Trial Outcomes & Findings for Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) (NCT NCT03186209)

NCT ID: NCT03186209

Last Updated: 2024-04-24

Results Overview

Annual asthma exacerbation rate over the 48-week treatment period among benralizumab and placebo groups

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

695 participants

Primary outcome timeframe

From randomization through Study Week 48

Results posted on

2024-04-24

Participant Flow

695 participants were randomized to receive treatment in study D3250C00036 (MIRACLE) with Benralizumab or placebo. All the 695 randomized participants received treatment with study drug.

At the first visit, ie, the enrollment visit 1, participants were evaluated regarding the protocol mandated inclusion and exclusion criteria. After enrollment, eligible participants were randomized to either placebo or Benralizumab 30 mg at a 1:1 ratio, administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks thereafter.

Participant milestones

Participant milestones
Measure	Benralizumab 30 mg Benralizumab administered subcutaneously	Placebo Placebo administered subcutaneously
Overall Study STARTED	348	347
Overall Study Dosed	348	347
Overall Study COMPLETED	331	321
Overall Study NOT COMPLETED	17	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Benralizumab 30 mg Benralizumab administered subcutaneously	Placebo Placebo administered subcutaneously
Overall Study Withdrawal by Subject	11	22
Overall Study Pregnancy	1	0
Overall Study Adverse Event	4	0
Overall Study V18 SKIPPED DUE TO LOGISTICS REASON	1	0
Overall Study PI DECIDED TO DISCONTINUE THE STUDY DUE TO THE LACK OF CRC RESOURCES	0	2
Overall Study Fail to meet randomization criteria	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benralizumab 30 mg n=348 Participants Benralizumab administered subcutaneously	Placebo n=347 Participants Placebo administered subcutaneously	Total n=695 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 11.56 • n=5 Participants	51.0 years STANDARD_DEVIATION 12.56 • n=7 Participants	51.1 years STANDARD_DEVIATION 12.06 • n=5 Participants
Age, Customized >=12 - <18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized >=18 - <65 years	299 Participants n=5 Participants	295 Participants n=7 Participants	594 Participants n=5 Participants
Age, Customized >=65 - <=75	48 Participants n=5 Participants	52 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Female	221 Participants n=5 Participants	207 Participants n=7 Participants	428 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	140 Participants n=7 Participants	267 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic or Latino	348 Participants n=5 Participants	347 Participants n=7 Participants	695 Participants n=5 Participants
Race/Ethnicity, Customized Asian	348 Participants n=5 Participants	347 Participants n=7 Participants	695 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL

Annual asthma exacerbation rate over the 48-week treatment period among benralizumab and placebo groups

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=236 Participants Benralizumab administered subcutaneously	Placebo n=237 Participants Placebo administered subcutaneously
Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL	0.49 events/patient-year Interval 0.33 to 0.72	1.88 events/patient-year Interval 1.35 to 2.61

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Change from baseline at Week 48 in Pre-bronchodilator FEV1 (L)

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=215 Participants Benralizumab administered subcutaneously	Placebo n=204 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	0.333 Liter Standard Deviation 0.4499	0.103 Liter Standard Deviation 0.4841

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Daytime and nighttime symptoms are reported using a response scale ranging from 0 to 3 where 0 indicates no asthma symptoms. The total asthma symptom score is the sum of the daytime and nighttime scores and ranges from 0 to 6; a decrease in score indicates symptom improvement.

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=213 Participants Benralizumab administered subcutaneously	Placebo n=206 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	-1.07 Scores on a scale Standard Deviation 1.126	-0.80 Scores on a scale Standard Deviation 1.129

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Change from baseline at week 48 in total rescue medication use (number of puffs/day)

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=213 Participants Benralizumab administered subcutaneously	Placebo n=206 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	-0.85 Puffs/day Standard Deviation 1.865	-0.89 Puffs/day Standard Deviation 2.213

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Change from baseline at week 48 in morning PEF

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=213 Participants Benralizumab administered subcutaneously	Placebo n=207 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	54.194 L/min Standard Deviation 86.3963	12.995 L/min Standard Deviation 68.7947

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Change from baseline at week 48 in evening PEF

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=217 Participants Benralizumab administered subcutaneously	Placebo n=209 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Evening Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	45.661 L/min Standard Deviation 85.4642	7.989 L/min Standard Deviation 68.0632

