Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (NCT NCT03896581)

NCT ID: NCT03896581

Last Updated: 2026-01-28

Results Overview

The ACR50 response rate was based on a 50% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1.≥ 50% improvement in 68-tender joint count; 2.≥ 50% improvement in 66-swollen joint count; and 3.≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity \[100 mm visual analog scale (VAS) (0=no symptoms;100=severe symptoms)\], Patient global assessment of disease activity \[100 mm VAS (0=no limitation of normal activities;100=very poor\], Patient assessment of pain \[100 mm VAS (0=no pain;100=most severe pain)\], Health Assessment Questionnaire - Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 400 participants
• Primary outcome timeframe: From Baseline to Week 16
• Results posted on: 2026-01-28

Participant Flow

The study started to enroll study participants in March 2019 and concluded in February 2022.

Participant Flow refers to the Randomized Set.

Participant milestones

Measure	Placebo Participants received placebo as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 16 weeks.	Bimekizumab 160mg Participants received bimekizumab (BKZ) 160 milligrams (mg) as a sc injection Q4W for up to 16 weeks.
Overall Study STARTED	133	267
Overall Study COMPLETED	125	263
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Measure	Placebo Participants received placebo as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 16 weeks.	Bimekizumab 160mg Participants received bimekizumab (BKZ) 160 milligrams (mg) as a sc injection Q4W for up to 16 weeks.
Overall Study Other (Covid-19 Pandemic Circumstances)	1	0
Overall Study Withdrawal by Subject	4	1
Overall Study Lost to Follow-up	1	0
Overall Study Lack of Efficacy	2	1
Overall Study Adverse event, non-fatal	0	2

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.	Total n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=158 Participants	226 Participants n=157 Participants	337 Participants n=315 Participants
Age, Categorical >=65 years	22 Participants n=158 Participants	41 Participants n=157 Participants	63 Participants n=315 Participants
Age, Continuous	51.30 years STANDARD_DEVIATION 12.876 • n=158 Participants	50.13 years STANDARD_DEVIATION 12.382 • n=157 Participants	50.52 years STANDARD_DEVIATION 12.545 • n=315 Participants
Sex: Female, Male Female	73 Participants n=158 Participants	137 Participants n=157 Participants	210 Participants n=315 Participants
Sex: Female, Male Male	60 Participants n=158 Participants	130 Participants n=157 Participants	190 Participants n=315 Participants
Race/Ethnicity, Customized Asian	4 Participants n=158 Participants	9 Participants n=157 Participants	13 Participants n=315 Participants
Race/Ethnicity, Customized White	128 Participants n=158 Participants	256 Participants n=157 Participants	384 Participants n=315 Participants
Race/Ethnicity, Customized Other/Mixed	1 Participants n=158 Participants	2 Participants n=157 Participants	3 Participants n=315 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=158 Participants	1 Participants n=157 Participants	4 Participants n=315 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	130 Participants n=158 Participants	266 Participants n=157 Participants	396 Participants n=315 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized. Participants who had missing ACR50 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non-responders.

The ACR50 response rate was based on a 50% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1.≥ 50% improvement in 68-tender joint count; 2.≥ 50% improvement in 66-swollen joint count; and 3.≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity [100 mm visual analog scale (VAS) (0=no symptoms;100=severe symptoms)], Patient global assessment of disease activity [100 mm VAS (0=no limitation of normal activities;100=very poor], Patient assessment of pain [100 mm VAS (0=no pain;100=most severe pain)], Health Assessment Questionnaire - Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response	6.8 percentage of participants	43.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using multiple imputation.

The HAQ-DI contains 20 items that measured the degree of difficulty experienced in the following 8 categories of the daily living activities: dressing and grooming (2 items), arising (2 items), eating (3 items), walking (2 items), hygiene (3 items), reach (2 items), grip (3 items), and common daily activities (3 items). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). The overall HAQ-DI total score was calculated by dividing the sum of the highest category scores (0 to 24) by the number of categories with at least 1 question answered. The HAQ-DI score ranges from 0 (no difficulty) to 3 (maximum difficulty). A lower HAQ-DI score indicated an improvement in function. Change from baseline was computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicated an improvement.

