Trial Outcomes & Findings for Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis (NCT NCT05006573)
NCT ID: NCT05006573
Last Updated: 2025-07-20
Results Overview
Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
through Double-blind period, at least 28 weeks and up to 52 weeks
Results posted on
2025-07-20
Participant Flow
The plan was to randomize 420 eligible patients in a 1:1 ratio to receive either benralizumab or a matching placebo after screening. Patients were stratified at randomization by screening blood eosinophil category, country, and current chronic macrolide use. Due to the decision to stop recruitment early, 100 patients were randomized to receive benralizumab or placebo (20:80 in the low \& high blood eosinophil strata). The revised DB treatment period was at least 28 weeks and up to 52 weeks.
All patients completed a screening period of 2 to 6 weeks during which inclusion/exclusion criteria was assessed, disease activity, lung function and patient reported outcomes (PROs) were recorded, medical history and clinical laboratory were taken.
Participant milestones
| Measure |
Benralizumab 30 mg
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Double-blind Treatment Period
STARTED
|
54
|
45
|
|
Double-blind Treatment Period
Treated
|
54
|
45
|
|
Double-blind Treatment Period
COMPLETED
|
42
|
42
|
|
Double-blind Treatment Period
NOT COMPLETED
|
12
|
3
|
|
Open-label Extension Period
STARTED
|
38
|
40
|
|
Open-label Extension Period
COMPLETED
|
38
|
39
|
|
Open-label Extension Period
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Benralizumab 30 mg
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Double-blind Treatment Period
Physician Decision
|
2
|
0
|
|
Double-blind Treatment Period
Study terminated by sponsor
|
1
|
0
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
7
|
2
|
|
Double-blind Treatment Period
Protocol Violation
|
2
|
0
|
|
Double-blind Treatment Period
Subject decision without consent withdrawn
|
0
|
1
|
|
Open-label Extension Period
Subject decision without consent withdrawn
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
Baseline characteristics by cohort
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 13.14 • n=99 Participants
|
59.2 years
STANDARD_DEVIATION 15.49 • n=107 Participants
|
59.2 years
STANDARD_DEVIATION 14.18 • n=206 Participants
|
|
Age, Customized
>= 18 to <= 65 years
|
34 participants
n=99 Participants
|
21 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Age, Customized
> 65 years
|
20 participants
n=99 Participants
|
24 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period
|
1.44 exacerbations per year
Interval 1.05 to 1.97
|
1.27 exacerbations per year
Interval 0.89 to 1.8
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Time to first NCFB exacerbation in the double-blind treatment period
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Time to First Exacerbation in the Double-blind Treatment Period
|
233 days
Interval 118.0 to
The upper limit of the median time to first exacerbation is not estimable due to insufficient number of participants with events.
|
316 days
Interval 141.0 to
The upper limit of the median time to first exacerbation is not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Quality of Life-Bronchiectasis-Respiratory Symptoms Scale over the double-blind treatment period. QoL-B-RSS scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 2
|
6.6 score on a scale
Standard Deviation 12.57
|
3.1 score on a scale
Standard Deviation 11.65
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 4
|
5.8 score on a scale
Standard Deviation 12.53
|
-1.5 score on a scale
Standard Deviation 12.49
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 26
|
7.4 score on a scale
Standard Deviation 15.07
|
3.8 score on a scale
Standard Deviation 18.40
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 32
|
12.1 score on a scale
Standard Deviation 14.37
|
2.4 score on a scale
Standard Deviation 19.09
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 34
|
7.6 score on a scale
Standard Deviation 12.58
|
2.8 score on a scale
Standard Deviation 18.90
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 42
|
7.1 score on a scale
Standard Deviation 14.93
|
3.3 score on a scale
Standard Deviation 16.25
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 46
|
8.6 score on a scale
Standard Deviation 17.76
|
3.4 score on a scale
Standard Deviation 18.89
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 6
|
6.8 score on a scale
Standard Deviation 14.39
|
0.7 score on a scale
Standard Deviation 10.94
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 8
|
6.6 score on a scale
Standard Deviation 14.17
|
2.1 score on a scale
Standard Deviation 16.29
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 10
|
5.3 score on a scale
Standard Deviation 13.02
|
-1.0 score on a scale
Standard Deviation 14.46
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 12
|
7.2 score on a scale
Standard Deviation 11.47
|
0.9 score on a scale
Standard Deviation 15.44
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 14
|
8.0 score on a scale
Standard Deviation 12.28
|
3.7 score on a scale
Standard Deviation 14.63
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 16
|
6.2 score on a scale
Standard Deviation 14.51
|
1.3 score on a scale
Standard Deviation 15.79
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 18
|
8.6 score on a scale
Standard Deviation 14.41
|
2.6 score on a scale
Standard Deviation 18.60
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 20
|
8.6 score on a scale
Standard Deviation 15.41
|
1.4 score on a scale
Standard Deviation 18.58
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 22
|
8.4 score on a scale
Standard Deviation 13.30
|
3.9 score on a scale
Standard Deviation 20.33
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 24
|
9.3 score on a scale
Standard Deviation 17.31
|
4.4 score on a scale
