Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563). (NCT NCT00768079)
NCT ID: NCT00768079
Last Updated: 2020-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Week 12
Results posted on
2020-11-18
Participant Flow
A total of 110 participants were randomized in the study.
Participant milestones
| Measure |
Placebo
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
4
|
|
Overall Study
Participant incarcerated
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.9 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
37.9 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
34.8 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
36.2 Years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Evaluable population included all participants who received any study drug and were followed according to the protocol through Day 42.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Percentage of Participants With Asthma Exacerbations at Week 12
Non-adjudicated Exacerbations
|
38.9 percentage of participants
|
25.0 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants With Asthma Exacerbations at Week 12
Adjudicated Exacerbations
|
38.9 percentage of participants
|
25.0 percentage of participants
|
41.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 84Population: Safety population included all participants who received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
30 Participants
|
32 Participants
|
30 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
9 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Weeks 4 and 24Population: Evaluable population included all participants who received any study drug and were followed according to the protocol through Day 42.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24
Week 4: Non-adjudicated Exacerbations
|
22.2 percentage of participants
|
11.1 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24
Week 4: Adjudicated Exacerbations
|
22.2 percentage of participants
|
11.1 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24
Week 24: Non-adjudicated Exacerbations
|
47.2 percentage of participants
|
36.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24
Week 24: Adjudicated Exacerbations
|
47.2 percentage of participants
|
36.1 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 42, and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Asthma Control Questionnaire (ACQ) Scores
Symptoms on waking: Day 7
|
1.8 units on a scale
Standard Deviation 1.3
|
2.0 units on a scale
Standard Deviation 1.4
|
1.4 units on a scale
Standard Deviation 1.2
|
|
Asthma Control Questionnaire (ACQ) Scores
Overall ACQ: Day 0
|
3.69 units on a scale
Standard Deviation 0.82
|
3.72 units on a scale
Standard Deviation 1.18
|
3.26 units on a scale
Standard Deviation 1.27
|
|
Asthma Control Questionnaire (ACQ) Scores
Overall ACQ: Day 7
|
1.89 units on a scale
Standard Deviation 1.16
|
1.89 units on a scale
Standard Deviation 1.36
|
1.52 units on a scale
Standard Deviation 0.96
|
|
Asthma Control Questionnaire (ACQ) Scores
Overall ACQ: Day 42
|
1.70 units on a scale
Standard Deviation 1.23
|
1.76 units on a scale
Standard Deviation 1.25
|
1.50 units on a scale
Standard Deviation 1.13
|
|
Asthma Control Questionnaire (ACQ) Scores
Overall ACQ: Day 84
|
1.59 units on a scale
Standard Deviation 1.23
|
1.75 units on a scale
Standard Deviation 1.33
|
1.70 units on a scale
Standard Deviation 1.12
|
|
Asthma Control Questionnaire (ACQ) Scores
Night-time waking: Day 0
|
3.1 units on a scale
Standard Deviation 1.4
|
3.5 units on a scale
Standard Deviation 1.8
|
2.9 units on a scale
Standard Deviation 1.7
|
|
Asthma Control Questionnaire (ACQ) Scores
Night-time waking: Day 7
|
1.7 units on a scale
Standard Deviation 1.6
|
1.7 units on a scale
Standard Deviation 1.7
|
1.0 units on a scale
Standard Deviation 1.0
|
|
Asthma Control Questionnaire (ACQ) Scores
Night-time waking: Day 42
|
1.4 units on a scale
Standard Deviation 1.6
|
1.6 units on a scale
Standard Deviation 1.5
|
1.2 units on a scale
Standard Deviation 1.4
|
|
Asthma Control Questionnaire (ACQ) Scores
Night-time waking: Day 84
|
1.3 units on a scale
Standard Deviation 1.4
|
1.4 units on a scale
Standard Deviation 1.6
|
1.2 units on a scale
Standard Deviation 1.2
|
|
Asthma Control Questionnaire (ACQ) Scores
Symptoms on waking: Day 0
|
3.4 units on a scale
Standard Deviation 1.4
|
3.5 units on a scale
Standard Deviation 1.5
|
2.8 units on a scale
Standard Deviation 1.5
|
|
Asthma Control Questionnaire (ACQ) Scores
Symptoms on waking: Day 42
|
1.6 units on a scale
Standard Deviation 1.3
|
1.6 units on a scale
Standard Deviation 1.3
|
1.2 units on a scale
Standard Deviation 1.0
|
|
Asthma Control Questionnaire (ACQ) Scores
Symptoms on waking: Day 84
|
1.5 units on a scale
Standard Deviation 1.6
|
1.7 units on a scale
Standard Deviation 1.4
|
1.6 units on a scale
Standard Deviation 1.2
|
|
Asthma Control Questionnaire (ACQ) Scores
Activity limitation: Day 0
|
3.6 units on a scale
Standard Deviation 1.3
|
3.5 units on a scale
Standard Deviation 1.4
|
3.2 units on a scale
Standard Deviation 1.8
|
|
Asthma Control Questionnaire (ACQ) Scores
Activity limitation: Day 7
|
1.7 units on a scale
Standard Deviation 1.3
|
1.8 units on a scale
Standard Deviation 1.5
|
1.5 units on a scale
Standard Deviation 1.5
|
|
Asthma Control Questionnaire (ACQ) Scores
Activity limitation: Day 42
|
1.6 units on a scale
Standard Deviation 1.5
|
1.6 units on a scale
Standard Deviation 1.5
|
1.4 units on a scale
Standard Deviation 1.3
|
|
Asthma Control Questionnaire (ACQ) Scores
Activity limitation: Day 84
|
1.3 units on a scale
Standard Deviation 1.3
|
1.5 units on a scale
Standard Deviation 1.3
|
2.0 units on a scale
Standard Deviation 1.9
|
|
Asthma Control Questionnaire (ACQ) Scores
Shortness of breath: Day 0
|
4.4 units on a scale
Standard Deviation 1.0
|
4.2 units on a scale
Standard Deviation 1.3
|
3.7 units on a scale
Standard Deviation 1.5
|
|
Asthma Control Questionnaire (ACQ) Scores
Shortness of breath: Day 7
|
1.9 units on a scale
Standard Deviation 1.4
|
2.1 units on a scale
Standard Deviation 1.5
|
1.8 units on a scale
Standard Deviation 1.4
|
|
Asthma Control Questionnaire (ACQ) Scores
Shortness of breath: Day 42
|
2.0 units on a scale
Standard Deviation 1.3
|
2.1 units on a scale
Standard Deviation 1.5
|
1.9 units on a scale
Standard Deviation 1.5
|
|
Asthma Control Questionnaire (ACQ) Scores
Shortness of breath: Day 84
|
1.8 units on a scale
Standard Deviation 1.3
|
2.0 units on a scale
Standard Deviation 1.4
|
1.9 units on a scale
Standard Deviation 1.4
|
|
Asthma Control Questionnaire (ACQ) Scores
Wheeze: Day 0
|
4.5 units on a scale
Standard Deviation 1.1
|
4.2 units on a scale
Standard Deviation 1.5
|
4.0 units on a scale
Standard Deviation 1.6
|
|
Asthma Control Questionnaire (ACQ) Scores
Wheeze: Day 7
|
2.6 units on a scale
Standard Deviation 1.9
|
2.2 units on a scale
Standard Deviation 1.6
|
2.0 units on a scale
Standard Deviation 1.8
|
|
Asthma Control Questionnaire (ACQ) Scores
Wheeze: Day 42
|
2.1 units on a scale
Standard Deviation 1.5
|
2.0 units on a scale
Standard Deviation 1.5
|
1.8 units on a scale
Standard Deviation 1.5
|
|
Asthma Control Questionnaire (ACQ) Scores
Wheeze: Day 84
|
2.1 units on a scale
Standard Deviation 1.7
|
2.2 units on a scale
Standard Deviation 1.7
|
1.8 units on a scale
Standard Deviation 1.6
|
|
Asthma Control Questionnaire (ACQ) Scores
Rescue beta-2 agonist use: Day 0
|
3.0 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.6
|
3.2 units on a scale
Standard Deviation 1.5
|
|
Asthma Control Questionnaire (ACQ) Scores
Rescue beta-2 agonist use: Day 7
|
1.7 units on a scale
Standard Deviation 1.1
|
1.6 units on a scale
Standard Deviation 1.5
|
1.3 units on a scale
Standard Deviation 0.9
|
|
Asthma Control Questionnaire (ACQ) Scores
Rescue beta-2 agonist use: Day 42
|
1.5 units on a scale
Standard Deviation 1.3
|
1.6 units on a scale
Standard Deviation 1.3
|
1.6 units on a scale
Standard Deviation 1.6
|
|
Asthma Control Questionnaire (ACQ) Scores
Rescue beta-2 agonist use: Day 84
|
1.5 units on a scale
Standard Deviation 1.2
|
1.7 units on a scale
Standard Deviation 1.4
|
1.8 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Days 0, 7, 42, and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites
Day 7
|
2.008 liters
Standard Deviation 0.632
|
2.003 liters
Standard Deviation 0.655
|
2.254 liters
Standard Deviation 0.723
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites
