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

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ClinicalTrials.gov Identifier: NCT02258542
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Asthma
Intervention Biological: Benralizumab
Enrollment 2133
Recruitment Details 2133 patients entered BORA. 10 were excluded due to a GCP breach. Of remaining 2123 patients, 1926 entered from SIROCCO/CALIMA and 197 from ZONDA. 2 patients were not treated, and a total of 447 patients (348 SIROCCO/CALIMA and 99 ZONDA) were later enrolled into MELTEMI without completing the follow-up in BORA, so not in the main analyses.
Pre-assignment Details 953 participants from SIROCCO/CALIMA receive benralizumab 30 mg at every 4 weeks during BORA. 971 participants from SIROCCO/CALIMA receive treatment at every 8 weeks during BORA. 100 participants from ZONDA receive treatment at every 4 weeks during BORA. 97 participants from study ZONDA receive treatment at every 8 weeks during BORA.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 8 weeks Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 8 weeks
Period Title: Overall Study
Started 953 973 100 97
Treated 953 971 100 97
Completed [1] 892 [2] 871 [3] 92 [4] 92 [5]
Not Completed 61 102 8 5
Reason Not Completed
eg. not made to the visit             7             4             0             1
study specific discount. criteria             1             1             0             0
Withdrawal by Subject             20             17             7             1
Lost to Follow-up             5             10             1             2
Death             5             4             0             1
Adverse Event             3             4             0             0
Protocol Violation             1             2             0             0
Eligibility criteria not fulfilled             0             2             0             0
Ongoing             19             58             0             0
[1]
Include patients enrolled into study MELTEMI (study 37)
[2]
170 enrolled into study MELTEMI
[3]
178 enrolled into study MELTEMI
[4]
51 enrolled into study MELTEMI
[5]
48 enrolled into study MELTEMI
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks Total
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 8 weeks Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 783 793 49 49 1674
Hide Baseline Analysis Population Description
Full analysis population defined as treated for at least 1 treatment, excluding patients enrolled in MELTEMI.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 783 participants 793 participants 49 participants 49 participants 1674 participants
51.1  (13.79) 48.9  (15.53) 49.7  (10.35) 52.7  (8.90) 50.1  (14.48)
[1]
Measure Analysis Population Description: Full analysis set, excluding MELTEMI patients
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 783 participants 793 participants 49 participants 49 participants 1674 participants
Female
503
  64.2%
470
  59.3%
27
  55.1%
29
  59.2%
1029
  61.5%
Male
280
  35.8%
323
  40.7%
22
  44.9%
20
  40.8%
645
  38.5%
[1]
Measure Analysis Population Description: Full analysis set, exclude MELTEMI patients
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 783 participants 793 participants 49 participants 49 participants 1674 participants
White 599 612 45 42 1298
Black and African American 16 19 0 1 36
Asian 138 136 4 6 284
Other 30 26 0 0 56
[1]
Measure Analysis Population Description: Full analysis set
1.Primary Outcome
Title Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in hematologic lab parameter of Basophils.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 691 703 39 42
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
-0.005  (0.0223) -0.005  (0.0239) -0.007  (0.0283) -0.005  (0.0244)
2.Primary Outcome
Title Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in hematologic lab parameter of Leukocytes.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 695 710 39 42
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
-0.344  (2.0412) -0.128  (1.8614) -0.808  (1.8177) -0.507  (3.3612)
3.Primary Outcome
Title Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in hematologic lab parameter of Lymphocytes.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 691 703 39 42
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
-0.032  (0.6242) 0.003  (0.5402) -0.093  (0.6403) 0.007  (0.6864)
4.Primary Outcome
Title Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in hematologic lab parameter of Neutrophils.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 691 703 39 42
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
-0.171  (1.8746) 0.013  (1.7024) -0.501  (1.7096) -0.368  (3.2057)
5.Primary Outcome
Title Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in hematologic lab parameter of Eosinophils.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 691 703 39 42
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
-0.1220  (0.30599) -0.1271  (0.26161) -0.1451  (0.30766) -0.1664  (0.35139)
