Overview

A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Treatments:
Antibodies, Monoclonal
Criteria
Inclusion Criteria:

- Body weight 40 kg--150 kg

- Chest radiograph with no evidence of clinically significant abnormality

- Uncontrolled 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