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

This study has been completed.

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00930163

First received: June 29, 2009

Last updated: June 30, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2009

Last Updated Date

June 30, 2011

Start Date ^ICMJE

July 2009

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00930163 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in pre-bronchodilator FEV1 [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
Change in quality of life and symptom scores [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
Change in peak flow [ Time Frame: From baseline to Week 1 ] [ Designated as safety issue: No ]
Rate of asthma exacerbations [ Time Frame: During the 24 week treatment period ] [ Designated as safety issue: No ]
Change in rescue medication use [ Time Frame: From baseline to Week 1 ] [ Designated as safety issue: No ]
Frequency and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Incidence of human anti-therapeutic antibodies (ATA) [ Time Frame: At the end of the follow-up period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: lebrikizumab (MILR1444A)
Subcutaneous repeating dose
Drug: placebo
Subcutaneous repeating dose

Study Arm (s)

Experimental: 1
Intervention: Drug: lebrikizumab (MILR1444A)
Placebo Comparator: 2
Intervention: Drug: placebo

Publications *

Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011 Sep 22;365(12):1088-98. Epub 2011 Aug 3.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

218

Completion Date

September 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00930163

Other Study ID Numbers ^ICMJE

ILR4646g

Has Data Monitoring Committee

Not Provided

Responsible Party

Disclosures Group, Genentech, Inc.

Study Sponsor ^ICMJE

Genentech

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Michelle Freemer, M.D.

Genentech

Information Provided By

Genentech

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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