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

Description

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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Study Overview

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Study Details

Study overview

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.

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).

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

Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention / Treatment

-

Contacts and Locations

Huntsville

Research Site, Huntsville, Alabama, United States, 35801

Sheffield

Research Site, Sheffield, Alabama, United States, 35660

Tempe

Research Site, Tempe, Arizona, United States, 85283

Bakersfield

Research Site, Bakersfield, California, United States, 93301

Lincoln

Research Site, Lincoln, California, United States, 95648

Newport Beach

Research Site, Newport Beach, California, United States, 92663

Northridge

Research Site, Northridge, California, United States, 91324

Boynton Beach

Research Site, Boynton Beach, Florida, United States, 33435

Cape Coral

Research Site, Cape Coral, Florida, United States, 33990

Ormond Beach

Research Site, Ormond Beach, Florida, United States, 32174

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

40 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-08-17