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)

AstraZeneca AB0 sites0 target enrollmentFebruary 28, 2024

ConditionsJ449 Chronic obstructive pulmonary disease, unspecified Chronic obstructive pulmonary disease, unspecified J449

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: J449 Chronic obstructive pulmonary disease, unspecified
Sponsor: AstraZeneca AB
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 28, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1\.Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor study(TITANIA).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 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
•Reproduction
•1\.FOCBP must have a negative urine pregnancy test at Visit 1\.(a)For a definition of FOCBP, refer to Appendix E.2\. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. (a)Male participants: Non\-sterile male participants who are sexually active with a female partner of childbearing potential pomumust agree to use a male condom while engaging in sexual activity from enrolment throughout the study duration and until 14 weeks after last dose of IP. For a definition of non\-sterile male, refer to Appendix E. In countries where spermicide is available, it is strongly recommended. It is also strongly recommended for the female partner of a male participant to use a highly effective method of contraception throughout this period. Non\-sterilised male patients should also refrain from biologically fathering a child or donating sperm during the same period. (b)Female participants: female(s) of childbearing potential who are sexually active with a non\-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 14 weeks after last dose of IP. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post\-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
•A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Highly effective birth control methods include: sexual abstinence (periodic abstinence eg, calendar, ovulation, symptothermal, post\-ovulation methods, declaration of abstinence for the duration of exposure to IP, and withdrawal are not acceptable methods of contraception), a vasectomised partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo\-Provera™ injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.. It is highly recommended for the male partner of a FOCBP participant to use a male condom whilst engaging in sexual activity throughout this period. Note that there are no contraception requirements for female participants who are not of childbearing potential. However, all female participants should refrain from egg cell donation and breastfeeding throughout the study
•Informed Consent
•Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol Participants are excluded from the study if any of the following criteria ap

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 (refer to Section 7\.1\.1\) as judged by the Investigator or the Sponsor.
•Prior/Concomitant Clinical Study Experience
•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 that, in the opinion of the Investigator or the Sponsor, may put the participant's safety at risk and/or impact the interpretation of the study results.
•Other Exclusions
•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, as judged by the Investigator or the Sponsor.