Standard Deviation 17.70
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 28
|
6.5 score on a scale
Standard Deviation 15.92
|
2.7 score on a scale
Standard Deviation 21.33
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 30
|
7.5 score on a scale
Standard Deviation 14.26
|
1.2 score on a scale
Standard Deviation 17.32
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 36
|
9.6 score on a scale
Standard Deviation 17.44
|
3.6 score on a scale
Standard Deviation 19.31
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 38
|
8.1 score on a scale
Standard Deviation 14.96
|
1.3 score on a scale
Standard Deviation 17.68
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 40
|
9.6 score on a scale
Standard Deviation 17.32
|
-1.1 score on a scale
Standard Deviation 18.50
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 44
|
7.5 score on a scale
Standard Deviation 15.00
|
0.8 score on a scale
Standard Deviation 20.76
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 48
|
8.1 score on a scale
Standard Deviation 16.75
|
3.2 score on a scale
Standard Deviation 20.52
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 50
|
9.8 score on a scale
Standard Deviation 14.63
|
0.1 score on a scale
Standard Deviation 15.42
|
|
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Week 52
|
7.3 score on a scale
Standard Deviation 17.91
|
0.2 score on a scale
Standard Deviation 18.12
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in pre-dose pre-bronchodilator (BD) forced expiratory volume in one second (FEV1) over the double-blind treatment period
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 4
|
0.0139 L
Standard Deviation 0.14327
|
-0.0477 L
Standard Deviation 0.10758
|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 8
|
0.0048 L
Standard Deviation 0.15392
|
-0.0465 L
Standard Deviation 0.15263
|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 16
|
-0.0191 L
Standard Deviation 0.15964
|
-0.0282 L
Standard Deviation 0.11452
|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 24
|
-0.0378 L
Standard Deviation 0.17290
|
-0.0595 L
Standard Deviation 0.16409
|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 32
|
-0.0248 L
Standard Deviation 0.16782
|
-0.0921 L
Standard Deviation 0.17543
|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 40
|
-0.0597 L
Standard Deviation 0.18924
|
-0.1037 L
Standard Deviation 0.16808
|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 48
|
-0.1236 L
Standard Deviation 0.16353
|
-0.0849 L
Standard Deviation 0.13783
|
|
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Week 52
|
-0.1093 L
Standard Deviation 0.13130
|
-0.1186 L
Standard Deviation 0.14969
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Leicester Cough Questionnaire (LCQ) total score over the double-blind treatment period. LCQ total scores range from 3 to 21. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 8
|
0.8 score on a scale
Standard Deviation 3.37
|
0.3 score on a scale
Standard Deviation 2.85
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 10
|
1.0 score on a scale
Standard Deviation 2.77
|
0.1 score on a scale
Standard Deviation 2.76
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 14
|
1.4 score on a scale
Standard Deviation 2.78
|
0.8 score on a scale
Standard Deviation 3.16
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 16
|
0.9 score on a scale
Standard Deviation 2.61
|
0.5 score on a scale
Standard Deviation 3.10
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 26
|
0.9 score on a scale
Standard Deviation 3.58
|
1.0 score on a scale
Standard Deviation 3.54
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 28
|
0.5 score on a scale
Standard Deviation 4.31
|
0.9 score on a scale
Standard Deviation 4.08
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 30
|
0.7 score on a scale
Standard Deviation 3.33
|
0.8 score on a scale
Standard Deviation 4.06
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 32
|
1.8 score on a scale
Standard Deviation 3.45
|
0.7 score on a scale
Standard Deviation 4.14
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 2
|
0.5 score on a scale
Standard Deviation 2.22
|
0.5 score on a scale
Standard Deviation 2.13
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 4
|
0.7 score on a scale
Standard Deviation 2.35
|
0.0 score on a scale
Standard Deviation 2.15
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 6
|
0.8 score on a scale
Standard Deviation 2.76
|
0.6 score on a scale
Standard Deviation 2.56
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 12
|
1.0 score on a scale
Standard Deviation 2.51
|
0.4 score on a scale
Standard Deviation 3.03
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 18
|
1.0 score on a scale
Standard Deviation 3.42
|
1.1 score on a scale
Standard Deviation 3.55
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 20
|
1.4 score on a scale
Standard Deviation 3.28
|
0.8 score on a scale
Standard Deviation 3.39
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 22
|
0.9 score on a scale
Standard Deviation 3.32
|
0.8 score on a scale
Standard Deviation 4.03
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 24
|
1.0 score on a scale
Standard Deviation 3.43
|
1.2 score on a scale
Standard Deviation 3.48
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 34
|
0.8 score on a scale
Standard Deviation 2.43
|
0.8 score on a scale
Standard Deviation 3.92
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 36
|
1.2 score on a scale
Standard Deviation 3.48
|
0.8 score on a scale
Standard Deviation 3.95
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 38
|
1.0 score on a scale
Standard Deviation 3.61
|
0.6 score on a scale
Standard Deviation 4.24
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 40
|
1.2 score on a scale
Standard Deviation 3.93
|
0.2 score on a scale
Standard Deviation 3.86
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 42
|
0.6 score on a scale
