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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,068
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
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
Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
Time frame: Baseline up to Week 52
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Week 52
Time to First Asthma Exacerbation
Time frame: Baseline up to Week 52
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score
Time frame: Baseline, Week 52
Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)
Time frame: Baseline, Week 52
Rate of Urgent Asthma-Related Urgent Health Care Utilization
Time frame: Baseline up to Week 52
Percentage of Participants With Adverse Events
Time frame: Baseline up to Week 124
Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab
Time frame: Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
Time frame: Baseline, Week 52
Minimum Serum Concentration (Cmin) of Lebrikizumab
Time frame: Predose (0 hour) on Weeks 4, 12, 24, 36, and 52
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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
...and 222 more locations