Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01227278)
NCT ID: NCT01227278
Last Updated: 2016-10-05
Results Overview
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.
COMPLETED
PHASE2
421 participants
Day 1 up to 393
2016-10-05
Participant Flow
A total of 421 participants were screened and 101 participants were randomized into the study.
Participant milestones
| Measure |
Placebo
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=51 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 393Population: The per protocol (PP) population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
|
0.92 AECOPD events/person-year
Interval 0.67 to 1.25
|
0.95 AECOPD events/person-year
Interval 0.68 to 1.29
|
SECONDARY outcome
Timeframe: Day 1 up to 561Population: The safety population included all participants who received at least one dose of investigational drug.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=51 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
41 participants
|
45 participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
9 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Day 1 up to 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 up to 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
|
11.9 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
|
0.11 hospitalizations/person-year
Interval 0.05 to 0.26
|
0.05 hospitalizations/person-year
Interval 0.01 to 0.18
|
SECONDARY outcome
Timeframe: Baseline, Day 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Baseline: Total Score (n=42, 40)
|
48.04 units on scale
Standard Deviation 19.14
|
51.75 units on scale
Standard Deviation 20.45
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Change at Day 393: Total Score (n=42, 37)
|
-4.43 units on scale
Standard Deviation 11.71
|
-5.51 units on scale
Standard Deviation 16.64
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Baseline: Symptoms (n=42, 40)
|
64.59 units on scale
Standard Deviation 24.38
|
67.18 units on scale
Standard Deviation 21.47
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Change at Day 393: Symptoms (n=42, 37)
|
-3.19 units on scale
Standard Deviation 17.44
|
-9.02 units on scale
Standard Deviation 21.27
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Baseline: Activity (n=42, 40)
|
58.85 units on scale
Standard Deviation 23.22
|
61.45 units on scale
Standard Deviation 25.53
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Change at Day 393: Activity (n=42, 37)
|
-5.65 units on scale
Standard Deviation 14.85
|
-4.37 units on scale
Standard Deviation 24.89
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Baseline: Impact (n=42, 40)
|
35.94 units on scale
Standard Deviation 18.95
|
40.69 units on scale
Standard Deviation 22.49
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Change at Day 393: Impact (n=42, 37)
|
-4.16 units on scale
Standard Deviation 14.62
|
-4.95 units on scale
Standard Deviation 16.97
|
SECONDARY outcome
Timeframe: Day 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Day 393, Total: 4-point change (n=42, 37)
|
59.5 percentage of participants
|
54.1 percentage of participants
|
|
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Day 393: 8-point change (n=42, 37)
|
38.1 percentage of participants
|
40.5 percentage of participants
|
|
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Day 393, Total: 12-point change (n=42, 37)
|
21.4 percentage of participants
|
24.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Change at Day 393: Mastery (n=42, 37)
|
0.24 units on scale
Standard Deviation 1.12
|
0.28 units on scale
Standard Deviation 1.24
|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Baseline: Dyspnea (n=42, 40)
|
4.97 units on scale
Standard Deviation 1.45
|
4.74 units on scale
Standard Deviation 1.32
|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Change at Day 393: Dyspnea (n=42, 37)
|
-0.08 units on scale
Standard Deviation 1.29
|
0.09 units on scale
Standard Deviation 1.00
|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Baseline: Fatigue (n=42, 40)
|
4.38 units on scale
Standard Deviation 1.26
|
3.96 units on scale
Standard Deviation 1.40
|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Change at Day 393: Fatigue (n=42, 37)
|
0.11 units on scale
Standard Deviation 0.94
|
0.11 units on scale
Standard Deviation 1.15
|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Baseline: Emotional function (n=42, 40)
|
4.84 units on scale
Standard Deviation 1.24
|
4.72 units on scale
Standard Deviation 1.17
|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Change at Day 393: Emotional function (n=42, 37)
|
0.18 units on scale
Standard Deviation 0.98
|
0.08 units on scale
Standard Deviation 1.18
|
|
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Baseline: Mastery (n=42, 40)
|
4.89 units on scale
Standard Deviation 1.50
|
4.67 units on scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Day 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Day 393: Dyspnea (n=42, 37)
|
28.6 percentage of participants
|
32.4 percentage of participants
|
|
Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Day 393: Fatigue (n=42, 37)
|
35.7 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Day 393: Emotional function (n=42, 37)
|
35.7 percentage of participants
|
27.0 percentage of participants
|
|
Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Day 393: Mastery (n=42, 37)
|
47.6 percentage of participants
|
