ong-term Efficacy and Safety of Tozorakimab in Participants with ChronicObstructive Pulmonary Disease with a History of Exacerbations
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2023/05/052694
- Lead Sponsor
- AstraZeneca AB 151 85 Sodertalje, Sweden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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previous 12 weeks and were not withdrawn from the predecessor study.
Reproduction
3 FOCBP must have a negative urine pregnancy test at Visit 1.
(a) For a definition of FOCBP, refer to Appendix E.
4 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 FOCPB partner must
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:
FOCBP 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 can be found in Appendix E. 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
5 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.
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.
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,
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the time to first severe COPD exacerbation in former smokers.Timepoint: 52 weeks
- Secondary Outcome Measures
Name Time Method