A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL).
Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count.
The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.
Inclusion Criteria:
Provision of informed consent
Age 40 to 85 years
Male and/or female.
Current or former smoker with a tobacco history of ≥10 pack-years.
History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.
Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.
Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for ≥3 months immediately prior to enrollment.
Blood eosinophil count ≥300/μL at screening and documented historical eosinophil count of ≥150/μL within 52 weeks of enrollment (or repeated testing during run-in).
CAT total score ≥15 at Visit 1.
Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.
Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP.
Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).
Exclusion Criteria:
CABA, C1012AAR, Argentina
Ciudad Autónoma de Buenos Aire, C1440BRR, Argentina
Ciudad de Buenos Aires, 1425, Argentina
Chile, 7770484, Chile
Exohi Thessaloniki, 57010, Greece
Himeji-shi, 672-8064, Japan
Joyo-shi, 610-0113, Japan
Kawachinagano-shi, 586-8521, Japan
Kishiwada-shi, 596-8501, Japan
Kure-shi, 737-0023, Japan
Matsusaka-shi, 515-8544, Japan
Mizunami-shi, 509-6134, Japan
Nagaoka-shi, 940-2085, Japan
Nishinomiya-shi, 663-8501, Japan
Sagamihara-shi, 252-0315, Japan
Sakaide-shi, 762-8550, Japan
Seto-shi, 489-8642, Japan
Shinagawa-ku, 140-8522, Japan
Shinagawa-ku, 142-8666, Japan
Toshima-ku, 170-0002, Japan
Toshima-ku, 170-0003, Japan
Toshima-ku, 171-0014, Japan
Toyonaka-shi, 560-8552, Japan
Ueda-shi, 386-8610, Japan
Yanagawa-shi, 832-0059, Japan
Hospitalet de Llobregat(Barcel, 08907, Spain
Göteborg, 413 45, Sweden
Hồ Chí Minh, 700000, Vietnam