A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768079

Enrollment

110

Registered

2008-10-07

Start date

2009-02-02

Completion date

2011-03-10

Last updated

2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Benralizumab, MEDI-563, Asthma

Brief summary

The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.

Detailed description

The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) (0.3 milligram per kilogram \[mg/kg\] of body weight and 1.0 mg/kg of body weight) on the proportion of adult subjects with asthma exacerbations (relapse and de novo) who required an urgent healthcare visit for treatment of an acute asthma exacerbation.

Interventions

OTHERPlacebo

A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.

BIOLOGICALBenralizumab

A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male or female subjects aged 18 to 60 years at the time of the administration of investigational product * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations * Physician-diagnosed asthma with a duration of greater than or equal to (\>=) 2 years by medical chart or subject report * Had an asthma exacerbation requiring urgent care in the year prior to screening * Meets National Heart, Lung, and Blood Institute (NHLBI) for persistent asthma in the 3 months prior to the current urgent healthcare visit * Current asthma exacerbation that must have lasted \>= 2 hours prior to arrival to the urgent healthcare setting * Requires at least 2 treatments of inhaled bronchodilators for the current asthma exacerbation in the urgent healthcare setting or within the emergency medical system (EMS) for \>= 1 hour * Shows an FEV1 or PEF of not more than 70 percent (%) predicted after 1 hour of treatment of the current asthma exacerbation * Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) from screening through the end of the study (Day 84; Cessation of birth control after this point should be discussed with a responsible physician) * Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Day 0 through Day 84 * Otherwise healthy by medical history and physical examination * A chest x-ray that is normal for an asthmatic population and excludes alternative diagnosis per the investigation * Ability to complete the follow-up period until Day 168 as required by protocol * The investigator has determined that the subject is clinically stable and the FEV1, is \>= 30% predicted prior to receiving investigational product on Day 0.

Exclusion criteria

* Known history of allergy or reaction to any component of the investigational product formulation * Acute illness other than asthma at the start of the study * Fever more than (\>) 38.6 degrees Celsius (C) (\>101.5 degrees Fahrenheit \[F\]) * Current acute asthma attack is due to aspirin-induced asthma * Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute bronchospasm * Evidence of clinically significant non-respiratory active infection, including ongoing chronic infection * History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in stools or have minor symptoms and have exposure to stream or lake water, been exposed to someone who has a parasitic infection (like a family member), or study subject has traveled outside the United States of America (USA) and/or Canada within the last year * Use of immunosuppressive medication (except oral prednisone and inhaled and topical corticosteroids) within 30 days before randomization into the study * Have received Xolair within 6 months before randomization into the study * Receipt of immunoglobulin or blood products within 30 days before randomization into the study * Receipt of any investigational drug therapy within 6 months before the first dose of investigational product in this study through Day 168 * History of primary immunodeficiency * Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study * History of clinically significant abnormality on ECG in the opinion of the investigator * Pregnancy (must have a negative serum pregnancy test prior to the first dose of investigational product) * Breastfeeding or lactating woman * History of treatment for alcohol or drug abuse within the past year * Diagnosis of chronic obstructive pulmonary disease (COPD) by a healthcare professional * Evidence of any clinically significant systemic disease on physical examination * History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>1 year prior to entry or other malignancies treated with apparent success with curative therapy \>5 years prior to entry * Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma * Any condition (that is, impending ventilatory failure or hemodynamic compromise) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results * Any employee of the clinical study site who is involved with the conduct of the study * History of cigarette smoking \>20 pack years * Previously received benralizumab (MEDI-563) * Asthma exacerbation due to acute inhalational exposure.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Asthma Exacerbations at Week 12	Week 12	Percentage of participants who required urgent healthcare visit for treatment of acute asthma exacerbation were reported. As per protocol, asthma exacerbation (relapse/de novo) was defined as either 1) increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that did not resolve within 2 hours after use of rescue albuterol or corticosteroids and required an unscheduled medical visit or 2) during scheduled study visit, participant had acute worsening of asthma symptoms and a reduction of greater than or equal to (\>=) 20 percent (%) in Peak Expiratory Flow (PEF) or Forced Expiratory Volume in 1 Second (FEV1), which in the opinion of the investigator required treatment with systemic corticosteroids. Asthma exacerbations were analyzed in a non-adjudicated manner (by investigator), which were then adjudicated in a blinded fashion by the sponsor medical monitor prior to database lock to determine whether the reported exacerbation met the protocol definition.