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Change from baseline at Week 48 in proportion of night awakening due to asthma and requiring rescue medication

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=217 Participants Benralizumab administered subcutaneously	Placebo n=208 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in the Proportion of Night Awakening Due to Asthma and Requiring Rescue Medication for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	-0.15 Proportion of nights Standard Deviation 0.220	-0.15 Proportion of nights Standard Deviation 0.260

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=218 Participants Benralizumab administered subcutaneously	Placebo n=212 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Asthma Control Questionnaire 6 (ACQ-6) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	-1.22 Scores on a scale Standard Deviation 0.901	-0.79 Scores on a scale Standard Deviation 0.962

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL

Time to first asthma exacerbation over 48-week treatment period

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=236 Participants Benralizumab administered subcutaneously	Placebo n=237 Participants Placebo administered subcutaneously
Time to First Asthma Exacerbation for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	NA Days The number of exacerbations is small, thus the Median survival time to first exacerbation has not reached.	227 Days Interval 146.0 to Insufficient number of exacerbations to estimate upper limit of 95% CI.

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL

Number and percentage of patients with at least one exacerbation over 48-week treatment period

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=236 Participants Benralizumab administered subcutaneously	Placebo n=237 Participants Placebo administered subcutaneously
Number and Percentage of Patients With >=1 Asthma Exacerbations Among Patients Who Were on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	55 Participants	125 Participants

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

The SGRQ is a 50-item PRO instrument developed to measure the HRQoL of patients with airway diseases. The questionnaire is divided into two parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The total score indicates the impact of disease on overall HRQoL. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible HRQoL and 0 indicates the best possible HRQoL.

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=209 Participants Benralizumab administered subcutaneously	Placebo n=200 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Total Score of St. George's Respiratory Questionnaire (SGRQ) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	-23.24 Scores on a scale Standard Deviation 20.509	-14.75 Scores on a scale Standard Deviation 21.838

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL

Annual asthma exacerbation rate associated with an emergency room/urgent care visit or a hospitalization over 48-week treatment period

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=236 Participants Benralizumab administered subcutaneously	Placebo n=237 Participants Placebo administered subcutaneously
Annual Asthma Exacerbation Rate Associated With an Emergency Room/Urgent Care Visit or a Hospitalization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	0.06 events/patient-year Interval 0.04 to 0.11	0.14 events/patient-year Interval 0.09 to 0.2

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL

Asthma specific health care resource utilization over 48-week treatment period.

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=236 Participants Benralizumab administered subcutaneously	Placebo n=237 Participants Placebo administered subcutaneously
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL Hospitalisations	6 Participants	21 Participants
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL Emergency Department Visits	11 Participants	12 Participants
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL Unscheduled Outpatient Visits	53 Participants	99 Participants
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL Home Visits	1 Participants	2 Participants
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL Telephone Calls	35 Participants	71 Participants
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL Ambulance Transports	2 Participants	2 Participants
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL Advanced Pulmonary Function Test	4 Participants	8 Participants

SECONDARY outcome

Timeframe: week 0, week 24, week 48

Population: PK analysis set; number analyzed includes participants with available value at each specified time point.

PK trough concentrations at each visit

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=345 Participants Benralizumab administered subcutaneously	Placebo Placebo administered subcutaneously
The Pharmacokinetics (PK) of Benralizumab as Assessed by Trough Concentration Week 0	0 ng/mL Geometric Coefficient of Variation 0	—
The Pharmacokinetics (PK) of Benralizumab as Assessed by Trough Concentration Week 24	137.914 ng/mL Geometric Coefficient of Variation 432.419	—
The Pharmacokinetics (PK) of Benralizumab as Assessed by Trough Concentration Week 48	123.476 ng/mL Geometric Coefficient of Variation 395.951	—

SECONDARY outcome

Timeframe: Pre-treatment until end of 48-week end of treatment

Population: Safety analysis set; number analyzed includes participants with available value at each specified time point.

Anti-drug antibodies (ADA) responses at baseline and post baseline.

