EUCTR2014-000275-14-GB进行中（未招募）1 期
A Phase II, randomized, double-blind, placebo-controlled bronchoscopy study to evaluate the effects of Lebrikizumab on airway eosinophilic inflammation in patients with uncontrolled asthma on inhaled corticosteroids and a second controller medication
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- 性别
- All
入选标准
- •- Age 18-75 years old at study start
- •- Asthma diagnosis for >/= 12 months prior to study start
- •- Documented Bronchodilator Reversibility within past 12 months or during screening
- •- Pre-bronchodilator FEV1 of 40% - 80% predicted at both screening visits 2 and 3
- •- On ICS therapy at a total daily dose of 500-2000 ug of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to study start, with no changes within 4 weeks prior, and no anticipated changes throughout the study
- •- On an eligible second controller medication (LABA, LTRA, LAMA, or theophylline) for 6 months prior to study start, with no changes within 4 weeks prior, and no anticipated changes throughout the study
- •- Uncontrolled asthma at screenings visits 1 and/or 2, and at visit 3
- •- Chest X-ray or computed tomography (CT) scan within 12 months prior to Visit 1 or chest X-ray during the screening period that confirms the absence of other clinically significant lung disease
- •- Demonstrated adherence with controller medication during the screening period
- •- Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start
- •- Treatment with systemic corticosteroids within 4 weeks prior to study start or during the screening period for any reason
- •- Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start or during screening. Any infection requiring oral antibiotic treatment with 2 weeks of study start, or any parasitic infection within 6 months of study start or during screening
- •- Active tuberculosis requiring treatment within 12 months prior to study start or during screening
- •- Known immunodeficiency, including, but not limited to, HIV infection
- •- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
- •- Known current malignancy or current evaluation for a potential malignancy
- •- Unable to safely undergo elective flexible fiberoptic bronchoscopy
- •- Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments
- •- History of alcohol or drug abuse that would impair or risk the patients full participation in the study, in the opinion of the investigator
- •- Current or history of smoking ( > 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
- •- Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
- •- Use of a licensed or investigational monoclonal antibody other than anti-IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
- •- Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening
- •- Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening
- •- Initiation of or increase in allergen immunotherapy within 3 months prior to study start or during screening
- •- Body mass index > 38 kg/m2
- •- Body weight < 40 kg
- •- History of bronchial thermoplasty
研究者
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