A Randomized Placebo-Controlled Safety and Pharmacodynamic Study of KB002, an Anti-GM-CSF Monoclonal Antibody, in Patients with Persistent Symptomatic Asthma

Kalobios Pharmaceuticals Inc.0 个研究点目标入组 24 人开始时间: 2007年10月29日最近更新: 2020年1月13日

适应症

试验速览

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•1. Aged 18 – 75 years inclusive at screening 2. Males and females. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study 3. An established diagnosis of asthma for at least 2 years at screening 4. Astthma control questionaire score of >0.75 at screening 5. Have persistent asthma as defined as being symptomatic despite being treated with >/= 500 µg/day beclomethasone (BDP) equivalent of inhaled and/or >/= 7.5mg prednisolone equivalent oral corticosteroids

•1. Acute asthma attack or lower respiratory tract infection within 1 month prior to baseline (Day 0)
•2. History of life threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past three years
•3. History of any cardiovascular, neurological, hepatic, renal, or other medical conditions that in the Investigator’s opinion may interfere with the interpretation of data or the patient’s participation in the study
•4. History of smoking within the past year or a greater than 20 pack year history of smoking
•5. History of alcohol or drug abuse
•6. Omalizumab (Xolair) therapy within 2 months prior to baseline (Day 0)
•7. Participation in another research trial within 1 month prior to baseline (Day 0)
•8. Inability to give consent and/or unwillingness/inability to comply with study procedures

发起方

Kalobios Pharmaceuticals Inc.