This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
University of Arizona
Tucson, Arizona, United States
LAC-USC Medical Center
Los Angeles, California, United States
University of California Davis Health System; Division of Pulmonary and Critical Care Medicine
Sacramento, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
University of Miami School of Medicine - Sylvester at Deerfield
Deerfield Beach, Florida, United States
Relative Change From Baseline in the Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells per Square Millimeter [Cells/mm^2])
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time frame: From Baseline to Week 12
Relative Change From Baseline in the Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time frame: From Baseline to Week 12
Relative Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells per Cubic Millimeter [Cells/mm^3])
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells/mm^3)
Time frame: From Baseline to Week 12
Relative Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Time frame: Form Baseline to Week 12
Change From Baseline in Blood Eosinophil Count
Time frame: From Baseline to Week 12
Change From Baseline in Immunoglobulin E (IgE) Levels
Time frame: From Baseline to Week 12
Change From Baseline in Serum Periostin Levels
Time frame: From Baseline to Week 12
Change From Baseline in Chemokine Ligand (CCL)-13 Levels
Time frame: From Baseline to Week 12
Change From Baseline in CCL-17 Levels
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Chloride Channel Accessory 1 (CLCA1) Gene Expression
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell SerpinB2 Gene Expression at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell CCL-26 Gene Expression
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Nitric Oxide Synthase 2 (NOS2) Gene Expression
Time frame: From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Periostin (POSTN) Gene Expression
Time frame: From Baseline to Week 12
Relative Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: From Baseline to Week 12
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: From Baseline to Week 12
Percentage of Participants With Treatment-Emergent Adverse Events
Time frame: From Baseline to Week 20
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Lebrikizumab
Time frame: Baseline up to Week 20 (assessed at Baseline, Weeks 8 and 20/dosing termination or early termination)
Serum Lebrikizumab Concentration at Week 12
Time frame: Predose (Hour 0) at Week 12
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Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics; Internal Medicine
Iowa City, Iowa, United States
Brigham and Women's Hospital; Pulmonary Division
Boston, Massachusetts, United States
Washington University; Pediatrics
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 18 more locations