Trial Outcomes & Findings for A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO) (NCT NCT04612725)
NCT ID: NCT04612725
Last Updated: 2024-03-13
Results Overview
The urticaria participant daily diary (UPDD) was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the itch severity score (ISS). The ISS represents severity on a scale ranging from 0 to 3 (where 0= none, 1= mild, 2= moderate and 3= severe). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
Baseline (Day -1) and Week 12
Results posted on
2024-03-13
Participant Flow
This Phase 2b, randomized, double-blind study was conducted in participants with chronic spontaneous urticaria (CSU) who were symptomatic despite the use of antihistamines at 46 study centers in Bulgaria, Germany, Japan, Korea, Poland, Spain, and United States of America between 27 October 2020 and 28 March 2023. The study was terminated early by the sponsor as primary results did not support the continued development of benralizumab for the indication of CSU.
The study had a run-in period (10 days to 4 weeks), followed by a double-blind treatment period (24 weeks) and extension period (28 weeks). A total of 155 participants were randomized and treated in this study.
Participant milestones
| Measure |
Double-blind Then Extension Period: Benralizumab 30 mg Q4W
Participants were randomized to receive benralizumab 30 milligram (mg) subcutaneous (SC) injection every 4 weeks (Q4W) until Week 24 in the double-blind treatment period and then 30 mg Q4W during the extension period until Week 52.
|
Double-blind Then Extension Period: Benralizumab 30 mg Q8W
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg every 8 weeks (Q8W) during the extension period until Week 52.
|
Double-blind Then Extension Period: Benralizumab 60 mg Q4W
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W during the extension period until Week 52.
|
Double-blind Then Extension Period: Benralizumab 60 mg Q8W
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q8W during the extension period until Week 52.
|
Double-blind Then Extension Period: Placebo
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
28
|
28
|
40
|
|
Overall Study
Completed the Treatment Period
|
26
|
27
|
25
|
28
|
37
|
|
Overall Study
Entered Extension Period
|
24
|
26
|
25
|
28
|
37
|
|
Overall Study
COMPLETED
|
16
|
21
|
20
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
8
|
5
|
16
|
Reasons for withdrawal
| Measure |
Double-blind Then Extension Period: Benralizumab 30 mg Q4W
Participants were randomized to receive benralizumab 30 milligram (mg) subcutaneous (SC) injection every 4 weeks (Q4W) until Week 24 in the double-blind treatment period and then 30 mg Q4W during the extension period until Week 52.
|
Double-blind Then Extension Period: Benralizumab 30 mg Q8W
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg every 8 weeks (Q8W) during the extension period until Week 52.
|
Double-blind Then Extension Period: Benralizumab 60 mg Q4W
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W during the extension period until Week 52.
|
Double-blind Then Extension Period: Benralizumab 60 mg Q8W
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q8W during the extension period until Week 52.
|
Double-blind Then Extension Period: Placebo
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
3
|
1
|
2
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
5
|
1
|
9
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
Baseline characteristics by cohort
| Measure |
Benralizumab 30 mg
n=59 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=56 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=40 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<35 years
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Customized
>=35 to <=55 years
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Age, Customized
>55 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Week 12Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
The urticaria participant daily diary (UPDD) was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the itch severity score (ISS). The ISS represents severity on a scale ranging from 0 to 3 (where 0= none, 1= mild, 2= moderate and 3= severe). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Outcome measures
| Measure |
Benralizumab 30 mg
n=55 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=52 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=37 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12
|
-7.50 units on a scale
Interval -8.94 to -6.05
|
-8.28 units on a scale
Interval -9.76 to -6.8
|
-6.49 units on a scale
Interval -8.24 to -4.74
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Participants with data at baseline and each time point were analyzed. The overall number analyzed included those with data at baseline and at least 1 of the reported time points.
The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the UAS7. Participants were asked to document the number of hives they experienced on a scale ranging from 0 to 3 (where 0= none, 1= mild \[1 - 6 hives/12 hour\], 2= moderate \[7 - 12 hives/12 hour\] and 3= intense \[(\> 12 hives/12 hour\]). The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Outcome measures
| Measure |
Benralizumab 30 mg
n=55 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=53 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=37 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24
Week 12
|
-14.48 units on a scale
Interval -17.58 to -11.38
|
-16.77 units on a scale
Interval -19.94 to -13.59
|
-12.41 units on a scale
Interval -16.17 to -8.65
|
|
LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24
Week 24
|
-17.99 units on a scale
Interval -21.29 to -14.68
|
-19.17 units on a scale
Interval -22.51 to -15.83
|
-15.43 units on a scale
Interval -19.43 to -11.44
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Week 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the ISS. The ISS represents severity on a scale ranging from 0 to 3 (where 0= none, 1= mild, 2= moderate and 3= severe). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Outcome measures
| Measure |
Benralizumab 30 mg
n=52 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=53 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=36 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
LS Mean Change From Baseline in ISS7 at Week 24
|
-9.19 units on a scale
Interval -10.77 to -7.61
|
-9.33 units on a scale
Interval -10.93 to -7.73
|
-7.57 units on a scale
Interval -9.48 to -5.66
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
Responder was defined as a participant whose condition was considered clinically well controlled with UAS7 \<=6 at specific time points. The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms.
