Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis (NCT NCT02963506)
NCT ID: NCT02963506
Last Updated: 2023-06-06
Results Overview
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
303 participants
Primary outcome timeframe
Week 12
Results posted on
2023-06-06
Participant Flow
The study started to enroll participants in October 2016 and concluded in August 2018.
The study included a 28-Day Screening Period, followed by a Double-Blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post Week 48. The Participant Flow refers to the Randomized Set and Dose-Blind Set.
Participant milestones
| Measure |
Placebo
Participants received placebo during the 12 weeks Double-Blind Period.
|
BKZ 16 mg
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
|
BKZ 64 mg
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
|
BKZ 160 mg
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
|
BKZ 320 mg
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
|
Placebo - BKZ 160 mg
After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
|
Placebo - BKZ 320 mg
After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period
|
BKZ 16 mg - BKZ 160 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 16 mg - BKZ 320 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 64 mg - BKZ 160 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 64 mg - BKZ 320 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 160 mg - BKZ 160 mg
Participants randomized to bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 160 mg Q4W in the 36 weeks Dose-Blind Period.
|
BKZ 320 mg - BKZ 320 mg
Participants randomized to bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 320 mg Q4W in the 36 weeks Dose-Blind Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Period
STARTED
|
60
|
61
|
61
|
60
|
61
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Completed Double-Blind Period
|
60
|
59
|
59
|
58
|
61
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Completed Week 12 - Started Dose-Blind
|
60
|
58
|
59
|
58
|
61
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
COMPLETED
|
60
|
58
|
59
|
58
|
61
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
NOT COMPLETED
|
0
|
3
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose-Blind Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
24
|
36
|
31
|
27
|
34
|
25
|
58
|
61
|
|
Dose-Blind Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
20
|
31
|
26
|
24
|
30
|
24
|
56
|
54
|
|
Dose-Blind Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
4
|
5
|
5
|
3
|
4
|
1
|
2
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo during the 12 weeks Double-Blind Period.
|
BKZ 16 mg
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
|
BKZ 64 mg
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
|
BKZ 160 mg
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
|
BKZ 320 mg
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
|
Placebo - BKZ 160 mg
After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period.
|
Placebo - BKZ 320 mg
After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period
|
BKZ 16 mg - BKZ 160 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 16 mg - BKZ 320 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 64 mg - BKZ 160 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 64 mg - BKZ 320 mg
After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period.
|
BKZ 160 mg - BKZ 160 mg
Participants randomized to bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 160 mg Q4W in the 36 weeks Dose-Blind Period.
|
BKZ 320 mg - BKZ 320 mg
Participants randomized to bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 320 mg Q4W in the 36 weeks Dose-Blind Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Period
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
No compliance
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Adverse event, non fatal after Wk12
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose-Blind Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
2
|
2
|
2
|
1
|
1
|
6
|
|
Dose-Blind Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Dose-Blind Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Dose-Blind Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Dose-Blind Period
Sponsor decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose-Blind Period
Meeting exclusion criteria 9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period.
|
BKZ 16 mg
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
|
BKZ 64 mg
n=61 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period.
|
BKZ 160 mg
n=60 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
|
BKZ 320 mg
n=61 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period.
|
Total Title
n=303 Participants
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
291 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
|
Age, Continuous
|
39.65 years
STANDARD_DEVIATION 10.30 • n=99 Participants
|
43.31 years
STANDARD_DEVIATION 12.59 • n=107 Participants
|
40.41 years
STANDARD_DEVIATION 10.93 • n=206 Participants
|
42.38 years
STANDARD_DEVIATION 13.11 • n=7 Participants
|
45.02 years
STANDARD_DEVIATION 11.39 • n=31 Participants
|
42.16 years
STANDARD_DEVIATION 11.80 • n=30 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
47 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
256 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
298 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The FAS consisted of all randomized participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline.