Secondary

Measure	Time frame	Description
Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Weeks 4 and 24	Percentage of participants who required an urgent healthcare visit for treatment of an acute asthma exacerbation were reported. As per protocol, asthma exacerbation (relapse or de novo) was defined as either 1) an increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that did not resolve within 2 hours after the use of rescue albuterol or corticosteroids and required an unscheduled medical visit or 2) during a scheduled study visit, the participant had acute worsening of asthma symptoms and a reduction of \>=20% in PEF or FEV1, which in the opinion of the investigator required treatment with systemic corticosteroids. Asthma exacerbations were analyzed in a non-adjudicated manner (by investigator), which were then adjudicated in a blinded fashion by the sponsor medical monitor prior to database lock to determine whether the reported exacerbation met the protocol definition.
Asthma Control Questionnaire (ACQ) Scores	Days 0, 7, 42, and 84	Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Results were reported for overall ACQ score and 6 item scores.
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Days 0, 7, 42, and 84	The FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 2 but no more than 5) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis.
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 1 to Day 84	The FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Home peak flow testing for FEV1 was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean FEV1 values for each week were reported starting from Day 1 to Day 84.
Peak Expiratory Flow (PEF) Recorded at Home	Day 1 to Day 84	The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean PEF values for each week were reported starting from Day 1 to Day 84.
Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 1 to Day 84	Rescue beta-2 agonist use (total number of puffs for the prior day) was collected daily in the morning by the participants in the electronic daily diary provided to them. Participants were instructed not to collect rescue beta-2 agonist used prior to exercise. Average values for each week were reported starting from Day 1 to Day 84.
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Days 42 and 84	Physician Global Assessment (PGA) consisted of a single physician-rated question assessing participant's status as 'excellent', 'good', 'moderate', 'poor', 'worsening' or 'not applicable (NA)'. Number of participants were categorically summarized.
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Days 0, 42, and 84	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	Day 0 to Day 84	An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 84 that were absent before treatment or that worsened relative to pretreatment state.
Maximum Observed Serum Concentration (Cmax) for Benralizumab	Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84	The Cmax of benralizumab is reported. Non-compartmental pharmacokinetic (PK) analysis was used for evaluation.
Area Under the Serum Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) for Benralizumab	Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84	AUClast = area under the concentration-time curve from time 0 to last measurable concentration. Non-compartmental PK analysis was used for evaluation.
Area Under the Serum Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUC [0 - Infinity]) for Benralizumab	Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84	AUC \[0 - infinity\] = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). Non-compartmental PK analysis was used for evaluation.
Systemic Clearance (CL) for Benralizumab	Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84	Systemic clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Non-compartmental PK analysis was used for evaluation. Clearance was normalized to participant's body weight.
Terminal Phase Elimination Half-Life (t1/2) for Benralizumab	Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84	Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half. Non-compartmental PK analysis was used for evaluation.
Volume of Distribution of the Central Compartment (Vc) for Benralizumab	Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Vc = volume of distribution of the central compartment, calculated as Dose/Cmax; where Cmax = maximum observed serum concentration. Non-compartmental PK analysis was used for evaluation. Results were normalized to participant's body weight.
Volume of Distribution at Steady State (Vss) for Benralizumab	Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Vss = steady state volume of distribution, calculated as MRT\*CL, where MRT is the Mean Residence Time and CL is systemic clearance; which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Non-compartmental PK analysis was used for evaluation. Results were normalized to participant's body weight.
Number of Participants With Anti-Drug Antibodies to Benralizumab	Day 0 and 84	Number of participants with anti-drug antibodies to benralizumab is reported.
Number of Healthcare Resources Utilized by Resource Type	Day 0 to Day 168	Healthcare resource use was summarized by resource type from information on asthma exacerbations, and asthma related medications. Healthcare resource utilization assessed the total number of hospitalizations, urgent care, primary care clinic visits, asthma specialist clinic visits, telephone calls, and home management.

Countries

Canada, United States

Participant flow

Recruitment details

A total of 110 participants were randomized in the study.

Participants by arm

Arm	Count
Placebo A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.	38
Benralizumab 0.3 mg/kg A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0.	36
Benralizumab 1.0 mg/kg A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.	36
Total	110

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	2	0	4
Overall Study	Participant incarcerated	0	1	0

Baseline characteristics

Characteristic	Placebo	Benralizumab 0.3 mg/kg	Benralizumab 1.0 mg/kg	Total
Age, Continuous	35.9 Years STANDARD_DEVIATION 10.5	37.9 Years STANDARD_DEVIATION 11.4	34.8 Years STANDARD_DEVIATION 10	36.2 Years STANDARD_DEVIATION 10.6
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	2 Participants	7 Participants	15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants	34 Participants	29 Participants	95 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	26 Participants	19 Participants	19 Participants	64 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	11 Participants	14 Participants	16 Participants	41 Participants
Sex: Female, Male Female	30 Participants	24 Participants	23 Participants	77 Participants
Sex: Female, Male Male	8 Participants	12 Participants	13 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 38	0 / 36	0 / 36
other Total, other adverse events	28 / 38	30 / 36	28 / 36
serious Total, serious adverse events	9 / 38	8 / 36	11 / 36

Outcome results

Primary

Percentage of Participants With Asthma Exacerbations at Week 12

Percentage of participants who required urgent healthcare visit for treatment of acute asthma exacerbation were reported. As per protocol, asthma exacerbation (relapse/de novo) was defined as either 1) increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that did not resolve within 2 hours after use of rescue albuterol or corticosteroids and required an unscheduled medical visit or 2) during scheduled study visit, participant had acute worsening of asthma symptoms and a reduction of greater than or equal to (\>=) 20 percent (%) in Peak Expiratory Flow (PEF) or Forced Expiratory Volume in 1 Second (FEV1), which in the opinion of the investigator required treatment with systemic corticosteroids. Asthma exacerbations were analyzed in a non-adjudicated manner (by investigator), which were then adjudicated in a blinded fashion by the sponsor medical monitor prior to database lock to determine whether the reported exacerbation met the protocol definition.

