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Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01238861
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : November 17, 2016
Last Update Posted : November 17, 2016
Sponsor:
Collaborator:
MedImmune Ltd
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Biological: Benralizumab 2 mg
Biological: Benralizumab 20 mg
Biological: Benralizumab 100 mg
Other: Placebo
Enrollment 964
Recruitment Details  
Pre-assignment Details Participants were stratified based on the protocol defined eosinophilic phenotype (EOS+ versus EOS-) and inhaled corticosteroid (ICS) use during a 3-week screening period. A total of 964 participants were screened out of which 609 were randomized in the study, and of which 606 participants received at least one dose of investigational product.
Arm/Group Title Eosinophilic Phenotype (EOS+) Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg EOS+ Benralizumab, 100 mg Non-eosinophil Phenotype (EOS-) Placebo EOS- Benralizumab, 100 mg
Hide Arm/Group Description EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Period Title: Overall Study
Started 80 81 81 82 142 140
Completed 69 73 70 69 129 125
Not Completed 11 8 11 13 13 15
Reason Not Completed
Lost to Follow-up             4             2             3             1             1             2
Unplanned surgery             1             0             0             0             0             0
Did not meet entry ACQ-6 criteria             0             0             1             0             1             1
Incorrect enrollment/randomization             0             0             1             0             1             0
Subject traveled to Argentina by 1 year             0             0             1             0             0             0
Subject moved out of state/area             0             0             1             1             0             0
Strongyloides stercoralis antibodies +             0             0             0             1             0             0
Personal problems             0             0             0             1             0             0
Unable to continue visits             0             0             0             1             0             1
Serious adverse event             0             0             0             0             0             1
Lack of compliance             0             0             0             0             0             1
Adverse Event             0             1             0             0             0             0
Withdrawal by Subject             6             5             4             8             10             9
Arm/Group Title Eosinophilic Phenotype (EOS+) Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg EOS+ Benralizumab, 100 mg Non-eosinophil Phenotype (EOS-) Placebo EOS- Benralizumab, 100 mg Total
Hide Arm/Group Description EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. Total of all reporting groups
Overall Number of Baseline Participants 80 81 81 82 142 140 606
Hide Baseline Analysis Population Description
The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 81 participants 81 participants 82 participants 142 participants 140 participants 606 participants
45.6  (11.7) 47.1  (12.8) 46.6  (13.2) 47.8  (12.9) 50.0  (12.3) 50.0  (11.5) 48.3  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 81 participants 82 participants 142 participants 140 participants 606 participants
Female
53
  66.3%
58
  71.6%
48
  59.3%
60
  73.2%
100
  70.4%
98
  70.0%
417
  68.8%
Male
27
  33.8%
23
  28.4%
33
  40.7%
22
  26.8%
42
  29.6%
42
  30.0%
189
  31.2%
1.Primary Outcome
Title Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants
Hide Description The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.
Time Frame Week 1 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.
Arm/Group Title Eosinophilic Phenotype (EOS+) Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg EOS+ Benralizumab, 100 mg
Hide Arm/Group Description:
EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Overall Number of Participants Analyzed 80 81 81 82
Measure Type: Number
Unit of Measure: AER events/person-year
0.57 0.65 0.37 0.34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eosinophilic Phenotype (EOS+) Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments [Not Specified]
Method Poisson Regression Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.09
Confidence Interval (2-Sided) 80%
0.74 to 1.59
Estimation Comments The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eosinophilic Phenotype (EOS+) Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method Poisson Regression Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.64
Confidence Interval (2-Sided) 80%
0.42 to 0.97
Estimation Comments The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eosinophilic Phenotype (EOS+) Placebo, EOS+ Benralizumab, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method Poisson Regression Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.59
Confidence Interval (2-Sided) 80%
0.40 to 0.89
Estimation Comments The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.
2.Secondary Outcome
Title Dose Response in EOS+ Participants
Hide Description [Not Specified]
Time Frame Baseline up to Week 66
Hide Outcome Measure Data
Hide Analysis Population Description
Due to change in planned analysis after unblinding of study data, dose response was not performed.
