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

Genentech

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Drug: lebrikizumab (MILR1444A)

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00971035

ILR4660g

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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