Time frame: Week 12

Population: Evaluable population included all participants who received any study drug and were followed according to the protocol through Day 42.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Asthma Exacerbations at Week 12	Non-adjudicated Exacerbations	38.9 percentage of participants
Placebo	Percentage of Participants With Asthma Exacerbations at Week 12	Adjudicated Exacerbations	38.9 percentage of participants
Benralizumab 0.3 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 12	Non-adjudicated Exacerbations	25.0 percentage of participants
Benralizumab 0.3 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 12	Adjudicated Exacerbations	25.0 percentage of participants
Benralizumab 1.0 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 12	Non-adjudicated Exacerbations	41.7 percentage of participants
Benralizumab 1.0 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 12	Adjudicated Exacerbations	41.7 percentage of participants

Comparison: Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 0.312Fisher Exact

Comparison: Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 1Fisher Exact

Comparison: Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 0.312Fisher Exact

Comparison: Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 1Fisher Exact

Secondary

Area Under the Serum Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUC [0 - Infinity]) for Benralizumab

AUC \[0 - infinity\] = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). Non-compartmental PK analysis was used for evaluation.

Time frame: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84

Population: Safety population included all participants who received any study drug. Only participants in benralizumab arms were included in pharmacokinetic evaluation. Only those participants who had PK values above the quantification limit were analyzed for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Area Under the Serum Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUC [0 - Infinity]) for Benralizumab	67.1 microgram*day per milliliter	Standard Deviation 18
Benralizumab 0.3 mg/kg	Area Under the Serum Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUC [0 - Infinity]) for Benralizumab	268 microgram*day per milliliter	Standard Deviation 65.7

Secondary

Area Under the Serum Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) for Benralizumab

AUClast = area under the concentration-time curve from time 0 to last measurable concentration. Non-compartmental PK analysis was used for evaluation.

Time frame: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Area Under the Serum Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) for Benralizumab	65.7 microgram*day per milliliter	Standard Deviation 18.5
Benralizumab 0.3 mg/kg	Area Under the Serum Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) for Benralizumab	263 microgram*day per milliliter	Standard Deviation 64.1

Secondary

Asthma Control Questionnaire (ACQ) Scores

Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Results were reported for overall ACQ score and 6 item scores.

Time frame: Days 0, 7, 42, and 84

Population: Evaluable population included all participants who received any study drug and were followed according to the protocol through Day 42. Here, Number Analyzed signified those participants who were evaluable for this outcome measure at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 7	1.8 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 84	1.59 units on a scale	Standard Deviation 1.23
Placebo	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 42	2.0 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 42	1.6 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 84	1.5 units on a scale	Standard Deviation 1.2
Placebo	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 7	1.9 units on a scale	Standard Deviation 1.4
Placebo	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 84	1.5 units on a scale	Standard Deviation 1.6
Placebo	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 0	3.0 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 0	4.4 units on a scale	Standard Deviation 1
Placebo	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 0	3.6 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 0	3.1 units on a scale	Standard Deviation 1.4
Placebo	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 84	1.3 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 7	1.7 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 7	1.89 units on a scale	Standard Deviation 1.16
Placebo	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 42	1.6 units on a scale	Standard Deviation 1.5
Placebo	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 84	2.1 units on a scale	Standard Deviation 1.7
Placebo	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 7	1.7 units on a scale	Standard Deviation 1.6
Placebo	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 42	1.5 units on a scale	Standard Deviation 1.3
Placebo	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 42	2.1 units on a scale	Standard Deviation 1.5
Placebo	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 42	1.4 units on a scale	Standard Deviation 1.6
Placebo	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 42	1.70 units on a scale	Standard Deviation 1.23
Placebo	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 7	2.6 units on a scale	Standard Deviation 1.9
Placebo	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 84	1.3 units on a scale	Standard Deviation 1.4
Placebo	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 0	3.69 units on a scale	Standard Deviation 0.82
Placebo	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 0	4.5 units on a scale	Standard Deviation 1.1
Placebo	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 0	3.4 units on a scale	Standard Deviation 1.4
Placebo	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 7	1.7 units on a scale	Standard Deviation 1.1
Placebo	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 84	1.8 units on a scale	Standard Deviation 1.3
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 42	1.6 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 84	2.2 units on a scale	Standard Deviation 1.7
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 0	3.72 units on a scale	Standard Deviation 1.18
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 42	1.76 units on a scale	Standard Deviation 1.25
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 84	1.75 units on a scale	Standard Deviation 1.33
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 0	3.5 units on a scale	Standard Deviation 1.8
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 7	1.7 units on a scale	Standard Deviation 1.7
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 7	1.89 units on a scale	Standard Deviation 1.36
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 84	1.4 units on a scale	Standard Deviation 1.6
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 0	3.5 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 7	2.0 units on a scale	Standard Deviation 1.4
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 42	1.6 units on a scale	Standard Deviation 1.3
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 84	1.7 units on a scale	Standard Deviation 1.4
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 0	3.5 units on a scale	Standard Deviation 1.4
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 7	1.8 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 42	1.6 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 84	1.5 units on a scale	Standard Deviation 1.3
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 0	4.2 units on a scale	Standard Deviation 1.3
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 7	2.1 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 42	2.1 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 84	2.0 units on a scale	Standard Deviation 1.4
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 0	4.2 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 7	2.2 units on a scale	Standard Deviation 1.6
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 42	2.0 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 0	3.3 units on a scale	Standard Deviation 1.6
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 7	1.6 units on a scale	Standard Deviation 1.5
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 42	1.6 units on a scale	Standard Deviation 1.3
Benralizumab 0.3 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 84	1.7 units on a scale	Standard Deviation 1.4
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 42	1.50 units on a scale	Standard Deviation 1.13
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 42	1.9 units on a scale	Standard Deviation 1.5
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 0	2.8 units on a scale	Standard Deviation 1.5
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 0	3.26 units on a scale	Standard Deviation 1.27
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 84	1.9 units on a scale	Standard Deviation 1.4
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 84	1.2 units on a scale	Standard Deviation 1.2
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 7	1.3 units on a scale	Standard Deviation 0.9
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 0	4.0 units on a scale	Standard Deviation 1.6
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 42	1.2 units on a scale	Standard Deviation 1.4
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 7	1.52 units on a scale	Standard Deviation 0.96
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 7	2.0 units on a scale	Standard Deviation 1.8
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 7	1.0 units on a scale	Standard Deviation 1
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 84	1.8 units on a scale	Standard Deviation 1.3
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 42	1.8 units on a scale	Standard Deviation 1.5
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Night-time waking: Day 0	2.9 units on a scale	Standard Deviation 1.7
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 7	1.5 units on a scale	Standard Deviation 1.5
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Wheeze: Day 84	1.8 units on a scale	Standard Deviation 1.6
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 42	1.4 units on a scale	Standard Deviation 1.3
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 0	3.2 units on a scale	Standard Deviation 1.8
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Overall ACQ: Day 84	1.70 units on a scale	Standard Deviation 1.12
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Activity limitation: Day 84	2.0 units on a scale	Standard Deviation 1.9
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 84	1.6 units on a scale	Standard Deviation 1.2
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 42	1.6 units on a scale	Standard Deviation 1.6
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 0	3.7 units on a scale	Standard Deviation 1.5
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 42	1.2 units on a scale	Standard Deviation 1
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Rescue beta-2 agonist use: Day 0	3.2 units on a scale	Standard Deviation 1.5
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Shortness of breath: Day 7	1.8 units on a scale	Standard Deviation 1.4
Benralizumab 1.0 mg/kg	Asthma Control Questionnaire (ACQ) Scores	Symptoms on waking: Day 7	1.4 units on a scale	Standard Deviation 1.2

