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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00971035
First received: September 1, 2009
Last updated: June 30, 2011
Last verified: June 2011

September 1, 2009
June 30, 2011
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Change in quality of life and symptom scores [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in peak flow [ Time Frame: 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: From the first study-specific procedure through the last observation visit ] [ Designated as safety issue: No ]
  • Incidence of human anti-therapeutic antibodies (ATA) [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
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 Blind (Subject, 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00971035
ILR4660g
Not Provided
Disclosures Group, Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Michelle Freemer, M.D. Genentech, Inc.
Genentech, Inc.
June 2011

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