Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis (NCT NCT05020249)

NCT ID: NCT05020249

Last Updated: 2025-03-18

Results Overview

The PASI90 response assessments are based on a 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the 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 the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 47 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2025-03-18

Participant Flow

The study started to enroll study participants in September 2021 and concluded in September 2022.

The Participant Flow refers to the Randomized Set.

Participant milestones

Measure	Placebo Participants received placebo matched to bimekizumab subcutaneous (sc) injection every 4 weeks (Q4W) until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W Participants received bimekizumab 320 milligrams (mg) sc injection Q4W until Week 16.
Overall Study STARTED	15	32
Overall Study COMPLETED	14	32
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Placebo Participants received placebo matched to bimekizumab subcutaneous (sc) injection every 4 weeks (Q4W) until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W Participants received bimekizumab 320 milligrams (mg) sc injection Q4W until Week 16.
Overall Study Protocol Violation	1	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	32 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.2 years STANDARD_DEVIATION 11.3 • n=5 Participants	39.7 years STANDARD_DEVIATION 9.0 • n=7 Participants	39.9 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	26 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Asian	15 Participants n=5 Participants	32 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	15 Participants n=5 Participants	32 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (Non responder imputation (NRI)).

The PASI90 response assessments are based on a 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the 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 the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	0 percentage of participants	81.3 percentage of participants

PRIMARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0/1 response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16	0 percentage of participants	87.5 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the 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 the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16	0 percentage of participants	21.9 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16	0 percentage of participants	21.9 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP) prior to their Week 4 PASI assessment or who had missing data at Week 4 are counted as non-responders (NRI).

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the 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 the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4	0 percentage of participants	75.0 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. The denominator when calculating the percentage of participants with a response to the PSD itch item is the number of participants with a baseline itch score \>=4 and the numerator is the number of participants with a PSD response for itch at Week 16. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including itch) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no itch)-10 (very severe itch)). Itch response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD itch weekly score.

Outcome measures

Measure	Placebo n=12 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=26 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16	0 percentage of participants	57.7 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. The denominator when calculating the percentage of participants with a response to the PSD pain item is the number of participants with a baseline pain score \>=4 and the numerator is the number of participants with a PSD response for pain at Week 16. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point NRS where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including pain) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no pain)-10 (very severe pain)). Pain response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD pain weekly score.

Outcome measures

Measure	Placebo n=10 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=24 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16	0 percentage of participants	62.5 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. The denominator when calculating the percentage of participants with a response to the PSD scaling item is the number of participants with a baseline scaling score \>=4 and the numerator is the number of participants with a PSD response for scaling at Week 16. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including scaling) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no scaling)-10 (very severe scaling)). Scaling response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD scaling weekly score.

Outcome measures

Measure	Placebo n=13 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=28 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16	0 percentage of participants	64.3 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. Here, Number of Participants analyzed reflect those with a scalp IGA Baseline score \>=2. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA response 0/1 at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.

Outcome measures

Measure	Placebo n=14 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=29 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With Scalp IGA Response 0/1 (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) at Week 16 for Study Participants With Scalp Psoriasis (PSO) at Baseline	7.1 percentage of participants	86.2 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are counted as non-responders (NRI).

The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect study participants' health related quality of life (QOL). This instrument asks study participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in study participants with PSO. The DLQI total score ranges from 0 to 30, with higher scores indicating lower health related QOL. A 4-point change in the DLQI total score has been reported to be meaningful for the study participant (within-participant minimal important difference); while a DLQI total score of 0 or 1 indicates no impact of the skin disease on participant's life.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16	6.7 percentage of participants	46.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Randomized Set consisted of all randomized study participants. Study participants with an intercurrent event (discontinuation of IMP prior to Week 16) or who had missing data at Week 16 are imputed using last observation carried forward (LOCF).

The Total BSA affected by PSO was entered as a percentage from 0 to 100.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16	-3.028 percent change Standard Error 8.926	-83.472 percent change Standard Error 6.026

SECONDARY outcome

Timeframe: From Baseline to End of Safety Follow-Up (SFU) (up to Week 32)

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

An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study	40.0 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to End of Safety Follow-Up (up to Week 32)

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

A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Resulted in persistent disability/incapacity 5) Is a congenital anomaly or birth defect 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study	6.7 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to End of Safety Follow-Up (up to Week 32)

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

An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of IMP through the end of the time at risk.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The Safety Set consisted of all study participants that received at least 1 dose of the IMP. Study participants with missing data at Week 16 were imputed using LOCF.

The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 score ranges from 0 to 27 with higher scores indicating a worse state. A score of 5 to 9 is considered to be minimal symptoms of depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major depression. A score of 15 to 19 is considered to indicate moderately severe major depression, and a score ≥20 is considered to be severe major depression. Change from Baseline is derived as post-Baseline score minus Baseline score, where a positive change indicates worsening and a negative change indicates improvement.

Outcome measures

Measure	Placebo n=15 Participants Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 Participants Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16	-2.1 scores on a scale Standard Deviation 5.1	-2.4 scores on a scale Standard Deviation 3.2

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=15 participants at risk Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 participants at risk Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
Injury, poisoning and procedural complications Ankle fracture	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	0.00% 0/32 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.

Other adverse events

Measure	Placebo n=15 participants at risk Participants received placebo matched to bimekizumab sc injection Q4W until Week 16. Placebo was used to maintain the blinding and is a real comparator in this study.	Bimekizumab 320 mg Q4W n=32 participants at risk Participants received bimekizumab 320 mg sc injection Q4W until Week 16.
General disorders Oedema peripheral	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	0.00% 0/32 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Infections and infestations Corona virus infection	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	21.9% 7/32 • Number of events 7 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Infections and infestations Tinea pedis	0.00% 0/15 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	6.2% 2/32 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Infections and infestations Bacteriuria	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	3.1% 1/32 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Infections and infestations Urinary tract infection	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	0.00% 0/32 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Investigations Blood creatinine increased	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	0.00% 0/32 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Investigations Psychiatric evaluation abnormal	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	0.00% 0/32 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	0.00% 0/32 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 1/15 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	0.00% 0/32 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/15 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.	6.2% 2/32 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to Week 32) Treatment-emergent AEs (TEAEs) were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk. TEAEs were analyzed for Safety Set.

Additional Information

UCB

Cares

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Email: UCBCares@ucb.com

Results disclosure agreements

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

Restriction type: GT60