A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.
A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.
The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.
Inclusion Criteria:.
Informed consent.
Subjects 40-85 y.o.
Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%.
-≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1.
Modified Medical Research Council (mMRC) score ≥1 at Visit 1.
Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1.
Tobacco history of ≥10 pack-years.
Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose.
Compliance with maintenance therapy during run-in ≥70%.
Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.
Exclusion criteria:
CABA, 1426, Argentina
CABA, C1056ABJ, Argentina
CABA, C1425BEN, Argentina
CABA, C1431FWO, Argentina
Ciudad Autónoma de Buenos Aire, C1440BRR, Argentina
Ciudad de Buenos Aires, 1425, Argentina
Medillin, Colombia
Gorzów Wlkp, 66-400, Poland
Bangkoknoi, 10700, Thailand
Muang,, 55000, Thailand