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

Phase 2

Completed

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

• Registration Number: NCT00930163
• Lead Sponsor: Genentech, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-09
• 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: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	lebrikizumab (MILR1444A)	-
2	placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in quality of life and symptom scores	From baseline to Week 12
Rate of asthma exacerbations	During the 24 week treatment period
Change in rescue medication use	From baseline to Week 1
Frequency and severity of adverse events	Through study completion or early study discontinuation
Incidence of human anti-therapeutic antibodies (ATA)	At the end of the follow-up period
Change in pre-bronchodilator FEV1	From baseline to Week 24
Change in peak flow	From baseline to Week 1