PER-050-13已完成未知
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH UNCONTROLLED ASTHMA WHO ARE ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICATI
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 75（—）
入选标准
- •Able and willing to provide written informed consent and to comply with the study protocol
- •Age 18–75 years old at Visit 1
- •Asthma diagnosis for >=12 months prior to Visit 1
- •Bronchodilator response at Visit 1, 2, or 3
- •Pre-bronchodilator FEV1 of 40%–80% predicted at both Visits 2 and 3
- •On ICS therapy at a total daily dose of 500–2000 ug of fluticasone propionate DPI or equivalent for >=6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1 and no anticipated changes throughout the study
- •On an eligible second controller medication (LABA, LTRA, LAMA, or theophylline) for 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1 and no anticipated changes throughout the study (except for theophylline dose, which may be adjusted on the basis of theophylline levels)
- •Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
- •Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X ray during the screening period (prior to Visit 3) that confirms the absence of other clinically significant lung disease
- •Demonstrated adherence with controller medication during the screening period.Adherence is defined as patients responding affirmatively that they have taken their asthma controller therapy >= 70% of days during the screening.
排除标准
- •History of a severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to any component of the lebrikizumab injection•Maintenance oral, systemic or intra-articular corticosteroid therapy•Infection•Active tuberculosis•Known immunodeficiency•Evidence of acute or chronic hepatitis or known liver cirrhosis•AST,ALT,or total bilirubin elevation•Clinically significant abnormality on screening ECG or laboratory tests•History of interstitial lung disease, chronic obstructive pulmonary disease, or other significant lung disease •Known malignancy or evaluation for a potential malignancy•Other significant medical disease that is uncontrolled•History of alcohol or drug abuse•Current smoker, former smoker with smoking history of >10 pack-years,or unwilling to abstain from smoking•Past and/or current use of any anti–IL13 or anti–IL4/IL13 therapy•Use of a licensed or investigational monoclonal antibody other than anti–IL13 or anti IL4/IL13•Use of an immunomodulatory or immunosuppressive therapy•Use of other investigational therapy not described•Use of zileuton or roflumilast•Use of traditional Chinese herbal medicine•Initiation of or change in allergen immunotherapy•Receipt of a live attenuated vaccine•Female patients of reproductive potential who are unwilling to use a method of contraception for the duration of the study Pregnant or lactating•Body mass index >38 kg/m2•Body weight <40 kg•History of bronchial thermoplasty*More information,see the protocol
研究者
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