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

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ClinicalTrials.gov Identifier: NCT00930163
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : November 29, 2016
Sponsor:
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

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
Primary Completion Date : July 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00930163


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Michelle Freemer, M.D. Genentech, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00930163     History of Changes
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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs