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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 (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00930163
First received: June 29, 2009
Last updated: November 25, 2016
Last verified: November 2016

June 29, 2009
November 25, 2016
July 2009
July 2010   (Final data collection date for primary outcome measure)
Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: From baseline to Week 12 ]
Same as current
Complete list of historical versions of study NCT00930163 on ClinicalTrials.gov Archive Site
  • Change in pre-bronchodilator FEV1 [ Time Frame: From baseline to Week 24 ]
  • Change in quality of life and symptom scores [ Time Frame: From baseline to Week 12 ]
  • Change in peak flow [ Time Frame: From baseline to Week 1 ]
  • Rate of asthma exacerbations [ Time Frame: During the 24 week treatment period ]
  • Change in rescue medication use [ Time Frame: From baseline to Week 1 ]
  • Frequency and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence of human anti-therapeutic antibodies (ATA) [ Time Frame: At the end of the follow-up period ]
Same as current
Not Provided
Not Provided
 
A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
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
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: lebrikizumab (MILR1444A)
    Subcutaneous repeating dose
  • Drug: placebo
    Subcutaneous repeating dose
  • Experimental: 1
    Intervention: Drug: lebrikizumab (MILR1444A)
  • Placebo Comparator: 2
    Intervention: Drug: placebo
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. doi: 10.1056/NEJMoa1106469. Epub 2011 Aug 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
September 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United Kingdom,   United States
 
NCT00930163
ILR4646g
Not Provided
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Michelle Freemer, M.D. Genentech, Inc.
Genentech, Inc.
November 2016

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