Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis (NCT NCT03928743)

Results Overview

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) assessed disease activity on a scale of 0 \[not active\] to 10 \[very active\], higher score=more disease activity, Pain assessment on a scale of 0 \[no pain\] to 10 \[most severe pain\], higher score=more severity, Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) assessed participant's level of ability on a scale of 0 \[easy\] to 10 \[impossible\], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) defined as 6 item questionnaire: measured disease activity on a scale of 0 \[none\] to 10 \[severe\], higher score=more disease activity) and no worsening at all in the remaining domain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

332 participants

Primary outcome timeframe

Week 16

Results posted on

2025-12-24

Participant Flow

The study started to enroll study participants in April 2019 and concluded in August 2022.

The Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Placebo (up to Week 16) Participants received placebo matched to bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (Week 16 up to Week 52) At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.
Double-Blind Treatment Period:Weeks 1-16 STARTED	111	221	0
Double-Blind Treatment Period:Weeks 1-16 COMPLETED	109	213	0
Double-Blind Treatment Period:Weeks 1-16 NOT COMPLETED	2	8	0
Maintenance Period: Weeks 16-52 STARTED	0	0	319
Maintenance Period: Weeks 16-52 COMPLETED	0	0	298
Maintenance Period: Weeks 16-52 NOT COMPLETED	0	0	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (up to Week 16) Participants received placebo matched to bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (Week 16 up to Week 52) At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.
Double-Blind Treatment Period:Weeks 1-16 Due To COVID-19 Pandemic and Site Restrictions	1	1	0
Double-Blind Treatment Period:Weeks 1-16 Withdrawal by Subject	1	3	0
Double-Blind Treatment Period:Weeks 1-16 Lack of Efficacy	0	1	0
Double-Blind Treatment Period:Weeks 1-16 Adverse Event	0	2	0
Double-Blind Treatment Period:Weeks 1-16 Adverse Event, serious non-fatal	0	1	0
Maintenance Period: Weeks 16-52 PI Decision Due To Non-Compliance and COVID 19	0	0	1
Maintenance Period: Weeks 16-52 Withdrawal by Subject	0	0	4
Maintenance Period: Weeks 16-52 Lost to Follow-up	0	0	2
Maintenance Period: Weeks 16-52 Lack of Efficacy	0	0	3
Maintenance Period: Weeks 16-52 Adverse Event	0	0	9
Maintenance Period: Weeks 16-52 Adverse event, serious non-fatal	0	0	2

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Total n=332 Participants Total of all reporting groups	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	212 Participants n=30 Participants	321 Participants n=60 Participants	109 Participants n=30 Participants
Age, Categorical >=65 years	9 Participants n=30 Participants	11 Participants n=60 Participants	2 Participants n=30 Participants
Age, Continuous	41.0 years STANDARD_DEVIATION 12.1 • n=30 Participants	40.4 years STANDARD_DEVIATION 12.3 • n=60 Participants	39.2 years STANDARD_DEVIATION 12.6 • n=30 Participants
Sex: Female, Male Female	61 Participants n=30 Participants	92 Participants n=60 Participants	31 Participants n=30 Participants
Sex: Female, Male Male	160 Participants n=30 Participants	240 Participants n=60 Participants	80 Participants n=30 Participants
Race/Ethnicity, Customized Asian	37 Participants n=30 Participants	57 Participants n=60 Participants	20 Participants n=30 Participants
Race/Ethnicity, Customized Black	0 Participants n=30 Participants	1 Participants n=60 Participants	1 Participants n=30 Participants
Race/Ethnicity, Customized White	177 Participants n=30 Participants	267 Participants n=60 Participants	90 Participants n=30 Participants
Race/Ethnicity, Customized Other/Mixed	3 Participants n=30 Participants	3 Participants n=60 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Missing	1 Participants n=30 Participants	1 Participants n=60 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=30 Participants	3 Participants n=60 Participants	1 Participants n=30 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	218 Participants n=30 Participants	328 Participants n=60 Participants	110 Participants n=30 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The Randomized Set consisted of all randomized study participants.