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=60 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12
|
13.3 percentage of participants
|
29.5 percentage of participants
|
42.6 percentage of participants
|
46.7 percentage of participants
|
45.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI question 2 result) 0.058 x Duration of morning stiffness (BASDAI question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI question 3 result) 0.579 x (natural logarithm of the (hs-CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score since CRP does not have a set upper limit. If one component for the ASDAS-CRP was missing at a given visit, that component was imputed by carrying the last observation forward, and the ASDAS-CRP was calculated accordingly. If the hs-CRP value was below 2 mg/L, then it was imputed as the constant value of 2 mg/L.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=60 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
|
-0.3 scores on a scale
Standard Error 0.17
|
-0.8 scores on a scale
Standard Error 0.17
|
-1.4 scores on a scale
Standard Error 0.17
|
-1.3 scores on a scale
Standard Error 0.17
|
-1.4 scores on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Week 12Population: The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
The ASAS20 response was defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain \[deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit\]. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=60 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12
|
28.3 percentage of participants
|
41.0 percentage of participants
|
62.3 percentage of participants
|
58.3 percentage of participants
|
72.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
The ASAS 5/6 response was defined as at least 20% improvement in at least 5 of the 6 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP). Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=60 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12
|
6.7 percentage of participants
|
29.5 percentage of participants
|
49.2 percentage of participants
|
53.3 percentage of participants
|
54.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
The BASDAI is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=60 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
-1.0 scores on a scale
Standard Error 0.38
|
-1.6 scores on a scale
Standard Error 0.38
|
-2.6 scores on a scale
Standard Error 0.38
|
-2.6 scores on a scale
Standard Error 0.38
|
-2.9 scores on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline.
The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=60 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
|
-0.7 scores on a scale
Standard Error 0.39
|
-1.4 scores on a scale
Standard Error 0.38
|
-1.8 scores on a scale
Standard Error 0.38
|
-1.9 scores on a scale
Standard Error 0.38
|
-2.2 scores on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: From Screening until Safety Follow-Up Visit (up to Week 77)Population: The SS consisted of all randomized participants who received at least 1 dose of IMP.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=58 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=149 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=150 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE) During the Study
|
45.0 percentage of participants
|
44.3 percentage of participants
|
34.5 percentage of participants
|
69.8 percentage of participants
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Screening until Safety Follow-Up Visit (up to Week 77)Population: The SS consisted of all randomized participants who received at least 1 dose of IMP.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=58 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=149 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=150 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
|
3.3 percentage of participants
|
0 percentage of participants
|
3.4 percentage of participants
|
3.4 percentage of participants
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Screening until Safety Follow-Up Visit (up to Week 77)Population: The SS consisted of all randomized participants who received at least 1 dose of IMP.
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Secondary Outcome Measure were summarized from the adverse event pages of the Case Report Forms.
Outcome measures
| Measure |
Placebo (FAS)
n=60 Participants
Participants received placebo during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 16 mg (FAS)
n=61 Participants
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 64 mg (FAS)
n=58 Participants
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 160 mg (FAS)
n=149 Participants
Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
BKZ 320 mg (FAS)
n=150 Participants
Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS).
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
|
1.7 percentage of participants
|
3.3 percentage of participants
|
1.7 percentage of participants
|
4.7 percentage of participants
|
6.7 percentage of participants
|
Adverse Events
Placebo (SS) - up to Wk 12
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
BKZ 16 mg (SS) - up to Wk 12
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BKZ 64 mg (SS) - up to Wk 12
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
BKZ 160 mg (SS) - up to Wk 73
Serious events: 5 serious events
Other events: 42 other events
Deaths: 1 deaths
BKZ 320 mg (SS) - up to Wk 73
Serious events: 6 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (SS) - up to Wk 12
n=60 participants at risk
This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
|
BKZ 16 mg (SS) - up to Wk 12
n=61 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
|
BKZ 64 mg (SS) - up to Wk 12
n=58 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
|
BKZ 160 mg (SS) - up to Wk 73
n=149 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
|
BKZ 320 mg (SS) - up to Wk 73
n=150 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/149 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Postoperative wound infection
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
Other adverse events
| Measure |
Placebo (SS) - up to Wk 12
n=60 participants at risk
This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS).
|
BKZ 16 mg (SS) - up to Wk 12
n=61 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
|
BKZ 64 mg (SS) - up to Wk 12
n=58 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
|
BKZ 160 mg (SS) - up to Wk 73
n=149 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
|
BKZ 320 mg (SS) - up to Wk 73
n=150 participants at risk
This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS.
|
|---|---|---|---|---|---|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
5.4%
8/149 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
5.3%
8/150 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
5.4%
8/149 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
4.0%
6/150 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Bronchitis
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
3.4%
2/58 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
2.7%
4/149 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
8.0%
12/150 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
3.3%
2/61 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
8.7%
13/149 • Number of events 19 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
12.7%
19/150 • Number of events 22 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/60 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
7.4%
11/149 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
4.7%
7/150 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
0.00%
0/61 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
3.4%
5/149 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
7.3%
11/150 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60