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16	-0.0701 score on a scale Standard Error 0.0432	-0.3751 score on a scale Standard Error 0.0286

SECONDARY outcome

Timeframe: From Baseline to Week 4

Population: Subset of study participants in Randomized Set with psoriasis involving at least 3% BSA at Baseline. Participants who had missing PASI90 data at Week 4 or who discontinued study treatment before or at Week 4 regardless whether they had data or not are considered as non-responders.

The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo n=88 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=176 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline	0 percentage of participants	26.7 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 16

Population: Subset of study participants in Randomized Set with psoriasis involving at least 3% BSA at Baseline. Participants who had missing PASI90 data at Week 16 or who discontinued study treatment before or at Week 16 regardless whether they had data or not are considered as non-responders.

The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo n=88 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=176 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline	6.8 percentage of participants	68.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized.

The SF-36 (version 2, standard recall) is a 36-item generic HRQoL instrument that uses a recall period of 4 weeks. The questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Domains 1 to 4 primarily contribute to the PCS score of the SF-36. Domains 5-8 primarily contribute to the MCS score of the SF-36. Each of the 8 domain scores and the component summary score range from 0=worst to 100=best. Higher scores represent better health status. A positive change in value indicated improvement from baseline.

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	1.413 score on a scale Standard Error 0.714	7.258 score on a scale Standard Error 0.531

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized.

MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: Tender joint count (0-68 joints) <=1; Swollen joint count (0-66 joints) <=1; PASI <=1 for participants with psoriasis covering BSA <=3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; Patient's Assessment of Arthritis Pain <=15 [using VAS on a scale of 0 (no pain) to 100 (serious pain)]; Patient's Global Assessment of Disease Activity <=20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score <=0.5; Leeds Enthesitis Index score <=1 for participants with enthesitis at baseline.

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Minimal Disease Activity (MDA) at Week 16	6.0 percentage of participants	44.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized. Participants who had missing ACR20 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non-responders.

The ACR20 response rate was based on a 20% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1.≥ 20% improvement in 68-tender joint count; 2.≥ 20% improvement in 66-swollen joint count; and 3.≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity [100 mm VAS (0=no symptoms;100=severe symptoms)], Patient global assessment of disease activity [100 mm VAS (0=no limitation of normal activities;100=very poor], Patient assessment of pain [100 mm VAS (0=no pain;100=most severe pain)], HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP.

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Percentage of Participants With American College of Rheumatology 20 (ACR20) Response	15.8 percentage of participants	67.0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized. Participants who had missing ACR70 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non-responders.

The ACR70 response rate was based on a 70% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1.≥ 70% improvement in 68-tender joint count; 2.≥ 70% improvement in 66-swollen joint count; and 3.≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity [100 mm VAS (0=no symptoms;100=severe symptoms)], Patient global assessment of disease activity [100 mm VAS (0=no limitation of normal activities;100=very poor], Patient assessment of pain [100 mm VAS (0=no pain;100=most severe pain)], HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP.

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Percentage of Participants With American College of Rheumatology 70 (ACR70) Response	0.8 percentage of participants	26.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Subset of study participants in Randomized Set with psoriatic skin lesions at Baseline. Participants who had missing data at the Week 4 or who discontinued study treatment before or at the Week 4 regardless whether they had data or not are considered as non-responders.

IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0=clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1=almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2=mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3=moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.

Outcome measures

Measure	Placebo n=82 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=163 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 4 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	1.2 percentage of participants	30.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Subset of study participants in Randomized Set with psoriatic skin lesions at Baseline. Participants who had missing data at the Week 16 or who discontinued study treatment before or at the Week 16 regardless whether they had data or not are considered as non-responders.

IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0=clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1=almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2=mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3=moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.

Outcome measures

Measure	Placebo n=82 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=163 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 16 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	3.7 percentage of participants	60.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized.

The PtAAP Visual Analog Scale (VAS) is part of the American College of Rheumatology core set of measures in arthritis. Participants assessed their arthritis pain using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16	-4.5 score on a scale Standard Error 2.1	-27.7 score on a scale Standard Error 1.7

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Randomized Set consisted of all enrolled participants who had been randomized.

The PsAID-12 is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score was multiplied by a weighting factor and the results were then summed to provide the total score. The total score ranged from 0 to 10, with higher scores indicating a worse status. A negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=133 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16	-0.32 score on a scale Standard Error 0.16	-2.24 score on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: From Baseline until Safety Follow-Up (up to 37 weeks)

Population: The Safety Set consisted of all participants who received at least 1 dose of the IMP.

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could 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. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP.

Outcome measures

Measure	Placebo n=132 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	44 Participants	108 Participants

SECONDARY outcome

Timeframe: From Baseline until Safety Follow-Up (up to 37 weeks)

Population: The Safety Set consisted of all participants who received at least 1 dose of the IMP.

A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization; 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 jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP.

Outcome measures

Measure	Placebo n=132 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study	0 Participants	5 Participants

SECONDARY outcome

Timeframe: From Baseline until Safety Follow-Up (up to 37 weeks)

Population: The Safety Set consisted of all participants who received at least 1 dose of the IMP.

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could 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. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP.

Outcome measures

Measure	Placebo n=132 Participants Participants received placebo as a sc injection Q4W for up to 16 weeks.	Bimekizumab 160mg n=267 Participants Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study	0 Participants	2 Participants

Adverse Events

Bimekizumab 160mg

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bimekizumab 160mg n=267 participants at risk Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.	Placebo n=132 participants at risk Participants received placebo as a sc injection Q4W for up to 16 weeks.
Gastrointestinal disorders Intestinal obstruction	0.37% 1/267 • Number of events 1 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	0.00% 0/132 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Infections and infestations Bronchitis	0.37% 1/267 • Number of events 1 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	0.00% 0/132 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Infections and infestations Pneumonia	0.37% 1/267 • Number of events 1 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	0.00% 0/132 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Injury, poisoning and procedural complications Joint injury	0.37% 1/267 • Number of events 1 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	0.00% 0/132 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Nervous system disorders Toxic encephalopathy	0.37% 1/267 • Number of events 1 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	0.00% 0/132 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.

Other adverse events

Measure	Bimekizumab 160mg n=267 participants at risk Participants received bimekizumab 160 mg as a sc injection Q4W for up to 16 weeks.	Placebo n=132 participants at risk Participants received placebo as a sc injection Q4W for up to 16 weeks.
Infections and infestations Corona virus infection	1.9% 5/267 • Number of events 5 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	4.5% 6/132 • Number of events 6 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Infections and infestations Nasopharyngitis	3.7% 10/267 • Number of events 11 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	0.76% 1/132 • Number of events 1 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Infections and infestations Oral candidiasis	2.6% 7/267 • Number of events 9 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	0.00% 0/132 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Infections and infestations Upper respiratory tract infection	2.2% 6/267 • Number of events 6 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	1.5% 2/132 • Number of events 2 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Infections and infestations Urinary tract infection	1.9% 5/267 • Number of events 6 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	2.3% 3/132 • Number of events 3 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.
Vascular disorders Hypertension	1.1% 3/267 • Number of events 3 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.	2.3% 3/132 • Number of events 3 • From Baseline until Safety Follow-Up (up to 37 weeks) Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the date of first IMP administration and up to 20 weeks after the last (most recent) dose of IMP. TEAEs were analyzed for Safety Set.

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: UCBCares@ucb.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60