A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 23
- 主要终点
- The Ability of AVTX-002 to Improve Asthma Control in Subjects With Poorly Controlled Non-eosinophilic Asthma (NEA) Based on the Percentage of Patients Who Experience Asthma Related Events.
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of AVTX-002 compared with placebo in patients with poorly controlled non-eosinophilic asthma (NEA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented non-eosinophilic asthma diagnosis (<300 eosinophils/μL).
- •Symptoms consistent with a diagnosis of asthma that is poorly controlled as determined by an ACQ score ≥ 1.
- •Poorly controlled asthma despite the use of a Long-Acting Beta-Agonists and Inhaled Corticosteroid for at least 3 consecutive months immediately prior to screening.
- •Subjects must have had at least one asthma exacerbation in the last 24 months.
排除标准
- •Pulmonary disease other than asthma.
- •Currently on biologic therapy. Previous biologic therapy is permitted with adequate washout (12 weeks or 5 half-lives, whichever is longer).
- •Use of systemic immunosuppressants within the last 6 months.
- •Use of systemic corticosteroids within 6 weeks prior to Screening or use of antibiotics within 4 weeks prior to Screening.
- •Subject has alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) >5 upper limit of normal (ULN) and/or serum creatinine concentration >1.5 mg/dL.
- •Subject has hemoglobin ≤10 g/dL, neutrophils ≤1,500/μl, and/or platelets ≤75,000/μl.
研究组 & 干预措施
AVTX-002
Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study.
干预措施: AVTX-002 (Drug)
Placebo
Approximately 40 subjects will receive placebo sourced as normal saline three times during the study.
干预措施: Placebo (Drug)
结局指标
主要结局
The Ability of AVTX-002 to Improve Asthma Control in Subjects With Poorly Controlled Non-eosinophilic Asthma (NEA) Based on the Percentage of Patients Who Experience Asthma Related Events.
时间窗: Through Week 14
Percentage of patients who experience any of the following asthma related events: * ≥6 additional reliever puffs of Short-Acting Beta-Agonist (compared to baseline) in a 24-hour period on 2 consecutive days or, * increase in inhaled corticosteroid dose ≥4 times than the dose at baseline or, * a decrease in peak flow of 30% or more (compared to baseline) on 2 consecutive days of treatment, or * an asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or * a hospitalization or emergency room visit because of an asthma exacerbation
次要结局
- Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]).(Through Week 14)
- Time to Asthma Exacerbation.(Through Week 14)
- Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ).(Through Week 14)
- Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity.(Through Week 14)
- Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO).(Through Week 14)
- Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12).(Through Week 14)
- Change From Baseline to Week 14 in Asthma Symptom Diary Score.(Through Week 14)
- Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS).(Through Week 14)
- Change From Baseline to Week 14 in Patient Global Impression of Change/Severity.(Through Week 14)
- The Number of Inhalations of Short-acting Beta Agonist (SABA) at Week 14.(Through Week 14)
- Change From Baseline to Week 14 in Serum Soluble LIGHT Levels (Lymphotoxin-like, Exhibits Inducible Expression, and Competes With Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator, a Receptor Expressed by T Lymphocytes).(Through Week 14)
- Incidence of Anti-drug Antibodies (ADAs) at Each Timepoint.(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.)