Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
309
Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
Matching placebo will be administered subcutaneously once in every 4 weeks.
Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12
Time frame: Baseline, Week 12
Rate of Moderate or Severe COPD Exacerbation
Time frame: Baseline up to Week 24
Absolute Change From Baseline in Post-bronchodilator FEV1 at Week 24
Time frame: Baseline, Week 24
Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24
Time frame: Baseline, Week 24
Time to First COPD Exacerbation
Time frame: Baseline up to Week 24
Change From Baseline in Health-related Quality of Life as Assessed by the Overall Score of the Saint George's Respiratory Questionnaire for COPD (SGRQ-C) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in COPD Symptoms as Measured by the Overall Score of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Cough and Sputum as Measured by the Cough and Sputum Domain Score of the EXACT at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24
Time frame: Baseline, Week 24
Percentage of Participants with Adverse Events And Serious Adverse Events
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC
Peoria, Arizona, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Palmtree Clinical research Inc
Palm Springs, California, United States
Finlay Medical Research
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Southeast Regional Res Group
Savannah, Georgia, United States
Centex Studies
Lake Charles, Louisiana, United States
The Clinical Research Ctr
St Louis, Missouri, United States
...and 56 more locations
Time frame: Baseline up to Week 36
Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab
Time frame: Baseline up to Week 36
Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin)
Time frame: Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24
Plasma Decay Half-Life (t1/2)
Time frame: Pre-dose (Hour 0) on Day 1 (Baseline) and Weeks 1, 4, 8, 12, 16, 20; at Weeks 24, 28, and 36