Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (NCT NCT03928704)
NCT ID: NCT03928704
Last Updated: 2025-12-24
Results Overview
ASAS40 response is defined as relative improvements of at least 40% and absolute improvement of at least 2 units in at least 3 of the 4 following components:1) Patient's Global Assessment of Disease Activity (PGADA) assessed on a scale ranging from 0 \[not active\] to 10 \[very active\], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 \[no pain\] to 10 \[most severe pain\], higher score= higher pain intensity, 3) Bath Ankylosing Spondylitis Functional Index (BASFI) assessing participant's level of ability on a scale ranging from 0 \[easy\] to 10 \[impossible\] on 10 physical activities,4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), each assessed on a scale ranging from 0 \[none / 0 hour\] to 10 \[very severe / 2 or more hours\], higher score=higher severity; and no worsening at all in the remaining component.
COMPLETED
PHASE3
274 participants
Week 16
2025-12-24
Participant Flow
The study started to enroll participants in April 2019 and concluded in April 2023. Among the total of 274 participants, 254 participants were enrolled under the global study protocol by June 2021, including 16 enrolled in China. The enrolment was extended in China to achieve the target of 36 participants as agreed with the local agency and additional 20 Chinese participants were enrolled by February 2022 in the China Extension population.
Out of 36 Chinese participants, 16 participants were included in the analysis of global population and the results of the remaining 20 Chinese participants are reported separately as the China Extension Population. Participant Flow refers to the Randomized Set and AS0010 China Extension Participants.
Participant milestones
| Measure |
Placebo (up to Week 16) (Global Population)
Participants received placebo matched to bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (Week 16 up to Week 52) (Global Population)
At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period:Week 1-16
STARTED
|
126
|
128
|
0
|
11
|
9
|
0
|
|
Double-Blind Treatment Period:Week 1-16
Started Chinese Participants
|
7
|
9
|
0
|
11
|
9
|
0
|
|
Double-Blind Treatment Period:Week 1-16
COMPLETED
|
118
|
126
|
0
|
11
|
9
|
0
|
|
Double-Blind Treatment Period:Week 1-16
NOT COMPLETED
|
8
|
2
|
0
|
0
|
0
|
0
|
|
Maintenance Period: Week 16-52
STARTED
|
0
|
0
|
242
|
0
|
0
|
20
|
|
Maintenance Period: Week 16-52
COMPLETED
|
0
|
0
|
220
|
0
|
0
|
17
|
|
Maintenance Period: Week 16-52
NOT COMPLETED
|
0
|
0
|
22
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo (up to Week 16) (Global Population)
Participants received placebo matched to bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (Week 16 up to Week 52) (Global Population)
At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period:Week 1-16
Patient Compliance
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period:Week 1-16
Withdrawal By Study Participant
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period:Week 1-16
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period:Week 1-16
Adverse Event
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period: Week 16-52
Withdrawal By Study Participant
|
0
|
0
|
12
|
0
|
0
|
0
|
|
Maintenance Period: Week 16-52
Lack of Efficacy
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Maintenance Period: Week 16-52
Adverse Event
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Maintenance Period: Week 16-52
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period: Week 16-52
COVID-19 pandemic situation & site restrictions
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Maintenance Period: Week 16-52
Non- Compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 - <65
|
123 Participants
n=30 Participants
|
125 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
9 Participants
n=219 Participants
|
268 Participants
n=880 Participants
|
|
Age, Customized
65 - <85
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
6 Participants
n=880 Participants
|
|
Age, Customized
>= 85
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=30 Participants
|
55 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
2 Participants
n=219 Participants
|
125 Participants
n=880 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=30 Participants
|
73 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
7 Participants
n=219 Participants
|
149 Participants
n=880 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
9 Participants
n=219 Participants
|
48 Participants
n=880 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
3 Participants
n=880 Participants
|
|
Race/Ethnicity, Customized
White
|
110 Participants
n=30 Participants
|
109 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
219 Participants
n=880 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
2 Participants
n=880 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
2 Participants
n=880 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
5 Participants
n=880 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
122 Participants
n=30 Participants
|
125 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
9 Participants
n=219 Participants
|
267 Participants
n=880 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Randomized set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment.