6.Primary Outcome
Title Change From Baseline in ALT, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in chemistry tests ALT.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 684 712 37 43
Mean (Standard Deviation)
Unit of Measure: ukat/L
-0.007  (0.2102) 0.017  (0.4651) -0.064  (0.3547) -0.023  (0.1940)
7.Primary Outcome
Title Change From Baseline in AST, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in chemistry tests AST.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 684 712 37 43
Mean (Standard Deviation)
Unit of Measure: ukat/L
-0.005  (0.1431) 0.004  (0.3303) -0.027  (0.2291) -0.026  (0.1178)
8.Primary Outcome
Title Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
Hide Description Change from baseline in chemistry test Bilirubin.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 685 712 37 43
Mean (Standard Deviation)
Unit of Measure: umol/L
0.187  (3.6261) 0.391  (3.9945) 0.146  (2.8094) 0.279  (3.8765)
9.Secondary Outcome
Title Number of Overall Patients With Asthma Exacerbations During Study Period
Hide Description 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
Time Frame From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4 SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 518 265 783 512 281 793 31 18 49 31 18 49
Measure Type: Count of Participants
Unit of Measure: Participants
Sirocco/Calima patients with eos>=300/μL Number Analyzed 347 participants 172 participants 519 participants 339 participants 188 participants 527 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
Number of exacerbation
99
  28.5%
60
  34.9%
159
  30.6%
104
  30.7%
66
  35.1%
170
  32.3%
Sirocco/Calima patients with eos<300/μL Number Analyzed 171 participants 93 participants 264 participants 173 participants 93 participants 266 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
Number of exacerbation
69
  40.4%
44
  47.3%
113
  42.8%
65
  37.6%
32
  34.4%
97
  36.5%
Zonda Patients with asthma exacerbations Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 31 participants 18 participants 49 participants 31 participants 18 participants 49 participants
Number of exacerbation
12
  38.7%
5
  27.8%
17
  34.7%
13
  41.9%
11
  61.1%
24
  49.0%
10.Secondary Outcome
Title Change From Baseline in Pre-brochodilator FEV1 (L)
Hide Description Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4 SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 444 221 665 440 220 660 31 18 38 28 15 43
Mean (Standard Deviation)
Unit of Measure: L
Sirocco/Calima patients with eos>=300/μL Number Analyzed 297 participants 142 participants 439 participants 291 participants 151 participants 442 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
-0.006  (0.295) 0.131  (0.422) 0.038  (0.346) 0.019  (0.317) 0.081  (0.419) 0.040  (0.356)
Sirocco/Calima patients with eos<300/μL Number Analyzed 147 participants 79 participants 226 participants 149 participants 69 participants 218 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
-0.021  (0.376) -0.011  (0.280) -0.017  (0.345) -0.015  (0.293) 0.030  (0.350) -0.001  (0.312)
Number of Zonda Patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 31 participants 18 participants 38 participants 28 participants 15 participants 43 participants
0.013  (0.354) 0.167  (0.533) 0.057  (0.412) -0.093  (0.280) 0.138  (0.329) -0.012  (0.314)
11.Secondary Outcome
Title Change From Baseline in Post-brochodilator FEV1 (L)
Hide Description Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. Only summarize for patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; separated by predecessor treatment groups. Patients from Study ZONDA are not summarized.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4 SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 439 220 659 438 214 652
Mean (Standard Deviation)
Unit of Measure: L
Sirocco/Calima patients with eos>=300/μL Number Analyzed 296 participants 144 participants 440 participants 292 participants 151 participants 443 participants
-0.066  (0.280) 0.089  (0.455) -0.015  (0.354) -0.029  (0.281) 0.045  (0.401) -0.004  (0.329)
Sirocco/Calima patients with eos<300/μL Number Analyzed 143 participants 76 participants 219 participants 146 participants 63 participants 209 participants
-0.058  (0.379) -0.024  (0.289) -0.046  (0.350) -0.043  (0.273) 0.049  (0.394) -0.015  (0.316)
12.Secondary Outcome
Title Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
Hide Description Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4 SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 447 265 671 444 220 664 28 11 39 28 15 43
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Sirocco/Calima patients with eos>=300/μL Number Analyzed 298 participants 146 participants 444 participants 294 participants 153 participants 447 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
-0.04  (0.83) -0.20  (1.04) -0.09  (0.91) -0.06  (0.82) -0.25  (1.06) -0.12  (0.91)
Sirocco/Calima patients with eos<300/μL Number Analyzed 149 participants 78 participants 227 participants 150 participants 67 participants 217 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
