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

ACTIVE_NOT_RECRUITINGPHASE3

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

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).

NCT05742802•AstraZeneca

View on ClinicalTrials.gov

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.

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

Eligibility

Age

40 - 130 years

Sex

ALL

Healthy Volunteers

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 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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

Locations (335)

Research Site

Sheffield, Alabama, United States

Research Site

Tempe, Arizona, United States

Research Site

Lincoln, California, United States

Research Site

Newport Beach, California, United States

Research Site

Northridge, California, United States

Research Site

Boynton Beach, Florida, United States

Research Site

Cape Coral, Florida, United States

Research Site

Ormond Beach, Florida, United States

Research Site

Pensacola, Florida, United States

Research Site

Plantation, Florida, United States

Key Dates

Start Date

March 6, 2023

Primary Completion Date

February 26, 2026

Completion Date

May 28, 2026

Last Updated

March 13, 2026

Enrollment

1,713

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Tozorakimab 1

COMBINATION_PRODUCT

Tozorakimab 2

COMBINATION_PRODUCT

Placebo

COMBINATION_PRODUCT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A