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A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.
Age
12 - 75 years
Sex
ALL
Healthy Volunteers
No
Kern Allergy Med Clinic, Inc.
Bakersfield, California, United States
Allergy & Asthma Care Center of Southern California
Long Beach, California, United States
South Florida Research Center, Inc.
Miami, Florida, United States
Georgia Pollens
Albany, Georgia, United States
Mount Sinai Medical Center
New York, New York, United States
Allergy & Immunology
Tulsa, Oklahoma, United States
Pioneer Research Solutions
Houston, Texas, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, United States
Pulmonary Consultants PLLC
Tacoma, Washington, United States
Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
Brisbane, Queensland, Australia
Start Date
February 28, 2014
Primary Completion Date
December 20, 2016
Completion Date
December 20, 2016
Last Updated
May 22, 2017
230
ACTUAL participants
Lebrikizumab
DRUG
Placebo
DRUG
Lead Sponsor
Hoffmann-La Roche
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 ConditionsNCT07219173