临床试验/NCT01603277

NCT01603277已完成2 期

A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

Humanigen, Inc.70 个研究点分布在 4 个国家目标入组 160 人开始时间: 2012年7月最近更新: 2015年2月2日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Humanigen, Inc.
入组人数: 160
试验地点: 70
主要终点: Change in Percent Predicted FEV1 at Week 24

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

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: 16 Years 至 75 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•A diagnosis of asthma established for at least 2 years
•Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
•Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
•Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
•At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose

排除标准

•Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
•History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
•Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
•History of any cardiovascular, neurological, hepatic, or renal condition
•History of smoking within the past 12 months

结局指标

主要结局

Change in Percent Predicted FEV1 at Week 24

时间窗: Baseline to Week 24

次要结局

To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate(Week 24)
To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)(Week 24)
To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments(Week 24)

研究者

发起方

Humanigen, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (70)

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