Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 18.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 40-80 years old at Visit 1 - Able and willing to use the electronic device for patient-reported data collection - Documented history of COPD diagnosis for >=12 months prior to Visit 1 - Post-bronchodilator FEV1/forced vital capacity (FVC) =10 pack-years (20 cigarettes/day for 10 years) - On inhaled corticosteroids therapy for >=6 months prior to Visit 1 - On an eligible bronchodilator medication for >=6 months prior to Visit 1 - Chest X-ray or computed tomography scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 2) that confirms the absence of clinically significant lung disease besides COPD - Demonstrated adherence with background COPD inhaler medication during the screening period. - For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection - History of clinically significant pulmonary disease other than COPD - Diagnosis of alpha-1-antitrypsin deficiency - Lung volume reduction surgery or procedure within 12 months prior to Visit 1 - Supplemental oxygen requirement >2 Liter/minute at rest or with exertion - Current diagnosis of asthma - Patients participating in, or scheduled for, an intensive COPD rehabilitation program - Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy, within 3 months prior to Visit 1 - Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event - Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that, in the opinion of the investigator, may put the patient at risk or negatively affect the study outcome - Any infection that resulted in hospital admission for >=24 hours and/or treatment with oral, intravenous (IV), or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening - Active tuberculosis requiring treatment within 12 months prior to Visit 1. Patients who have completed treatment for tuberculosis at least 12 months prior to Visit 1 and have no evidence of recurrent disease are permitted. - Known immunodeficiency, including, but not limited to, HIV infection - Evidence of acute or chronic hepatitis or known liver cirrhosis - Aspartate transaminase, Alanine transaminase, or total bilirubin elevation >=2.0 × the upper limit of normal (ULN) during screening - Clinically significant abnormality on screening electrocardiogram or laboratory tests (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient - Known current malignancy or current evaluation for a potential malignancy - Other clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study or impact the study efficacy or safety assessments - History of alcohol or drug abuse that would impair or risk the patient’s full participation in the study, in the opinion of the investigator - Past and/or current use of any anti–interleukin 13 (IL-13) or anti–IL-4/IL-13 therapy, including lebrikizumab. - Treatment with an immunomodulatory or immunosuppressive monoclonal antibody within 6 months or 5 drug half-lives prior to Visit 1 or during screening - Use of an immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to Visit 1 or during screening - Use of other investigational therapy not described above within 4 weeks or 5 drug half-lives prior to Visit 1 or during screening - Receipt of a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening - Pregnant or lactating - Body weight <40 kilogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Absolute change in pre-bronchodilator FEV1 (liters) from Baseline to Week 12;Timepoint(s) of evaluation of this end point: Baseline to Week 12;Main Objective: • To evaluate the efficacy of lebrikizumab compared with placebo in improving lung function, as measured by the absolute change in pre-bronchodilator forced expiratory volume in one second (FEV1) in patients with COPD and a history of exacerbations in the biomarker-high group (elevated serum periostin and blood eosinophils) and biomarker low group. ;Secondary Objective: • To evaluate in the biomarker high and biomarker-low groups the rate of moderate and severe COPD exacerbations, change in post-bronchodilator FEV1, time to first exacerbation, and change in health-related quality of life and change in symptoms as measured by the Saint George’s Respiratory Questionnaire for COPD patients (SGRQ-C), EXAcerbations of Chronic Pulmonary Disease Tool (EXACT), and Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) • To evaluate the safety of lebrikizumab compared with placebo in patients with COPD and a history of exacerbations, focusing on the nature, frequency, and severity of serious and non-serious adverse events • To evaluate serum lebrikizumab concentrations and PK parameters in patients with COPD and a history of exacerbations | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Rate of moderate/severe COPD exacerbations during the 24-week placebo-controlled period 2. Absolute change in post-bronchodilator FEV1 (liters) from Baseline to Week 24 3. Absolute change in pre-bronchodilator FEV1 (liters) from Baseline to Week 24 4. Time to first COPD exacerbation during the 24-week placebo-controlled period 5. Change in health-related quality of life, as assessed by the overall score of the SGRQ-C, from Baseline to Week 24 6. Change in COPD symptoms as measured by the overall score on the EXACT from Baseline to Week 24 7. Change in cough and sputum as measured by the cough and sputum domain of the EXACT from Baseline to Week 24 8. Change in dyspnea, as assessed by the BDI/TDI from Baseline to Week 24 9. Frequency and severity of adverse events during the 24-week placebo-controlled period 10. Incidence of Anti-therapeutic antibody against lebrikizumab throughout the study 11. Frequency and severity of adverse events during the safety follow-up period 12. Predose trough (minimum concentration [Cmin]) serum lebrikizumab concentrations at Weeks 4 and Week 12 (Cmin, Week 4 and Cmin, Week 12) 13. Serum lebrikizumab concentration at Week 24 (Cmin, Week 24) 14. Elimination half-life (t1/2) ;Timepoint(s) of evaluation of this end point: 1. Upto 24 weeks 2. Baseline to Week 24 3. Baseline to Week 24 4. Upto 24 weeks 5. Baseline to Week 24 6. Baseline to Week 24 7. Baseline to Week 24 8. Baseline to Week 24 9. Upto 24 weeks 10. Upto 36 weeks 11. Week 25 to Week 36 12. At Week 4 and Week 12 13. At Week 24 14. Week 24 to Week 36 | — |
Countries
Argentina, Bulgaria, Canada, Denmark, Hungary, Mexico, Poland, Russian Federation, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed