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)

Genentech, Inc.0 sites210 target enrollmentNovember 2009

ConditionsAsthma

Interventionslebrikizumab (MILR1444A)placebo

Drugslebrikizumab (MILR1444A)placebo

Overview

Phase: Phase 2
Intervention: lebrikizumab (MILR1444A)
Conditions: Asthma
Sponsor: Genentech, Inc.
Enrollment: 210
Primary Endpoint: Change in forced expiratory volume in 1 second (FEV1)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

February 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: lebrikizumab (MILR1444A)

B

Intervention: lebrikizumab (MILR1444A)

C

Intervention: lebrikizumab (MILR1444A)

D

Intervention: placebo

Outcomes

Primary Outcomes

Change in forced expiratory volume in 1 second (FEV1)

Time Frame: Baseline to Week 12

Secondary Outcomes

Change in pre-bronchodilator FEV1(Baseline to Week 24)
Rate of asthma exacerbations(During the 24-week treatment period)
Change in quality of life and symptom scores(Baseline to Week 12)
Change in peak flow(Baseline to Week 1)
Change in rescue medication use(From baseline to Week 1)
Frequency and severity of adverse events(From the first study-specific procedure through the last observation visit)
Incidence of human anti-therapeutic antibodies (ATA)(Baseline to Week 32)