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) assessed disease activity on a scale of 0 \[not active\] to 10 \[very active\], higher score=more disease activity, Pain assessment on a scale of 0 \[no pain\] to 10 \[most severe pain\], higher score=more severity, Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) assessed participant's level of ability on a scale of 0 \[easy\] to 10 \[impossible\], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) defined as 6 item questionnaire: measured disease activity on a scale of 0 \[none\] to 10 \[severe\], higher score=more disease activity) and no worsening at all in the remaining domain.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16	22.5 percentage of participants	44.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set consisted of all randomized study participants. Here, Number of Participants Analyzed signifies those who were evaluable for this outcome measure.

ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units 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 assessed disease activity on a scale of 0 \[not active\] to 10 \[very active\], higher score=more disease activity, Pain assessment on a scale of 0 \[no pain\] to 10 \[most severe pain\], higher score=more severity, Function (BASFI) assessed participant's level of ability on a scale of 0 \[easy\] to 10 \[impossible\], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 \[none\] to 10 \[severe\], higher score=more disease activity) and no worsening at all in the remaining domain.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=94 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=184 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response in TNFα Inhibitor-naïve Participants at Week 16	23.4 percentage of participants	45.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set consisted of all randomized study participants.

ASAS20 response was defined as relative improvements 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 assessed disease activity on a scale of 0 \[not active\] to 10 \[very active\], higher score=more disease activity, Pain assessment on a scale of 0 \[no pain\] to 10 \[most severe pain\], higher score=more severity, Function (BASFI) assessed participant's level of ability on a scale of 0 \[easy\] to 10 \[impossible\], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 \[none\] to 10 \[severe\], higher score=more disease activity) and no worsening at all in the remaining domain.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Assessment of SpondyloArthritis International Society 20% Response Criteria (ASAS20) Response at Week 16	43.2 percentage of participants	66.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The Randomized Set consisted of all randomized study participants.

BASDAI is a validated self-reported instrument, which consisted of 6 questions to measure the disease activity of ankylosing spondylitis (AS) from the participant's perspective. It measured the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration). Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0=none to 10= very severe, where higher score indicated high disease activity. A negative value indicated improvement and a positive value indicated worsening.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Week 16	-1.70 scores on a scale Standard Error 0.21	-2.74 scores on a scale Standard Error 0.17	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set consisted of all randomized study participants.

The Assessment of SpondyloArthritis International Society partial remission was defined as a score of less than or equal to (\<=) 2 units (on a scale of 0-10, where 0=no disease activity and 10=high disease activity) in each of the 4 domains. These 4 domains included: PGADA assessed disease activity on a scale of 0 \[not active\] to 10 \[very active\], higher score=more disease activity, Pain assessment on a scale of 0 \[no pain\] to 10 \[most severe pain\], higher score=more severity, Function (BASFI) assessed participant's level of ability on a scale of 0 \[easy\] to 10 \[impossible\], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 \[none\] to 10 \[severe\], higher score=more disease activity).

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) at Week 16	7.2 percentage of participants	24.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set consisted of all randomized study participants.

ASDAS-MI is achieved when there is a reduction (improvement) of greater than or equal to (\>=) 2.0 in the Ankylosing Spondylitis Disease Activity Score (ASDAS) relative to Baseline. ASDAS is calculated as the sum of the following components: 1) 0.121 × Total back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 result), 2) 0.058 × Duration of morning stiffness (BASDAI Q6 result), 3) 0.110 × Patient's Global Assessment of Disease Activity (PGADA), 4) 0.073 × Peripheral pain/swelling (BASDAI Q3 result), 5) 0.579 × (natural logarithm of the C-reactive protein (CRP) \[mg/L\] + 1). Total back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 \[no disease activity\] to 10 \[high disease activity\] units). High ASDAS scores mean worse disease. If a participant achieves the ASDAS-MI it indicates a major improvement of their disease.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) at Week 16	5.4 percentage of participants	25.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Randomized Set consisted of all randomized study participants.

