Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients With Moderate to Very Severe COPD With a History of Exacerbations
Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients With Moderate to Very Severe COPD With a History of 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:1.Informed consent. 2.Subjects 40-85 y.o. 3.Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%. 4.≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. 5. Modified Medical Research Council (mMRC) score ≥1 at Visit 1. 6.Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. 7.Tobacco history of ≥10 pack-years. 8.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. 9.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. 10.Compliance with maintenance therapy during run-in ≥70%. 11. 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levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.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: 1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
2. Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration.
3. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.
5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1or during the enrolment and run-in period.
6. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
7. Pregnant, breastfeeding, or lactating women. 8. Risk factors for pneumonia 9. History of anaphylaxis to any other biologic therapy. 10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
11. Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
13. Evidence of active tuberculosis (TB) without an appropriate course of treatment.
14. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
15. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
16. Previous treatment with benralizumab. 17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
Rodgau-Dudenhofen, 63110, Germany
Farkasgyepü, 8582, Hungary
Fukuyama-shi, 720-0001, Japan
Higashiibaraki-gun, 311-3193, Japan
Himeji-shi, 670-0849, Japan
Himeji-shi, 672-8064, Japan
Hirosaki-shi, 036-8545, Japan
Iwata-shi, 438-8550, Japan
Izumo-shi, 693-8501, Japan
Joyo-shi, 610-0113, Japan
Kasuga-shi, 816-0813, Japan
Kasugai-shi, 486-8510, Japan
Kawaguchi-shi, 333-0833, Japan
Kawasaki-shi, 211-0041, Japan
Kiryu-shi, 376-0024, Japan
Kishiwada-shi, 596-8501, Japan
Kitakami-shi, 024-8506, Japan
Kodaira-shi, 187-0024, Japan
Kokubunji-shi, 185-0014, Japan
Koshi-shi, 861-1196, Japan
Kuki-shi, 349-1105, Japan
Kurashiki-shi, 711-0921, Japan
Kurume-shi, 830-0011, Japan
Matsumoto-shi, 390-0872, Japan
Matsusaka-shi, 515-8544, Japan
Meguro-ku, 153-8515, Japan
Mizunami-shi, 509-6134, Japan
Nagaoka-shi, 940-8621, Japan
Obihiro-shi, 080-0805, Japan
Ohota-ku, 145-0063, Japan
Ota-shi, 373-8585, Japan
Saiki-shi, 876-0813, Japan
Sakaide-shi, 762-8550, Japan
Seto-shi, 489-8642, Japan
Shinagawa-ku, 142-8666, Japan
Shinjuku-ku, 162-8655, Japan
Takatsuki-shi, 569-1096, Japan
Toon-shi, 791-0281, Japan
Toshima-ku, 171-0014, Japan
Ube-shi, 755-0241, Japan
Ueda-shi, 386-8610, Japan
Uji-shi, 611-0041, Japan
Urasoe-shi, 901-2132, Japan
Yachiyo-shi, 276-8524, Japan
Yanagawa-shi, 832-0059, Japan
Gauteng, 2193, South Africa
LE3 9QP, United Kingdom