Day 0
|
1.696 liters
Standard Deviation 0.523
|
1.689 liters
Standard Deviation 0.698
|
2.067 liters
Standard Deviation 0.746
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites
Day 42
|
1.962 liters
Standard Deviation 0.714
|
2.130 liters
Standard Deviation 0.713
|
2.150 liters
Standard Deviation 0.723
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites
Day 84
|
2.048 liters
Standard Deviation 0.761
|
2.043 liters
Standard Deviation 0.710
|
2.209 liters
Standard Deviation 0.791
|
SECONDARY outcome
Timeframe: Day 1 to Day 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 1 to 7
|
1.6346 liters
Standard Deviation 0.4868
|
1.7119 liters
Standard Deviation 0.6309
|
1.8404 liters
Standard Deviation 0.7222
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 8 to 14
|
1.7800 liters
Standard Deviation 0.5608
|
1.8562 liters
Standard Deviation 0.6467
|
1.7674 liters
Standard Deviation 0.7305
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 15 to 21
|
1.7024 liters
Standard Deviation 0.5200
|
1.7874 liters
Standard Deviation 0.6529
|
1.8219 liters
Standard Deviation 0.7241
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 22 to 28
|
1.6751 liters
Standard Deviation 0.5814
|
1.8188 liters
Standard Deviation 0.6461
|
1.8351 liters
Standard Deviation 0.7107
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 29 to 35
|
1.6446 liters
Standard Deviation 0.4962
|
1.7937 liters
Standard Deviation 0.6229
|
1.7486 liters
Standard Deviation 0.7093
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 36 to 42
|
1.7230 liters
Standard Deviation 0.5844
|
1.7935 liters
Standard Deviation 0.6341
|
1.7298 liters
Standard Deviation 0.6923
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 43 to 49
|
1.7326 liters
Standard Deviation 0.5426
|
1.7999 liters
Standard Deviation 0.6735
|
1.7803 liters
Standard Deviation 0.6655
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 50 to 56
|
1.6965 liters
Standard Deviation 0.5756
|
1.7532 liters
Standard Deviation 0.6530
|
1.7806 liters
Standard Deviation 0.6558
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 57 to 63
|
1.6600 liters
Standard Deviation 0.6013
|
1.7682 liters
Standard Deviation 0.6619
|
1.8504 liters
Standard Deviation 0.7636
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 64 to 70
|
1.7218 liters
Standard Deviation 0.6308
|
1.8735 liters
Standard Deviation 0.7701
|
1.7904 liters
Standard Deviation 0.7959
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 71 to 77
|
1.7180 liters
Standard Deviation 0.5969
|
1.7811 liters
Standard Deviation 0.6721
|
1.7401 liters
Standard Deviation 0.6891
|
|
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
Day 78 to 84
|
1.7591 liters
Standard Deviation 0.6944
|
1.6655 liters
Standard Deviation 0.6032
|
1.7818 liters
Standard Deviation 0.7009
|
SECONDARY outcome
Timeframe: Day 1 to Day 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 71 to 77
|
160.717 liters per minute (L/min)
Standard Deviation 61.017
|
175.379 liters per minute (L/min)
Standard Deviation 59.158
|
160.167 liters per minute (L/min)
Standard Deviation 59.618
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 78 to 84
|
167.197 liters per minute (L/min)
Standard Deviation 58.690
|
172.788 liters per minute (L/min)
Standard Deviation 56.722
|
164.982 liters per minute (L/min)
Standard Deviation 60.271
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 1 to 7
|
161.845 liters per minute (L/min)
Standard Deviation 45.186
|
179.000 liters per minute (L/min)
Standard Deviation 61.653
|
177.929 liters per minute (L/min)
Standard Deviation 58.791
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 8 to 14
|
175.093 liters per minute (L/min)
Standard Deviation 50.914
|
186.538 liters per minute (L/min)
Standard Deviation 52.945
|
172.811 liters per minute (L/min)
Standard Deviation 59.941
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 15 to 21
|
169.489 liters per minute (L/min)
Standard Deviation 51.560
|
180.627 liters per minute (L/min)
Standard Deviation 55.853
|
180.362 liters per minute (L/min)
Standard Deviation 60.894
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 22 to 28
|
163.844 liters per minute (L/min)
Standard Deviation 57.753
