drugset / Trial / NCT02104674
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lebrikizumab | Monoclonal antibody | 125 mg | Subcutaneous |
| Comparator | Montelukast | Other / unclassified | 10 mg | Oral |