Arm/Group Title EOS+ Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg EOS+ Benralizumab, 100 mg
Hide Arm/Group Description:
EOS+ participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)
Hide Description [Not Specified]
Time Frame Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.
Arm/Group Title EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab, 100 mg
Hide Arm/Group Description:
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 81 81 223
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter
34.7  (131) 182  (180) 869  (665)
4.Secondary Outcome
Title Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)
Hide Description [Not Specified]
Time Frame Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.
Arm/Group Title EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab, 100 mg
Hide Arm/Group Description:
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 81 81 223
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter
17.3  (65.3) 9.10  (9.02) 8.69  (6.65)
5.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants
Hide Description Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer >=50 at any point in the study. It was observed at baseline and any visit during the study.
Time Frame Baseline up to Week 92
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product.
Arm/Group Title EOS+ Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg EOS+ Benralizumab, 100 mg
Hide Arm/Group Description:
EOS+ participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Overall Number of Participants Analyzed 80 81 81 82
Measure Type: Number
Unit of Measure: percentage of participants
3.8 42.0 30.9 25.6
6.Secondary Outcome
Title Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52
Hide Description 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 was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title EOS+ Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg EOS+ Benralizumab, 100 mg EOS- Placebo EOS- Benralizumab, 100 mg
Hide Arm/Group Description:
EOS+ participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Overall Number of Participants Analyzed 80 81 81 82 142 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=80,80,80,82,142,140) 2.7479  (0.9762) 2.6479  (0.9908) 2.4750  (0.9106) 2.5346  (0.9728) 2.4742  (0.8408) 2.6381  (0.8330)
Change at Week 52 (n=34,42,40,39,64,73) -0.8922  (1.1969) -1.1032  (1.1207) -1.2500  (1.2247) -1.1239  (1.2852) -0.8418  (1.1343) -1.1295  (1.1301)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EOS+ Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EOS+ Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection EOS+ Placebo, EOS+ Benralizumab, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection EOS- Placebo, EOS- Benralizumab, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
7.Secondary Outcome
Title Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52
Hide Description Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
EOS+ and EOS- participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=71,27,25,81) 4.3  (2.0) 4.8  (2.0) 5.3  (1.8) 4.4  (2.1)
Change at Week 52 (n=89,39,39,106) -0.4  (2.90) -0.8  (2.01) -1.0  (2.96) -0.8  (2.24)
8.Secondary Outcome
Title Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52
Hide Description Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline up to Week 51-52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=204,72,74,210) 1.58  (0.60) 1.65  (0.65) 1.60  (0.61) 1.60  (0.62)
Change at Week 51-52 (n=111,36,39,111) -0.37  (0.61) -0.56  (0.76) -0.56  (0.69) -0.53  (0.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.182
Confidence Interval (2-Sided) 80%
-0.336 to -0.028
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.173
Confidence Interval (2-Sided) 80%
-0.317 to -0.028
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.140
Confidence Interval (2-Sided) 80%
-0.247 to -0.032
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Rescue Medication Use at Week 51-52
Hide Description Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.
