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).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,713
- 试验地点
- 335
- 主要终点
- Annualised rate of severe COPD exacerbations in former smokers.
研究概览
简要总结
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.
详细描述
Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, 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 efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
- •Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
- •FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit
- •Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
- •Capable of giving signed informed consent.
排除标准
- •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 make the participation of the participant inappropriate.
- •Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
- •Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
- •Known history of:
- •Severe allergic reaction to any monoclonal and polyclonal antibody.
- •Allergy or reaction to any component of the IP formulation.
- •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.
- •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).
- •Participants who are not able to comply with the study requirements, procedures, and restrictions.
研究组 & 干预措施
Placebo
Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.
干预措施: Placebo (Combination Product)
Tozorakimab Dose 2
Injection subcutaneously Tozorakimab via pre-filled syringe.
干预措施: Tozorakimab 2 (Combination Product)
Tozorakimab Dose 1
Injection subcutaneously Tozorakimab via pre-filled syringe.
干预措施: Tozorakimab 1 (Combination Product)
结局指标
主要结局
Annualised rate of severe COPD exacerbations in former smokers.
时间窗: Up to 104 weeks.
The primary efficacy endpoint is the rate of severe COPD exacerbations.
次要结局
- The annualised rate of severe COPD exacerbations(Up to 104 weeks.)
- Time to First Severe COPD Exacerbations(Up to 104 weeks.)
- Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.(Up to 104 weeks.)
- Time to first moderate-to-severe COPD exacerbation.(Up to 104 weeks.)
- Annualised rate of moderate to severe COPD exacerbations.(Up to 104 weeks.)
- Time to all-cause death.(Up to 104 weeks.)
- Trough serum concentrations of Tozorakimab over the treatment period.(Up to 104 weeks.)
- Incidence of anti-drug antibodies.(Up to 104 weeks.)