A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)

This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.

Inclusion Criteria:

• Body weight ≥ 50 kg and ≤ 150 kg at Visit 1
• Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
• Stable asthma

Exclusion Criteria:

• Asthma exacerbation during screening
• Known malignancy
• Known immunodeficiency
• Pre-existing lung disease other than asthma
• Uncontrolled clinically significant medical disease
• Current smoker
• History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
• Prior allergic reaction to a monoclonal antibody
• Patients (men and women) of reproductive potential who are not willing to use contraception
• Pregnancy