ASAS40 response is defined as relative improvements of at least 40% and absolute improvement of at least 2 units in at least 3 of the 4 following components:1) Patient's Global Assessment of Disease Activity (PGADA) assessed on a scale ranging from 0 \[not active\] to 10 \[very active\], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 \[no pain\] to 10 \[most severe pain\], higher score= higher pain intensity, 3) Bath Ankylosing Spondylitis Functional Index (BASFI) assessing participant's level of ability on a scale ranging from 0 \[easy\] to 10 \[impossible\] on 10 physical activities,4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), each assessed on a scale ranging from 0 \[none / 0 hour\] to 10 \[very severe / 2 or more hours\], higher score=higher severity; and no worsening at all in the remaining component.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16
|
27.3 percentage of participants
|
33.3 percentage of participants
|
21.4 percentage of participants
|
47.7 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment. Participants analyzed are those from the RS who are TNFα inhibitor-naïve.
ASAS40 response is defined as relative improvements of at least 40% and absolute improvement of at least 2 units in at least 3 of the 4 following components:1) Patient's Global Assessment of Disease Activity (PGADA) assessed on a scale ranging from 0 \[not active\] to 10 \[very active\], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 \[no pain\] to 10 \[most severe pain\], higher score= higher pain intensity, 3) Bath Ankylosing Spondylitis Functional Index (BASFI) assessing participant's level of ability on a scale ranging from 0 \[easy\] to 10 \[impossible\] on 10 physical activities,4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), each assessed on a scale ranging from 0 \[none / 0 hour\] to 10 \[very severe / 2 or more hours\], higher score=higher severity; and no worsening at all in the remaining component.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=8 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=109 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=118 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response in TNFα Inhibitor-naïve Subjects at Week 16
|
27.3 percentage of Participants
|
37.5 percentage of Participants
|
22.9 percentage of Participants
|
46.6 percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment. Here, 'Number of Participants Analyzed' signifies participants who were evaluable for this outcome measure.
BASDAI is a well-established patient-reported endpoint assessing severity of AS symptoms. It is made of 6 items assessing severity of fatigue, spinal pain, peripheral joint pain \& swelling, enthesitis, \& morning stiffness (both severity and duration). Each question is rated using a numerical rating scale ranging from 0 (none) to 10 (very severe), higher score=higher symptom severity.BASDAI score is calculated by computing mean of questions 5 and 6 \& adding it to sum of questions 1 to 4.This score is then divided by 5.Total BASDAI score ranges from 0=no disease activity to 10=maximal disease activity, higher score indicates higher symptom severity. A negative change reflects improvement.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=10 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Week 16
|
-2.09 score on a scale
Standard Error 0.564
|
-2.99 score on a scale
Standard Error 0.571
|
-1.55 score on a scale
Standard Error 0.22
|
-3.07 score on a scale
Standard Error 0.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment.
ASAS20 response is defined as relative improvements of at least 20% and absolute improvement of at least 1 unit in at least 3 of the 4 following components:1) PGADA assessed on a scale ranging from 0 \[not active\] to 10 \[very active\], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 \[no pain\] to 10 \[most severe pain\], higher score= higher pain intensity, 3) BASFI assessing participant's level of ability on a scale ranging from 0 \[easy\] to 10 \[impossible\] on 10 physical activities, 4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the BASDAI, each assessed on a scale ranging from 0 \[none / 0 hour\] to 10 \[very severe / 2 or more hours\], higher score=higher severity; and no worsening at all in the remaining component.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Assessment of SpondyloArthritis International Society 20% Response Criteria (ASAS20) Response at Week 16
|
54.5 percentage of participants
|
44.4 percentage of participants
|
38.1 percentage of participants
|
68.8 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment.
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of less than or equal to (\<=) 2 units in each of the 4 following components:1) PGADA assessed on a scale ranging from 0 \[not active\] to 10 \[very active\], higher score=higher disease activity,2) Spinal Pain assessed on a scale ranging from 0 \[no pain\] to 10 \[most severe pain\], higher score= higher pain intensity, 3) BASFI assessing participant's level of ability on a scale ranging from 0 \[easy\] to 10 \[impossible\] on 10 physical activities, and 4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the BASDAI scale, each assessed on a scale ranging from 0 \[none / 0 hour\] to 10 \[very severe / 2 or more hours\], higher score=higher severity.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) at Week 16
|
9.1 percentage of participants
|
33.3 percentage of participants
|
7.1 percentage of participants
|
25.8 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment.
