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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: lebrikizumab (MILR1444A); Drug: placebo

• Registration Number: NCT00971035
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Study Start: 2009-11
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Disposition First Submitted: 2011-06-30
• Disposition First Submitted QC: 2011-06-30
• Disposition First Posted: 2011-07-13
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-25
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	lebrikizumab (MILR1444A)	-
A	lebrikizumab (MILR1444A)	-
D	placebo	-
B	lebrikizumab (MILR1444A)	-

Primary Outcome Measures

Name	Time	Method
Change in forced expiratory volume in 1 second (FEV1)	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change in pre-bronchodilator FEV1	Baseline to Week 24
Change in quality of life and symptom scores	Baseline to Week 12
Rate of asthma exacerbations	During the 24-week treatment period
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