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A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Oxford, Alabama, United States
Long Beach, California, United States
Los Angeles, California, United States
Orange, California, United States
Redwood City, California, United States
San Mateo, California, United States
Stockton, California, United States
Centennial, Colorado, United States
Colorado Springs, Colorado, United States
Kissimmee, Florida, United States
Start Date
March 1, 2012
Primary Completion Date
July 1, 2013
Completion Date
July 1, 2013
Last Updated
November 2, 2016
205
ACTUAL participants
lebrikizumab
DRUG
lebrikizumab
DRUG
lebrikizumab
DRUG
placebo
DRUG
Lead Sponsor
Genentech, Inc.
NCT07219173
NCT02327897
NCT07486401
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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