The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains: PGADA assessed disease activity on a scale of 0 \[not active\] to 10 \[very active\], higher score=more disease activity, Pain assessment on a scale of 0 \[no pain\] to 10 \[most severe pain\], higher score=more severity), Function (BASFI) assessed participant's level of ability on a scale of 0 \[easy\] to 10 \[impossible\], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measured disease activity on a scale of 0 \[none\] to 10 \[severe\], higher score=more disease activity), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP)\].

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 16	18.9 percentage of participants	49.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The Randomized Set consisted of all randomized study participants.

The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranged from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16	-0.95 scores on a scale Standard Error 0.20	-2.00 scores on a scale Standard Error 0.16	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The Randomized Set consisted of all randomized study participants.

Nocturnal spinal pain experienced by ankylosing spondylitis (AS) participants is measured by one question: pain in the spine at night due to AS?. When responding, the participant is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale of 0 (no pain) to 10 (most severe pain) units. A lower score indicates less pain and a negative change represents an improvement.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Change From Baseline in Nocturnal Spinal Pain Score Numeric Rating Scale (NRS) at Week 16	-1.68 scores on a scale Standard Error 0.25	-3.16 scores on a scale Standard Error 0.20	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The Randomized Set consisted of all randomized study participants.

The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in participants with ankylosing spondylitis and has shown to be responsive in axial spondyloarthritis (axSpA). Each statement on the ASQoL is given a score of 1=Yes or 0=No. A score of "1" was given where the item was affirmed, indicating adverse quality of life. All item scores were summed to generate the total score ranging from 0 to 18 with a higher score indicating worse health-related quality of life. A negative change from baseline represents an improvement.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Week 16	-3.07 scores on a scale Standard Error 0.41	-4.59 scores on a scale Standard Error 0.32	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The Randomized Set consisted of all randomized study participants.

SF-36 is a 36-item HRQoL instrument with recall period of 4 weeks. Items are grouped into 8 domains: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items) and 1 item for Health Transition during last year. PCS and Mental Component Summary (MCS) scores are calculated from 8 domains (excluding Health Transition item). Each of SF-36 derived raw scores range from 0 to 100; higher score = better function. PCS score is calculated from 8 domain scores. It is standardized score ranging from 7.3 to 70.1, with a mean of 50 and SD of 10 in general US population, higher values = better function, and positive change reflects improvement. A PCS score mean below 47 indicates impaired physical functioning. Individual respondent's score that falls outside T-score range of 45 to 55 are outside average general US population range.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Change From Baseline in the Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	5.17 T-score Standard Error 0.82	8.54 T-score Standard Error 0.67	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The Randomized Set consisted of all randomized study participants.

The Bath Ankylosing Spondylitis Disease Metrology Index characterizes the spinal mobility of participants with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis. It is a disease-specific measure consisting of 5 clinical measures to reflect participant axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the 5 scores provides the total BASMI score (ranging from 0 to 10). The higher the BASMI score, the more severe the participant's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value, the better the improvement.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Change From Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16	-0.17 scores on a scale Standard Error 0.09	-0.45 scores on a scale Standard Error 0.07	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Subset of study participants in Randomized Set with enthesitis at Baseline.

The Maastricht Ankylosing Spondylitis Enthesitis is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process), each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score reflects higher severity and a negative change represents an improvement.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=67 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=132 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Change From Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the Subgroup of Participants With Enthesitis at Baseline at Week 16	-1.04 scores on a scale Standard Error 0.33	-2.12 scores on a scale Standard Error 0.26	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Subset of study participants in Randomized Set with enthesitis at Baseline.