Time Frame Baseline up to Week 51-52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: rescue medication per 2 weeks
Baseline without prophylactic (n=204,72,74,210) 3.09  (2.55) 3.57  (3.67) 3.82  (4.34) 3.16  (2.82)
Baseline with prophylactic (n=204,72,74,210) 4.07  (3.34) 4.71  (5.56) 5.24  (6.40) 4.22  (3.90)
Change Week 51-52 -prophylactic(n=111,36,39,111) -1.2540  (2.4571) -1.4116  (2.8722) -1.8804  (5.3129) -1.1589  (2.0086)
Change Week 51-52 +prophylactic(n=111,36,39,111) -1.6855  (3.2875) -1.6810  (4.2247) -2.5118  (7.6814) -1.4693  (2.5603)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments Analysis reported for rescue medication use without prophylactic at Week 51-52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.174
Confidence Interval (2-Sided) 80%
-0.654 to 0.306
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments Analysis reported for rescue medication use without prophylactic at Week 51-52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.111
Confidence Interval (2-Sided) 80%
-0.533 to 0.756
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments Analysis reported for rescue medication use without prophylactic at Week 51-52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.029
Confidence Interval (2-Sided) 80%
-0.297 to 0.355
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments Analysis reported for rescue medication use with prophylactic at Week 51-52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.992
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.004
Confidence Interval (2-Sided) 80%
-0.602 to 0.593
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments Analysis reported for rescue medication use with prophylactic at Week 51-52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.337
Confidence Interval (2-Sided) 80%
-0.548 to 1.222
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments Analysis reported for rescue medication use with prophylactic at Week 51-52.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.150
Confidence Interval (2-Sided) 80%
-0.267 to 0.567
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Hide Description FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=215,80,81,218) 2.033  (0.669) 1.978  (0.701) 2.080  (0.751) 2.012  (0.672)
Change at Week 52 (n=150,51,58,160) 0.0098  (0.3615) 0.1631  (0.4691) 0.1847  (0.5234) 0.0998  (0.3541)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.157
Confidence Interval (2-Sided) 80%
0.076 to 0.237
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.184
Confidence Interval (2-Sided) 80%
0.102 to 0.266
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.091
Confidence Interval (2-Sided) 80%
0.039 to 0.143
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52
Hide Description Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title EOS+ Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg EOS+ Benralizumab, 100 mg EOS- Placebo EOS- Benralizumab, 100 mg
Hide Arm/Group Description:
EOS+ participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Overall Number of Participants Analyzed 80 81 81 82 142 140
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=80,80,81,82,135,136) 3.282  (1.030) 3.069  (0.957) 3.285  (1.028) 3.110  (0.851) 3.043  (0.864) 3.126  (0.981)
Change at Week 52 (n=51,51,58,59,99,101) 0.029  (0.514) 0.129  (0.565) 0.190  (0.586) 0.166  (0.445) -0.030  (0.426) 0.056  (0.371)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EOS+ Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.384
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EOS+ Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection EOS+ Placebo, EOS+ Benralizumab, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection EOS- Placebo, EOS- Benralizumab, 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
12.Secondary Outcome
Title Change From Baseline in Peak Expiratory Flow (PEF) at Week 52
Hide Description The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: liters per minute
Baseline (n=215,80,81,218) 319.3  (104.7) 325.5  (101.6) 323.1  (100.8) 323.8  (101.7)
Change at Week 52 (n=150,51,58,160) 13.0  (64.6) 29.0  (64.1) 45.9  (95.5) 26.6  (66.3)
13.Secondary Outcome
Title Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52
Hide Description AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma 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). The AQLQ(S) responses were categorized as improvement (defined as change from baseline >=0.5), no change (defined as change from baseline >= -0.5 to less than [<] 0.5), and worse (defined as change from baseline < -0.5). Data was summarized by each treatment group.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=214,78,80,217) 3.72  (1.04) 3.72  (1.17) 3.79  (1.06) 3.72  (1.01)
Change at Week 52 (n=88,39,38,105) 0.9634  (1.3342) 1.2612  (1.2082) 1.4474  (1.4262) 1.1223  (1.2636)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.404
Confidence Interval (2-Sided) 80%
0.121 to 0.687
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.462
Confidence Interval (2-Sided) 80%
0.163 to 0.761
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.238
Confidence Interval (2-Sided) 80%
0.017 to 0.459
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52
Hide Description The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=213,79,74,209) 0.7629  (0.2153) 0.7418  (0.2376) 0.7877  (0.1878) 0.7679  (0.1623)
Change at Week 52 (n=148,58,53,161) 0.0853  (0.2096) 0.0822  (0.3137) 0.1223  (0.2132) 0.0824  (0.2179)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.020
Confidence Interval (2-Sided) 80%
-0.058 to 0.019
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.041
Confidence Interval (2-Sided) 80%
0.008 to 0.074
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.599
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.011
Confidence Interval (2-Sided) 80%
-0.016 to 0.038
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52
Hide Description The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=213,79,74,208) 65.0798  (17.8903) 65.4937  (18.5063) 64.3378  (18.1427) 64.6250  (19.7778)
Change at Week 52 (n=148,58,53,161) 12.8041  (19.1036) 12.5517  (20.8008) 15.4906  (21.7297) 13.7391  (20.5139)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.373
Confidence Interval (2-Sided) 80%
-3.333 to 2.586
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.857
Confidence Interval (2-Sided) 80%
-0.175 to 5.889
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.503
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.139
Confidence Interval (2-Sided) 80%
-1.041 to 3.319
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52
Hide Description Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline up to Week 51-52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: percent nocturnal awakening-free nights
Baseline (n=204,72,74,210) 52.05  (36.96) 45.07  (40.04) 51.57  (39.72) 50.92  (37.72)
Change at Week 51-52 (n=111,36,39,111) 19.7595  (39.1388) 27.1749  (41.7342) 29.6181  (38.4315) 23.3054  (36.2761)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.907
Confidence Interval (2-Sided) 80%
-4.483 to 12.297
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.659
Confidence Interval (2-Sided) 80%
-0.262 to 15.579
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.413
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.540
Confidence Interval (2-Sided) 80%
-2.006 to 9.086
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52
Hide Description Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo EOS+ Benralizumab, 2 mg EOS+ Benralizumab, 20 mg Benralizumab (100 mg)
Hide Arm/Group Description:
Participants received two placebo injections subcutaneously.
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Overall Number of Participants Analyzed 222 81 81 222
Mean (Standard Deviation)
Unit of Measure: parts per billion
Baseline (n=222,81,81,222) 26.88  (23.57) 39.52  (32.67) 40.79  (31.03) 26.68  (23.10)
Change at Week 52 (n=148,57,56,157) 1.2523  (16.0200) -3.2222  (33.2543) -6.1905  (30.1103) 1.4384  (28.9090)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 2 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.896
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EOS+ Benralizumab, 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.944
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Benralizumab (100 mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.667
Comments [Not Specified]
Method ANCOVA
Comments P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.
Time Frame From initiation of investigational product administration up to Week 92
Adverse Event Reporting Description The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
 
Arm/Group Title EOS POS Placebo EOS POS Benralizumab 2 mg EOS POS Benralizumab 20 mg EOS POS Benralizumab 100 mg EOS NEG Placebo EOS NEG Benralizumab 100 mg
Hide Arm/Group Description EOS+ participants received two placebo injections subcutaneously. EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously. EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously. EOS+ participants received two benralizumab 50 mg injections subcutaneously. EOS- participants received two placebo injections subcutaneously. EOS- participants received two benralizumab 50 mg injections subcutaneously.
All-Cause Mortality
EOS POS Placebo EOS POS Benralizumab 2 mg EOS POS Benralizumab 20 mg EOS POS Benralizumab 100 mg EOS NEG Placebo EOS NEG Benralizumab 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EOS POS Placebo EOS POS Benralizumab 2 mg EOS POS Benralizumab 20 mg EOS POS Benralizumab 100 mg EOS NEG Placebo EOS NEG Benralizumab 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/80 (8.75%)      10/81 (12.35%)      6/81 (7.41%)      6/82 (7.32%)      16/141 (11.35%)      18/141 (12.77%)    
Cardiac disorders             
Acute myocardial infarct  1  0/80 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Atrial fibrillation  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Cardiac failure acute  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Myocardial ischaemia  1  0/80 (0.00%)  0 0/81 (0.00%)  0 2/81 (2.47%)  2 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Supraventricular tachyca  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Gastrointestinal disorders             
Abdominal hernia  1  1/80 (1.25%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Abdominal pain  1  1/80 (1.25%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0 1/82 (1.22%)  1 0/141 (0.00%)  0 1/141 (0.71%)  4
Gastrooesophageal reflux  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Intestinal obstruction  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Umbilical hernia  1  1/80 (1.25%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Cholecystitis acute  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Immune system disorders             
Drug hypersensitivity  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 1/82 (1.22%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0
Anaphylactic reaction  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Infections and infestations             
Bronchitis  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Cholecystitis infective  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Eczema infected  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Enteritis infectious  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Gastritis viral  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 1/82 (1.22%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0
Herpes zoster  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Pneumonia  1  0/80 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0 1/82 (1.22%)  1 1/141 (0.71%)  2 3/141 (2.13%)  3
Gastroenteritis  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Lower respiratory tract  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Post procedural cellulit  1  0/80 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Postoperative wound infe  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 1/82 (1.22%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0
Tonsillitis bacterial  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 1/82 (1.22%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0
Injury, poisoning and procedural complications             
Abdominal wound dehiscen  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Ulna fracture  1  0/80 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Metabolism and nutrition disorders             
Hypercholesterolaemia  1  0/80 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  0/80 (0.00%)  0 2/81 (2.47%)  2 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Musculoskeletal pain  1  0/80 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Osteochondrosis  1  0/80 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Spinal osteoarthritis  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Fibrous histiocytoma  1  1/80 (1.25%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Malignant melanoma  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Thyroid neoplasm  1  0/80 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Uterine leiomyoma  1  0/80 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1 1/82 (1.22%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0
Nervous system disorders             
Convulsion  1  0/80 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Grand mal convulsion  1  0/80 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Ischaemic stroke  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Syncope  1  1/80 (1.25%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Psychiatric disorders             
Depression  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Insomnia  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  2/80 (2.50%)  2 2/81 (2.47%)  2 0/81 (0.00%)  0 2/82 (2.44%)  3 8/141 (5.67%)  14 5/141 (3.55%)  5
Asthmatic crisis  1  1/80 (1.25%)  1 0/81 (0.00%)  0 1/81 (1.23%)  1 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Nasal polyps  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 1/82 (1.22%)  1 0/141 (0.00%)  0 1/141 (0.71%)  1
Pulmonary embolism  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Interstitial lung diseas  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Skin and subcutaneous tissue disorders             
Erythema nodosum  1  0/80 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1 0/82 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0
Urticaria  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Eczema  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0
Vascular disorders             
Hypertension  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 1/82 (1.22%)  3 0/141 (0.00%)  0 0/141 (0.00%)  0
Polyarteritis nodosa  1  0/80 (0.00%)  0 0/81 (0.00%)  0 0/81 (0.00%)  0 0/82 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
EOS POS Placebo EOS POS Benralizumab 2 mg EOS POS Benralizumab 20 mg EOS POS Benralizumab 100 mg EOS NEG Placebo EOS NEG Benralizumab 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/80 (55.00%)      54/81 (66.67%)      57/81 (70.37%)      68/82 (82.93%)      94/141 (66.67%)      93/141 (65.96%)    
Gastrointestinal disorders             
Nausea  1  2/80 (2.50%)  3 3/81 (3.70%)  3 2/81 (2.47%)  2 1/82 (1.22%)  1 2/141 (1.42%)  2 2/141 (1.42%)  2
General disorders             
Injection site erythema  1  0/80 (0.00%)  0 2/81 (2.47%)  2 2/81 (2.47%)  4 8/82 (9.76%)  17 0/141 (0.00%)  0 10/141 (7.09%)  17
Injection site pain  1  0/80 (0.00%)  0 6/81 (7.41%)  6 4/81 (4.94%)  17 2/82 (2.44%)  3 6/141 (4.26%)  12 2/141 (1.42%)  4
Pyrexia  1  1/80 (1.25%)  1 4/81 (4.94%)  4 3/81 (3.70%)  3 1/82 (1.22%)  1 1/141 (0.71%)  1 2/141 (1.42%)  2
Infections and infestations             
Influenza  1  4/80 (5.00%)  4 3/81 (3.70%)  5 7/81 (8.64%)  7 6/82 (7.32%)  6 10/141 (7.09%)  11 6/141 (4.26%)  6
Sinusitis  1  3/80 (3.75%)  6 4/81 (4.94%)  7 3/81 (3.70%)  3 2/82 (2.44%)  3 2/141 (1.42%)  2 0/141 (0.00%)  0
Acute sinusitis  1  3/80 (3.75%)  7 4/81 (4.94%)  6 2/81 (2.47%)  2 3/82 (3.66%)  3 2/141 (1.42%)  4 6/141 (4.26%)  8
Bronchitis  1  3/80 (3.75%)  4 8/81 (9.88%)  10 6/81 (7.41%)  8 3/82 (3.66%)  4 13/141 (9.22%)  20 9/141 (6.38%)  11
Nasopharyngitis  1  8/80 (10.00%)  13 11/81 (13.58%)  19 7/81 (8.64%)  13 13/82 (15.85%)  16 5/141 (3.55%)  6 13/141 (9.22%)  17
Pharyngitis  1  3/80 (3.75%)  3 8/81 (9.88%)  10 3/81 (3.70%)  3 7/82 (8.54%)  9 5/141 (3.55%)  5 6/141 (4.26%)  6
Rhinitis  1  3/80 (3.75%)  3 3/81 (3.70%)  3 3/81 (3.70%)  3 2/82 (2.44%)  3 5/141 (3.55%)  5 3/141 (2.13%)  7
Upper respiratory tract  1  4/80 (5.00%)  6 7/81 (8.64%)  12 7/81 (8.64%)  8 5/82 (6.10%)  6 10/141 (7.09%)  12 11/141 (7.80%)  14
Urinary tract infection  1  4/80 (5.00%)  4 2/81 (2.47%)  3 1/81 (1.23%)  1 3/82 (3.66%)  4 5/141 (3.55%)  5 3/141 (2.13%)  3
Musculoskeletal and connective tissue disorders             
Arthralgia  1  1/80 (1.25%)  1 4/81 (4.94%)  5 5/81 (6.17%)  6 3/82 (3.66%)  3 1/141 (0.71%)  1 3/141 (2.13%)  3
Back pain  1  3/80 (3.75%)  3 4/81 (4.94%)  4 2/81 (2.47%)  2 2/82 (2.44%)  4 1/141 (0.71%)  1 3/141 (2.13%)  3
Myalgia  1  1/80 (1.25%)  1 2/81 (2.47%)  2 3/81 (3.70%)  3 2/82 (2.44%)  3 1/141 (0.71%)  1 5/141 (3.55%)  5
Nervous system disorders             
Headache  1  8/80 (10.00%)  13 8/81 (9.88%)  13 6/81 (7.41%)  10 9/82 (10.98%)  10 8/141 (5.67%)  9 13/141 (9.22%)  17
Respiratory, thoracic and mediastinal disorders             
Asthma  1  30/80 (37.50%)  51 28/81 (34.57%)  59 24/81 (29.63%)  42 26/82 (31.71%)  36 42/141 (29.79%)  67 42/141 (29.79%)  77
Rhinitis allergic  1  3/80 (3.75%)  3 3/81 (3.70%)  5 8/81 (9.88%)  13 6/82 (7.32%)  8 4/141 (2.84%)  8 5/141 (3.55%)  11
Vascular disorders             
Hypertension  1  1/80 (1.25%)  2 3/81 (3.70%)  3 0/81 (0.00%)  0 3/82 (3.66%)  3 4/141 (2.84%)  4 10/141 (7.09%)  12
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: Rene van der Merwe, MBChB, MFPM, Medical Officer
Organization: MedImmune, LLC
Phone: 301-398-0000
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01238861     History of Changes
Other Study ID Numbers: MI-CP220
2010-020126-17 ( EudraCT Number )
First Submitted: November 9, 2010
First Posted: November 11, 2010
Results First Submitted: May 31, 2016
Results First Posted: November 17, 2016
Last Update Posted: November 17, 2016