37.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 393Population: The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=40 Participants
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393
Baseline (n=40, 39)
|
2.8 units on scale
Standard Deviation 2.0
|
2.9 units on scale
Standard Deviation 1.8
|
|
Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393
Change at Day 393 (n=37, 32)
|
-0.1 units on scale
Standard Deviation 1.4
|
-0.5 units on scale
Standard Deviation 1.4
|
Adverse Events
Placebo
Benralizumab 100 mg
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=51 participants at risk
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
General disorders
Asthenia
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
General disorders
Sudden death
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • Number of events 3 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Lower respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Nervous system disorders
Presyncope
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
12.0%
6/50 • Number of events 8 • Day 1 to 561
|
11.8%
6/51 • Number of events 8 • Day 1 to 561
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Day 1 to 561
|
2.0%
1/51 • Number of events 2 • Day 1 to 561
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
Benralizumab 100 mg
n=51 participants at risk
Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
4/50 • Number of events 4 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
4/50 • Number of events 4 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.0%
3/50 • Number of events 3 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
General disorders
Asthenia
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
General disorders
Injection site erythema
|
0.00%
0/50 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
General disorders
Injection site inflammation
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
General disorders
Injection site pain
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
General disorders
Injection site reaction
|
0.00%
0/50 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
General disorders
Oedema peripheral
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
General disorders
Pyrexia
|
0.00%
0/50 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Infections and infestations
Acute sinusitis
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Bronchitis
|
6.0%
3/50 • Number of events 3 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Infections and infestations
Cystitis
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
3.9%
2/51 • Number of events 3 • Day 1 to 561
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
2.0%
1/50 • Number of events 3 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Infections and infestations
Nasopharyngitis
|
22.0%
11/50 • Number of events 13 • Day 1 to 561
|
9.8%
5/51 • Number of events 8 • Day 1 to 561
|
|
Infections and infestations
Oral candidiasis
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
7.8%
4/51 • Number of events 4 • Day 1 to 561
|
|
Infections and infestations
Pneumonia
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Infections and infestations
Rhinitis
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 2 • Day 1 to 561
|
|
Infections and infestations
Sinusitis
|
8.0%
4/50 • Number of events 4 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
9.8%
5/51 • Number of events 6 • Day 1 to 561
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/50 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Investigations
Breath sounds abnormal
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Investigations
C-reactive protein increased
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/50 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
3/50 • Number of events 3 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50 • Day 1 to 561
|
5.9%
3/51 • Number of events 3 • Day 1 to 561
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Nervous system disorders
Headache
|
6.0%
3/50 • Number of events 3 • Day 1 to 561
|
7.8%
4/51 • Number of events 7 • Day 1 to 561
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Nervous system disorders
Sciatica
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 3 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
50.0%
25/50 • Number of events 62 • Day 1 to 561
|
51.0%
26/51 • Number of events 53 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50 • Number of events 4 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
5/50 • Number of events 5 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
4/50 • Number of events 4 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.0%
3/50 • Number of events 3 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Vascular disorders
Aortic arteriosclerosis
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
0.00%
0/51 • Day 1 to 561
|
|
Vascular disorders
Hot flush
|
2.0%
1/50 • Number of events 1 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
|
Vascular disorders
Hypertension
|
4.0%
2/50 • Number of events 2 • Day 1 to 561
|
2.0%
1/51 • Number of events 1 • Day 1 to 561
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Day 1 to 561
|
3.9%
2/51 • Number of events 2 • Day 1 to 561
|
Additional Information
Rene van der Merwe, MBChB/Senior Director, Clinical Development
MedImmune, LLC.
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