A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
MILLY
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
1 other identifier
interventional
218
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jul 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedNovember 29, 2016
November 1, 2016
1 year
June 29, 2009
November 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in forced expiratory volume in 1 second (FEV1)
From baseline to Week 12
Secondary Outcomes (7)
Change in pre-bronchodilator FEV1
From baseline to Week 24
Change in quality of life and symptom scores
From baseline to Week 12
Change in peak flow
From 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 (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Body weight 40 kg--150 kg
- Chest radiograph with no evidence of clinically significant abnormality
- Uncontrolled 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
Related Publications (1)
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.
PMID: 21812663DERIVED
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
June 29, 2009
First Posted
June 30, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2010
Study Completion
September 1, 2010
Last Updated
November 29, 2016
Record last verified: 2016-11