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=348 Participants Benralizumab administered subcutaneously	Placebo n=347 Participants Placebo administered subcutaneously
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) ADA positive at any time, including baseline and/or post-baseline (ADA prevalence)	58 Participants	6 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) Treatment-emergent ADA positive, including treatment-induced and treatment-boosted ADA positive	58 Participants	2 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) Treatment-induced ADA positive	56 Participants	2 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) Treatment-boosted ADA positive	2 Participants	0 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) ADA positive at both baseline and at least one post-baseline assessment	2 Participants	2 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) ADA positive at baseline only	0 Participants	2 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) ADA persistently positive	40 Participants	1 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) ADA transiently positive	16 Participants	1 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) ADA positive with maximum titre > median of maximum titres	25 Participants	2 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) ADA positive with maximum titre <= median of maximum titres	33 Participants	4 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) nAb prevalence (nAb positive at any time, including baseline and/or post-baseline)	55 Participants	1 Participants
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) nAb incidence	55 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Percent change from baseline at Week 48 in blood eosinophil levels

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=213 Participants Benralizumab administered subcutaneously	Placebo n=199 Participants Placebo administered subcutaneously
Percent Change From Baseline at Week 48 in Blood Eosinophil Levels for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL	-80.6 Percent change Standard Deviation 34.65	42.3 Percent change Standard Deviation 380.86

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization through Study Week 48.

Population: Full analysis set, Baseline eosinophils \<300/uL

Annual asthma exacerbation rate over the 48-week treatment period among benralizumab and placebo groups

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=112 Participants Benralizumab administered subcutaneously	Placebo n=110 Participants Placebo administered subcutaneously
Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL	0.72 events/patient-year Interval 0.49 to 1.06	0.87 events/patient-year Interval 0.61 to 1.24

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \<300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Change from baseline at Week 48 in Pre-bronchodilator FEV1 (L)

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=101 Participants Benralizumab administered subcutaneously	Placebo n=97 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL	0.178 Liter Standard Deviation 0.4068	0.045 Liter Standard Deviation 0.3626

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization through Study Week 48

Population: Full analysis set, Baseline eosinophils \<300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure

Outcome measures

Outcome measures
Measure	Benralizumab 30 mg n=101 Participants Benralizumab administered subcutaneously	Placebo n=94 Participants Placebo administered subcutaneously
Change From Baseline at Week 48 in Total Asthma Symptom Score for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL	-0.97 Scores on a scale Standard Deviation 1.260	-0.75 Scores on a scale Standard Deviation 1.105

Adverse Events

Placebo

Serious events: 63 serious events

Other events: 194 other events

Deaths: 0 deaths

Benralizumab 30 mg

Serious events: 44 serious events

Other events: 194 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=347 participants at risk Placebo administered subcutaneously	Benralizumab 30 mg n=348 participants at risk Benralizumab administered subcutaneously
General disorders Pyrexia	2.6% 9/347 • Number of events 9 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	5.2% 18/348 • Number of events 22 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Bronchitis	7.8% 27/347 • Number of events 40 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	3.2% 11/348 • Number of events 15 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations COVID-19	1.7% 6/347 • Number of events 6 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	3.2% 11/348 • Number of events 11 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Nasopharyngitis	9.5% 33/347 • Number of events 48 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	8.0% 28/348 • Number of events 36 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Otitis media	2.3% 8/347 • Number of events 9 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	3.2% 11/348 • Number of events 11 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Pharyngitis	3.7% 13/347 • Number of events 14 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	3.7% 13/348 • Number of events 13 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Pneumonia	4.6% 16/347 • Number of events 19 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	2.6% 9/348 • Number of events 13 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Rhinitis	1.7% 6/347 • Number of events 9 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	3.7% 13/348 • Number of events 14 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Upper respiratory tract infection	34.6% 120/347 • Number of events 230 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	34.5% 120/348 • Number of events 200 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Infections and infestations Urinary tract infection	3.5% 12/347 • Number of events 14 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	2.6% 9/348 • Number of events 10 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Nervous system disorders Dizziness	2.3% 8/347 • Number of events 14 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	3.2% 11/348 • Number of events 11 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	4.3% 15/347 • Number of events 17 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	6.3% 22/348 • Number of events 41 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.
Vascular disorders Hypertension	3.7% 13/347 • Number of events 14 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.	2.0% 7/348 • Number of events 7 • From initial dose of the study treatment to the end of study, i.e., up to 56 weeks of follow-up. All treated participants from the first dose to the end of study. Total of 695 participants with 348 participants treated with Benralizumab administered every 4 weeks for the first 3 doses and then every 8 weeks and 347 were under placebo treatment.

Additional Information

Global Clinical Head

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

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