Back to resultsA Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
lebrikizumab (MILR1444A)
lebrikizumab (MILR1444A)
lebrikizumab (MILR1444A)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring MILR1444A
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
A
B
C
D
Arm Description
Outcomes
Primary Outcome Measures
Change in forced expiratory volume in 1 second (FEV1)
Secondary Outcome Measures
Change in pre-bronchodilator FEV1
Change in quality of life and symptom scores
Change in peak flow
Rate of asthma exacerbations
Change in rescue medication use
Frequency and severity of adverse events
Incidence of human anti-therapeutic antibodies (ATA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00971035
Brief Title
A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids
Acronym
MOLLY
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
MILR1444A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Title
D
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lebrikizumab (MILR1444A)
Intervention Description
Subcutaneous repeating dose
Intervention Type
Drug
Intervention Name(s)
lebrikizumab (MILR1444A)
Intervention Description
Subcutaneous repeating dose
Intervention Type
Drug
Intervention Name(s)
lebrikizumab (MILR1444A)
Intervention Description
Subcutaneous repeating dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subcutaneous repeating dose
Primary Outcome Measure Information:
Title
Change in forced expiratory volume in 1 second (FEV1)
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in pre-bronchodilator FEV1
Time Frame
Baseline to Week 24
Title
Change in quality of life and symptom scores
Time Frame
Baseline to Week 12
Title
Change in peak flow
Time Frame
Baseline to Week 1
Title
Rate of asthma exacerbations
Time Frame
During the 24-week treatment period
Title
Change in rescue medication use
Time Frame
From baseline to Week 1
Title
Frequency and severity of adverse events
Time Frame
From the first study-specific procedure through the last observation visit
Title
Incidence of human anti-therapeutic antibodies (ATA)
Time Frame
Baseline to Week 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Freemer, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids
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