NCT06940141已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants With Asthma and Type 2 Inflammation
Connect Biopharm LLC85 个研究点 分布在 6 个国家目标入组 160 人开始时间: 2025年8月8日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 85
- 主要终点
- Treatment failure rate within 28 days after randomization
研究概览
简要总结
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
详细描述
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma with duration of ≥12 months.
- •Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
- •Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
- •For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
- •Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
- •Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
- •Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
- •FEV1 ≥30% predicted.
排除标准
- •Regular use of immunosuppressive medication.
- •Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
- •Current or former smoker, has a smoking history including: If <30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
- •COPD and other clinically significant pulmonary disease other than asthma.
- •Known or suspected history of immunosuppression.
- •History of known immunodeficiency disorder or hepatitis B or C.
- •History of alcohol abuse and/or drug abuse.
- •Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy or other malignancies treated with apparent success with curative therapy.
- •Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization.
- •Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate).
- •Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.
- •Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.
- •Participants that have been recently treated with bronchial thermoplasty.
- •Recent treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of asthma.
- •Recent receipt of any investigational nonbiologic drug.
- •A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population.
- •The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Rademikibart
Experimental
干预措施: Rademikibart in prefilled syringe (Combination Product)
Placebo
Placebo Comparator
干预措施: Matching placebo in prefilled syringe (Drug)
结局指标
主要结局
Treatment failure rate within 28 days after randomization
时间窗: 28 days
Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.
次要结局
- Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1(Week 1)
- Mean CFB in morning/evening asthma symptom score(Week 1, Week 2, and Week 4)
- Mean CFB in nocturnal awakenings (e-diary)(Week 1, Week 2, and Week 4)
- Absolute CFB in post-BD FEV1(Day 3 and Week 4)
- Rate of new asthma exacerbations in the 28 days after randomization(28 days)
- Time to the first new asthma exacerbation in the 28 days after randomization(28 days)
- Mean change from baseline (CFB) in morning/evening asthma symptom score(Week 1, Week 2, and Week 4)
- Mean change from baseline (CFB) in nocturnal awakenings (e-diary)(Week 1, Week 2, and Week 4)
- Absolute CFB in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)(Day 3, Week 1, and Week 4)
- Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported(56 days)
- Incidence of unanticipated adverse device effects (UADEs)(56 days)
- Incidence of injection site reactions(56 days)
研究者
研究点 (85)
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