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: 20 August 2018
• Main ID: EUCTR2014-001086-27-CZ
• Date of registration: 01/10/2014
• 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 Longacting ß2 Agonist (BORA)
• Date of first enrolment: 07/11/2014
• 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, Italy, Japan, Korea, Republic of, Mexico, 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

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

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

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)

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• Electrocardiogram (ECG)• 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.

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

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)• Prebronchodilator
Forced expiratory volume in 1 second (FEV1) and postbronchodilator
FEV1 at the study centre• Blood eosinophils

Secondary ID(s)

2014-001086-27-GB

NCT02258542

D3250C00021

Source(s) of Monetary Support

AstraZeneca AB