A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

• Register: EUCTR
• Last refreshed on: 10 December 2018
• Main ID: EUCTR2014-001086-27-BG
• Date of registration: 07/01/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
• Scientific title: A Multicenter, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting ß2 Agonist (BORA) - BORA
• Date of first enrolment: 19/01/2015
• Target sample size: 2200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001086-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Open study for EU adolescents.; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Two dosing regimens; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Japan, Korea, Republic of, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States, Vietnam

Contacts

• Name: Clinical Trial Transparency
• Affiliation: AstraZeneca AB

• Name: Clinical Trial Transparency
• Affiliation: AstraZeneca AB

Key inclusion & exclusion criteria

Inclusion criteria:
1. Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
Patients that enter this study as an adolescent (at Visit 1) will be re-consented using
the appropriate ICF at the study visit following their 18th birthday, prior to any
study procedures being performed.
2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Invesigational Product (IP).
4. For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
5. All male patients who are sexually active must agree to use a double barrier method of contraception from the first dose of IP until 16 weeks after their last dose.
Are the trial subjects under 18? yes
Number of subjects for this age range: 93
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2040
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67

Exclusion criteria:
1.Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:
-Affect the safety of the patient throughout the study
-Influence the findings of the studies or their interpretations
-Impede the patient’s ability to complete the entire duration of study
2.A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
3.Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient’s ability to complete the entire duration of the study
4.Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
5. Patients with major protocol deviations in any of the predecessor studies at the
discretion of the Sponsor


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: benralizumab
Product Code: MEDI-563
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: benralizumab
CAS Number: 1044511-01-4
Current Sponsor code: MEDI-563
Other descriptive name: benralizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To assess the safety and tolerability of two dosing regimens of benralizumab for adult and adolescent patients.

Secondary Objective: 1.To evaluate the effect of two dosing regimens of benralizumab on asthma exacerbations.
2.To evaluate the effect of two dosing regimens of benralizumab on health care utilization and work and productivity loss.
3.To assess the effect of two dosing regimens of benralizumab on asthma related and general health-related quality of life.
4.To assess the effect two dosing regimens of benralizumab on asthma control.
5.To evaluate the pharmacokinetics and immunogenicity of two dosing regimens of benralizumab.
6.To assess the effect of two dosing regimens of benralizumab on pulmonary function.
7.To assess the impact of two dosing regimens of benralizumab on blood eosinophil levels.

Primary end point(s): • Number of Adverse Events/Serious Adverse Events (AEs/SAEs)
• Laboratory variables
• Physical Examination

Timepoint(s) of evaluation of this end point: 56 weeks in adult patients
108 weeks in adolescent patients

Data from adult patients choosing to enter the safety extension study, D3250C00037, will be summarized separately from those remaining in this study (Bora), unless otherwise noted in the SAP.
Those patients will stay in BORA for at least 16 weeks and no more than 40 weeks.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 56 weeks in adult patients
108 weeks in adolescent patients

Data from adult patients choosing to enter the safety extension study, D3250C00037, will be summarized separately from those remaining in this study (Bora), unless otherwise noted in the SAP.
Those patients will stay in BORA for at least 16 weeks and no more than 40 weeks.

Secondary end point(s): • Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
• Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions (WPAI+CIQ)
• Hospitalizations, Emergency Department (ED) visits, urgent care visits and all other outpatient visits due to asthma
• Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12)
• European Quality of Life-5 Dimensions (EQ-5D-5L) questionnaire
• Asthma Control Questionnaire 6 (ACQ-6)
• Pharmacokinetic (PK) parameters
• Anti-drug antibodies (ADA)
• Pre-bronchodilator Forced expiratory volume in 1 second (FEV1) and post-bronchodilator FEV1 at the study centre
• Blood eosinophils

Secondary ID(s)

2014-001086-27-GB

D3250C00021

NCT02258542

Source(s) of Monetary Support

AstraZeneca AB