Secondary

Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores

Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).

Time frame: Days 0, 42, and 84

Population: Evaluable population included participants who received any study drug and were followed according to the protocol through Day 42. Here, Number Analyzed signified those participants who were evaluable for this outcome measure at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 84	4.94 units on a scale	Standard Deviation 1.68
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 84	4.91 units on a scale	Standard Deviation 1.71
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 42	4.30 units on a scale	Standard Deviation 1.96
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 0	3.56 units on a scale	Standard Deviation 0.97
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 42	4.74 units on a scale	Standard Deviation 1.65
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 0	2.73 units on a scale	Standard Deviation 1.25
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 42	4.96 units on a scale	Standard Deviation 1.54
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 0	3.35 units on a scale	Standard Deviation 1.31
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 84	5.11 units on a scale	Standard Deviation 1.74
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 0	2.84 units on a scale	Standard Deviation 0.94
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 84	4.69 units on a scale	Standard Deviation 1.8
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 0	3.14 units on a scale	Standard Deviation 0.91
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 42	4.77 units on a scale	Standard Deviation 1.82
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 42	4.59 units on a scale	Standard Deviation 1.69
Placebo	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 84	4.59 units on a scale	Standard Deviation 2.04
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 84	4.59 units on a scale	Standard Deviation 1.75
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 0	3.18 units on a scale	Standard Deviation 0.95
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 42	4.76 units on a scale	Standard Deviation 1.46
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 84	5.01 units on a scale	Standard Deviation 1.44
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 0	2.79 units on a scale	Standard Deviation 1.08
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 42	4.82 units on a scale	Standard Deviation 1.45
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 84	4.95 units on a scale	Standard Deviation 1.53
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 0	3.74 units on a scale	Standard Deviation 1.13
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 42	4.92 units on a scale	Standard Deviation 1.51
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 84	5.23 units on a scale	Standard Deviation 1.36
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 0	2.44 units on a scale	Standard Deviation 1.16
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 42	4.35 units on a scale	Standard Deviation 1.77
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 0	3.72 units on a scale	Standard Deviation 1.29
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 42	4.63 units on a scale	Standard Deviation 1.53
Benralizumab 0.3 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 84	5.08 units on a scale	Standard Deviation 1.62
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 84	5.09 units on a scale	Standard Deviation 1.36
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 42	4.99 units on a scale	Standard Deviation 1.44
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 42	4.91 units on a scale	Standard Deviation 1.66
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 42	5.19 units on a scale	Standard Deviation 1.62
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Symptoms: Day 0	3.11 units on a scale	Standard Deviation 1.25
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 84	4.84 units on a scale	Standard Deviation 1.73
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 84	5.11 units on a scale	Standard Deviation 1.35
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 0	3.35 units on a scale	Standard Deviation 1.11
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 0	3.42 units on a scale	Standard Deviation 1.48
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 42	5.30 units on a scale	Standard Deviation 1.42
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Overall: Day 42	5.16 units on a scale	Standard Deviation 1.44
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 84	5.24 units on a scale	Standard Deviation 1.44
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Activity limitation: Day 0	3.98 units on a scale	Standard Deviation 1.29
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Environmental stimuli: Day 84	5.13 units on a scale	Standard Deviation 1.35
Benralizumab 1.0 mg/kg	Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores	Emotional function: Day 0	2.47 units on a scale	Standard Deviation 1.48

Secondary

Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home

The FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Home peak flow testing for FEV1 was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean FEV1 values for each week were reported starting from Day 1 to Day 84.