|
183.066 liters per minute (L/min)
Standard Deviation 54.902
|
181.199 liters per minute (L/min)
Standard Deviation 62.497
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 29 to 35
|
163.999 liters per minute (L/min)
Standard Deviation 53.078
|
179.064 liters per minute (L/min)
Standard Deviation 55.297
|
171.458 liters per minute (L/min)
Standard Deviation 65.889
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 36 to 42
|
169.510 liters per minute (L/min)
Standard Deviation 57.745
|
178.373 liters per minute (L/min)
Standard Deviation 51.881
|
168.228 liters per minute (L/min)
Standard Deviation 64.673
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 43 to 49
|
171.373 liters per minute (L/min)
Standard Deviation 56.824
|
185.847 liters per minute (L/min)
Standard Deviation 57.767
|
169.727 liters per minute (L/min)
Standard Deviation 65.110
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 50 to 56
|
169.487 liters per minute (L/min)
Standard Deviation 58.325
|
178.070 liters per minute (L/min)
Standard Deviation 57.414
|
169.230 liters per minute (L/min)
Standard Deviation 62.696
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 57 to 63
|
169.723 liters per minute (L/min)
Standard Deviation 61.318
|
176.761 liters per minute (L/min)
Standard Deviation 56.410
|
169.374 liters per minute (L/min)
Standard Deviation 70.249
|
|
Peak Expiratory Flow (PEF) Recorded at Home
Day 64 to 70
|
166.968 liters per minute (L/min)
Standard Deviation 57.401
|
188.805 liters per minute (L/min)
Standard Deviation 59.186
|
164.368 liters per minute (L/min)
Standard Deviation 66.619
|
SECONDARY outcome
Timeframe: Day 1 to Day 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 1 to 7
|
1.95 puffs per week
Standard Deviation 1.75
|
1.74 puffs per week
Standard Deviation 2.05
|
1.47 puffs per week
Standard Deviation 1.76
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 8 to 14
|
1.80 puffs per week
Standard Deviation 2.01
|
1.63 puffs per week
Standard Deviation 1.90
|
1.38 puffs per week
Standard Deviation 2.07
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 15 to 21
|
1.57 puffs per week
Standard Deviation 2.00
|
2.01 puffs per week
Standard Deviation 3.34
|
1.42 puffs per week
Standard Deviation 1.70
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 22 to 28
|
1.93 puffs per week
Standard Deviation 2.65
|
1.83 puffs per week
Standard Deviation 2.55
|
1.45 puffs per week
Standard Deviation 1.76
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 29 to 35
|
1.76 puffs per week
Standard Deviation 2.79
|
1.62 puffs per week
Standard Deviation 2.17
|
1.53 puffs per week
Standard Deviation 1.73
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 36 to 42
|
1.86 puffs per week
Standard Deviation 3.36
|
1.42 puffs per week
Standard Deviation 1.65
|
1.59 puffs per week
Standard Deviation 1.92
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 43 to 49
|
1.85 puffs per week
Standard Deviation 3.53
|
1.33 puffs per week
Standard Deviation 1.44
|
1.71 puffs per week
Standard Deviation 2.05
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 50 to 56
|
2.16 puffs per week
Standard Deviation 4.83
|
1.52 puffs per week
Standard Deviation 1.94
|
1.87 puffs per week
Standard Deviation 2.32
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 57 to 63
|
2.59 puffs per week
Standard Deviation 6.63
|
1.43 puffs per week
Standard Deviation 1.73
|
1.54 puffs per week
Standard Deviation 1.56
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 64 to 70
|
2.69 puffs per week
Standard Deviation 6.43
|
1.50 puffs per week
Standard Deviation 1.76
|
1.48 puffs per week
Standard Deviation 1.65
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 71 to 77
|
1.69 puffs per week
Standard Deviation 1.96
|
1.39 puffs per week
Standard Deviation 1.84
|
1.48 puffs per week
Standard Deviation 1.44
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 78 to 84
|
1.27 puffs per week
Standard Deviation 1.56
|
2.04 puffs per week
Standard Deviation 3.11
|
1.47 puffs per week
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Days 42 and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 42: Excellent
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 42: Good
