Clinical Trials List
2023-06-01 - 2026-12-31
Phase III
Not yet recruiting3
Recruiting6
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)
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Wei- Chang Huang 無
- 王俊隆 無
- 張可昀 無
- 趙文震 無
- 李柏昕 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hung-Ling Huang 無
- 鄭孟軒 無
- 莊政皓 無
- Ming-Ju Tsai 無
- 蔡毓真 無
- 陳家閔 無
- Wei-An Chang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 郭書𡵓 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Fu-Tsai Chung 無
- Wan-Jing Ho 無
- 羅君禹 無
- 林倡葦 無
- 黃鴻育 無
- 萬永亮 無
- Horng-Chyuan Lin 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 張允中 Division of Thoracic Medicine
- 賀立婷 Division of Thoracic Medicine
- Jung-Yien Chien Division of Thoracic Medicine
- 郭耀文 Division of Thoracic Medicine
- 錢穎群 Division of Thoracic Medicine
- 許嘉林 Division of Thoracic Medicine
- 黃俊凱 Division of Thoracic Medicine
- Ping-Hung Kuo Division of Thoracic Medicine
- 鄭之勛 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Summary measure: Rate ratio.
Population: Full analysis set, former smokers.
Intercurrent events: Treatment policy using data regardless of treatment
discontinuation during study and imputing data post re-randomisation
or post-withdrawal from the study based upon reason for withdrawal.
Inclution Criteria
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. See Table E1 in Appendix E for acceptable
methods of contraception.
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
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
The Estimated Number of Participants
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Taiwan
40 participants
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Global
2120 participants