The Maastricht Ankylosing Spondylitis Enthesitis is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. Enthesitis free state is defined as having a MASES score of 0. A higher score reflects higher severity and a negative change represents an improvement.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=67 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=132 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Enthesitis-free State at Week 16 Based on the Maastricht Ankylosing Spondylitis Enthesitis Index in the Subgroup of Participants With Enthesitis at Baseline	32.8 percentage of participants	51.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)

Population: The Safety Set consisted of all randomized study participants who received at least one dose of the IMP.

TEAEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety follow up (SFU) period). TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),Maintenance Period (MP) (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W n=319 Participants At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W n=330 Participants Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	43.2 percentage of participants	54.3 percentage of participants	68.3 percentage of participants	75.8 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)

Population: The Safety Set consisted of all randomized study participants who received at least one dose of the IMP.

A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulted in 1) Death, 2) Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), 3) Significant or persistent disability/incapacity, 4) Congenital anomaly/birth defect (including that occurring in a fetus), 5) Important medical event that, based upon appropriate medical judgment, may jeopardize the participant or participant may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious (Important medical events may include, but are not limited to, potential Hy's Law \[see allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.)

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W n=319 Participants At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W n=330 Participants Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study	0.9 percentage of participants	2.3 percentage of participants	4.7 percentage of participants	6.1 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) until Safety-Follow-Up (up to Week 68)

Population: The Safety Set consisted of all randomized study participants who received at least one dose of the IMP.

TEAEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period).

Outcome measures

Outcome measures
Measure	Placebo (up to Week 16) n=111 Participants Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Bimekizumab 160 mg Q4W (up to Week 16) n=221 Participants Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W n=319 Participants At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W n=330 Participants Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study	0 percentage of participants	3.2 percentage of participants	2.8 percentage of participants	4.8 percentage of participants

Adverse Events

Double Blind Treatment Period (up to Week 16): Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Double Blind Treatment Period (up to Week 16): Bimekizumab 160 mg Q4W

Serious events: 5 serious events

Other events: 43 other events

Deaths: 0 deaths

Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W

Serious events: 15 serious events

Other events: 64 other events

Deaths: 0 deaths

Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W

Serious events: 20 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double Blind Treatment Period (up to Week 16): Placebo n=111 participants at risk Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16.	Double Blind Treatment Period (up to Week 16): Bimekizumab 160 mg Q4W n=221 participants at risk Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16.	Maintenance Period (Week 16 up to Week 52): Bimekizumab 160 mg Q4W n=319 participants at risk At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. All Participants received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48.	Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W n=330 participants at risk Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously were included in this group.
Gastrointestinal disorders Diarrhoea	0.90% 1/111 • Number of events 1 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	3.2% 7/221 • Number of events 7 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	3.8% 12/319 • Number of events 15 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	5.5% 18/330 • Number of events 22 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.
Infections and infestations Oral Candidiasis	0.00% 0/111 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	4.5% 10/221 • Number of events 11 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	3.8% 12/319 • Number of events 14 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	6.1% 20/330 • Number of events 25 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.
Infections and infestations Nasopharyngitis	3.6% 4/111 • Number of events 4 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	7.7% 17/221 • Number of events 21 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	5.3% 17/319 • Number of events 18 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	9.1% 30/330 • Number of events 39 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.
Infections and infestations Upper respiratory tract infection	7.2% 8/111 • Number of events 11 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	2.7% 6/221 • Number of events 6 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	5.0% 16/319 • Number of events 17 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	6.4% 21/330 • Number of events 23 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.
Nervous system disorders Headache	4.5% 5/111 • Number of events 5 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	4.1% 9/221 • Number of events 10 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	3.4% 11/319 • Number of events 13 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.	5.5% 18/330 • Number of events 23 • From Baseline (Day 1) until Safety-Follow-Up (up to Week 68) As pre-specified in SAP, Maintenance Period (MP) included adverse events of Safety follow up period for participants who did not enter the open label extension or discontinued early in MP. TEAEs were analyzed and have been reported for Double Blind Treatment Period (Safety set),MP (Maintenance Set) and Overall Period (Safety set) which includes all participants who received BKZ 60 mg Q4W during the study.

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60