Standard Deviation 3.42
|
0.3 score on a scale
Standard Deviation 4.19
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 44
|
0.5 score on a scale
Standard Deviation 3.23
|
0.3 score on a scale
Standard Deviation 4.02
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 46
|
0.7 score on a scale
Standard Deviation 3.68
|
0.6 score on a scale
Standard Deviation 4.22
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 48
|
0.3 score on a scale
Standard Deviation 3.78
|
0.5 score on a scale
Standard Deviation 4.20
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 50
|
0.7 score on a scale
Standard Deviation 3.29
|
-0.2 score on a scale
Standard Deviation 3.41
|
|
Change From Baseline in LCQ Total Score Over the Double-blind Period
Week 52
|
0.2 score on a scale
Standard Deviation 3.94
|
-0.1 score on a scale
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Physical Functioning Scale. QoL-B Physical Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 4
|
1.5 score on a scale
Standard Deviation 17.68
|
0.8 score on a scale
Standard Deviation 19.39
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 32
|
6.7 score on a scale
Standard Deviation 18.80
|
5.9 score on a scale
Standard Deviation 24.73
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 36
|
0.6 score on a scale
Standard Deviation 22.76
|
4.7 score on a scale
Standard Deviation 24.78
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 38
|
1.9 score on a scale
Standard Deviation 16.40
|
3.5 score on a scale
Standard Deviation 23.5
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 40
|
2.1 score on a scale
Standard Deviation 23.55
|
4.1 score on a scale
Standard Deviation 25.01
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 2
|
0.5 score on a scale
Standard Deviation 12.23
|
-0.0 score on a scale
Standard Deviation 16.50
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 6
|
4.1 score on a scale
Standard Deviation 20.81
|
0.2 score on a scale
Standard Deviation 17.97
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 8
|
3.3 score on a scale
Standard Deviation 15.07
|
0.3 score on a scale
Standard Deviation 20.81
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 10
|
1.5 score on a scale
Standard Deviation 19.22
|
1.0 score on a scale
Standard Deviation 22.06
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 12
|
3.1 score on a scale
Standard Deviation 19.54
|
0.5 score on a scale
Standard Deviation 21.89
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 14
|
4.4 score on a scale
Standard Deviation 15.48
|
4.2 score on a scale
Standard Deviation 22.15
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 16
|
3.5 score on a scale
Standard Deviation 18.06
|
3.3 score on a scale
Standard Deviation 25.17
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 18
|
4.8 score on a scale
Standard Deviation 19.15
|
2.2 score on a scale
Standard Deviation 23.01
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 20
|
4.5 score on a scale
Standard Deviation 18.45
|
4.7 score on a scale
Standard Deviation 25.18
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 22
|
3.1 score on a scale
Standard Deviation 19.62
|
2.2 score on a scale
Standard Deviation 22.96
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 24
|
5.2 score on a scale
Standard Deviation 18.21
|
4.7 score on a scale
Standard Deviation 23.03
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 26
|
3.6 score on a scale
Standard Deviation 20.68
|
3.6 score on a scale
Standard Deviation 24.40
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 28
|
3.8 score on a scale
Standard Deviation 24.77
|
4.8 score on a scale
Standard Deviation 24.39
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 30
|
2.5 score on a scale
Standard Deviation 21.33
|
4.8 score on a scale
Standard Deviation 25.50
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 34
|
2.7 score on a scale
Standard Deviation 19.14
|
3.5 score on a scale
Standard Deviation 24.90
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 42
|
1.3 score on a scale
Standard Deviation 21.13
|
5.5 score on a scale
Standard Deviation 28.92
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 44
|
0.6 score on a scale
Standard Deviation 23.62
|
4.2 score on a scale
Standard Deviation 24.03
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 46
|
2.0 score on a scale
Standard Deviation 22.89
|
7.9 score on a scale
Standard Deviation 23.42
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 48
|
0.0 score on a scale
Standard Deviation 27.89
|
7.6 score on a scale
Standard Deviation 22.98
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 50
|
5.3 score on a scale
Standard Deviation 23.46
|
1.3 score on a scale
Standard Deviation 21.08
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
Week 52
|
5.1 score on a scale
Standard Deviation 23.90
|
2.1 score on a scale
Standard Deviation 19.25
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Role Functioning Scale. QoL-B Role Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 26
|
-0.1 score on a scale
Standard Deviation 21.44
|
1.2 score on a scale
Standard Deviation 18.36
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 28
|
-1.9 score on a scale
Standard Deviation 21.02
|
2.7 score on a scale
Standard Deviation 17.79
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 34
|
1.4 score on a scale
Standard Deviation 18.01
|
1.7 score on a scale
Standard Deviation 17.97
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 2
|
1.1 score on a scale
Standard Deviation 13.64
|
-1.2 score on a scale
Standard Deviation 11.11
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 4
|
2.8 score on a scale
Standard Deviation 13.00
|
-0.3 score on a scale
Standard Deviation 14.53
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 6
|
2.7 score on a scale
Standard Deviation 14.80
|
2.5 score on a scale
Standard Deviation 12.05
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 8
