Efficacy and safety study of benralizumab added to medium dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma

• Register: EUCTR
• Last refreshed on: 2 June 2014
• Main ID: EUCTR2013-002352-32-SE
• Date of registration: 28/10/2013
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: Efficacy and safety study of benralizumab added to medium dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma
• Scientific title: A multicentre, randomised, double-blind, paralllel group, placebo-controlled, Phase 3 efficacy and safety study of benralizumab (MEDI-563) added to medium dose inhaled corticosteroid plus long acting Beta2 agonist in patients with uncontrolled asthma (PAMPERO) - PAMPERO
• Date of first enrolment: 09/01/2014
• Target sample size: 846
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002352-32
• 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: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Argentina, Brazil, Bulgaria, Germany, Japan, Mexico, Peru, Poland, Russian Federation, South Africa, Sweden, Turkey, Ukraine, United States

Contacts

• Name: AZ Clinical Study Information
• Affiliation: AstraZeneca AB

• Name: AZ Clinical Study Information
• Affiliation: AstraZeneca AB

Key inclusion & exclusion criteria

Inclusion criteria:
Provision of informed consent prior to any study specific procedure
Female and male aged 18-75 years, inclusively
History of physician diagnosed asthma requiring medium dose ICS (greater than 250 microgrammes fluticasone dry powder formulation equivalents total daily dose and a LABA for at least 12 months prior to Visit 1
Documented treatment with medium dose ICS (greater than 250 microgrammes and less than or equal to 500 microgrammes fluticasone dry powder formulation equivalents total daily dose) and a LABA for at least 3 months prior to Visit 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion criteria:
Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alphs 1 anti trypsin deficiency and primary ciliarydyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophillic syndrome).
Any disorder including, but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairement 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 patients ability to complete the entire duration of the study.
Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run in period.
Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry or urinalysis during screening/run in period, 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 the patients ability to complete the entire duration of the study


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

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 14.1 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
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: To assess the effect of benralizumab on pulmonary function
To assess the effect of benralizumab on asthma symptoms and other asthma control metrics (as per the ePRO)
To assess the effect of benralizumab on emergency room visits and hospitalisations due to asthma
To evaluate the pharmacokinetics and immunogenicity of benralizumab
To assess the safety and tolerability of benralizumab

Primary end point(s): Annual asthma exacerbation rate

Main Objective: To evaluate the effect of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma

Timepoint(s) of evaluation of this end point: week 48

Secondary Outcome(s)

Secondary end point(s): Pre-dose/pre-bronchodilator FEV1 at the study centre
Asthma symptom score (total, daytime and night time), rescue medication use, home lung function (morning and evening PEF), nights with awakening due to asthma, ACQ-6
Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalisation
PK parameters, anti drug antibodies
AE/SAE, Laboratory variables, ECG, physical examination

Timepoint(s) of evaluation of this end point: 48 weeks

Secondary ID(s)

D3250C00016

2013-002352-32-DE

Source(s) of Monetary Support

AstraZeneca AB