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

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00930163

Purpose

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).

Condition	Intervention	Phase
Asthma	Drug: lebrikizumab (MILR1444A) Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Corticosteroids

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	218
Study Start Date:	July 2009
Study Completion Date:	September 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: lebrikizumab (MILR1444A) Subcutaneous repeating dose
Placebo Comparator: 2	Drug: placebo Subcutaneous repeating dose

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930163

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Michelle Freemer, M.D.

Genentech

More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00930163 History of Changes
Other Study ID Numbers:	ILR4646g
Study First Received:	June 29, 2009
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Adult Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012