A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
Phase 3
Completed
NCT02104674
| Condition | Asthma |
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| Phase | Phase 3 |
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| Sponsor | Hoffmann-La Roche |
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| Status | Completed |
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| Enrollment | 313 participants |
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| Interventions | Lebrikizumab, Montelukast |
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| Start date | Jun 7, 2014 |
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| Completion date | Jan 22, 2016 |
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| Results posted | Jul 17, 2026 |
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Summary
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) |
Open in BENITIONS
View on ClinicalTrials.gov
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