|
0.5 score on a scale
Standard Deviation 16.27
|
0.2 score on a scale
Standard Deviation 15.02
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 10
|
1.2 score on a scale
Standard Deviation 14.09
|
2.7 score on a scale
Standard Deviation 16.32
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 12
|
1.7 score on a scale
Standard Deviation 16.36
|
2.3 score on a scale
Standard Deviation 16.96
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 14
|
3.0 score on a scale
Standard Deviation 16.10
|
2.1 score on a scale
Standard Deviation 16.70
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 16
|
0.1 score on a scale
Standard Deviation 17.77
|
-0.3 score on a scale
Standard Deviation 16.60
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 18
|
2.4 score on a scale
Standard Deviation 16.93
|
-0.0 score on a scale
Standard Deviation 17.67
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 20
|
0.9 score on a scale
Standard Deviation 16.01
|
0.5 score on a scale
Standard Deviation 18.25
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 22
|
2.8 score on a scale
Standard Deviation 21.11
|
4.0 score on a scale
Standard Deviation 20.47
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 24
|
1.9 score on a scale
Standard Deviation 22.60
|
0.6 score on a scale
Standard Deviation 19.67
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 30
|
1.1 score on a scale
Standard Deviation 20.83
|
-0.3 score on a scale
Standard Deviation 19.04
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 32
|
4.4 score on a scale
Standard Deviation 15.08
|
0.2 score on a scale
Standard Deviation 18.17
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 36
|
-0.6 score on a scale
Standard Deviation 19.18
|
0.5 score on a scale
Standard Deviation 16.69
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 38
|
1.4 score on a scale
Standard Deviation 18.15
|
-2.2 score on a scale
Standard Deviation 19.65
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 40
|
1.7 score on a scale
Standard Deviation 22.20
|
0.2 score on a scale
Standard Deviation 21.80
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 42
|
-1.3 score on a scale
Standard Deviation 21.48
|
1.8 score on a scale
Standard Deviation 20.19
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 44
|
0.6 score on a scale
Standard Deviation 25.33
|
-1.4 score on a scale
Standard Deviation 17.46
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 46
|
0.4 score on a scale
Standard Deviation 23.89
|
4.0 score on a scale
Standard Deviation 19.00
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 48
|
-1.2 score on a scale
Standard Deviation 25.03
|
0.2 score on a scale
Standard Deviation 18.16
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 50
|
0.7 score on a scale
Standard Deviation 21.26
|
-1.9 score on a scale
Standard Deviation 12.55
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Week 52
|
-0.8 score on a scale
Standard Deviation 23.28
|
1.1 score on a scale
Standard Deviation 17.81
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Emotional Functioning Scale. QoL-B Emotional Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 4
|
-0.7 score on a scale
Standard Deviation 14.07
|
1.4 score on a scale
Standard Deviation 14.42
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 6
|
3.5 score on a scale
Standard Deviation 17.99
|
4.2 score on a scale
Standard Deviation 14.98
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 8
|
-1.2 score on a scale
Standard Deviation 16.84
|
1.4 score on a scale
Standard Deviation 17.77
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 16
|
2.2 score on a scale
Standard Deviation 16.56
|
1.2 score on a scale
Standard Deviation 22.48
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 44
|
1.9 score on a scale
Standard Deviation 25.89
|
1.8 score on a scale
Standard Deviation 18.95
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 48
|
5.8 score on a scale
Standard Deviation 22.10
|
5.4 score on a scale
Standard Deviation 22.83
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 50
|
5.5 score on a scale
Standard Deviation 20.69
|
3.0 score on a scale
Standard Deviation 18.14
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 52
|
6.0 score on a scale
Standard Deviation 26.30
|
0.9 score on a scale
Standard Deviation 24.98
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 2
|
0.2 score on a scale
Standard Deviation 13.63
|
2.0 score on a scale
Standard Deviation 17.43
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 10
|
0.2 score on a scale
Standard Deviation 16.43
|
-1.0 score on a scale
Standard Deviation 16.58
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 12
|
2.8 score on a scale
Standard Deviation 17.30
|
1.6 score on a scale
Standard Deviation 21.38
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 14
|
4.7 score on a scale
Standard Deviation 14.31
|
1.8 score on a scale
Standard Deviation 20.79
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 18
|
3.2 score on a scale
Standard Deviation 15.57
|
3.8 score on a scale
Standard Deviation 21.68
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 20
|
3.9 score on a scale
Standard Deviation 15.82
|
1.4 score on a scale
Standard Deviation 22.27
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 22
|
2.8 score on a scale
Standard Deviation 18.46
|
2.1 score on a scale
Standard Deviation 23.09
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 24
|
2.4 score on a scale
Standard Deviation 17.80
|
2.9 score on a scale
Standard Deviation 19.32
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 26
|
3.0 score on a scale
Standard Deviation 17.15
|
4.3 score on a scale
Standard Deviation 22.00
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 28
|
0.4 score on a scale
Standard Deviation 25.82
|
1.6 score on a scale
Standard Deviation 24.43
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 30
|
2.7 score on a scale