Time frame: Day 1 to Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 22 to 28	1.6751 liters	Standard Deviation 0.5814
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 1 to 7	1.6346 liters	Standard Deviation 0.4868
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 8 to 14	1.7800 liters	Standard Deviation 0.5608
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 15 to 21	1.7024 liters	Standard Deviation 0.52
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 29 to 35	1.6446 liters	Standard Deviation 0.4962
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 36 to 42	1.7230 liters	Standard Deviation 0.5844
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 43 to 49	1.7326 liters	Standard Deviation 0.5426
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 50 to 56	1.6965 liters	Standard Deviation 0.5756
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 57 to 63	1.6600 liters	Standard Deviation 0.6013
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 64 to 70	1.7218 liters	Standard Deviation 0.6308
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 71 to 77	1.7180 liters	Standard Deviation 0.5969
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 78 to 84	1.7591 liters	Standard Deviation 0.6944
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 78 to 84	1.6655 liters	Standard Deviation 0.6032
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 43 to 49	1.7999 liters	Standard Deviation 0.6735
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 36 to 42	1.7935 liters	Standard Deviation 0.6341
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 57 to 63	1.7682 liters	Standard Deviation 0.6619
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 1 to 7	1.7119 liters	Standard Deviation 0.6309
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 64 to 70	1.8735 liters	Standard Deviation 0.7701
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 71 to 77	1.7811 liters	Standard Deviation 0.6721
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 8 to 14	1.8562 liters	Standard Deviation 0.6467
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 50 to 56	1.7532 liters	Standard Deviation 0.653
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 29 to 35	1.7937 liters	Standard Deviation 0.6229
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 15 to 21	1.7874 liters	Standard Deviation 0.6529
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 22 to 28	1.8188 liters	Standard Deviation 0.6461
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 15 to 21	1.8219 liters	Standard Deviation 0.7241
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 22 to 28	1.8351 liters	Standard Deviation 0.7107
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 64 to 70	1.7904 liters	Standard Deviation 0.7959
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 36 to 42	1.7298 liters	Standard Deviation 0.6923
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 43 to 49	1.7803 liters	Standard Deviation 0.6655
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 50 to 56	1.7806 liters	Standard Deviation 0.6558
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 71 to 77	1.7401 liters	Standard Deviation 0.6891
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 29 to 35	1.7486 liters	Standard Deviation 0.7093
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 1 to 7	1.8404 liters	Standard Deviation 0.7222
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 57 to 63	1.8504 liters	Standard Deviation 0.7636
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 8 to 14	1.7674 liters	Standard Deviation 0.7305
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home	Day 78 to 84	1.7818 liters	Standard Deviation 0.7009

Secondary

Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites

The FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 2 but no more than 5) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis.

Time frame: Days 0, 7, 42, and 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 0	1.696 liters	Standard Deviation 0.523
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 7	2.008 liters	Standard Deviation 0.632
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 42	1.962 liters	Standard Deviation 0.714
Placebo	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 84	2.048 liters	Standard Deviation 0.761
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 84	2.043 liters	Standard Deviation 0.71
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 0	1.689 liters	Standard Deviation 0.698
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 42	2.130 liters	Standard Deviation 0.713
Benralizumab 0.3 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 7	2.003 liters	Standard Deviation 0.655
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 84	2.209 liters	Standard Deviation 0.791
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 7	2.254 liters	Standard Deviation 0.723
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 42	2.150 liters	Standard Deviation 0.723
Benralizumab 1.0 mg/kg	Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites	Day 0	2.067 liters	Standard Deviation 0.746

Secondary

Maximum Observed Serum Concentration (Cmax) for Benralizumab

The Cmax of benralizumab is reported. Non-compartmental pharmacokinetic (PK) analysis was used for evaluation.

Time frame: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Maximum Observed Serum Concentration (Cmax) for Benralizumab	7.03 microgram per milliliter (mcg/mL)	Standard Deviation 1.78
Benralizumab 0.3 mg/kg	Maximum Observed Serum Concentration (Cmax) for Benralizumab	26.7 microgram per milliliter (mcg/mL)	Standard Deviation 6.49

Secondary

Number of Healthcare Resources Utilized by Resource Type

Healthcare resource use was summarized by resource type from information on asthma exacerbations, and asthma related medications. Healthcare resource utilization assessed the total number of hospitalizations, urgent care, primary care clinic visits, asthma specialist clinic visits, telephone calls, and home management.

Time frame: Day 0 to Day 168

Population: Evaluable population included all participants who received any study drug and were followed according to the protocol through Day 42.