ASDAS-MI is achieved when there is a reduction (improvement) greater or equal to (\>=) 2.0 in ASDAS relative to Baseline. ASDAS is calculated by adding the 5 following components: 1) 0.121 × Neck, back or hip pain (BASDAI Q2), 2) 0.058 × Duration of morning stiffness (BASDAI Q6), 3) 0.110 × Patient's Global Assessment of Disease Activity (PGADA), 4) 0.073 × Peripheral pain/swelling in joints (BASDAI Q3), 5) 0.579 × (natural logarithm of the C-reactive protein (CRP) \[mg/L\] + 1). Q2, Q3 and Q6 from BASDAI and PGADA, are all assessed on a numerical scale from 0 \[none / not active\] to 10 \[very severe / very active\]. There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 is assumed for values of hs-CRP below the lower limit of quantification (LLOQ)), but no defined upper score. Higher ASDAS scores reflect higher disease activity and participants achieving ASDAS-MI are considered to have a major improvement in their disease.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) at Week 16
|
9.1 percentage of participants
|
11.1 percentage of participants
|
7.1 percentage of participants
|
27.3 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment.
ASAS 5/6 response is defined as achieving at least 20% improvement in 5 of the following 6 components:1) PGADA assessed on a scale ranging from 0 \[not active\] to 10 \[very active\], higher score=higher disease activity, 2) Spinal Pain assessed on a scale ranging from 0 \[no pain\] to 10 \[most intense pain\], higher score=higher pain intensity,3) BASFI assessing participant's level of ability on a scale ranging from 0 \[easy\] to 10 \[impossible\] on 10 physical activities,4) morning stiffness, assessed as the mean of Q5 (intensity) and Q6 (duration) from the BASDAI scale, each assessed on a scale ranging from 0 \[none/ 0 hour\] to 10 \[very severe / 2 or more hours\], higher score=higher severity;5) spinal mobility (ie, lateral spinal flexion component of Bath Ankylosing Spondylitis Disease Metrology Index) on a scale ranging from 0 \[no limitation of movement\] to 10 \[very severe limitation of movement\] and 6) high sensitivity C-reactive protein (hs-CRP).
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 16
|
18.2 percentage of participants
|
44.4 percentage of participants
|
20.6 percentage of participants
|
45.3 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment. Here, 'Number of Participants Analyzed' signifies participants who were evaluable for this outcome measure.
The BASFI is a well-established PRO measure of physical functioning used in AxSpA trials. It assesses participants' level of ability during the past week in conducting 10 physical activities on a scale ranging from 0 \[easy\] to 10 \[impossible\]. The BASFI score is the mean of the 10 item scores and ranges from 0 to 10, with lower scores indicating better physical function. A negative change in BASFI indicates improvement. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=10 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
|
-0.79 score on a scale
Standard Error 0.340
|
-2.03 score on a scale
Standard Error 0.368
|
-0.91 score on a scale
Standard Error 0.22
|
-2.39 score on a scale
Standard Error 0.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment. Here, 'Number of Participants Analyzed' signifies participants who were evaluable for this outcome measure.
Nocturnal spinal pain experienced by participants with axial spondyloarthritis (axSpA) was assessed on a numerical rating scale ranging from 0 (no pain) to 10 (most severe pain). A lower score indicates less pain and a negative change represents an improvement.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=10 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Nocturnal Spinal Pain Score Using Numeric Rating Scale (NRS) at Week 16
|
-2.41 score on a scale
Standard Error 0.638
|
-3.51 score on a scale
Standard Error 0.658
|
-1.71 score on a scale
Standard Error 0.27
|
-3.51 score on a scale
Standard Error 0.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment. Here, 'Number of Participants Analyzed' signifies participants who were evaluable for this outcome measure.
The Ankylosing Spondylitis Quality of Life (ASQoL) is an 18-item PRO measure developed specifically for measuring health-related quality of life (HRQoL) in participants with ankylosing spondylitis and validated in the full spectrum of axial spondyloarthritis (axSpA). Each item is given a score of 1 for positive responses indicating impaired quality of life, and a score of 0 for negative responses. All item scores are summed to generate the total score ranging from 0 to 18 with a higher score indicating worse HRQoL. A negative change represents an improvement.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=10 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Week 16
|
0.18 score on a scale
Standard Error 0.970
|
-1.66 score on a scale
Standard Error 0.967
|
-2.30 score on a scale
Standard Error 0.43
|
-4.94 score on a scale
Standard Error 0.42
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment. 'Number of Participants Analyzed' signifies participants who were evaluable for this outcome measure.
SF-36 is a 36-item HRQoL instrument with recall period of 4 weeks. Items are grouped into 8 domains: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items) and 1 item for Health Transition during last year. PCS and Mental Component Summary (MCS) scores are calculated from 8 domains (excluding Health Transition item). Each of SF-36 derived raw scores range from 0 to 100; higher score = better function. PCS score is calculated from 8 domain scores. It is standardized score ranging from 7.3 to 70.1, with a mean of 50 and SD of 10 in general US population, higher values = better function, and positive change reflects improvement. A PCS score mean below 47 indicates impaired physical functioning. Individual respondent's score that falls outside T-score range of 45 to 55 are outside average general US population range.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=10 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
|
-3.52 T-score
Standard Error 2.462
|
3.75 T-score
Standard Error 2.364
|
5.36 T-score
Standard Error 0.79
|
9.32 T-score
Standard Error 0.76
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The Randomized Set consisted of all randomized study participants. AS0010 China Extension Participants refer to an additional randomized set recruited in China after the closure of the global study recruitment.