Standard Deviation 22.55
|
1.5 score on a scale
Standard Deviation 23.79
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 32
|
4.0 score on a scale
Standard Deviation 15.82
|
3.0 score on a scale
Standard Deviation 22.42
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 34
|
1.4 score on a scale
Standard Deviation 19.64
|
1.9 score on a scale
Standard Deviation 23.23
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 36
|
1.9 score on a scale
Standard Deviation 17.89
|
4.5 score on a scale
Standard Deviation 22.75
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 38
|
2.6 score on a scale
Standard Deviation 20.79
|
1.9 score on a scale
Standard Deviation 22.64
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 40
|
1.7 score on a scale
Standard Deviation 23.35
|
2.3 score on a scale
Standard Deviation 22.28
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 42
|
1.1 score on a scale
Standard Deviation 21.97
|
3.4 score on a scale
Standard Deviation 22.67
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Week 46
|
3.9 score on a scale
Standard Deviation 22.02
|
6.8 score on a scale
Standard Deviation 22.77
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Social Functioning Scale. QoL-B Social Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 2
|
6.4 score on a scale
Standard Deviation 17.60
|
4.5 score on a scale
Standard Deviation 17.35
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 4
|
4.4 score on a scale
Standard Deviation 18.62
|
6.3 score on a scale
Standard Deviation 22.69
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 6
|
8.4 score on a scale
Standard Deviation 21.60
|
5.8 score on a scale
Standard Deviation 20.05
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 8
|
9.7 score on a scale
Standard Deviation 23.10
|
9.2 score on a scale
Standard Deviation 20.53
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 10
|
9.4 score on a scale
Standard Deviation 19.64
|
6.0 score on a scale
Standard Deviation 20.31
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 12
|
10.6 score on a scale
Standard Deviation 23.32
|
5.8 score on a scale
Standard Deviation 21.42
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 14
|
10.9 score on a scale
Standard Deviation 23.03
|
7.7 score on a scale
Standard Deviation 20.52
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 28
|
8.8 score on a scale
Standard Deviation 24.67
|
8.7 score on a scale
Standard Deviation 24.83
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 30
|
10.2 score on a scale
Standard Deviation 26.57
|
7.7 score on a scale
Standard Deviation 24.82
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 32
|
12.8 score on a scale
Standard Deviation 23.84
|
8.6 score on a scale
Standard Deviation 24.48
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 36
|
12.0 score on a scale
Standard Deviation 27.06
|
8.1 score on a scale
Standard Deviation 25.53
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 38
|
10.2 score on a scale
Standard Deviation 27.83
|
6.5 score on a scale
Standard Deviation 25.41
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 40
|
13.9 score on a scale
Standard Deviation 32.35
|
8.3 score on a scale
Standard Deviation 27.77
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 16
|
9.1 score on a scale
Standard Deviation 20.73
|
6.0 score on a scale
Standard Deviation 23.53
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 18
|
11.6 score on a scale
Standard Deviation 21.61
|
10.3 score on a scale
Standard Deviation 22.43
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 20
|
11.8 score on a scale
Standard Deviation 22.59
|
8.9 score on a scale
Standard Deviation 21.43
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 22
|
7.2 score on a scale
Standard Deviation 20.42
|
9.5 score on a scale
Standard Deviation 24.09
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 24
|
10.1 score on a scale
Standard Deviation 24.90
|
10.7 score on a scale
Standard Deviation 24.14
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 26
|
10.1 score on a scale
Standard Deviation 22.86
|
9.9 score on a scale
Standard Deviation 22.46
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 34
|
9.6 score on a scale
Standard Deviation 27.93
|
9.3 score on a scale
Standard Deviation 24.95
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 42
|
10.2 score on a scale
Standard Deviation 29.40
|
8.6 score on a scale
Standard Deviation 28.16
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 44
|
9.9 score on a scale
Standard Deviation 28.68
|
1.8 score on a scale
Standard Deviation 24.50
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 46
|
9.1 score on a scale
Standard Deviation 27.40
|
6.6 score on a scale
Standard Deviation 29.11
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 48
|
12.1 score on a scale
Standard Deviation 27.11
|
3.9 score on a scale
Standard Deviation 30.74
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 50
|
10.2 score on a scale
Standard Deviation 23.60
|
-1.7 score on a scale
Standard Deviation 26.85
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Week 52
|
11.6 score on a scale
Standard Deviation 27.91
|
2.3 score on a scale
Standard Deviation 25.29
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Vitality Scale. QoL-B Vitality Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 12
|
5.8 score on a scale
Standard Deviation 18.48
|
-3.9 score on a scale
Standard Deviation 16.24
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 22
|
5.7 score on a scale
Standard Deviation 21.66
|
-0.6 score on a scale
Standard Deviation 21.04
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 24
|
4.1 score on a scale
Standard Deviation 20.87
|
1.0 score on a scale
Standard Deviation 19.67
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 30
|
4.4 score on a scale
Standard Deviation 21.84
|
-4.3 score on a scale
Standard Deviation 22.74
