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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 evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection 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. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Medical Research of Arizona; Allergy, Asthma & Immu
Scottsdale, Arizona, United States
Quality of Life Medical & Research Center
Tucson, Arizona, United States
Kern Allergy Med Clinic, Inc.
Bakersfield, California, United States
Allergy and Asthma Relief Experts
Granada Hills, California, United States
Southern California Institute For Respiratory
Los Angeles, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
Integrated Research Group Inc
Upland, California, United States
Allergy & Asthma Medical Group; Clinical Research Division
Walnut Creek, California, United States
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, United States
Start Date
July 31, 2013
Primary Completion Date
January 2, 2017
Completion Date
January 2, 2017
Last Updated
May 19, 2017
1,068
ACTUAL participants
Lebrikizumab
DRUG
Placebo
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT07486401
NCT07219173
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.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02327897