Benralizumab efficacy in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with exacerbation history - GALATHEA

Study identifier:D3251C00003

ClinicalTrials.gov identifier:NCT02138916

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Moderate to very severe Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

Study drug

Benralizumab Arm A, Benralizumab Arm B, Placebo

Sex

All

Actual Enrollment

1656

Study type

Interventional

Age

40 Years - 85 Years

Date

Study Start Date: 13 Jun 2014

Primary Completion Date: 10 Apr 2018

Study Completion Date: 10 Apr 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2019 by AstraZeneca

Collaborators

MedImmune

Inclusion and exclusion criteria

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levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.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.

No locations available

Arms	Assigned Interventions
Experimental: Benralizumab Arm A Benralizumab administered subcutaneously	Drug: Benralizumab Arm A Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Experimental: Benralizumab Arm B Benralizumab administered subcutaneously	Drug: Benralizumab Arm B Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Placebo Comparator: Placebo Placebo administered subcutaneously	Drug: Placebo Placebo subcutaneously on study week 0 until study week 48 inclusive

Documents available

Clinical Study protocol
Download
Statistical Analysis Plan (SAP)
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AstraZeneca Clinica Study Information

+ 800-236-9933