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A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971035
First Posted: September 3, 2009
Last Update Posted: November 29, 2016
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.
Information provided by (Responsible Party):
Genentech, Inc.
September 1, 2009
September 3, 2009
November 29, 2016
November 2009
December 2010   (Final data collection date for primary outcome measure)
Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 12 ]
Same as current
Complete list of historical versions of study NCT00971035 on ClinicalTrials.gov Archive Site
  • Change in pre-bronchodilator FEV1 [ Time Frame: Baseline to Week 24 ]
  • Change in quality of life and symptom scores [ Time Frame: Baseline to Week 12 ]
  • Change in peak flow [ Time Frame: 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: From the first study-specific procedure through the last observation visit ]
  • Incidence of human anti-therapeutic antibodies (ATA) [ Time Frame: Baseline to Week 32 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)
This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: lebrikizumab (MILR1444A)
    Subcutaneous repeating dose
  • Drug: placebo
    Subcutaneous repeating dose
  • Experimental: A
    Intervention: Drug: lebrikizumab (MILR1444A)
  • Experimental: B
    Intervention: Drug: lebrikizumab (MILR1444A)
  • Experimental: C
    Intervention: Drug: lebrikizumab (MILR1444A)
  • Placebo Comparator: D
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
February 2011
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body weight ≥ 50 kg and ≤ 150 kg at Visit 1
  • Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
  • Stable 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
Hungary,   Poland,   Russian Federation,   South Africa,   United States
 
NCT00971035
ILR4660g
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