-0.16  (0.90) -0.12  (0.80) -0.15  (0.86) -0.10  (0.83) -0.09  (1.06) -0.10  (0.90)
Number of Zonda Patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 28 participants 11 participants 39 participants 28 participants 15 participants 43 participants
-0.05  (0.89) -0.61  (0.74) -0.21  (0.87) 0.15  (1.02) -0.43  (1.00) -0.05  (1.04)
13.Secondary Outcome
Title Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
Hide Description Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4 SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 444 224 668 442 220 662 26 11 37 28 15 43
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Sirocco/Calima patients with eos>=300/μL Number Analyzed 296 participants 146 participants 442 participants 293 participants 153 participants 446 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0.02  (0.80) 0.21  (0.98) 0.08  (0.87) 0.08  (0.91) 0.26  (1.00) 0.15  (0.94)
Sirocco/Calima patients with eos<300/μL Number Analyzed 148 participants 78 participants 226 participants 149 participants 67 participants 216 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0.11  (0.84) 0.03  (0.89) 0.09  (0.85) 0.15  (0.90) 0.02  (1.06) 0.11  (0.95)
Number of Zonda Patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 26 participants 11 participants 37 participants 28 participants 15 participants 43 participants
0.13  (0.93) 0.43  (0.91) 0.22  (0.92) -0.04  (0.94) 0.40  (1.03) 0.11  (0.98)
14.Secondary Outcome
Title Change of Blood Eosinophil Levels' Measurement in Overall Patients
Hide Description Change from baseline to Week 56 in Blood eosinophils
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separate by predecessor treatment groups.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4 SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 454 237 691 461 242 703 28 11 39 27 15 42
Mean (Standard Deviation)
Unit of Measure: cell/uL
Sirocco/Calima patients with eos>=300/μL Number Analyzed 306 participants 156 participants 462 participants 302 participants 162 participants 464 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
4.9  (177.42) -449.6  (360.6) -148.6  (332.91) -10.1  (134.7) -422.5  (330.01) -154.1  (297.34)
Sirocco/Calima patients with eos<300/μL Number Analyzed 148 participants 81 participants 229 participants 159 participants 80 participants 239 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
15.7  (87.04) -222.1  (325.03) -68.4  (234.40) -2.9  (59.11) -217.4  (198.56) -74.7  (160.29)
Number of Zonda Patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 28 participants 11 participants 39 participants 27 participants 15 participants 42 participants
2.5  (69.85) -520.9  (360.79) -145.1  (307.66) -17.0  (107.48) -435.3  (468.64) -166.4  (351.39)
15.Secondary Outcome
Title Change From Baseline in EQ-5D-5L Visual Analog Scale
Hide Description The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 682 709 21 28
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Sirocco/Calima patients with eos>=300/μL Number Analyzed 454 participants 468 participants 0 participants 0 participants
6.08  (15.68) 6.02  (17.68)
Sirocco/Calima patients with eos<300/μL Number Analyzed 228 participants 241 participants 0 participants 0 participants
4.38  (14.99) 6.69  (15.96)
Number of Zonda Patients Number Analyzed 0 participants 0 participants 21 participants 28 participants
5.00  (10.35) 1.36  (13.58)
16.Secondary Outcome
Title Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Hide Description The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.
Time Frame Baseline and Week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, adults, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA. Questionnaires are collected at multiple time points, only non-missing values are summarized.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 783 793 49 49
Mean (Standard Deviation)
Unit of Measure: percentage
Sirocco/Calima patients with eos>=300/μL-baseline Number Analyzed 234 participants 217 participants 0 participants 0 participants
25.3  (24.70) 25.0  (24.15)
Sirocco/Calima patients with eos>=300/μL-wk 68 Number Analyzed 236 participants 217 participants 0 participants 0 participants
23.3  (26.18) 21.0  (25.54)
Sirocco/Calima patients with eos<300/μL-baseline Number Analyzed 101 participants 93 participants 0 participants 0 participants
31.0  (27.06) 32.6  (26.29)
Sirocco/Calima patients with eos<300/μL-wk 68 Number Analyzed 113 participants 96 participants 0 participants 0 participants
32.7  (27.55) 25.8  (24.05)
Zonda Patients-baseline Number Analyzed 0 participants 0 participants 16 participants 17 participants
23.5  (25.13) 7.1  (10.47)
Zonda Patients-wk 68 Number Analyzed 0 participants 0 participants 19 participants 20 participants
18.9  (24.94) 21.0  (27.13)
17.Secondary Outcome
Title Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
Hide Description The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.