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 32
|
6.1 score on a scale
Standard Deviation 19.97
|
0.0 score on a scale
Standard Deviation 20.49
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 34
|
1.1 score on a scale
Standard Deviation 18.98
|
-0.8 score on a scale
Standard Deviation 20.96
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 50
|
7.7 score on a scale
Standard Deviation 20.81
|
0.0 score on a scale
Standard Deviation 18.14
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 52
|
5.3 score on a scale
Standard Deviation 18.74
|
-5.3 score on a scale
Standard Deviation 23.53
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 2
|
3.0 score on a scale
Standard Deviation 18.77
|
-2.4 score on a scale
Standard Deviation 13.54
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 4
|
3.1 score on a scale
Standard Deviation 17.82
|
0.3 score on a scale
Standard Deviation 15.21
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 6
|
4.0 score on a scale
Standard Deviation 18.83
|
-2.0 score on a scale
Standard Deviation 13.88
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 8
|
4.9 score on a scale
Standard Deviation 17.84
|
-1.1 score on a scale
Standard Deviation 16.26
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 10
|
6.4 score on a scale
Standard Deviation 16.32
|
-3.1 score on a scale
Standard Deviation 18.83
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 14
|
8.8 score on a scale
Standard Deviation 20.69
|
-2.7 score on a scale
Standard Deviation 18.22
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 16
|
5.2 score on a scale
Standard Deviation 19.66
|
-0.5 score on a scale
Standard Deviation 19.71
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 18
|
5.0 score on a scale
Standard Deviation 19.78
|
-1.4 score on a scale
Standard Deviation 18.69
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 20
|
7.1 score on a scale
Standard Deviation 19.99
|
-1.3 score on a scale
Standard Deviation 19.28
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 26
|
6.2 score on a scale
Standard Deviation 20.18
|
-1.6 score on a scale
Standard Deviation 20.66
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 28
|
3.9 score on a scale
Standard Deviation 21.75
|
-2.1 score on a scale
Standard Deviation 21.57
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 36
|
1.0 score on a scale
Standard Deviation 18.59
|
-2.7 score on a scale
Standard Deviation 18.72
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 38
|
4.1 score on a scale
Standard Deviation 18.88
|
-0.0 score on a scale
Standard Deviation 19.52
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 40
|
2.6 score on a scale
Standard Deviation 23.01
|
-2.7 score on a scale
Standard Deviation 21.97
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 42
|
3.0 score on a scale
Standard Deviation 21.54
|
-1.0 score on a scale
Standard Deviation 24.37
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 44
|
2.9 score on a scale
Standard Deviation 21.11
|
-3.4 score on a scale
Standard Deviation 21.24
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 46
|
5.2 score on a scale
Standard Deviation 24.65
|
1.0 score on a scale
Standard Deviation 20.10
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Week 48
|
2.0 score on a scale
Standard Deviation 23.48
|
-1.3 score on a scale
Standard Deviation 20.97
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Health Perceptions Scale. QoL-B Health Perceptions Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 6
|
3.5 score on a scale
Standard Deviation 16.90
|
3.7 score on a scale
Standard Deviation 16.06
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 8
|
5.3 score on a scale
Standard Deviation 17.23
|
4.3 score on a scale
Standard Deviation 18.46
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 12
|
7.5 score on a scale
Standard Deviation 16.69
|
3.3 score on a scale
Standard Deviation 17.74
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 14
|
7.4 score on a scale
Standard Deviation 16.78
|
1.4 score on a scale
Standard Deviation 18.99
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 16
|
1.9 score on a scale
Standard Deviation 16.25
|
2.4 score on a scale
Standard Deviation 20.35
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 18
|
5.8 score on a scale
Standard Deviation 16.68
|
1.7 score on a scale
Standard Deviation 20.69
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 20
|
4.6 score on a scale
Standard Deviation 18.21
|
3.9 score on a scale
Standard Deviation 21.70
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 22
|
5.0 score on a scale
Standard Deviation 16.70
|
6.3 score on a scale
Standard Deviation 21.99
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 24
|
7.2 score on a scale
Standard Deviation 17.18
|
5.0 score on a scale
Standard Deviation 19.85
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 26
|
2.8 score on a scale
Standard Deviation 16.76
|
5.0 score on a scale
Standard Deviation 20.26
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 28
|
3.4 score on a scale
Standard Deviation 18.81
|
2.4 score on a scale
Standard Deviation 20.68
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 30
|
4.5 score on a scale
Standard Deviation 18.03
|
4.3 score on a scale
Standard Deviation 21.87
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 32
|
7.0 score on a scale
Standard Deviation 16.37
|
2.4 score on a scale
Standard Deviation 20.09
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 34
|
4.2 score on a scale
Standard Deviation 17.68
|
2.9 score on a scale
Standard Deviation 22.29
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 36
|
3.5 score on a scale
Standard Deviation 17.84
|
2.0 score on a scale
Standard Deviation 20.56
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 38
|
4.2 score on a scale
Standard Deviation 16.30
|
3.0 score on a scale
Standard Deviation 22.90
