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.

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. - PROSPERO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220659

Enrollment

Registered

2023-02-23

Start date

2023-03-06

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Arm Experimental: Tozorakimab Dose 1 Injection subcutaneously Tozorakimab or placebo via pre-filled syringe. Intervention/treatment Combination Product: Tozorakimab Participants previously randomised

Eligibility

Sex/Gender

All

Inclusion 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2 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study. 3 FOCBP must have a negative urine pregnancy test at Visit 1. 4 Participants who are willing to continue using contraceptive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

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 makes 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 study or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies. 4 Known history of: a. Severe allergic reaction to any monoclonal and polyclonal antibody. b. 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.

Design outcomes

Primary

Measure	Time frame
Annualised rate of severe COPD exacerbations in former smokers.	—

Countries

Argentina, Australia, Belgium, Brazill, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Peru, Portugal, South Korea, Spain, Sweden, Turkey, US, Vietnam

Contacts

Public ContactYuji Ageishi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026