BENITIONSClinical Trial Intelligence

A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Phase 3 Completed NCT02104674

ConditionAsthma
PhasePhase 3
SponsorHoffmann-La Roche
StatusCompleted
Enrollment313 participants
InterventionsLebrikizumab, Montelukast
Start dateJun 7, 2014
Completion dateJan 22, 2016
Results postedJul 17, 2026

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: 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)

Open in BENITIONS View on ClinicalTrials.gov

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