A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids
MOLLY
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)
1 other identifier
interventional
210
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Nov 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedNovember 29, 2016
November 1, 2016
1.1 years
September 1, 2009
November 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in forced expiratory volume in 1 second (FEV1)
Baseline to Week 12
Secondary Outcomes (7)
Change in pre-bronchodilator FEV1
Baseline to Week 24
Change in quality of life and symptom scores
Baseline to Week 12
Change in peak flow
Baseline to Week 1
Rate of asthma exacerbations
During the 24-week treatment period
Change in rescue medication use
From baseline to Week 1
- +2 more secondary outcomes
Study Arms (4)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALD
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michelle Freemer, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 3, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
November 29, 2016
Record last verified: 2016-11