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Healthcare Resources Utilized by Resource Type	Telephone calls	6 healthcare resources
Placebo	Number of Healthcare Resources Utilized by Resource Type	Urgent care	2 healthcare resources
Placebo	Number of Healthcare Resources Utilized by Resource Type	Asthma specialist clinic visits	5 healthcare resources
Placebo	Number of Healthcare Resources Utilized by Resource Type	Home management	2 healthcare resources
Placebo	Number of Healthcare Resources Utilized by Resource Type	Primary care clinic visits	3 healthcare resources
Placebo	Number of Healthcare Resources Utilized by Resource Type	Hospitalizations	64 healthcare resources
Benralizumab 0.3 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Primary care clinic visits	1 healthcare resources
Benralizumab 0.3 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Asthma specialist clinic visits	5 healthcare resources
Benralizumab 0.3 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Hospitalizations	40 healthcare resources
Benralizumab 0.3 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Telephone calls	1 healthcare resources
Benralizumab 0.3 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Home management	1 healthcare resources
Benralizumab 0.3 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Urgent care	0 healthcare resources
Benralizumab 1.0 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Urgent care	0 healthcare resources
Benralizumab 1.0 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Home management	4 healthcare resources
Benralizumab 1.0 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Hospitalizations	43 healthcare resources
Benralizumab 1.0 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Telephone calls	4 healthcare resources
Benralizumab 1.0 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Primary care clinic visits	5 healthcare resources
Benralizumab 1.0 mg/kg	Number of Healthcare Resources Utilized by Resource Type	Asthma specialist clinic visits	0 healthcare resources

Secondary

Number of Participants With Anti-Drug Antibodies to Benralizumab

Number of participants with anti-drug antibodies to benralizumab is reported.

Time frame: Day 0 and 84

Population: Safety population included all participants who received any study drug. Only participants from benralizumab arms were included in immunogenicity evaluation. Only participants with adequate sample were evaluable for this outcome measure.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Anti-Drug Antibodies to Benralizumab	Day 0	1 Participants
Placebo	Number of Participants With Anti-Drug Antibodies to Benralizumab	Day 84	2 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Anti-Drug Antibodies to Benralizumab	Day 0	0 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Anti-Drug Antibodies to Benralizumab	Day 84	4 Participants

Secondary

Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84

Physician Global Assessment (PGA) consisted of a single physician-rated question assessing participant's status as 'excellent', 'good', 'moderate', 'poor', 'worsening' or 'not applicable (NA)'. Number of participants were categorically summarized.

Time frame: Days 42 and 84

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Excellent	9 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Good	12 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Moderate	8 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Poor	3 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Worsening	1 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Not applicable	1 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Excellent	8 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Good	15 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Moderate	7 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Poor	3 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Worsening	2 Participants
Placebo	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Not applicable	1 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Not applicable	0 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Excellent	10 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Excellent	12 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Moderate	3 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Good	19 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Not applicable	0 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Worsening	3 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Moderate	3 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Good	13 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Worsening	1 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Poor	3 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Poor	4 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Poor	2 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Worsening	0 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Poor	1 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Not applicable	1 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Excellent	11 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Good	11 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Worsening	0 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Excellent	10 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Good	16 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Moderate	9 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 42: Moderate	7 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84	Day 84: Not applicable	0 Participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 84 that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Day 0 to Day 84

Population: Safety population included all participants who received any study drug.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TEAEs	30 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TESAEs	9 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TEAEs	32 Participants
Benralizumab 0.3 mg/kg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TESAEs	8 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TEAEs	30 Participants
Benralizumab 1.0 mg/kg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	TESAEs	11 Participants

Secondary

Number of Puffs of Rescue Beta-2 Agonist Per Week

Rescue beta-2 agonist use (total number of puffs for the prior day) was collected daily in the morning by the participants in the electronic daily diary provided to them. Participants were instructed not to collect rescue beta-2 agonist used prior to exercise. Average values for each week were reported starting from Day 1 to Day 84.

