ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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).

Quick Facts

Study Start:2023-03-06
Study Completion:2026-05-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05742802

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.

Ages Eligible for Study:40 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
  2. 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 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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. 3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
  4. 4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
  5. 5. Capable of giving signed informed consent.
  1. 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. 2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
  3. 3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
  4. 4. Known history of:
  5. 1. Severe allergic reaction to any monoclonal and polyclonal antibody.
  6. 2. Allergy or reaction to any component of the IP formulation.
  7. 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.
  8. 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).
  9. 7. Participants who are not able to comply with the study requirements, procedures, and restrictions.

Contacts and Locations

Study Locations (Sites)

Research Site
Sheffield, Alabama, 35660
United States
Research Site
Tempe, Arizona, 85283
United States
Research Site
Lincoln, California, 95648
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Northridge, California, 91324
United States
Research Site
Boynton Beach, Florida, 33435
United States
Research Site
Cape Coral, Florida, 33990
United States
Research Site
Ormond Beach, Florida, 32174
United States
Research Site
Pensacola, Florida, 32503
United States
Research Site
Plantation, Florida, 33324
United States
Research Site
Tampa, Florida, 33607
United States
Research Site
Winter Park, Florida, 32789
United States
Research Site
Evergreen Park, Illinois, 60805
United States
Research Site
Normal, Illinois, 61761
United States
Research Site
Greenwood, Indiana, 46143
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Bowling Green, Kentucky, 42101
United States
Research Site
Baton Rouge, Louisiana, 70836
United States
Research Site
Zachary, Louisiana, 70791
United States
Research Site
Baltimore, Maryland, 21224
United States
Research Site
White Marsh, Maryland, 21162
United States
Research Site
North Dartmouth, Massachusetts, 02747
United States
Research Site
Farmington Hills, Michigan, 48336
United States
Research Site
Grand Rapids, Michigan, 49546
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
St Louis, Missouri, 63110
United States
Research Site
Buffalo, New York, 14203
United States
Research Site
New York, New York, 10037
United States
Research Site
Durham, North Carolina, 27705
United States
Research Site
Gastonia, North Carolina, 28054
United States
Research Site
Fargo, North Dakota, 58104
United States
Research Site
Toledo, Ohio, 43617
United States
Research Site
Tulsa, Oklahoma, 74133
United States
Research Site
DuBois, Pennsylvania, 15801
United States
Research Site
Philadelphia, Pennsylvania, 19140
United States
Research Site
Pittsburgh, Pennsylvania, 15213
United States
Research Site
Sayre, Pennsylvania, 18840
United States
Research Site
Rock Hill, South Carolina, 29732
United States
Research Site
Franklin, Tennessee, 37067
United States
Research Site
Amarillo, Texas, 79106
United States
Research Site
Boerne, Texas, 78006
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
McKinney, Texas, 75069
United States
Research Site
Tomball, Texas, 77375
United States
Research Site
Colchester, Vermont, 05446
United States
Research Site
Williamsburg, Virginia, 23188
United States
Research Site
Cudahy, Wisconsin, 53110
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-06
Study Completion Date2026-05-28

Study Record Updates

Study Start Date2023-03-06
Study Completion Date2026-05-28

Terms related to this study

Keywords Provided by Researchers

  • Chronic Obstructive Pulmonary Disease
  • COPD
  • Tozorakimab
  • MEDI3506
  • exacerbations
  • ICS
  • LABA/LAMA

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease (COPD)