Posted : February 24, 2023
Last Update Posted : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Combination Product: Tozorakimab Combination Product: Placebo Phase 3

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 (MEDI3506) in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations.
Actual Study Start Date : March 6, 2023
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : August 27, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tozorakimab Dose 1
Injection subcutaneously Tozorakimab or placebo via pre-filled syringe.
 Combination Product: Tozorakimab
Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and regimen in the PROSPERO study.
Experimental: Tozorakimab Dose 2
Injection subcutaneously Tozorakimab via pre-filled syringe.
 Combination Product: Tozorakimab
Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and 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 reassigned to one of the active doses of Tozorakimab or placebo in a 1:1:2 ratio.


Outcome Measures
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Primary Outcome Measures :
  1. Time to first severe COPD exacerbation in former smokers. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    The primary efficacy endpoint is the time to first severe COPD exacerbation over the treatment period incorporating both the predecessor studies and PROSPERO. The primary endpoint will be assessed first in the Primary Population of former smokers, followed by the Overall Population of current and former smokers.


Secondary Outcome Measures :
  1. Time to first severe COPD exacerbation. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    To be analysed as a key secondary endpoint in the Overall Population of current and former smokers.

  2. Annualised rate of severe COPD exacerbations. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    The annualised rate of severe COPD exacerbations over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population of current and former smokers.

  3. Time to first moderate-to-severe COPD exacerbation. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.

  4. Annualised rate of moderate to severe COPD exacerbations. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    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.

  5. Time to all-cause death. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.

  6. Trough serum concentrations of tozorakimab over the treatment period. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    Pharmacokinetics: concentrations of Tozorakimab in trough serum.

  7. Incidence of anti-drug antibodies. [ Time Frame: 104 weeks total (52 weeks in this study) ]
    Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05742802


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05742802    
Other Study ID Numbers: D9180C00008
2022-501063-41-00 ( Registry Identifier: EU CT number )
First Posted: February 24, 2023    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame:

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease
COPD
Tozorakimab
MEDI3506
 exacerbations
ICS
LABA/LAMA
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes