NCT01545440

A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	lebrikizumab	subcutaneous dose every 4 weeks
DRUG	lebrikizumab	subcutaneous dose every 4 weeks
DRUG	lebrikizumab	subcutaneous dose every 4 weeks
DRUG	placebo	subcutaneous dose every 4 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2012-03-06
• Last updated: 2015-03-05

Locations

71 sites across 2 countries: United States, Australia