Time Frame Baseline and Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, adolescents, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA. Questionnaires are collected at multiple time points, only non-missing values are summarized.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 783 793 49 49
Mean (Standard Deviation)
Unit of Measure: Percentage
Sirocco/Calima patients with eos>=300/μL-Baseline Number Analyzed 11 participants 23 participants 0 participants 0 participants
13.0  (19.14) 30.7  (31.41)
Sirocco/Calima patients with eos>=300/μL-wk 56 Number Analyzed 8 participants 24 participants 0 participants 0 participants
3.8  (7.44) 15.2  (20.69)
Sirocco/Calima patients with eos<300/μL-Baseline Number Analyzed 4 participants 19 participants 0 participants 0 participants
42.1  (32.50) 35.4  (23.92)
Sirocco/Calima patients with eos<300/μL-wk 56 Number Analyzed 2 participants 24 participants 0 participants 0 participants
5.0  (7.07) 17.1  (20.06)
Zonda patients - Baseline Number Analyzed 0 participants 0 participants 1 participants 0 participants
10 [1]   (NA)
Zonda patients-wk 56 Number Analyzed 0 participants 0 participants 0 participants 0 participants
[1]
Only one record, thus standard deviation is not applicable
18.Secondary Outcome
Title Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Hide Description The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time Frame Baseline and Week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA. Questionnaires are collected at multiple time points, only non-missing values are summarized.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 783 793 49 49
Mean (Standard Deviation)
Unit of Measure: percentage
Sirocco/Calima patients with eos>=300/μL-baseline Number Analyzed 518 participants 524 participants 0 participants 0 participants
31.3  (26.44) 31.2  (25.63)
Sirocco/Calima patients with eos>=300/μL-wk 68 Number Analyzed 458 participants 454 participants 0 participants 0 participants
26.6  (26.14) 24.4  (25.26)
Sirocco/Calima patients with eos<300/μL-baseline Number Analyzed 261 participants 264 participants 0 participants 0 participants
39.6  (25.75) 36.3  (25.72)
Sirocco/Calima patients with eos<300/μL-wk 68 Number Analyzed 239 participants 220 participants 0 participants 0 participants
33.6  (26.55) 32.7  (26.58)
Zonda Patients-baseline Number Analyzed 0 participants 0 participants 26 participants 31 participants
31.5  (29.49) 24.5  (29.08)
Zonda Patients-wk 68 Number Analyzed 0 participants 0 participants 38 participants 41 participants
28.4  (27.85) 39.0  (34.36)
19.Secondary Outcome
Title Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Hide Description Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma
Time Frame From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 783 793 49 49
Measure Type: Count of Participants
Unit of Measure: Participants
Sirocco/Calima patients with eos>=300/μL Number Analyzed 519 participants 527 participants 0 participants 0 participants
193
  37.2%
198
  37.6%
Sirocco/Calima patients with eos<300/μL Number Analyzed 264 participants 266 participants 0 participants 0 participants
118
  44.7%
102
  38.3%
Number of Zonda Patients Number Analyzed 0 participants 0 participants 49 participants 49 participants
20
  40.8%
25
  51.0%
20.Secondary Outcome
Title Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
Hide Description Endpoint: Pharmacokinetic (PK) parameters
Time Frame Week 0 and Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received benralizumab, from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least 1 quantifiable serum PK observation post the first dose were included in the PK analysis dataset.
