NCT07780643招募中3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK5784283 (Felcorekibart) as an Add-On Therapy in Adults and Adolescents With Uncontrolled Asthma (PERSIST ASTHMA-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- Annualized rate of clinically significant asthma exacerbations
研究概览
简要总结
The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma 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)
盲法说明
This is a double-blind study
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).
- •Participants aged 12 to 80 years at the time of signing the informed consent.
- •Male or eligible female participants:
- •Female participants:
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.
- •A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.
- •If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.
- •A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines.
- •Evidence of variable airflow obstruction consistent with asthma.
- •Documented history of asthma exacerbation within 12 months prior to Visit
- •A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS).
- •At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist [LABA], Leukotriene receptor antagonists [LTRA], theophylline, Long-acting muscarinic agonists [LAMA], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening.
- •Uncontrolled asthma based on ACQ-5 score.
排除标准
- •Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.
- •History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).
- •Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.
- •New York Heart Association (NYHA) class III or IV heart failure.
- •Other significant medical conditions that could impact participants' safety or study outcomes.
- •History of an unresolved clinically significant infection within 30 days prior to Visit
- •A known immunodeficiency, other than that explained by the use of corticosteroids taken as therapy for asthma.
- •Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit
- •Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma).
- •Current smokers (tobacco and/or marijuana), current users of vaping products/electronic-cigarettes or participants with a smoking history >=10 pack-years.
研究组 & 干预措施
Participants receiving GSK5784283 plus standard of care
Experimental
干预措施: GSK5784283 (Drug)
Participants receiving GSK5784283 plus standard of care
Experimental
干预措施: Standard of care (Drug)
Participants receiving matching placebo plus standard of care
Placebo Comparator
干预措施: Placebo (Drug)
Participants receiving matching placebo plus standard of care
Placebo Comparator
干预措施: Standard of care (Drug)
结局指标
主要结局
Annualized rate of clinically significant asthma exacerbations
时间窗: Up to Week 52
A clinically significant exacerbation is defined as a worsening of asthma symptoms requiring the use of systemic corticosteroids or in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) due to asthma.
次要结局
- Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)(Baseline and at Week 52)
- Time to first clinically significant asthma exacerbation(Up to Week 52)
- Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score(Baseline and at Week 52)
- Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) score(Baseline and at Week 52)
- Annualized rate of clinically significant exacerbations requiring emergency department (EmD) visit or hospitalization(Up to Week 52)
研究者
研究点 (1)
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