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 40
|
5.1 score on a scale
Standard Deviation 16.95
|
1.4 score on a scale
Standard Deviation 22.35
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 42
|
4.7 score on a scale
Standard Deviation 18.38
|
4.4 score on a scale
Standard Deviation 23.77
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 44
|
4.8 score on a scale
Standard Deviation 21.03
|
1.5 score on a scale
Standard Deviation 20.78
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 46
|
6.6 score on a scale
Standard Deviation 22.45
|
1.8 score on a scale
Standard Deviation 19.07
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 48
|
7.3 score on a scale
Standard Deviation 21.32
|
3.9 score on a scale
Standard Deviation 23.68
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 50
|
6.9 score on a scale
Standard Deviation 20.42
|
4.7 score on a scale
Standard Deviation 18.65
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 52
|
4.0 score on a scale
Standard Deviation 21.53
|
0.4 score on a scale
Standard Deviation 24.13
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 10
|
5.6 score on a scale
Standard Deviation 16.57
|
2.1 score on a scale
Standard Deviation 18.47
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 2
|
1.3 score on a scale
Standard Deviation 12.95
|
3.3 score on a scale
Standard Deviation 14.12
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Week 4
|
1.2 score on a scale
Standard Deviation 14.87
|
-0.2 score on a scale
Standard Deviation 16.72
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Treatment Burden Scale. QoL-B Treatment Burden Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 2
|
3.6 score on a scale
Standard Deviation 22.56
|
-2.2 score on a scale
Standard Deviation 16.75
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 4
|
3.7 score on a scale
Standard Deviation 18.62
|
-2.1 score on a scale
Standard Deviation 13.34
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 6
|
6.0 score on a scale
Standard Deviation 23.20
|
-2.1 score on a scale
Standard Deviation 15.72
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 12
|
0.3 score on a scale
Standard Deviation 17.27
|
-0.4 score on a scale
Standard Deviation 12.54
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 14
|
0.6 score on a scale
Standard Deviation 20.74
|
-4.1 score on a scale
Standard Deviation 14.73
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 16
|
4.4 score on a scale
Standard Deviation 20.10
|
-1.1 score on a scale
Standard Deviation 16.34
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 18
|
-1.9 score on a scale
Standard Deviation 16.28
|
-1.2 score on a scale
Standard Deviation 14.92
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 20
|
4.1 score on a scale
Standard Deviation 16.01
|
0.3 score on a scale
Standard Deviation 15.84
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 22
|
-1.3 score on a scale
Standard Deviation 14.37
|
-0.8 score on a scale
Standard Deviation 16.82
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 24
|
-1.0 score on a scale
Standard Deviation 18.58
|
-1.1 score on a scale
Standard Deviation 14.45
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 26
|
1.9 score on a scale
Standard Deviation 17.32
|
2.5 score on a scale
Standard Deviation 15.37
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 28
|
-5.1 score on a scale
Standard Deviation 24.00
|
1.4 score on a scale
Standard Deviation 15.11
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 30
|
-2.0 score on a scale
Standard Deviation 19.14
|
-1.1 score on a scale
Standard Deviation 18.39
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 32
|
-2.1 score on a scale
Standard Deviation 16.32
|
-0.8 score on a scale
Standard Deviation 15.12
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 34
|
-0.4 score on a scale
Standard Deviation 16.70
|
-4.0 score on a scale
Standard Deviation 17.95
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 36
|
-0.7 score on a scale
Standard Deviation 16.68
|
-1.5 score on a scale
Standard Deviation 16.69
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 38
|
-4.2 score on a scale
Standard Deviation 25.27
|
-2.9 score on a scale
Standard Deviation 21.04
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 40
|
-2.0 score on a scale
Standard Deviation 24.76
|
-0.4 score on a scale
Standard Deviation 16.15
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 42
|
-1.5 score on a scale
Standard Deviation 23.52
|
1.7 score on a scale
Standard Deviation 18.78
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 44
|
2.1 score on a scale
Standard Deviation 17.22
|
1.4 score on a scale
Standard Deviation 21.00
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 46
|
-0.0 score on a scale
Standard Deviation 18.59
|
4.6 score on a scale
Standard Deviation 14.62
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 48
|
-0.9 score on a scale
Standard Deviation 17.25
|
3.6 score on a scale
Standard Deviation 19.96
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 50
|
-2.0 score on a scale
Standard Deviation 22.13
|
-1.9 score on a scale
Standard Deviation 18.77
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 52
|
-1.9 score on a scale
Standard Deviation 25.64
|
1.7 score on a scale
Standard Deviation 14.94
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 8
|
4.8 score on a scale
Standard Deviation 18.35
|
-1.9 score on a scale
Standard Deviation 14.87
|
|
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Week 10
|
4.0 score on a scale
Standard Deviation 17.31
|
1.1 score on a scale
Standard Deviation 17.83
|
SECONDARY outcome
Timeframe: through Double-blind period, at least 28 weeks and up to 52 weeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score over the double-blind treatment period. SGRQ total scores range from 0 to 100. 100 represents the worst possible health status and 0 indicates the best possible health status.
