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 subcutaneously (SC) 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 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
1,081
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.
Alabama Clinical Research Associates
Pell City, Alabama, United States
Clinical Trial Connection
Flagstaff, Arizona, United States
Desert Sun Clinical Research LLC
Tucson, Arizona, United States
Allianz Medical and Research Center
Fountain Valley, California, United States
Allergy & Asthma Medical Group & Research Center, Pc
Long Beach, California, United States
Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
Time frame: Baseline up to 52 weeks
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 52 weeks
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 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
Percentage of Participants With Adverse Events
Time frame: Baseline, Week 124
Minimum Serum Concentration (Cmin) of Lebrikizumab
Time frame: Predose (0 hour) on Weeks 4, 12, 24, 36, and 52
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Alliance Research LLC
Long Beach, California, United States
Allergy Medical Clinic
Los Angeles, California, United States
CA Allergy & Asthma Med Grp
Los Angeles, California, United States
North Bay Clinical Trials
Napa, California, United States
Choc Psf, Amc
Orange, California, United States
...and 220 more locations