Arm/Group Title SIROCCO/CALIMA - Benra 30 mg q.4 Weeks - Pre Benra q.4 SIROCCO/CALIMA - Benra 30 mg q.4 wk - Predecessor Placebo SIROCCO/CALIMA - Benra 30 mg q.8 Weeks - Pre Benra q.8 SIROCCO/CALIMA - Benra 30 mg q.8 wk - Predecessor Placebo ZONDA - Benra 30 mg q.4 Weeks - Pre Benra q.4 ZONDA - Benra 30 mg q.4 wk - Predecessor Placebo ZONDA - Benra 30 mg q.8 Weeks - Pre Benra q.8 ZONDA - Benra 30 mg q.8 wk - Predecessor Placebo
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment
Overall Number of Participants Analyzed 514 263 511 279 31 16 31 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
Baseline Number Analyzed 507 participants 260 participants 503 participants 275 participants 31 participants 16 participants 30 participants 17 participants
714.25
(624.48 to 816.93)
NA [1] 
(NA to NA)
142.92
(124.08 to 164.63)
NA [1] 
(NA to NA)
964.21
(589.87 to 1576.11)
NA [1] 
(NA to NA)
692.91
(428.49 to 1120.50)
NA [1] 
(NA to NA)
Week 56 Number Analyzed 442 participants 225 participants 440 participants 215 participants 27 participants 10 participants 27 participants 15 participants
930.04
(825.89 to 1047.33)
865.93
(721.50 to 1039.27)
173.95
(151.81 to 199.33)
162.03
(132.31 to 195.43)
823.62
(476.98 to 1422.17)
1160.58
(833.77 to 1615.49)
247.26
(165.87 to 368.57)
139.35
(61.90 to 313.70)
[1]
Concentration <LLOQ
21.Secondary Outcome
Title Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
Hide Description Assessments for the presence of ADA and nAb throughout study
Time Frame From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, excluding MELTEMI patients.
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description:
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Overall Number of Participants Analyzed 783 793 49 49
Measure Type: Number
Unit of Measure: Participants
Positive at any visit Number Analyzed 783 participants 793 participants 49 participants 49 participants
80 93 4 8
Base- and Post-baseline Positive Number Analyzed 774 participants 789 participants 47 participants 48 participants
23 41 2 4
Newly Persistently Positive Number Analyzed 774 participants 789 participants 47 participants 48 participants
28 34 1 3
Stable persistently positive Number Analyzed 774 participants 789 participants 47 participants 48 participants
21 29 2 2
Newly treatment-induced positive Number Analyzed 774 participants 789 participants 47 participants 48 participants
38 41 2 2
ADA treatment boosted positive Number Analyzed 774 participants 789 participants 47 participants 48 participants
6 6 0 1
Decreased in titre Number Analyzed 774 participants 789 participants 47 participants 48 participants
17 9 2 1
Only post-baseline positive Number Analyzed 774 participants 789 participants 47 participants 48 participants
48 48 2 1
ADA incidence Number Analyzed 774 participants 789 participants 47 participants 48 participants
44 47 2 3
Transiently Positive Number Analyzed 774 participants 789 participants 47 participants 48 participants
22 26 1 3
Only baseline positive Number Analyzed 774 participants 793 participants 49 participants 49 participants
9 4 0 0
nAb positive Number Analyzed 783 participants 793 participants 49 participants 49 participants
57 75 3 4
Time Frame All adults participants collected events during the entire study period. Adolescents data collection up to last adolescent completed Week 56 visit, which is April 20, 2017.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Hide Arm/Group Description Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 8 weeks Benralizumab administered subcutaneously every 4 weeks Benralizumab administered subcutaneously every 8 weeks
All-Cause Mortality
SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/783 (0.51%)      3/793 (0.38%)      0/49 (0.00%)      1/49 (2.04%)    
Show Serious Adverse Events Hide Serious Adverse Events
SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   101/783 (12.90%)      93/793 (11.73%)      10/49 (20.41%)      9/49 (18.37%)    
Blood and lymphatic system disorders         
Hypochromic anaemia  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Iron deficiency anaemia  1  0/783 (0.00%)  0 0/793 (0.00%)  0 1/49 (2.04%)  1 0/49 (0.00%)  0
Neutropenia  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Cardiac disorders         
Acute coronary syndrome  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Acute myocardial infarction  1  1/783 (0.13%)  1 2/793 (0.25%)  2 1/49 (2.04%)  1 0/49 (0.00%)  0
Angina unstable  1  1/783 (0.13%)  1 2/793 (0.25%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Atrial fibrillation  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Cardiac arrest  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Cardiac failure congestive  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Cardio-respiratory arrest  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Congestive cardiomyopathy  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Coronary artery disease  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Coronary artery insufficiency  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Supraventricular extrasystoles  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Supraventricular tachycardia  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Endocrine disorders         
