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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
230
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
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
Relative Change From Baseline in Daily OCS Dose at Week 44
Time frame: Baseline, Week 44
Absolute Change From Baseline in Daily OCS Dose at Week 44
Time frame: Baseline, Week 44
Relative Change From Week 12 in Average OCS Dose at Week 44
Time frame: Week 12, Week 44
Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline
Time frame: Baseline, Week 44
Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
Percentage of participants discontinuing OCS therapy or having achieved adrenal maintenance dose (cortisol level less than or equal to 100 nanomoles per liter) will be reported.
Time frame: Week 44
Percentage of Participants With Asthma Exacerbations
An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, or nocturnal awakenings due to these symptoms) that lead to treatment with systemic corticosteroids greater than or equal to (\>/=) 30 milligrams (mg) or 0.5 mg per kilogram (kg) for \>/=3 consecutive days or to hospitalization.
Time frame: Baseline up to Week 44
Percentage of Participants With Adverse Events
Time frame: Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab
Time frame: Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years)
Minimum Observed Serum Lebrikizumab Concentration (Cmin)
Time frame: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
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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
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