BENITIONSClinical Trial Intelligence

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
分期3期
申办方Hoffmann-La Roche
状态已完成
受试者人数313 人
干预(药物)Lebrikizumab, Montelukast
开始日期2014年6月7日
完成日期2016年1月22日
结果公布日2026年7月17日

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: Lebrikizumab0.15 ± 0.033 Liters
Double-Blind: Placebo0.07 ± 0.032 Liters
Open-Label: Montelukast0.05 ± 0.032 Liters
p-value0.06
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。