Goitre  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Hyperparathyroidism  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Eye disorders         
Cataract  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Abdominal pain lower  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Barrett's oesophagus  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Colitis ulcerative  1  0/783 (0.00%)  0 0/793 (0.00%)  0 0/49 (0.00%)  0 1/49 (2.04%)  1
Duodenal ulcer  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Duodenal ulcer haemorrhage  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Femoral hernia strangulated  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Gastritis  1  2/783 (0.26%)  3 0/793 (0.00%)  0 1/49 (2.04%)  1 0/49 (0.00%)  0
Gastrooesophageal reflux disease  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Ileus  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Inguinal hernia  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 1/49 (2.04%)  1
Irritable bowel syndrome  1  1/783 (0.13%)  1 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Oesophageal ulcer  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Oesophagitis  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Pancreatitis acute  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Vomiting  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
General disorders         
Death  1  2/783 (0.26%)  2 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Multiple organ dysfunction syndrome  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Oedema peripheral  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Hepatobiliary disorders         
Bile duct stone  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Cholecystitis  1  1/783 (0.13%)  1 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Cholecystitis acute  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Cholecystitis chronic  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Cholelithiasis  1  2/783 (0.26%)  2 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Hepatitis  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Immune system disorders         
Anaphylactic reaction  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Food allergy  1  0/783 (0.00%)  0 2/793 (0.25%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Infections and infestations         
Anal abscess  1  0/783 (0.00%)  0 1/793 (0.13%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Bronchitis  1  2/783 (0.26%)  3 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Cellulitis  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Diverticulitis  1  0/783 (0.00%)  0 0/793 (0.00%)  0 1/49 (2.04%)  2 0/49 (0.00%)  0
Erysipelas  1  1/783 (0.13%)  2 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Gastroenteritis salmonella  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Influenza  1  2/783 (0.26%)  2 2/793 (0.25%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Lower respiratory tract infection  1  0/783 (0.00%)  0 0/793 (0.00%)  0 0/49 (0.00%)  0 1/49 (2.04%)  1
Lower respiratory tract infection viral  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Lung infection  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Pneumonia  1  2/783 (0.26%)  2 4/793 (0.50%)  4 0/49 (0.00%)  0 1/49 (2.04%)  1
Pneumonia bacterial  1  1/783 (0.13%)  1 5/793 (0.63%)  6 0/49 (0.00%)  0 0/49 (0.00%)  0
Postoperative abscess  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Pulmonary sepsis  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Respiratory tract infection viral  1  1/783 (0.13%)  1 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Sepsis  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Sinusitis  1  1/783 (0.13%)  1 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Sinusitis bacterial  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Urinary tract infection  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Urinary tract infection bacterial  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Urosepsis  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod bite  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Bone contusion  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Clavicle fracture  1  0/783 (0.00%)  0 0/793 (0.00%)  0 1/49 (2.04%)  1 0/49 (0.00%)  0
Fall  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 1/49 (2.04%)  1