Outcome measures
| Measure |
Benralizumab 30 mg
n=59 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=56 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=40 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
Percentage of Responders at Weeks 12 and 24
Week 12
|
22.0 percentage of participants
|
21.4 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Responders at Weeks 12 and 24
Week 24
|
28.8 percentage of participants
|
37.5 percentage of participants
|
27.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the HSS7. Participants were asked to document the number of hives they experienced on a scale ranging from 0 to 3 (where 0= none, 1= mild \[1 - 6 hives/12 hour\], 2= moderate \[7 - 12 hives/12 hour\] and 3= intense \[(\> 12 hives/12 hour\]). The HSS7 is the sum of hives severity score for the previous 7 days. The HSS7 represents hives severity on a scale from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of hives. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization.
Outcome measures
| Measure |
Benralizumab 30 mg
n=55 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=53 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=37 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24
Week 12
|
-7.03 units on a scale
Interval -8.84 to -5.22
|
-8.47 units on a scale
Interval -10.32 to -6.62
|
-5.87 units on a scale
Interval -8.06 to -3.68
|
|
LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24
Week 24
|
-8.88 units on a scale
Interval -10.76 to -7.0
|
-9.81 units on a scale
Interval -11.71 to -7.91
|
-7.82 units on a scale
Interval -10.09 to -5.54
|
SECONDARY outcome
Timeframe: From Baseline (Day -1) up to Week 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Only participants with at least 1 \>=5-point decrease in ISS7 are analyzed.
The time to \>=5-point decrease (clinically relevant decrease) in ISS7 was reported. The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch.
Outcome measures
| Measure |
Benralizumab 30 mg
n=48 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=50 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=33 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
Time to >=5-Point Decrease in ISS7
|
3.0 weeks
Interval 2.0 to 5.0
|
2.0 weeks
Interval 2.0 to 3.0
|
8.0 weeks
Interval 3.0 to 11.0
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
Complete response was defined as participants with UAS7= 0 at specific time points. The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms.
Outcome measures
| Measure |
Benralizumab 30 mg
n=59 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=56 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=40 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
Percentage of Participants With Complete UAS7 Response at Weeks 12 and 24
Week 12
|
11.9 percentage of participants
|
7.1 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Complete UAS7 Response at Weeks 12 and 24
Week 24
|
16.9 percentage of participants
|
21.4 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Only participants with angioedema at baseline or history of angioedema are analyzed.
The UPDD included a daily yes/no question asking whether the participant experienced angioedema during the past 24 hours. If yes, the participant was asked a follow-up question about how they treated the swelling. The percentage of angioedema-free days was calculated over the past 7 days by (number of angioedema-free days/number of non-missing responses) x 100.
Outcome measures
| Measure |
Benralizumab 30 mg
n=36 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=28 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=22 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
Mean Percentage of Angioedema-Free Days Over the Past 7 Days at Weeks 12 and 24
Week 12
|
77.50 percentage of days
Standard Deviation 35.990
|
85.63 percentage of days
Standard Deviation 32.435
|
81.93 percentage of days
Standard Deviation 34.548
|
|
Mean Percentage of Angioedema-Free Days Over the Past 7 Days at Weeks 12 and 24
Week 24
|
78.50 percentage of days
Standard Deviation 36.992
|
91.33 percentage of days
Standard Deviation 27.032
|
86.79 percentage of days
Standard Deviation 31.798
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
Urticaria disease control was assessed by the UCT using the electronic participant-reported outcome device. The UCT has a retrospective approach using a recall period of 4 weeks and responses on 5-point Likert scales with score ranging from 0 to 4 for each question. Subsequently, the scores for all 4 questions were summed up. The UCT scale range from 0 (minimum) to 16 (maximum). Higher scores indicate better disease control.