|
12 Participants
|
19 Participants
|
16 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 42: Moderate
|
8 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 42: Poor
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 42: Worsening
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 42: Not applicable
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 84: Excellent
|
8 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 84: Good
|
15 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 84: Moderate
|
7 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 84: Poor
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 84: Worsening
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
Day 84: Not applicable
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 42, and 84Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 0
|
3.14 units on a scale
Standard Deviation 0.91
|
3.18 units on a scale
Standard Deviation 0.95
|
3.35 units on a scale
Standard Deviation 1.11
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 42
|
4.74 units on a scale
Standard Deviation 1.65
|
4.76 units on a scale
Standard Deviation 1.46
|
5.16 units on a scale
Standard Deviation 1.44
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 84
|
4.91 units on a scale
Standard Deviation 1.71
|
5.01 units on a scale
Standard Deviation 1.44
|
5.11 units on a scale
Standard Deviation 1.35
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptoms: Day 0
|
2.84 units on a scale
Standard Deviation 0.94
|
2.79 units on a scale
Standard Deviation 1.08
|
3.11 units on a scale
Standard Deviation 1.25
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptoms: Day 42
|
4.77 units on a scale
Standard Deviation 1.82
|
4.82 units on a scale
Standard Deviation 1.45
|
5.19 units on a scale
Standard Deviation 1.62
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptoms: Day 84
|
4.94 units on a scale
Standard Deviation 1.68
|
4.95 units on a scale
Standard Deviation 1.53
|
5.09 units on a scale
Standard Deviation 1.36
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity limitation: Day 0
|
3.56 units on a scale
Standard Deviation 0.97
|
3.74 units on a scale
Standard Deviation 1.13
|
3.98 units on a scale
Standard Deviation 1.29
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity limitation: Day 42
|
4.96 units on a scale
Standard Deviation 1.54
|
4.92 units on a scale
Standard Deviation 1.51
|
5.30 units on a scale
Standard Deviation 1.42
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity limitation: Day 84
|
5.11 units on a scale
Standard Deviation 1.74
|
5.23 units on a scale
Standard Deviation 1.36
|
5.24 units on a scale
Standard Deviation 1.44
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional function: Day 0
|
2.73 units on a scale
Standard Deviation 1.25
|
2.44 units on a scale
Standard Deviation 1.16
|
2.47 units on a scale
Standard Deviation 1.48
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional function: Day 42
|
4.30 units on a scale
Standard Deviation 1.96
|
4.35 units on a scale
Standard Deviation 1.77
|
4.91 units on a scale
Standard Deviation 1.66
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional function: Day 84
|
4.59 units on a scale
Standard Deviation 2.04
|
4.59 units on a scale
Standard Deviation 1.75
|
4.84 units on a scale
Standard Deviation 1.73
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environmental stimuli: Day 0
|
3.35 units on a scale
Standard Deviation 1.31
|
3.72 units on a scale
Standard Deviation 1.29
|
3.42 units on a scale
Standard Deviation 1.48
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environmental stimuli: Day 42
|
4.59 units on a scale
Standard Deviation 1.69
|
4.63 units on a scale
Standard Deviation 1.53
|
4.99 units on a scale
Standard Deviation 1.44
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environmental stimuli: Day 84
|
4.69 units on a scale
Standard Deviation 1.80
|
5.08 units on a scale
Standard Deviation 1.62
|
5.13 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Day 0 to Day 168Population: Evaluable population included all participants who received any study drug and were followed according to the protocol through Day 42.