Time frame: Day 1 to Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 29 to 35	1.76 puffs per week	Standard Deviation 2.79
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 78 to 84	1.27 puffs per week	Standard Deviation 1.56
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 1 to 7	1.95 puffs per week	Standard Deviation 1.75
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 8 to 14	1.80 puffs per week	Standard Deviation 2.01
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 15 to 21	1.57 puffs per week	Standard Deviation 2
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 22 to 28	1.93 puffs per week	Standard Deviation 2.65
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 36 to 42	1.86 puffs per week	Standard Deviation 3.36
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 43 to 49	1.85 puffs per week	Standard Deviation 3.53
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 50 to 56	2.16 puffs per week	Standard Deviation 4.83
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 57 to 63	2.59 puffs per week	Standard Deviation 6.63
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 64 to 70	2.69 puffs per week	Standard Deviation 6.43
Placebo	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 71 to 77	1.69 puffs per week	Standard Deviation 1.96
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 50 to 56	1.52 puffs per week	Standard Deviation 1.94
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 29 to 35	1.62 puffs per week	Standard Deviation 2.17
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 36 to 42	1.42 puffs per week	Standard Deviation 1.65
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 22 to 28	1.83 puffs per week	Standard Deviation 2.55
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 78 to 84	2.04 puffs per week	Standard Deviation 3.11
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 15 to 21	2.01 puffs per week	Standard Deviation 3.34
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 71 to 77	1.39 puffs per week	Standard Deviation 1.84
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 1 to 7	1.74 puffs per week	Standard Deviation 2.05
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 43 to 49	1.33 puffs per week	Standard Deviation 1.44
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 57 to 63	1.43 puffs per week	Standard Deviation 1.73
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 8 to 14	1.63 puffs per week	Standard Deviation 1.9
Benralizumab 0.3 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 64 to 70	1.50 puffs per week	Standard Deviation 1.76
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 8 to 14	1.38 puffs per week	Standard Deviation 2.07
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 15 to 21	1.42 puffs per week	Standard Deviation 1.7
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 71 to 77	1.48 puffs per week	Standard Deviation 1.44
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 22 to 28	1.45 puffs per week	Standard Deviation 1.76
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 36 to 42	1.59 puffs per week	Standard Deviation 1.92
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 64 to 70	1.48 puffs per week	Standard Deviation 1.65
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 78 to 84	1.47 puffs per week	Standard Deviation 1.41
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 29 to 35	1.53 puffs per week	Standard Deviation 1.73
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 50 to 56	1.87 puffs per week	Standard Deviation 2.32
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 43 to 49	1.71 puffs per week	Standard Deviation 2.05
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 1 to 7	1.47 puffs per week	Standard Deviation 1.76
Benralizumab 1.0 mg/kg	Number of Puffs of Rescue Beta-2 Agonist Per Week	Day 57 to 63	1.54 puffs per week	Standard Deviation 1.56

Secondary

Peak Expiratory Flow (PEF) Recorded at Home

The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean PEF values for each week were reported starting from Day 1 to Day 84.

Time frame: Day 1 to Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 64 to 70	166.968 liters per minute (L/min)	Standard Deviation 57.401
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 15 to 21	169.489 liters per minute (L/min)	Standard Deviation 51.56
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 8 to 14	175.093 liters per minute (L/min)	Standard Deviation 50.914
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 50 to 56	169.487 liters per minute (L/min)	Standard Deviation 58.325
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 22 to 28	163.844 liters per minute (L/min)	Standard Deviation 57.753
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 78 to 84	167.197 liters per minute (L/min)	Standard Deviation 58.69
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 71 to 77	160.717 liters per minute (L/min)	Standard Deviation 61.017
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 29 to 35	163.999 liters per minute (L/min)	Standard Deviation 53.078
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 57 to 63	169.723 liters per minute (L/min)	Standard Deviation 61.318
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 43 to 49	171.373 liters per minute (L/min)	Standard Deviation 56.824
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 36 to 42	169.510 liters per minute (L/min)	Standard Deviation 57.745
Placebo	Peak Expiratory Flow (PEF) Recorded at Home	Day 1 to 7	161.845 liters per minute (L/min)	Standard Deviation 45.186
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 36 to 42	178.373 liters per minute (L/min)	Standard Deviation 51.881
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 43 to 49	185.847 liters per minute (L/min)	Standard Deviation 57.767
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 50 to 56	178.070 liters per minute (L/min)	Standard Deviation 57.414
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 1 to 7	179.000 liters per minute (L/min)	Standard Deviation 61.653
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 57 to 63	176.761 liters per minute (L/min)	Standard Deviation 56.41
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 78 to 84	172.788 liters per minute (L/min)	Standard Deviation 56.722
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 8 to 14	186.538 liters per minute (L/min)	Standard Deviation 52.945
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 64 to 70	188.805 liters per minute (L/min)	Standard Deviation 59.186
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 15 to 21	180.627 liters per minute (L/min)	Standard Deviation 55.853
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 22 to 28	183.066 liters per minute (L/min)	Standard Deviation 54.902
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 29 to 35	179.064 liters per minute (L/min)	Standard Deviation 55.297
Benralizumab 0.3 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 71 to 77	175.379 liters per minute (L/min)	Standard Deviation 59.158
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 78 to 84	164.982 liters per minute (L/min)	Standard Deviation 60.271
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 64 to 70	164.368 liters per minute (L/min)	Standard Deviation 66.619
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 1 to 7	177.929 liters per minute (L/min)	Standard Deviation 58.791
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 8 to 14	172.811 liters per minute (L/min)	Standard Deviation 59.941
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 15 to 21	180.362 liters per minute (L/min)	Standard Deviation 60.894
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 22 to 28	181.199 liters per minute (L/min)	Standard Deviation 62.497
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 29 to 35	171.458 liters per minute (L/min)	Standard Deviation 65.889
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 36 to 42	168.228 liters per minute (L/min)	Standard Deviation 64.673
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 50 to 56	169.230 liters per minute (L/min)	Standard Deviation 62.696
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 57 to 63	169.374 liters per minute (L/min)	Standard Deviation 70.249
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 71 to 77	160.167 liters per minute (L/min)	Standard Deviation 59.618
Benralizumab 1.0 mg/kg	Peak Expiratory Flow (PEF) Recorded at Home	Day 43 to 49	169.727 liters per minute (L/min)	Standard Deviation 65.11

Secondary

Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24

Percentage of participants who required an urgent healthcare visit for treatment of an acute asthma exacerbation were reported. As per protocol, asthma exacerbation (relapse or de novo) was defined as either 1) an increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that did not resolve within 2 hours after the use of rescue albuterol or corticosteroids and required an unscheduled medical visit or 2) during a scheduled study visit, the participant had acute worsening of asthma symptoms and a reduction of \>=20% in PEF or FEV1, which in the opinion of the investigator required treatment with systemic corticosteroids. Asthma exacerbations were analyzed in a non-adjudicated manner (by investigator), which were then adjudicated in a blinded fashion by the sponsor medical monitor prior to database lock to determine whether the reported exacerbation met the protocol definition.