Outcome measures
| Measure |
Benralizumab 30 mg
n=55 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=52 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=38 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
LS Mean Change From Baseline in Urticaria Control Test (UCT) at Weeks 12 and 24
Week 12
|
4.74 units on a scale
Interval 3.71 to 5.76
|
6.11 units on a scale
Interval 5.05 to 7.17
|
5.02 units on a scale
Interval 3.78 to 6.26
|
|
LS Mean Change From Baseline in Urticaria Control Test (UCT) at Weeks 12 and 24
Week 24
|
5.24 units on a scale
Interval 4.04 to 6.45
|
6.87 units on a scale
Interval 5.65 to 8.09
|
5.88 units on a scale
Interval 4.44 to 7.32
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
The CU-Q2oL is a 23-item assessment of CSU-specific health-related quality of life. Participants were asked to rate their CSU symptoms and the impact of their symptoms over the last 2 weeks on several domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. The questions were scored as 1= not at all, 2= a little, 3= moderately, 4= very much, 5= extremely. The scores were transformed into percentages of the maximum possible score. The CU-Q2oL scale range from 0 (minimum) to 100 (maximum). Higher scores indicate greater impact of urticaria on health-related quality of life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=55 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=52 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=38 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24
Week 12
|
-16.47 units on a scale
Interval -20.1 to -12.84
|
-20.34 units on a scale
Interval -24.09 to -16.6
|
-18.10 units on a scale
Interval -22.46 to -13.74
|
|
LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24
Week 24
|
-17.60 units on a scale
Interval -21.81 to -13.4
|
-22.11 units on a scale
Interval -26.38 to -17.84
|
-19.07 units on a scale
Interval -24.09 to -14.05
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Weeks 12 and 24Population: The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
The DLQI is a 10-item assessment of dermatology-specific health-related quality of life. Participants were asked to rate their symptoms and the impact of their symptoms over the last week on several domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The questions (except question 7) were scored on a 4-point Likert scale: 0= not at all, 1= a little, 2= a lot, 3= very much. Scoring question 7, the first part asked: 'Over the last week, has your skin prevented you from working or studying?' Scoring was for response of 0= not relevant and 3= yes. If response was 'no', a further question was asked: 'How much has your skin been a problem at work or studying', and scored as: 0= not at all, 1= a little, 2= a lot. The DLQI was calculated by summing the score of each question. The DLQI scale range from 0 (minimum) to 30 (maximum). Higher scores indicate greater impact on participant's life.
Outcome measures
| Measure |
Benralizumab 30 mg
n=55 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=52 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=38 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
LS Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 12 and 24
Week 12
|
-7.58 units on a scale
Interval -9.18 to -5.98
|
-9.31 units on a scale
Interval -10.96 to -7.66
|
-8.06 units on a scale
Interval -9.98 to -6.14
|
|
LS Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 12 and 24
Week 24
|
-8.13 units on a scale
Interval -9.84 to -6.42
|
-10.25 units on a scale
Interval -11.98 to -8.51
|
-9.37 units on a scale
Interval -11.41 to -7.33
|
SECONDARY outcome
Timeframe: Pre-dose on Weeks 4, 12 and 24Population: The Pharmacokinetic (PK) analysis set included all participants who received study drug and from whom PK blood samples were assumed not to be affected by factors such as protocol violations and who had at least 1 quantifiable serum PK observation post first dose. Placebo group samples were not analyzed at Weeks 4 and 12 as they have not received benralizumab in double-blind treatment period.
Blood samples were collected to determine the serum concentration of benralizumab.
Outcome measures
| Measure |
Benralizumab 30 mg
n=55 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=54 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=34 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
Serum Concentration of Benralizumab
Week 12
|
1321.373 nanogram per milliliter (ng/mL)
Standard Deviation 740.5070
|
3145.352 nanogram per milliliter (ng/mL)
Standard Deviation 1577.6726
|
—
|
|
Serum Concentration of Benralizumab
Week 24
|
1372.806 nanogram per milliliter (ng/mL)
Standard Deviation 883.5830
|
1638.810 nanogram per milliliter (ng/mL)
Standard Deviation 946.9466
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Below the lower limit of quantification (LLOQ). The LLOQ is 3.86 ng/mL.
|
|
Serum Concentration of Benralizumab
Week 4
|
990.515 nanogram per milliliter (ng/mL)
Standard Deviation 448.6799
|
2167.606 nanogram per milliliter (ng/mL)
Standard Deviation 991.7509
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Weeks 12 and 24Population: The Safety analysis set included all participants who received at least 1 dose of study drug. Participants with data at baseline and at least 1 post baseline sample were analyzed.