Outcome measures
| Measure |
Benralizumab 30 mg
n=54 Participants
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
|
Placebo
n=45 Participants
Matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 4
|
-4.7 score on a scale
Standard Deviation 14.92
|
0.6 score on a scale
Standard Deviation 14.89
|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 8
|
-4.3 score on a scale
Standard Deviation 15.99
|
-2.4 score on a scale
Standard Deviation 15.33
|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 24
|
-6.3 score on a scale
Standard Deviation 16.21
|
-3.9 score on a scale
Standard Deviation 21.08
|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 32
|
-5.8 score on a scale
Standard Deviation 15.73
|
-1.6 score on a scale
Standard Deviation 21.46
|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 40
|
-5.8 score on a scale
Standard Deviation 17.63
|
-1.6 score on a scale
Standard Deviation 24.51
|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 52
|
-4.4 score on a scale
Standard Deviation 20.37
|
4.8 score on a scale
Standard Deviation 23.33
|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 16
|
-4.4 score on a scale
Standard Deviation 15.03
|
-0.1 score on a scale
Standard Deviation 16.06
|
|
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Week 48
|
-4.9 score on a scale
Standard Deviation 18.58
|
-0.0 score on a scale
Standard Deviation 22.45
|
Adverse Events
Benra 30 mg - DB
Serious events: 10 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo - DB
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Benra 30 mg - OLE
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Swithed to Benra 30 mg - OLE
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Benra 30 mg - DB
n=54 participants at risk
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks, Double-blind period
|
Placebo - DB
n=45 participants at risk
Matching placebo injection delivered subcutaneously every 4 weeks, Double-blind period
|
Benra 30 mg - OLE
n=38 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind benralizumab previously)
|
Placebo Swithed to Benra 30 mg - OLE
n=40 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind placebo previously)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
1/54 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
14.8%
8/54 • Number of events 9 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
6.7%
3/45 • Number of events 4 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
5.3%
2/38 • Number of events 2 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/54 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/54 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
1.9%
1/54 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/54 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.6%
1/38 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/54 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.6%
1/38 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/54 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.6%
1/38 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Haemophilus infection
|
1.9%
1/54 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/54 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/54 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.6%
1/38 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Benra 30 mg - DB
n=54 participants at risk
Benralizumab 30 mg injection delivered subcutaneously every 4 weeks, Double-blind period
|
Placebo - DB
n=45 participants at risk
Matching placebo injection delivered subcutaneously every 4 weeks, Double-blind period
|
Benra 30 mg - OLE
n=38 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind benralizumab previously)
|
Placebo Swithed to Benra 30 mg - OLE
n=40 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind placebo previously)
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
4/54 • Number of events 4 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
4.4%
2/45 • Number of events 2 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
9.3%
5/54 • Number of events 5 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
11.1%
5/45 • Number of events 7 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
3/54 • Number of events 4 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
5.6%
3/54 • Number of events 3 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
1.9%
1/54 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
6.7%
3/45 • Number of events 5 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
33.3%
18/54 • Number of events 18 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
22.2%
10/45 • Number of events 11 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
7.9%
3/38 • Number of events 3 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
5/54 • Number of events 8 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
11.1%
5/45 • Number of events 5 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
5.3%
2/38 • Number of events 2 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.6%
3/54 • Number of events 3 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.2%
1/45 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.6%
1/38 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
3/54 • Number of events 4 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.2%
1/45 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.6%
1/38 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
3/54 • Number of events 3 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.4%
4/54 • Number of events 6 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/45 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/38 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
0.00%
0/40 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/54 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
2.2%
1/45 • Number of events 1 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
5.3%
2/38 • Number of events 3 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Double-Blind Treatment Period: From first dose of study drug until end of double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the double-blind period (week 25 to 53) to the end of open-label extension period, up to 40 weeks.
For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee ≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER