CTRI/2023/05/052694招募中3 期
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 AB 151 85 Sodertalje, Sweden9 个研究点 分布在 1 个国家目标入组 2,544 人开始时间: 2023年6月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,544
- 试验地点
- 9
- 主要终点
- 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.
研究概览
简要总结
Phase III, multicentre, randomised, double-blind, chronic-dosing, parallel-group,
placebo-controlled extension study to evaluate the long-term efficacy and safety of
tozorakimab 300 mg Q4W and 300 mg Q8W administered SC, in participants with COPD with history of COPD exacerbations.
Eligible participants must have completed the treatment period and have not prematurely discontinued from IP in the predecessor studies and fulfil the inclusion/exclusion criteria. Participants will be encouraged to continue on the same stable COPD maintenance therapy throughout the study.
The primary and secondary objectives:
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.
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 and current smokers.
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of severe COPD exacerbations.
A total of 2544 participants will be randomized 1:1:1 to receive two dose regimen of Tozorakimab or placebo and includes:
I. Screening Period: Up to 2 to 12 weeks
a. Treatment Period: 48-weeks double-blind treatment period with:
II. Study intervention administration (Tozorakimab or placebo) SC Q4W , Q8W from Week 0 to Week 48 for a total of 14 doses
Follow-up Period: Up to 12 weeks after last efficacy assessment at Week 52 (ie, 12 weeks after last dose of study intervention)
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •(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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 52 weeks
次要结局
- 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 and current smokers(First severe COPD exacerbation - 52 weeks)
- To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the time to first moderate to severe COPD exacerbation.(Time to first moderate-to-severe COPD exacerbation. - 52 weeks)
- To evaluate the effect of tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.(Time to all-cause death. - 52 weeks)
- To evaluate the PK and immunogenicity of tozorakimab.(Trough serum concentrations of tozorakimab over the treatment)
- To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of severe COPD exacerbations.(Annualised rate of severe COPD exacerbations. - 52 weeks)
- To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations.(Annualised rate of moderate to severe COPD exacerbations. - 52 weeks)
- To assess the long-term safety and tolerability of tozorakimab as an add on to SoC compared with SoC plus placebo.(week 52)
- To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on measures of lung function.(Week 52)
- To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on mucus plugging, airway structure and function, and emphysema(progression.)
- To evaluate the effect of tozorakimab as an add on to SoC compared with SoC plus placebo on overall and COPD-related healthcare resource utilisation.(Week 52)
- To evaluate the effect of tozorakimab as an add on to SoC compared with SoC plus placebo on time to respiratory-related death.(Week 52)
研究者
研究点 (9)
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