Femur fracture  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Head injury  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Humerus fracture  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Incisional hernia  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Ligament rupture  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Limb injury  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Lower limb fracture  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Multiple fractures  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Patella fracture  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Radius fracture  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Rib fracture  1  1/783 (0.13%)  2 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Road traffic accident  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Subdural haemorrhage  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Upper limb fracture  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Investigations         
Endocrine test abnormal  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Obesity  1  0/783 (0.00%)  0 0/793 (0.00%)  0 1/49 (2.04%)  1 0/49 (0.00%)  0
Type 2 diabetes mellitus  1  2/783 (0.26%)  2 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Arthritis  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Intervertebral disc protrusion  1  1/783 (0.13%)  1 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Jaw cyst  1  0/783 (0.00%)  0 0/793 (0.00%)  0 1/49 (2.04%)  1 0/49 (0.00%)  0
Muscular weakness  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Osteoarthritis  1  0/783 (0.00%)  0 2/793 (0.25%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Rotator cuff syndrome  1  0/783 (0.00%)  0 0/793 (0.00%)  0 0/49 (0.00%)  0 1/49 (2.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
B-cell lymphoma  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Basal cell carcinoma  1  2/783 (0.26%)  2 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Benign neoplasm of eyelid  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Benign neoplasm of thyroid gland  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Chronic myeloid leukaemia  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Colon cancer stage 0  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Diffuse large B-cell lymphoma stage II  1  2/783 (0.26%)  2 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Large intestine benign neoplasm  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Lipoma  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Nasal cavity cancer  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Osteochondroma  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Ovarian germ cell teratoma benign  1  0/783 (0.00%)  0 0/793 (0.00%)  0 0/49 (0.00%)  0 1/49 (2.04%)  1
Prostate cancer  1  0/783 (0.00%)  0 2/793 (0.25%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Solid pseudopapillary tumour of the pancreas  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Thymoma  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Uterine leiomyoma  1  1/783 (0.13%)  1 2/793 (0.25%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Nervous system disorders         
Diabetic neuropathy  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Dysarthria  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Ischaemic stroke  1  0/783 (0.00%)  0 2/793 (0.25%)  2 0/49 (0.00%)  0 0/49 (0.00%)  0
Lumbosacral radiculopathy  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Syncope  1  1/783 (0.13%)  1 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Transient ischaemic attack  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Renal and urinary disorders         
Calculus urinary  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Chronic kidney disease  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Nephrolithiasis  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Ureterolithiasis  1  2/783 (0.26%)  2 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Reproductive system and breast disorders         
Cervical polyp  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Ovarian cyst  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Vaginal fistula  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Vaginal haemorrhage  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  35/783 (4.47%)  39 26/793 (3.28%)  31 3/49 (6.12%)  4 2/49 (4.08%)  2
Asthmatic crisis  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Interstitial lung disease  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Middle lobe syndrome  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Nasal polyps  1  2/783 (0.26%)  3 2/793 (0.25%)  2 1/49 (2.04%)  1 0/49 (0.00%)  0
Pleural effusion  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Pulmonary hypertension  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Status asthmaticus  1  1/783 (0.13%)  1 2/793 (0.25%)  2 1/49 (2.04%)  1 0/49 (0.00%)  0
Skin and subcutaneous tissue disorders         
Erythema nodosum  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Pemphigoid  1  0/783 (0.00%)  0 0/793 (0.00%)  0 0/49 (0.00%)  0 1/49 (2.04%)  1
Rosacea  1  1/783 (0.13%)  1 0/793 (0.00%)  0 0/49 (0.00%)  0 0/49 (0.00%)  0
Urticaria papular  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Vascular disorders         
Hypertensive emergency  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
Phlebitis  1  0/783 (0.00%)  0 1/793 (0.13%)  1 0/49 (0.00%)  0 0/49 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
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%
SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks ZONDA - Benralizumab 30 mg q.4 Weeks ZONDA - Benralizumab 30 mg q.8 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   404/783 (51.60%)      392/793 (49.43%)      33/49 (67.35%)      38/49 (77.55%)    
Eye disorders         
Conjunctivitis allergic  1  4/783 (0.51%)  5 8/793 (1.01%)  8 3/49 (6.12%)  3 0/49 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  12/783 (1.53%)  14 9/793 (1.13%)  9 1/49 (2.04%)  1 2/49 (4.08%)  2
Gastritis  1  6/783 (0.77%)  6 7/793 (0.88%)  8 2/49 (4.08%)  2 1/49 (2.04%)  1
Large intestine polyp  1  1/783 (0.13%)  1 1/793 (0.13%)  1 2/49 (4.08%)  2 1/49 (2.04%)  1
Nausea  1  10/783 (1.28%)  11 5/793 (0.63%)  13 2/49 (4.08%)  2 0/49 (0.00%)  0
General disorders         
Influenza like illness  1  26/783 (3.32%)  38 28/793 (3.53%)  32 3/49 (6.12%)  3 1/49 (2.04%)  1
Injection site bruising  1  0/783 (0.00%)  0 2/793 (0.25%)  4 0/49 (0.00%)  0 2/49 (4.08%)  2
Non-cardiac chest pain  1  2/783 (0.26%)  2 4/793 (0.50%)  6 0/49 (0.00%)  0 2/49 (4.08%)  3
Oedema peripheral  1  4/783 (0.51%)  4 6/793 (0.76%)  7 0/49 (0.00%)  0 4/49 (8.16%)  6
Immune system disorders         
Seasonal allergy  1  13/783 (1.66%)  15 8/793 (1.01%)  8 2/49 (4.08%)  2 0/49 (0.00%)  0
Infections and infestations         
Acute sinusitis  1  27/783 (3.45%)  45 44/793 (5.55%)  57 2/49 (4.08%)  5 2/49 (4.08%)  4
Bronchitis  1  49/783 (6.26%)  65 50/793 (6.31%)  73 3/49 (6.12%)  7 10/49 (20.41%)  16
Bronchitis bacterial  1  18/783 (2.30%)  23 15/793 (1.89%)  21 3/49 (6.12%)  3 2/49 (4.08%)  2
Chronic sinusitis  1  12/783 (1.53%)  13 10/793 (1.26%)  17 1/49 (2.04%)  1 2/49 (4.08%)  7
Herpes zoster  1  8/783 (1.02%)  8 2/793 (0.25%)  2 2/49 (4.08%)  2 0/49 (0.00%)  0
Oral candidiasis  1  14/783 (1.79%)  20 12/793 (1.51%)  15 1/49 (2.04%)  1 2/49 (4.08%)  2
Respiratory tract infection viral  1  8/783 (1.02%)  8 12/793 (1.51%)  13 2/49 (4.08%)  2 0/49 (0.00%)  0
Sinusitis  1  21/783 (2.68%)  23 18/793 (2.27%)  22 3/49 (6.12%)  3 4/49 (8.16%)  4
Upper respiratory tract infection  1  60/783 (7.66%)  94 55/793 (6.94%)  81 0/49 (0.00%)  0 7/49 (14.29%)  8
Upper respiratory tract infection bacterial  1  15/783 (1.92%)  17 22/793 (2.77%)  27 1/49 (2.04%)  1 2/49 (4.08%)  2
Urinary tract infection  1  14/783 (1.79%)  17 7/793 (0.88%)  7 0/49 (0.00%)  0 2/49 (4.08%)  2
Viral upper respiratory tract infection  1  121/783 (15.45%)  181 129/793 (16.27%)  187 14/49 (28.57%)  22 13/49 (26.53%)  19
Investigations         
Blood creatinine increased  1  0/783 (0.00%)  0 0/793 (0.00%)  0 0/49 (0.00%)  0 2/49 (4.08%)  2
Blood pressure increased  1  4/783 (0.51%)  5 3/793 (0.38%)  3 1/49 (2.04%)  1 2/49 (4.08%)  2
Musculoskeletal and connective tissue disorders         
Arthralgia  1  26/783 (3.32%)  32 20/793 (2.52%)  20 5/49 (10.20%)  5 0/49 (0.00%)  0
Back pain  1  24/783 (3.07%)  25 21/793 (2.65%)  21 2/49 (4.08%)  2 4/49 (8.16%)  4
Nervous system disorders         
Headache  1  38/783 (4.85%)  54 40/793 (5.04%)  54 2/49 (4.08%)  2 4/49 (8.16%)  4
Psychiatric disorders         
Insomnia  1  11/783 (1.40%)  12 8/793 (1.01%)  8 3/49 (6.12%)  3 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  62/783 (7.92%)  98 53/793 (6.68%)  72 4/49 (8.16%)  4 7/49 (14.29%)  9
Dyspnoea  1  6/783 (0.77%)  6 9/793 (1.13%)  9 3/49 (6.12%)  3 1/49 (2.04%)  1
Nasal congestion  1  2/783 (0.26%)  2 12/793 (1.51%)  12 0/49 (0.00%)  0 2/49 (4.08%)  2
Nasal polyps  1  5/783 (0.64%)  6 4/793 (0.50%)  4 2/49 (4.08%)  2 2/49 (4.08%)  2
Rhinitis allergic  1  38/783 (4.85%)  43 22/793 (2.77%)  31 0/49 (0.00%)  0 2/49 (4.08%)  2
Vascular disorders         
Hypertension  1  31/783 (3.96%)  32 28/793 (3.53%)  32 0/49 (0.00%)  0 2/49 (4.08%)  2
Peripheral venous disease  1  1/783 (0.13%)  1 3/793 (0.38%)  3 0/49 (0.00%)  0 2/49 (4.08%)  2
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Patients in this study had to complete treatment in predecessor studies. Therefore selection bias may exist. Baseline is defined for this study’s entry value, not all values are prior to active treatment due to some patients being treated previously.
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
Name/Title: Ubaldo Martin, Global Clinical Lead Benralizumab
Organization: AstraZeneca
Phone: +1 301 398 0163
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02258542     History of Changes
Other Study ID Numbers: D3250C00021
U1111-1162-2422 ( Other Identifier: WHO )
First Submitted: September 1, 2014
First Posted: October 7, 2014
Results First Submitted: October 18, 2018
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019