A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
3期
已完成
NCT02104674
| 适应症 | Asthma |
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| 分期 | 3期 |
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| 申办方 | Hoffmann-La Roche |
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| 状态 | 已完成 |
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| 受试者人数 | 313 人 |
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| 干预(药物) | Lebrikizumab, Montelukast |
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| 开始日期 | 2014年6月7日 |
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| 完成日期 | 2016年1月22日 |
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| 结果公布日 | 2026年7月17日 |
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摘要
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Baseline through Week 12 · Liters
| Double-Blind: Lebrikizumab | 0.15 ± 0.033 Liters |
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| Double-Blind: Placebo | 0.07 ± 0.032 Liters |
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| Open-Label: Montelukast | 0.05 ± 0.032 Liters |
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| p-value | 0.06 |
| Mean Difference (Final Values) | 0.08 (95% CI 0–0.17) |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。