Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02417961
Recruitment Status : Completed
First Posted : April 16, 2015
Results First Posted : June 12, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Biological: Benralizumab
Enrollment 162
Recruitment Details  
Pre-assignment Details 162 participants signed informed consent, 116 participants receive treatment with benralizumab 30 mg at every 4 weeks schedule.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks
Period Title: Overall Study
Started 116
Completed 112
Not Completed 4
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Withdrawal by Subject             2
Arm/Group Title Benra 30 mg
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks
Overall Number of Baseline Participants 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants
47.6  (13.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants
Female
64
  55.2%
Male
52
  44.8%
1.Primary Outcome
Title Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home
Hide Description Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of “Yes” to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.
Time Frame Week 12, Week 16, and Weeks 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12 Number Analyzed 114 participants
112
  98.2%
Week 16 Number Analyzed 109 participants
108
  99.1%
Weeks 12 and 16 Number Analyzed 114 participants
106
  93.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12)
Method of Estimation Estimation Parameter Percentage
Estimated Value 98.2
Confidence Interval 95%
93.81 to 99.79
Estimation Comments Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 99.1
Confidence Interval (2-Sided) 95%
94.99 to 99.98
Estimation Comments Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12 and 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 93.0
Confidence Interval (2-Sided) 95%
86.64 to 96.92
Estimation Comments Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)
2.Primary Outcome
Title Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional
Hide Description Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of “Yes” to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.
Time Frame Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12 Number Analyzed 114 participants
113
  99.1%
Week 16 Number Analyzed 109 participants
108
  99.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12)
Method of Estimation Estimation Parameter Percentage
Estimated Value 99.1
Confidence Interval (2-Sided) 95%
95.21 to 99.98
Estimation Comments Percentage of patients returned functional APFS administered at home (Week 12)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper Pearson Exact CI
Comments One sample confidence interval (Week 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 99.1
Confidence Interval (2-Sided) 95%
94.99 to 99.98
Estimation Comments Percentage of patients returned functional APFS administered at home (Week 16)
3.Primary Outcome
Title Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)
Hide Description Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.
Time Frame Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Units analyzed per row represents number of accessorized pre-filled syringes used at each time point.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 116
Overall Number of Units Analyzed
Type of Units Analyzed: Accessorized Pre-filled Syringe
573
Count of Units
Unit of Measure: Accessorized Pre-filled Syringe
Week 0 Number Analyzed 116 Accessorized Pre-filled Syringe
0
   0.0%
Week 4 Number Analyzed 117 Accessorized Pre-filled Syringe
1
   0.9%
Week 8 Number Analyzed 115 Accessorized Pre-filled Syringe
0
   0.0%
Week 12 Number Analyzed 116 Accessorized Pre-filled Syringe
0
   0.0%
Week 16 Number Analyzed 109 Accessorized Pre-filled Syringe
0
   0.0%
Week 0 to 8 Number Analyzed 348 Accessorized Pre-filled Syringe
1
   0.3%
Week 12 to 16 Number Analyzed 225 Accessorized Pre-filled Syringe
0
   0.0%
Week 0 to 16 Number Analyzed 573 Accessorized Pre-filled Syringe
1
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 0)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 3.13
Estimation Comments Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 4)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.02 to 4.67
Estimation Comments Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 8)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 3.16
Estimation Comments Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 3.13
Estimation Comments Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-Pearson Exact CI
Comments One sample Confidence Interval (Week 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 3.33
Estimation Comments Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 0 to 8)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.01 to 1.59
Estimation Comments Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 12 to 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 1.63
Estimation Comments Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Benra 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-pearson Exact CI
Comments One sample Confidence Interval (Week 0 to 16)
Method of Estimation Estimation Parameter Percentage
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.00 to 0.97
Estimation Comments Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)
4.Secondary Outcome
Title The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score
Hide Description The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.
Time Frame Week 0 (baseline) and weeks 4, 8, 12, 16, 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 116
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4 Number Analyzed 116 participants
-0.53  (0.71)
Week 8 Number Analyzed 115 participants
-0.54  (0.80)
Week 12 Number Analyzed 114 participants
-0.72  (0.86)
Week 16 Number Analyzed 109 participants
-0.82  (0.87)
Week 20 Number Analyzed 111 participants
-0.73  (0.93)
5.Secondary Outcome
Title The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab
Hide Description Mean PK Concentration at each visit
Time Frame Baseline, Week 8, Week 20, and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 116
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Baseline Number Analyzed 115 participants
NA [1] 
(NA%)
Week 8 Number Analyzed 113 participants
1031.644
(53.547%)
Week 20 Number Analyzed 111 participants
802.197
(267.033%)
Week 28 Number Analyzed 111 participants
56.330
(499.728%)
[1]
Value is less than lower limit of quantification
6.Secondary Outcome
Title The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels
Hide Description Blood eosinophil counts by timepoint
Time Frame Baseline, Week 20, and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 116
Mean (Standard Deviation)
Unit of Measure: cells/ uL
Baseline Number Analyzed 116 participants
362.2  (322.01)
Week 20 Number Analyzed 110 participants
13.0  (56.33)
Week 28 Number Analyzed 111 participants
47.1  (141.50)
7.Secondary Outcome
Title The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)
Hide Description Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive
Time Frame Baseline until Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all patients who were administered for at least one dose of Benralizumab.
Arm/Group Title Benra 30 mg
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: Participants
Positive at any visit 17
Base- and Post-baseline Positive 2
Only post-baseline positive 13
Only baseline positive 2
Persistently Positive 14
Transiently Positive 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benra 30 mg
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks
All-Cause Mortality
Benra 30 mg
Affected / at Risk (%)
Total   0/116 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Benra 30 mg
Affected / at Risk (%) # Events
Total   7/116 (6.03%)    
Gastrointestinal disorders   
Colitis  1  1/116 (0.86%)  1
Large intestine polyp  1  1/116 (0.86%)  1
General disorders   
Non-cardiac chest pain  1  1/116 (0.86%)  1
Infections and infestations   
Diverticulitis  1  1/116 (0.86%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain  1  1/116 (0.86%)  1
Spinal column stenosis  1  1/116 (0.86%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Papillary thyroid cancer  1  1/116 (0.86%)  1
Nervous system disorders   
Syncope  1  1/116 (0.86%)  1
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Benra 30 mg
Affected / at Risk (%) # Events
Total   43/116 (37.07%)    
Infections and infestations   
Bronchitis  1  4/116 (3.45%)  4
Nasopharyngitis  1  16/116 (13.79%)  19
Sinusitis  1  6/116 (5.17%)  7
Upper respiratory tract infection  1  13/116 (11.21%)  14
Viral upper respiratory tract infection  1  5/116 (4.31%)  5
Musculoskeletal and connective tissue disorders   
Back pain  1  4/116 (3.45%)  4
Nervous system disorders   
Headache  1  6/116 (5.17%)  10
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ’s Confidential Information without AZ’s written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mitchell Goldman, Global Clinical Lead Benralizumab
Organization: AstraZeneca
Phone: +1 301 398 0323
EMail: Mitchell.Goldman@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02417961     History of Changes
Other Study ID Numbers: D3250C00029
First Submitted: March 12, 2015
First Posted: April 16, 2015
Results First Submitted: March 13, 2017
Results First Posted: June 12, 2017
Last Update Posted: May 23, 2018