A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

This randomized, multicenter, double-blind, placebo-controlled. parallel-group study will evaluate the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid therapy and at least one second controller medication. Patients will be randomized 1:1:1 to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously 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 104 weeks. After study treatment, all patients will complete a 20 week safety follow-up.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Enrollment: 1081
Study Start Date: July 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Lebrikizumab high dose
- Experimental: Lebrikizumab low dose
- Placebo Comparator: Placebo