Time frame: Weeks 4 and 24

Population: Evaluable population included all participants who received any study drug and were followed according to the protocol through Day 42.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 4: Non-adjudicated Exacerbations	22.2 percentage of participants
Placebo	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 4: Adjudicated Exacerbations	22.2 percentage of participants
Placebo	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 24: Non-adjudicated Exacerbations	47.2 percentage of participants
Placebo	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 24: Adjudicated Exacerbations	47.2 percentage of participants
Benralizumab 0.3 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 24: Adjudicated Exacerbations	36.1 percentage of participants
Benralizumab 0.3 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 4: Non-adjudicated Exacerbations	11.1 percentage of participants
Benralizumab 0.3 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 24: Non-adjudicated Exacerbations	36.1 percentage of participants
Benralizumab 0.3 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 4: Adjudicated Exacerbations	11.1 percentage of participants
Benralizumab 1.0 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 24: Adjudicated Exacerbations	50.0 percentage of participants
Benralizumab 1.0 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 4: Adjudicated Exacerbations	22.2 percentage of participants
Benralizumab 1.0 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 24: Non-adjudicated Exacerbations	50.0 percentage of participants
Benralizumab 1.0 mg/kg	Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24	Week 4: Non-adjudicated Exacerbations	22.2 percentage of participants

Comparison: Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 0.343Fisher Exact

Comparison: Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 1Fisher Exact

Comparison: Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 0.343Fisher Exact

Comparison: Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 1Fisher Exact

Comparison: Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 0.474Fisher Exact

Comparison: Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 1Fisher Exact

Comparison: Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 0.474Fisher Exact

Comparison: Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.p-value: 1Fisher Exact

Secondary

Systemic Clearance (CL) for Benralizumab

Systemic clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Non-compartmental PK analysis was used for evaluation. Clearance was normalized to participant's body weight.

Time frame: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Systemic Clearance (CL) for Benralizumab	4.92 milliliter per kilogram per day	Standard Deviation 1.96
Benralizumab 0.3 mg/kg	Systemic Clearance (CL) for Benralizumab	3.97 milliliter per kilogram per day	Standard Deviation 1.02

Secondary

Terminal Phase Elimination Half-Life (t1/2) for Benralizumab

Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half. Non-compartmental PK analysis was used for evaluation.

Time frame: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Terminal Phase Elimination Half-Life (t1/2) for Benralizumab	11.5 days	Standard Deviation 3.14
Benralizumab 0.3 mg/kg	Terminal Phase Elimination Half-Life (t1/2) for Benralizumab	13.2 days	Standard Deviation 2.39

Secondary

Volume of Distribution at Steady State (Vss) for Benralizumab

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Vss = steady state volume of distribution, calculated as MRT\*CL, where MRT is the Mean Residence Time and CL is systemic clearance; which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Non-compartmental PK analysis was used for evaluation. Results were normalized to participant's body weight.

Time frame: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Volume of Distribution at Steady State (Vss) for Benralizumab	71.8 mL/kg	Standard Deviation 23.2
Benralizumab 0.3 mg/kg	Volume of Distribution at Steady State (Vss) for Benralizumab	64.0 mL/kg	Standard Deviation 15.1

Secondary

Volume of Distribution of the Central Compartment (Vc) for Benralizumab

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Vc = volume of distribution of the central compartment, calculated as Dose/Cmax; where Cmax = maximum observed serum concentration. Non-compartmental PK analysis was used for evaluation. Results were normalized to participant's body weight.

Time frame: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Volume of Distribution of the Central Compartment (Vc) for Benralizumab	46.4 milliliter per kilogram (mL/kg)	Standard Deviation 17
Benralizumab 0.3 mg/kg	Volume of Distribution of the Central Compartment (Vc) for Benralizumab	39.8 milliliter per kilogram (mL/kg)	Standard Deviation 10.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Asthma Exacerbations at Week 12

Area Under the Serum Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUC [0 - Infinity]) for Benralizumab

Area Under the Serum Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) for Benralizumab

Asthma Control Questionnaire (ACQ) Scores

Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores

Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home

Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites

Maximum Observed Serum Concentration (Cmax) for Benralizumab

Number of Healthcare Resources Utilized by Resource Type

Number of Participants With Anti-Drug Antibodies to Benralizumab

Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Number of Puffs of Rescue Beta-2 Agonist Per Week

Peak Expiratory Flow (PEF) Recorded at Home

Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24

Systemic Clearance (CL) for Benralizumab

Terminal Phase Elimination Half-Life (t1/2) for Benralizumab

Volume of Distribution at Steady State (Vss) for Benralizumab

Volume of Distribution of the Central Compartment (Vc) for Benralizumab