EUCTR2012-001791-11-GB进行中（未招募）1 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
KaloBios Pharmaceuticals, Inc.0 个研究点目标入组 150 人开始时间: 2012年6月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Written and signed informed consent from subject (or assent from legal guardian if under 18 years of age, or legal representative if applicable) prior to any study-specific assessments, and permission to use protected health information in accordance with regional regulations.
- •2. Males or females aged 16 to 75 years inclusive at Screening Visit.
- •3. Females of childbearing potential may participate if they have a negative pregnancy test, are nonlactating, and agree to practice a highly effective birth control method (e.g., abstinence, combination barrier and spermicide, hormonal) for the duration of
- •4. Physician diagnosis of asthma established for at least 2 years prior to Screening Visit.
- •5. Symptomatic asthma defined as having an ACQ score =1.5 at Screening and Randomization Visits.
- •6. Symptomatic asthma despite chronic treatment with inhaled corticosteroids =500 µg/day fluticasone (dry powder or hydrofluoroalkane [HFA] inhaler) or budesonide, or equivalent doses of other inhaled corticosteroids, for at least 12 weeks prior to Screening Visit. A stable dose is required for at least 4 weeks prior
- •to Screening Visit.
- •7. For the subset of subjects taking oral corticosteroids, asthma is symptomatic despite treatment with =7.5 mg of prednisolone per day for at least 12 weeks prior to screening. A stable dose is required for at least 4 weeks prior to Screening Visit.
- •8. Currently receiving LABA. Subjects not receiving LABA must have documented LABA intolerability or lack of responsiveness to LABA.
- •9. FEV1 from 40% to 80% of the predicted value at Screening and Randomization Visits.
- •10. At Screening or Randomization visits, demonstrated FEV1 bronchodilator response of =12% (i.e., reversibility) from baseline measurements 15 to 30 minutes after SABA administration.
- •11. 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 for 3 or more days.
- •12. Weight from 40 to 125 kg at Screening Visit.
- •13. Ability to perform spirometry tests according to protocol-specified standards as indicated in the Spirometry Manual.
- •14. Chest X-ray (CXR) within 12 months of Screening Visit with no evidence of clinically significant abnormality. For subjects who have had an intervening significant cardiac or pulmonary event, a post-event CXR should be obtained.
- •15. Ability to understand and comply with study requirements including study visits, diary completion. and daily peak flow measurements, as demonstrated during the run-in period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Acute asthma worsening (defined as 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.
- •2. History of life-threatening asthma, with admission to the intensive care unit requiring the use of mechanical ventilation, within the past 12 months.
- •3. Use of any immunosuppressive or immunomodulatory agents within 12 weeks or use of an investigational agent within 4 weeks prior to Screening Visit.
- •4. History of any cardiovascular, neurological, hepatic, renal, or other medical condition that in the Investigator’s opinion may interfere with the interpretation of data or the subject’s participation in the study.
- •5. History of cigarette or marijuana smoking within the 12 months prior to screening, a >10 pack-year history, or a positive test for nicotine (cotinine).
- •6. History of alcohol or drug abuse that in the opinion of the Investigator would preclude appropriate compliance with study procedures.
- •7. Omalizumab (Xolair) therapy within 12 weeks prior to Screening Visit.
- •8. History of malignancy within the last 5 years. Basal or squamous cell skin carcinoma adequately treated is allowed.
- •9. Known immunodeficiency including but not limited to human immunodeficiency virus (HIV) infection.
- •10. Pre-existing lung disease other than asthma that in the Investigator’s opinion may interfere with the interpretation of data or the subject’s participation in the study.
- •11. Known history of tuberculosis, chronic fungal infection (e.g., histoplasmosis, coccidioidomycosis), or hepatitis C.
- •12. Prior allergic reaction to a monoclonal antibody. Mild to moderate infusion reactions that are transient and easily treated with medications are allowed.
- •13. Inability to give consent/assent or unwillingness or inability to comply with study procedures.
研究者
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