The BASMI characterizes the spinal mobility of participants with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis. It is a disease-specific measure consisting of 5 clinical measures to reflect participant axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the 5 scores provides the total BASMI score (ranging from 0 to 10). The higher the BASMI score, the more severe the participant's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value, the better the improvement.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16
|
0.12 score on a scale
Standard Error 0.211
|
-0.38 score on a scale
Standard Error 0.232
|
-0.11 score on a scale
Standard Error 0.08
|
-0.44 score on a scale
Standard Error 0.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Subgroup of study participants in Randomized Set with enthesitis at Baseline (MASES index score \> 0). Subgroup of study participants in China Extension Population (randomized set) with enthesitis at Baseline (MASES index score \> 0).
The Maastricht Ankylosing Spondylitis Enthesitis is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process), each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score reflects higher severity and a negative change represents an improvement.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=5 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=3 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=92 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=94 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the Subgroup of Participants With Enthesitis at Baseline at Week 16
|
-1.35 score on a scale
Standard Error 0.692
|
-1.80 score on a scale
Standard Error 0.871
|
-1.11 score on a scale
Standard Error 0.38
|
-2.16 score on a scale
Standard Error 0.37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Subgroup of study participants in Randomized Set with enthesitis at Baseline (MASES index score \> 0). Subgroup of study participants in China Extension Population (randomized set) with enthesitis at Baseline (MASES index score \> 0).
The Maastricht Ankylosing Spondylitis Enthesitis is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process), each scored as 0 or 1 and then summed for a possible score of 0 to 13. Enthesitis free state is defined as having a MASES score of 0. A higher score reflects higher severity and a negative change represents an improvement.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=5 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=3 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=92 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=94 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Enthesitis-free State at Week 16 Based on the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the Subgroup of Participants With Enthesitis at Baseline
|
60.0 percentage of participants
|
66.7 percentage of participants
|
23.9 percentage of participants
|
51.1 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) (Week 48 last IMP intake + 20 weeks SFU)Population: Safety Set consisted of all randomized study participants who received at least 1 dose of IMP. Maintenance Set (MS) included all study participants who have received at least 1 dose of BKZ treatment in the MP. AS0010 China Extension Participants Safety Set included all randomized study participants who received at least 1 dose of IMP. AS0010 China Extension Participants Maintenance Set included all study participants who have received at least 1 dose of BKZ treatment in the MP.
TEAEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety follow up (SFU)). TEAEs were analyzed and have been reported separately for Double-Blind Treatment Period (Safety set),Maintenance Period (MP) (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 160 mg Q4W during the study. The overall period arm reports repeated TEAEs from the double blind treatment period arm and maintenance period arm. As pre-specified in SAP, Maintenance Period (MP) included AEs of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=242 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=244 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
n=20 Participants
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
n=20 Participants
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
|
67.8 percentage of participants
|
75.0 percentage of participants
|
56.3 percentage of participants
|
62.5 percentage of participants
|
72.7 percentage of participants
|
100 percentage of participants
|
80.0 percentage of participants
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety Follow-Up (up to Week 68)Population: Safety Set consisted of all randomized study participants who received at least 1 dose of IMP. Maintenance Set (MS) included all study participants who have received at least 1 dose of BKZ treatment in the MP. AS0010 China Extension Participants Safety Set included all randomized study participants who received at least 1 dose of IMP. AS0010 China Extension Participants Maintenance Set included all study participants who have received at least 1 dose of BKZ treatment in the MP.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulted in 1) Death, 2) Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), 3) Significant or persistent disability/incapacity, 4) Congenital anomaly/birth defect (including that occurring in a fetus), 5) Important medical event that, based upon appropriate medical judgment, may jeopardize the participant or participant may require medical or surgical intervention to prevent any of the above, 6) Initial inpatient hospitalization or prolongation of hospitalization. The overall period arm reports repeated SAEs from the double blind treatment period arm and maintenance period arm. As pre-specified in SAP, MP included SAEs of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=242 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=244 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
n=20 Participants
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
n=20 Participants
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
|
3.7 percentage of participants
|
3.7 percentage of participants
|
0.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
15.0 percentage of participants
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)Population: Safety Set consisted of all randomized study participants who received at least 1 dose of IMP. Maintenance Set (MS) included all study participants who have received at least 1 dose of BKZ treatment in the MP. AS0010 China Extension Participants Safety Set included all randomized study participants who received at least 1 dose of IMP. AS0010 China Extension Participants Maintenance Set included all study participants who have received at least 1 dose of BKZ treatment in the MP.
TEAEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). The overall period arm reports repeated events from the double blind treatment period arm and maintenance period arm. As pre-specified in SAP, MP included events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP.
Outcome measures
| Measure |
Placebo (up to Week 16) (China Extension Population)
n=242 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=244 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (Global Population)
n=126 Participants
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 Participants
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Placebo (up to Week 16) (China Extension Population)
n=11 Participants
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 Participants
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
n=20 Participants
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
n=20 Participants
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
|
2.5 percentage of participants
|
3.3 percentage of participants
|
4.0 percentage of participants
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Placebo (up to Week 16) (Global Population)
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
Bimekizumab 160 mg Q4W (Week 16 up to Week 52) (Global Population)
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (Global Population)
Placebo (up to Week 16) (China Extension Population)
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
Serious adverse events
| Measure |
Placebo (up to Week 16) (Global Population)
n=126 participants at risk
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 participants at risk
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (Week 16 up to Week 52) (Global Population)
n=242 participants at risk
At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (Global Population)
n=244 participants at risk
Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
Placebo (up to Week 16) (China Extension Population)
n=11 participants at risk
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 participants at risk
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
n=20 participants at risk
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
n=20 participants at risk
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.79%
1/126 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.83%
2/242 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.82%
2/244 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Reproductive system and breast disorders
Abortion induced
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
Other adverse events
| Measure |
Placebo (up to Week 16) (Global Population)
n=126 participants at risk
Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (Global Population)
n=128 participants at risk
Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (Week 16 up to Week 52) (Global Population)
n=242 participants at risk
At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (Global Population)
n=244 participants at risk
Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
Placebo (up to Week 16) (China Extension Population)
n=11 participants at risk
Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population)
n=9 participants at risk
Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16.
|
BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population)
n=20 participants at risk
At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52.
|
Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population)
n=20 participants at risk
Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.8%
6/126 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.2%
13/128 • Number of events 13 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
7.4%
18/242 • Number of events 21 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
12.3%
30/244 • Number of events 34 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
10/126 • Number of events 11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
7.0%
9/128 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
6.2%
15/242 • Number of events 17 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.4%
23/244 • Number of events 26 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
27.3%
3/11 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
15.0%
3/20 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
20.0%
4/20 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Corona virus infection
|
0.79%
1/126 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.78%
1/128 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
7.0%
17/242 • Number of events 17 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
7.0%
17/244 • Number of events 18 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
20.0%
4/20 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
20.0%
4/20 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
3.1%
4/128 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
7.0%
17/242 • Number of events 20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
7.4%
18/244 • Number of events 25 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Nervous system disorders
Headache
|
1.6%
2/126 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
3.1%
4/128 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
4.1%
10/242 • Number of events 12 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.7%
14/244 • Number of events 18 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.6%
2/128 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/244 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Eye disorders
Vision blurred
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/126 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.3%
3/128 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.5%
6/242 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
3.7%
9/244 • Number of events 10 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Gastrointestinal disorders
Gastritis
|
0.79%
1/126 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/126 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.9%
7/242 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.9%
7/244 • Number of events 8 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
General disorders
Injection site pain
|
1.6%
2/126 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.6%
2/128 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/242 • Number of events 7 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.0%
5/244 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
18.2%
2/11 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/126 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.3%
3/128 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.7%
4/242 • Number of events 6 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.9%
7/244 • Number of events 9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
22.2%
2/9 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
15.0%
3/20 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Investigations
Liver function test increased
|
0.79%
1/126 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.78%
1/128 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Investigations
Weight decreased
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/242 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/244 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.6%
2/126 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.6%
2/128 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.83%
2/242 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/244 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/242 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/244 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
11.1%
1/9 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
2.3%
3/128 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/244 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/242 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.41%
1/244 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.7%
4/242 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.6%
4/244 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
5.0%
1/20 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
9.1%
1/11 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/20 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.78%
1/128 • Number of events 1 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/242 • Number of events 4 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
1.2%
3/244 • Number of events 5 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 3 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/126 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/242 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/244 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
|
Musculoskeletal and connective tissue disorders
Axial spondyloarthritis
|
1.6%
2/126 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/128 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.83%
2/242 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.82%
2/244 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/11 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
0.00%
0/9 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
10.0%
2/20 • Number of events 2 • From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60