Blood samples were measured for the presence of ADAs for benralizumab using validated assays. The ADA incidence (treatment-emergent ADA positive) was defined as ADA negative at baseline and post-baseline ADA positive, or ADA positive at baseline and boosted the pre-existing titre by \> 4-fold during the study period. Persistently positive was defined as ADA negative at baseline and positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as ADA negative at baseline, having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. The median of maximum titres was calculated based on the maximum titre for each ADA positive participant within each treatment group (including both baseline and post-baseline measurements).
Outcome measures
| Measure |
Benralizumab 30 mg
n=59 Participants
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.
|
Benralizumab 60 mg
n=56 Participants
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
|
Placebo
n=40 Participants
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
|
|---|---|---|---|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
ADA prevalence
|
18 Participants
|
13 Participants
|
4 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
ADA negative (both baseline and post-baseline negative)
|
37 Participants
|
41 Participants
|
33 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
Only baseline positive
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
Baseline and at least 1 post-baseline positive
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
ADA incidence
|
15 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
ADA persistently positive
|
10 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
ADA transiently positive
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
ADA positive with maximum titre > median of maximum titres
|
8 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
ADA positive with maximum titre <= median of maximum titres
|
10 Participants
|
8 Participants
|
3 Participants
|
Adverse Events
Double-blind Period: Benralizumab 30 mg Q4W
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Double-blind Period: Benralizumab 60 mg Q4W
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Double-blind Period: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Extension Period: Benralizumab 30 mg Q4W
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Extension Period: Benralizumab 30 mg Q8W
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Extension Period: Placebo to Benralizumab
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind Period: Benralizumab 30 mg Q4W
n=59 participants at risk
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period.
|
Double-blind Period: Benralizumab 60 mg Q4W
n=56 participants at risk
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period.
|
Double-blind Period: Placebo
n=40 participants at risk
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period.
|
Extension Period: Benralizumab 30 mg Q4W
n=49 participants at risk
Participants were randomized to receive benralizumab 30 mg SC injection Q4W in the extension period until Week 52.
|
Extension Period: Benralizumab 30 mg Q8W
n=54 participants at risk
Participants were randomized to receive benralizumab 30 mg SC injection Q8W in the extension period until Week 52.
|
Extension Period: Placebo to Benralizumab
n=37 participants at risk
Participants randomized to placebo in the double-blind period received benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52 in the extension period.
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/59 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Hepatobiliary disorders
Biliary colic
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/59 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.7%
1/37 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/59 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/59 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/40 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
Other adverse events
| Measure |
Double-blind Period: Benralizumab 30 mg Q4W
n=59 participants at risk
Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period.
|
Double-blind Period: Benralizumab 60 mg Q4W
n=56 participants at risk
Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period.
|
Double-blind Period: Placebo
n=40 participants at risk
Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period.
|
Extension Period: Benralizumab 30 mg Q4W
n=49 participants at risk
Participants were randomized to receive benralizumab 30 mg SC injection Q4W in the extension period until Week 52.
|
Extension Period: Benralizumab 30 mg Q8W
n=54 participants at risk
Participants were randomized to receive benralizumab 30 mg SC injection Q8W in the extension period until Week 52.
|
Extension Period: Placebo to Benralizumab
n=37 participants at risk
Participants randomized to placebo in the double-blind period received benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52 in the extension period.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
8.5%
5/59 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
8.9%
5/56 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
8.2%
4/49 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
7.4%
4/54 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
13.5%
5/37 • Number of events 5 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/59 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
10.2%
5/49 • Number of events 7 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
3.7%
2/54 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
5.4%
2/37 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Nervous system disorders
Headache
|
5.1%
3/59 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
4.1%
2/49 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Infections and infestations
Sinusitis
|
3.4%
2/59 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.0%
1/49 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
8.1%
3/37 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/59 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
6.1%
3/49 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/59 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
5.0%
2/40 • Number of events 6 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/49 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
8.1%
3/37 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/59 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
4.1%
2/49 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
5.6%
3/54 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
3/59 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
1.8%
1/56 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
2.0%
1/49 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
0.00%
0/37 • Treatment-emergent adverse events (TEAEs) are reported from the first dose administration up to 30days after the last dose of study drug, a maximum of approximately 57 weeks.
The Safety analysis set included all participants who received at least 1 dose of study drug. Only TEAEs that started or worsened in severity on or after first dose of study drug are reported. TEAEs occurred prior to first dose of study drug are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place