Trial · NCT02258542

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

NCT02258542, Phase 3, Completed, AstraZeneca; results first posted 2019-02-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA. Trials, record NCT02258542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02258542

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
NCT number: NCT02258542
Status: Completed
Phases: Phase 3
Enrollment: 2,133 participants, actual
Lead sponsor: AstraZeneca
Conditions: Asthma
Interventions: Benralizumab, Benralizumab
First posted: 2014-10-07
Last updated: 2019-08-21
Results first posted: 2019-02-06
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes42

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Change from baseline in hematologic lab parameter of Basophils.
Primary	Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Change from baseline in hematologic lab parameter of Basophils.
Primary	Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Change from baseline in hematologic lab parameter of Leukocytes.
Primary	Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Change from baseline in hematologic lab parameter of Leukocytes.
Primary	Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Change from baseline in hematologic lab parameter of Lymphocytes.
Primary	Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Change from baseline in hematologic lab parameter of Lymphocytes.
Primary	Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Change from baseline in hematologic lab parameter of Neutrophils.
Primary	Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Change from baseline in hematologic lab parameter of Neutrophils.
Primary	Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Change from baseline in hematologic lab parameter of Eosinophils.
Primary	Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Change from baseline in hematologic lab parameter of Eosinophils.

1 to 10 of 42Source ClinicalTrials.gov

See all 42 registered outcomes

Outcomes42

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients	Week 56	Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN
PRIMARY	Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Week 108	Full analysis set, adolescents only(studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.	10^9 cells/L	MEAN

1 to 10 of 42Source ClinicalTrials.gov

See all 42 outcomes

Results by group402

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	-0.005	Standard Deviation 0.0223	10^9 cells/L
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	-0.005	Standard Deviation 0.0239	10^9 cells/L
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	ZONDA - Benralizumab 30 mg q.4 Weeks	-0.007	Standard Deviation 0.0283	10^9 cells/L
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	ZONDA - Benralizumab 30 mg q.8 Weeks	-0.005	Standard Deviation 0.0244	10^9 cells/L
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	-0.006	Standard Deviation 0.0145	10^9 cells/L
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	0.001	Standard Deviation 0.0208	10^9 cells/L
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	-0.344	Standard Deviation 2.0412	10^9 cells/L
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	-0.128	Standard Deviation 1.8614	10^9 cells/L
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	ZONDA - Benralizumab 30 mg q.4 Weeks	-0.808	Standard Deviation 1.8177	10^9 cells/L
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	ZONDA - Benralizumab 30 mg q.8 Weeks	-0.507	Standard Deviation 3.3612	10^9 cells/L

1 to 10 of 402Source ClinicalTrials.gov

See all 402 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	953
Overall Study	STARTED	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	973
Overall Study	STARTED	ZONDA - Benralizumab 30 mg q.4 Weeks	100
Overall Study	STARTED	ZONDA - Benralizumab 30 mg q.8 Weeks	97
Overall Study	Treated	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	953
Overall Study	Treated	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	971
Overall Study	Treated	ZONDA - Benralizumab 30 mg q.4 Weeks	100
Overall Study	Treated	ZONDA - Benralizumab 30 mg q.8 Weeks	97
Overall Study	Adolescents Only	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	25
Overall Study	Adolescents Only	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	61

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events712

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Influenza like illness	General disorders	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	27	783	41
other	Influenza like illness	General disorders	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	30	793	35
other	Influenza like illness	General disorders	ZONDA - Benralizumab 30 mg q.4 Weeks	3	49	3
other	Influenza like illness	General disorders	ZONDA - Benralizumab 30 mg q.8 Weeks	1	49	1
other	Bronchitis	Infections and infestations	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	50	783	66
other	Bronchitis	Infections and infestations	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	51	793	76
other	Bronchitis	Infections and infestations	ZONDA - Benralizumab 30 mg q.4 Weeks	3	49	7
other	Bronchitis	Infections and infestations	ZONDA - Benralizumab 30 mg q.8 Weeks	10	49	16
other	Upper respiratory tract infection	Infections and infestations	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	61	783	95
other	Upper respiratory tract infection	Infections and infestations	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	56	793	82

1 to 10 of 712Source ClinicalTrials.gov

See all 712 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	5	783
Total, all-cause mortality	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	4	793
Total, all-cause mortality	ZONDA - Benralizumab 30 mg q.4 Weeks	0	49
Total, all-cause mortality	ZONDA - Benralizumab 30 mg q.8 Weeks	1	49
Total, other adverse events	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	415	783
Total, other adverse events	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	409	793
Total, other adverse events	ZONDA - Benralizumab 30 mg q.4 Weeks	33	49
Total, other adverse events	ZONDA - Benralizumab 30 mg q.8 Weeks	38	49
Total, serious adverse events	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	102	783
Total, serious adverse events	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	94	793

1 to 10 of 12Source ClinicalTrials.gov

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30416083	DERIVED	PubMed
33609624	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02258542

GET https://conductscience.org/api/trials/v1/NCT02258542/registered?page=2

API reference For AI assistants