EUCTR2012-000190-24-PL进行中（未招募）1 期
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL TO ASSESS THE ORAL CORTICOSTEROID–SPARING EFFECT OF LEBRIKIZUMAB IN PATIENTS WITH SEVERE CORTICOSTEROID-DEPENDENT ASTHMA.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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
- •- Patients, age 12-75 years at the time of informed consent
- •- Severe asthma despite intensive follow-up by an asthma specialist for at least 6 months prior to Visit 1
- •- Baseline forced expiratory volume in 1 second (FEV1) >=40% of predicted prior to randomization
- •-Receiving high doses of inhaled glucocorticosteroids at a total daily dose of >= 1500 mcg beclomethasone dipropionate daily or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
- •- Chronic treatment with maintenance oral corticosteroids (prednisone/prednisolone) for at least 6 months prior to Visit 1
- •- Assessment to ensure diagnosis of refractory asthma and oral corticosteroid (prednisone/prednisolone) dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- •- Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
- •- For adults: Active tuberculosis requiring treatment within the 12 months prior to visit 1
- •- For adolescents: History of active tuberculosis requiring treatment
- •- Evidence of acute or chronic hepatitis or known liver cirrhosis
- •- Known current malignancy or current evaluation for a potential malignancy
- •- History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
- •- Infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to visit 1 or during screening
- •- Upper or lower respiratory tract infection within 4 weeks prior to visit 1 or during screening
- •- Active parasitic infection or Listeria monocytogenes infection within 6 months prior to visit 1 or during screening
- •- Current smoker or former smoker with a smoking history of >15 pack-years
- •- Current use of an immunomodulatory/immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to visit 1
- •- 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 (whichever is longer) prior to visit 1
- •- Receipt of a live, attenuated vaccine within the 4 weeks prior to visit 1, during screening or anticipation of receipt of alive, attenuated vaccine throughout the study
研究者
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