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.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
Benralizumab 1.0 mg/kg
n=36 Participants
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Number of Healthcare Resources Utilized by Resource Type
Hospitalizations
|
64 healthcare resources
|
40 healthcare resources
|
43 healthcare resources
|
|
Number of Healthcare Resources Utilized by Resource Type
Urgent care
|
2 healthcare resources
|
0 healthcare resources
|
0 healthcare resources
|
|
Number of Healthcare Resources Utilized by Resource Type
Primary care clinic visits
|
3 healthcare resources
|
1 healthcare resources
|
5 healthcare resources
|
|
Number of Healthcare Resources Utilized by Resource Type
Asthma specialist clinic visits
|
5 healthcare resources
|
5 healthcare resources
|
0 healthcare resources
|
|
Number of Healthcare Resources Utilized by Resource Type
Telephone calls
|
6 healthcare resources
|
1 healthcare resources
|
4 healthcare resources
|
|
Number of Healthcare Resources Utilized by Resource Type
Home management
|
2 healthcare resources
|
1 healthcare resources
|
4 healthcare resources
|
SECONDARY outcome
Timeframe: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84Population: 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.
The Cmax of benralizumab is reported. Non-compartmental pharmacokinetic (PK) analysis was used for evaluation.
Outcome measures
| Measure |
Placebo
n=32 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=33 Participants
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.
|
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.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Benralizumab
|
7.03 microgram per milliliter (mcg/mL)
Standard Deviation 1.78
|
26.7 microgram per milliliter (mcg/mL)
Standard Deviation 6.49
|
—
|
SECONDARY outcome
Timeframe: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84Population: 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.
AUClast = area under the concentration-time curve from time 0 to last measurable concentration. Non-compartmental PK analysis was used for evaluation.
Outcome measures
| Measure |
Placebo
n=31 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=27 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
263 microgram*day per milliliter
Standard Deviation 64.1
|
—
|
SECONDARY outcome
Timeframe: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=27 Participants
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.
|
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.
|
|---|---|---|---|
|
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 18.0
|
268 microgram*day per milliliter
Standard Deviation 65.7
|
—
|
SECONDARY outcome
Timeframe: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=27 Participants
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.
|
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.
|
|---|---|---|---|
|
Systemic Clearance (CL) for Benralizumab
|
4.92 milliliter per kilogram per day
Standard Deviation 1.96
|
3.97 milliliter per kilogram per day
Standard Deviation 1.02
|
—
|
SECONDARY outcome
Timeframe: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=27 Participants
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.
|
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.
|
|---|---|---|---|
|
Terminal Phase Elimination Half-Life (t1/2) for Benralizumab
|
11.5 days
Standard Deviation 3.14
|
13.2 days
Standard Deviation 2.39
|
—
|
SECONDARY outcome
Timeframe: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=32 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=33 Participants
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.
|
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.
|
|---|---|---|---|
|
Volume of Distribution of the Central Compartment (Vc) for Benralizumab
|
46.4 milliliter per kilogram (mL/kg)
Standard Deviation 17.0
|
39.8 milliliter per kilogram (mL/kg)
Standard Deviation 10.3
|
—
|
SECONDARY outcome
Timeframe: Predose and 1 hour post-end of infusion on Day 0; Days 7, 42, and 84Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=27 Participants
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.
|
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.
|
|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) for Benralizumab
|
71.8 mL/kg
Standard Deviation 23.2
|
64.0 mL/kg
Standard Deviation 15.1
|
—
|
SECONDARY outcome
Timeframe: Day 0 and 84Population: 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.
