A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms.
研究概览
简要总结
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with CF who are older than 50 years of age may participate if treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms (CF exacerbation) in the 12 months before the Screening Visit
- •Confirmed diagnosis of CF
- •At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The most recent positive Pa culture must be within 12 weeks before the Screening Visit (or obtain a positive culture at screening)
- •FEV1 % levels within acceptable ranges (per the study protocol)
- •Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit
排除标准
- •Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit
- •Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit
- •Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0 Visit
- •History of sputum cultures positive for B. cepacia complex in the 2 years before the Screening Visit
- •History of organ transplantation
- •Current smoker (tobacco, marijuana, or any other material). Use of smokeless inhalers/vaporizers for these materials is also prohibited
- •History of drug addiction or alcohol abuse in the 12 months before the Screening Visit
- •History of hepatic disease (clinical cirrhosis or portal hypertension), renal dysfunction
- •Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test
- •Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0 Visit, whichever is longer
研究组 & 干预措施
KB001-A
KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.
干预措施: KB001-A (Biological)
Placebo Comparator
Placebo administered up to 5x intravenously
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms.
时间窗: 16 Weeks
Time-to-need for ABX treatment will be the length of time between study material dosing and administration of ABX as needed for worsening respiratory conditions.
次要结局
- Safety and tolerability of KB001-A(16 Weeks)