drugset / Trial / NCT02104674

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

NCT02104674

Phase 3 Completed 313 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-06-07
Primary completion
2016-01-22
Completion
2016-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Lebrikizumab Monoclonal antibody 125 mg Subcutaneous
Comparator Montelukast Other / unclassified 10 mg Oral

Indications