Number of participants with anti-drug antibodies to benralizumab is reported.
Outcome measures
| Measure |
Placebo
n=36 Participants
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies to Benralizumab
Day 84
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies to Benralizumab
Day 0
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Benralizumab 0.3 mg/kg
Serious events: 8 serious events
Other events: 30 other events
Deaths: 0 deaths
Benralizumab 1.0 mg/kg
Serious events: 11 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=38 participants at risk
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 participants at risk
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.
|
Benralizumab 1.0 mg/kg
n=36 participants at risk
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Pyrexia
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Abscess limb
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Pneumonia
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
23.7%
9/38 • Number of events 16 • Day 0 to Day 84
|
11.1%
4/36 • Number of events 8 • Day 0 to Day 84
|
16.7%
6/36 • Number of events 9 • Day 0 to Day 84
|
Other adverse events
| Measure |
Placebo
n=38 participants at risk
A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
|
Benralizumab 0.3 mg/kg
n=36 participants at risk
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.
|
Benralizumab 1.0 mg/kg
n=36 participants at risk
A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/38 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/38 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Vascular disorders
Flushing
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.9%
3/38 • Number of events 3 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/38 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Renal and urinary disorders
Dysuria
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Reproductive system and breast disorders
Amenorrhoea
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
47.4%
18/38 • Number of events 36 • Day 0 to Day 84
|
33.3%
12/36 • Number of events 34 • Day 0 to Day 84
|
38.9%
14/36 • Number of events 24 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
3/38 • Number of events 3 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
16.7%
6/36 • Number of events 6 • Day 0 to Day 84
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/38 • Number of events 2 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Nervous system disorders
Dizziness
|
2.6%
1/38 • Number of events 2 • Day 0 to Day 84
|
13.9%
5/36 • Number of events 5 • Day 0 to Day 84
|
8.3%
3/36 • Number of events 3 • Day 0 to Day 84
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Nervous system disorders
Headache
|
10.5%
4/38 • Number of events 5 • Day 0 to Day 84
|
13.9%
5/36 • Number of events 7 • Day 0 to Day 84
|
25.0%
9/36 • Number of events 10 • Day 0 to Day 84
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Nervous system disorders
Migraine
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Nervous system disorders
Paraesthesia
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Nervous system disorders
Syncope
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Nervous system disorders
Tremor
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 3 • Day 0 to Day 84
|
|
Psychiatric disorders
Depression
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Cardiac disorders
Tachycardia
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Eye disorders
Diplopia
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Eye disorders
Vision blurred
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 3 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/38 • Day 0 to Day 84
|
8.3%
3/36 • Number of events 3 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
8.3%
3/36 • Number of events 3 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Procedural nausea
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
General disorders
Asthenia
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
General disorders
Chest discomfort
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Chest pain
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
General disorders
Chills
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
General disorders
Fatigue
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
General disorders
Feeling cold
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Generalised oedema
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Influenza like illness
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
General disorders
Infusion site oedema
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Infusion site pain
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
General disorders
Infusion site rash
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Oedema peripheral
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
General disorders
Pyrexia
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 2 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Bronchitis
|
7.9%
3/38 • Number of events 3 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 3 • Day 0 to Day 84
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Candidiasis
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Cellulitis staphylococcal
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Gastroenteritis
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Infections and infestations
Otitis externa
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Otitis media
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Pneumonia
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Respiratory tract infection
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Sinusitis
|
0.00%
0/38 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
3/38 • Number of events 4 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Vaginal infection
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Infections and infestations
Viral infection
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/38 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Investigations
Blood creatinine increased
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
8.3%
3/36 • Number of events 3 • Day 0 to Day 84
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Investigations
Blood pressure decreased
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Investigations
Weight decreased
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Investigations
White blood cell count increased
|
0.00%
0/38 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
3/38 • Number of events 3 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
5.6%
2/36 • Number of events 2 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
2/38 • Number of events 2 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/38 • Day 0 to Day 84
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 84
|
0.00%
0/36 • Day 0 to Day 84
|
Additional Information
Joseph M. Parker, Director, Clinical Development
MedImmune, LLC
Phone: +1 301-398-4095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER