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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930163
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Asthma Drug: lebrikizumab (MILR1444A) Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: 1 Drug: lebrikizumab (MILR1444A)
Subcutaneous repeating dose

Placebo Comparator: 2 Drug: placebo
Subcutaneous repeating dose

Primary Outcome Measures :
  1. Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: From baseline to Week 12 ]

Secondary Outcome Measures :
  1. Change in pre-bronchodilator FEV1 [ Time Frame: From baseline to Week 24 ]
  2. Change in quality of life and symptom scores [ Time Frame: From baseline to Week 12 ]
  3. Change in peak flow [ Time Frame: From baseline to Week 1 ]
  4. Rate of asthma exacerbations [ Time Frame: During the 24 week treatment period ]
  5. Change in rescue medication use [ Time Frame: From baseline to Week 1 ]
  6. Frequency and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
  7. Incidence of human anti-therapeutic antibodies (ATA) [ Time Frame: At the end of the follow-up period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930163

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Michelle Freemer, M.D. Genentech, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. Identifier: NCT00930163    
Other Study ID Numbers: ILR4646g
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Keywords provided by Genentech, Inc.:
Adult Asthma
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases