Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (NCT NCT02905006)

Last Updated: 2022-07-21

Results Overview

The PASI90 response assessments are based on at least 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

PHASE2

Target enrollment

250 participants

Primary outcome timeframe

Week 12

Results posted on

2022-07-21

Participant Flow

The study started to enroll participants in August 2016 and concluded in July 2017.

The study included a 2-4 week Screening Period and a 12-week Treatment Period. Completed study was defined as completed the 12-week double-blind Treatment Period. After Treatment Period participants either enrolled in an extension study (PS0011) or entered a 20-week Safety Follow-Up Period. Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Placebo Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).	Bimekizumab 64 mg Q4W Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W.	Bimekizumab 160 mg Q4W Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W.	Bimekizumab 160 mg w/ LD Q4W Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W.	Bimekizumab 320 mg Q4W Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W.	Bimekizumab 480 mg Q4W Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.
Overall Study STARTED	42	39	43	40	43	43
Overall Study Completed Treatment Period	37	36	38	34	40	39
Overall Study Enrolled in Extension Study (PS0011)	38	35	39	38	42	40
Overall Study Entered Safety Follow-up Period	4	4	4	2	1	3
Overall Study COMPLETED	37	36	38	34	40	39
Overall Study NOT COMPLETED	5	3	5	6	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).	Bimekizumab 64 mg Q4W Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W.	Bimekizumab 160 mg Q4W Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W.	Bimekizumab 160 mg w/ LD Q4W Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W.	Bimekizumab 320 mg Q4W Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W.	Bimekizumab 480 mg Q4W Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.
Overall Study Adverse Event	1	1	1	1	0	1
Overall Study Lack of Efficacy	1	0	0	0	0	0
Overall Study Protocol Violation	2	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	0	1	1	0
Overall Study Withdrawal by Subject	0	0	1	1	0	1
Overall Study Screening exclusion criteria met	1	0	0	0	0	0
Overall Study Lab withdrawal criterion met	0	1	2	2	2	1
Overall Study Positive for Tuberculosis	0	1	0	0	0	0
Overall Study Subject positive for Hep B	0	0	1	0	0	0
Overall Study Patient moved abroad	0	0	0	1	0	0
Overall Study Patient randomized by mistake	0	0	0	0	0	1

Baseline Characteristics

Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W).	Bimekizumab 64 mg Q4W n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W.	Bimekizumab 160 mg Q4W n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W.	Bimekizumab 160 mg w/ LD Q4W n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W.	Bimekizumab 320 mg Q4W n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W.	Bimekizumab 480 mg Q4W n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W.	Total Title n=250 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	36 Participants n=7 Participants	40 Participants n=5 Participants	35 Participants n=4 Participants	39 Participants n=21 Participants	36 Participants n=8 Participants	225 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	22 Participants n=8 Participants
Age, Continuous	46.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	44.2 years STANDARD_DEVIATION 13.8 • n=7 Participants	43.4 years STANDARD_DEVIATION 12.4 • n=5 Participants	46.5 years STANDARD_DEVIATION 15.2 • n=4 Participants	42.6 years STANDARD_DEVIATION 13.6 • n=21 Participants	42.9 years STANDARD_DEVIATION 15.2 • n=8 Participants	44.3 years STANDARD_DEVIATION 13.7 • n=8 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	15 Participants n=21 Participants	14 Participants n=8 Participants	87 Participants n=8 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	20 Participants n=7 Participants	32 Participants n=5 Participants	29 Participants n=4 Participants	28 Participants n=21 Participants	29 Participants n=8 Participants	163 Participants n=8 Participants
Race/Ethnicity, Customized American Indian/Alaskan native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	22 Participants n=8 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized White	39 Participants n=5 Participants	35 Participants n=7 Participants	39 Participants n=5 Participants	33 Participants n=4 Participants	39 Participants n=21 Participants	38 Participants n=8 Participants	223 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12	0 percentage of participants	46.2 percentage of participants	67.4 percentage of participants	75.0 percentage of participants	79.1 percentage of participants	72.1 percentage of participants

SECONDARY outcome

Timeframe: Week 12

The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12	4.8 percentage of participants	51.3 percentage of participants	74.4 percentage of participants	75.0 percentage of participants	86.0 percentage of participants	76.7 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8	4.8 percentage of participants	46.2 percentage of participants	62.8 percentage of participants	77.5 percentage of participants	86.0 percentage of participants	72.1 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8	0 percentage of participants	41.0 percentage of participants	58.1 percentage of participants	67.5 percentage of participants	86.0 percentage of participants	69.8 percentage of participants

SECONDARY outcome

Timeframe: Week 12

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

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12	4.8 percentage of participants	61.5 percentage of participants	81.4 percentage of participants	85.0 percentage of participants	93.0 percentage of participants	83.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12	0 percentage of participants	28.2 percentage of participants	27.9 percentage of participants	60.0 percentage of participants	55.8 percentage of participants	48.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.

Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=39 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=42 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Plasma Concentrations of Bimekizumab During the Study Baseline	NA µg/mL Values were below the level of detection; Participants had no prior BKZ treatment.	NA µg/mL Values were below the level of detection; Participants had no prior BKZ treatment.	NA µg/mL Values were below the level of detection; Participants had no prior BKZ treatment.	NA µg/mL Values were below the level of detection; Participants had no prior BKZ treatment.	NA µg/mL Values were below the level of detection; Participants had no prior BKZ treatment.	—
Plasma Concentrations of Bimekizumab During the Study Week 1	4.4490 µg/mL Interval 3.7526 to 5.2746	9.2481 µg/mL Interval 6.9779 to 12.2569	20.7892 µg/mL Interval 14.9192 to 28.9688	21.8622 µg/mL Interval 16.0624 to 29.7563	31.8019 µg/mL Interval 23.3488 to 43.3154	—
Plasma Concentrations of Bimekizumab During the Study Week 2	3.4704 µg/mL Interval 3.0167 to 3.9923	8.6862 µg/mL Interval 7.5316 to 10.0179	19.0428 µg/mL Interval 16.5381 to 21.9267	19.0324 µg/mL Interval 16.8925 to 21.4434	27.5641 µg/mL Interval 23.8485 to 31.8586	—
Plasma Concentrations of Bimekizumab During the Study Week 4	2.1282 µg/mL Interval 1.8398 to 2.4617	5.3751 µg/mL Interval 4.5233 to 6.3872	11.2903 µg/mL Interval 9.4809 to 13.445	11.9194 µg/mL Interval 10.4503 to 13.5951	17.1811 µg/mL Interval 14.7612 to 19.9977	—
Plasma Concentrations of Bimekizumab During the Study Week 8	2.3069 µg/mL Interval 1.778 to 2.9931	7.1859 µg/mL Interval 5.3747 to 9.6075	10.2208 µg/mL Interval 8.8561 to 11.7957	16.3187 µg/mL Interval 13.9947 to 19.0285	23.3285 µg/mL Interval 19.8863 to 27.3665	—
Plasma Concentrations of Bimekizumab During the Study Week 12	2.3121 µg/mL Interval 1.6037 to 3.3335	9.5278 µg/mL Interval 8.0614 to 11.2608	10.2557 µg/mL Interval 8.6807 to 12.1165	18.3166 µg/mL Interval 15.1652 to 22.1228	28.0908 µg/mL Interval 23.2463 to 33.9448	—
Plasma Concentrations of Bimekizumab During the Study SFU	NA µg/mL Values were below the level of detection.	NA µg/mL Values were below the level of detection.	NA µg/mL Values were below the level of detection.	NA µg/mL Values were below the level of detection.	0.5165 µg/mL Interval 0.0032 to 84.5222	—

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)

Population: The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group.

The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=249 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab	0.362 L/Day Geometric Coefficient of Variation 41.7	—	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)

The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=249 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab	11.5 liters Geometric Coefficient of Variation 146	—	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)

Population: The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. EC50 was estimated based on all available data and cannot be derived for each treatment arm.

The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=249 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)	0.55 µg/mL Geometric Coefficient of Variation 126	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0)

Antibody positive status prior study treatment was defined as having an antibody level greater than (\>) 28.5% at Baseline (Week 0).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=42 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment	0 percentage of participants	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)

Overall antibody positive was defined as having a value of \> 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=42 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment	0 percentage of participants	10.3 percentage of participants	4.8 percentage of participants	5.0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

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

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

An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (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.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With at Least One Adverse Event (AE) During the Study	38.1 percentage of participants	76.9 percentage of participants	55.8 percentage of participants	65.0 percentage of participants	60.5 percentage of participants	60.5 percentage of participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity Mild	11.9 percentage of participants	43.6 percentage of participants	27.9 percentage of participants	22.5 percentage of participants	39.5 percentage of participants	44.2 percentage of participants
Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity Moderate	26.2 percentage of participants	30.8 percentage of participants	27.9 percentage of participants	40.0 percentage of participants	20.9 percentage of participants	11.6 percentage of participants
Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity Severe	0 percentage of participants	2.6 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	4.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Platelets was measured in number of platelets per liter (10\^9/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) Week 1	12.1 10^9 platelets per liter Standard Deviation 34.7	3.2 10^9 platelets per liter Standard Deviation 21.0	-4.6 10^9 platelets per liter Standard Deviation 30.8	-14.0 10^9 platelets per liter Standard Deviation 30.8	3.5 10^9 platelets per liter Standard Deviation 25.2	-0.1 10^9 platelets per liter Standard Deviation 35.0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) Week 2	6.4 10^9 platelets per liter Standard Deviation 37.8	-8.6 10^9 platelets per liter Standard Deviation 26.8	-5.6 10^9 platelets per liter Standard Deviation 36.4	-8.9 10^9 platelets per liter Standard Deviation 27.8	7.8 10^9 platelets per liter Standard Deviation 31.2	-3.9 10^9 platelets per liter Standard Deviation 41.8
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) Week 4	-0.1 10^9 platelets per liter Standard Deviation 32.0	-5.8 10^9 platelets per liter Standard Deviation 28.3	-8.6 10^9 platelets per liter Standard Deviation 40.1	-11.4 10^9 platelets per liter Standard Deviation 21.8	-7.0 10^9 platelets per liter Standard Deviation 28.9	-7.5 10^9 platelets per liter Standard Deviation 36.8
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) Week 6	5.6 10^9 platelets per liter Standard Deviation 47.5	-5.2 10^9 platelets per liter Standard Deviation 26.3	-13.6 10^9 platelets per liter Standard Deviation 34.3	-5.6 10^9 platelets per liter Standard Deviation 30.3	-0.3 10^9 platelets per liter Standard Deviation 44.0	-7.6 10^9 platelets per liter Standard Deviation 37.3
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) Week 8	6.9 10^9 platelets per liter Standard Deviation 37.6	-2.3 10^9 platelets per liter Standard Deviation 44.7	-6.1 10^9 platelets per liter Standard Deviation 43.7	6.3 10^9 platelets per liter Standard Deviation 35.6	0.7 10^9 platelets per liter Standard Deviation 39.5	-4.7 10^9 platelets per liter Standard Deviation 36.4
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) Week 12	2.8 10^9 platelets per liter Standard Deviation 36.7	-6.0 10^9 platelets per liter Standard Deviation 36.2	-13.2 10^9 platelets per liter Standard Deviation 40.1	-3.6 10^9 platelets per liter Standard Deviation 37.5	-5.4 10^9 platelets per liter Standard Deviation 36.1	-5.5 10^9 platelets per liter Standard Deviation 38.8
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) SFU	14.8 10^9 platelets per liter Standard Deviation 33.3	-30.3 10^9 platelets per liter Standard Deviation 71.6	7.8 10^9 platelets per liter Standard Deviation 20.0	-33.0 10^9 platelets per liter Standard Deviation 31.1	39.0 10^9 platelets per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	39.3 10^9 platelets per liter Standard Deviation 27.4

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Ery. mean corpuscular HGB Week 1	0.1 g/L Standard Deviation 8.1	-2.0 g/L Standard Deviation 10.3	-0.3 g/L Standard Deviation 8.8	-1.0 g/L Standard Deviation 11.6	0.5 g/L Standard Deviation 8.6	0.3 g/L Standard Deviation 8.1
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Ery. mean corpuscular HGB Week 2	0.1 g/L Standard Deviation 7.9	1.1 g/L Standard Deviation 6.6	1.6 g/L Standard Deviation 9.4	-0.3 g/L Standard Deviation 9.8	2.6 g/L Standard Deviation 7.9	1.8 g/L Standard Deviation 8.8
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Ery. mean corpuscular HGB Week 4	-0.2 g/L Standard Deviation 9.1	0.2 g/L Standard Deviation 8.3	-0.1 g/L Standard Deviation 9.9	-2.9 g/L Standard Deviation 6.3	0.1 g/L Standard Deviation 8.0	-0.4 g/L Standard Deviation 11.7
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Ery. mean corpuscular HGB Week 6	-2.5 g/L Standard Deviation 11.0	-1.7 g/L Standard Deviation 8.6	-0.5 g/L Standard Deviation 9.4	-2.9 g/L Standard Deviation 7.0	-0.5 g/L Standard Deviation 7.8	-1.3 g/L Standard Deviation 8.9
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Ery. mean corpuscular HGB Week 8	-2.2 g/L Standard Deviation 8.0	-1.4 g/L Standard Deviation 12.7	0.3 g/L Standard Deviation 10.3	-2.5 g/L Standard Deviation 7.9	-2.1 g/L Standard Deviation 9.2	-2.9 g/L Standard Deviation 9.2
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Ery. mean corpuscular HGB Week 12	-6.3 g/L Standard Deviation 12.5	-2.2 g/L Standard Deviation 14.7	-1.6 g/L Standard Deviation 9.1	-4.5 g/L Standard Deviation 10.1	-2.0 g/L Standard Deviation 12.7	-3.6 g/L Standard Deviation 13.7
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Ery. mean corpuscular HGB SFU	-12.5 g/L Standard Deviation 11.0	5.3 g/L Standard Deviation 26.2	-5.5 g/L Standard Deviation 10.6	-9.5 g/L Standard Deviation 7.8	-2.0 g/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-22.0 g/L Standard Deviation 18.0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Hemoglobin Week 1	-2.9 g/L Standard Deviation 7.3	0.1 g/L Standard Deviation 6.1	1.0 g/L Standard Deviation 6.8	-2.6 g/L Standard Deviation 5.2	-1.0 g/L Standard Deviation 7.0	-0.8 g/L Standard Deviation 5.0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Hemoglobin Week 2	-3.0 g/L Standard Deviation 6.7	0.5 g/L Standard Deviation 5.3	0.6 g/L Standard Deviation 6.0	-1.5 g/L Standard Deviation 7.5	-1.1 g/L Standard Deviation 7.0	0.5 g/L Standard Deviation 6.6
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Hemoglobin Week 4	-2.9 g/L Standard Deviation 8.2	0.8 g/L Standard Deviation 6.1	-0.9 g/L Standard Deviation 6.2	-2.1 g/L Standard Deviation 5.9	-1.8 g/L Standard Deviation 8.7	-0.4 g/L Standard Deviation 6.3
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Hemoglobin Week 6	-2.4 g/L Standard Deviation 7.8	0.7 g/L Standard Deviation 6.3	-0.3 g/L Standard Deviation 6.6	-1.2 g/L Standard Deviation 4.8	-2.1 g/L Standard Deviation 8.4	0.9 g/L Standard Deviation 6.3
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Hemoglobin Week 8	-2.7 g/L Standard Deviation 8.0	1.1 g/L Standard Deviation 7.6	0.8 g/L Standard Deviation 7.1	-0.6 g/L Standard Deviation 7.5	-1.8 g/L Standard Deviation 8.1	0.9 g/L Standard Deviation 6.5
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Hemoglobin Week 12	-1.8 g/L Standard Deviation 9.1	3.2 g/L Standard Deviation 9.6	-0.1 g/L Standard Deviation 8.1	-1.0 g/L Standard Deviation 8.5	-1.2 g/L Standard Deviation 9.3	0.3 g/L Standard Deviation 7.1
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) Hemoglobin SFU	-4.8 g/L Standard Deviation 7.4	7.8 g/L Standard Deviation 31.0	-6.5 g/L Standard Deviation 4.7	-8.5 g/L Standard Deviation 2.1	6.0 g/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-6.7 g/L Standard Deviation 11.0

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) Week 1	-0.09 picograms (pg) Standard Deviation 0.57	-0.01 picograms (pg) Standard Deviation 0.56	-0.10 picograms (pg) Standard Deviation 0.55	0.07 picograms (pg) Standard Deviation 0.51	-0.09 picograms (pg) Standard Deviation 0.87	0.00 picograms (pg) Standard Deviation 0.53
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) Week 2	-0.04 picograms (pg) Standard Deviation 0.59	0.04 picograms (pg) Standard Deviation 0.54	0.05 picograms (pg) Standard Deviation 0.49	0.10 picograms (pg) Standard Deviation 0.78	-0.03 picograms (pg) Standard Deviation 0.60	0.14 picograms (pg) Standard Deviation 0.54
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) Week 4	-0.07 picograms (pg) Standard Deviation 0.66	0.10 picograms (pg) Standard Deviation 0.84	-0.07 picograms (pg) Standard Deviation 0.63	-0.01 picograms (pg) Standard Deviation 0.42	-0.10 picograms (pg) Standard Deviation 0.68	0.04 picograms (pg) Standard Deviation 0.50
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) Week 6	-0.17 picograms (pg) Standard Deviation 0.64	-0.09 picograms (pg) Standard Deviation 0.84	-0.16 picograms (pg) Standard Deviation 0.61	-0.11 picograms (pg) Standard Deviation 0.47	-0.12 picograms (pg) Standard Deviation 0.84	-0.04 picograms (pg) Standard Deviation 0.60
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) Week 8	-0.19 picograms (pg) Standard Deviation 0.64	0.09 picograms (pg) Standard Deviation 1.09	-0.16 picograms (pg) Standard Deviation 1.10	-0.16 picograms (pg) Standard Deviation 0.64	-0.26 picograms (pg) Standard Deviation 0.99	-0.16 picograms (pg) Standard Deviation 0.53
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) Week 12	-0.34 picograms (pg) Standard Deviation 0.71	0.09 picograms (pg) Standard Deviation 1.53	-0.08 picograms (pg) Standard Deviation 0.58	-0.14 picograms (pg) Standard Deviation 0.66	-0.09 picograms (pg) Standard Deviation 1.14	-0.16 picograms (pg) Standard Deviation 0.67
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) SFU	-0.33 picograms (pg) Standard Deviation 0.79	2.93 picograms (pg) Standard Deviation 6.66	-0.15 picograms (pg) Standard Deviation 0.17	-0.55 picograms (pg) Standard Deviation 0.78	0.70 picograms (pg) Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.60 picograms (pg) Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Erythrocytes mean corpuscular volume was measured in femtolitres (fL).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) Week 1	-0.35 femtolitres (fL) Standard Deviation 1.55	0.52 femtolitres (fL) Standard Deviation 2.29	-0.25 femtolitres (fL) Standard Deviation 1.64	0.51 femtolitres (fL) Standard Deviation 2.63	-0.23 femtolitres (fL) Standard Deviation 2.14	-0.04 femtolitres (fL) Standard Deviation 1.37
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) Week 2	-0.14 femtolitres (fL) Standard Deviation 1.65	-0.16 femtolitres (fL) Standard Deviation 1.31	-0.33 femtolitres (fL) Standard Deviation 1.96	0.31 femtolitres (fL) Standard Deviation 1.32	-0.64 femtolitres (fL) Standard Deviation 1.40	-0.05 femtolitres (fL) Standard Deviation 1.60
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) Week 4	-0.11 femtolitres (fL) Standard Deviation 1.60	0.23 femtolitres (fL) Standard Deviation 1.89	-0.25 femtolitres (fL) Standard Deviation 1.81	0.67 femtolitres (fL) Standard Deviation 1.76	-0.10 femtolitres (fL) Standard Deviation 1.64	0.22 femtolitres (fL) Standard Deviation 2.87
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) Week 6	0.20 femtolitres (fL) Standard Deviation 2.84	0.14 femtolitres (fL) Standard Deviation 2.47	-0.29 femtolitres (fL) Standard Deviation 1.90	0.39 femtolitres (fL) Standard Deviation 1.79	-0.02 femtolitres (fL) Standard Deviation 1.92	0.25 femtolitres (fL) Standard Deviation 1.85
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) Week 8	0.05 femtolitres (fL) Standard Deviation 2.11	0.71 femtolitres (fL) Standard Deviation 2.88	-0.54 femtolitres (fL) Standard Deviation 2.57	0.16 femtolitres (fL) Standard Deviation 2.57	-0.02 femtolitres (fL) Standard Deviation 2.29	0.36 femtolitres (fL) Standard Deviation 2.37
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) Week 12	0.76 femtolitres (fL) Standard Deviation 3.81	0.87 femtolitres (fL) Standard Deviation 3.23	0.17 femtolitres (fL) Standard Deviation 2.39	0.78 femtolitres (fL) Standard Deviation 2.55	0.47 femtolitres (fL) Standard Deviation 2.88	0.51 femtolitres (fL) Standard Deviation 3.89
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) SFU	2.58 femtolitres (fL) Standard Deviation 5.10	7.80 femtolitres (fL) Standard Deviation 14.07	0.90 femtolitres (fL) Standard Deviation 2.38	0.85 femtolitres (fL) Standard Deviation 0.35	2.80 femtolitres (fL) Standard Deviation NA Value was not evaluable because only one participant was analyzed.	4.87 femtolitres (fL) Standard Deviation 8.46

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Erythrocytes was measured in number of red blood cells per liter (10\^12/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) Week 1	-0.081 10^12 red blood cells per liter Standard Deviation 0.282	0.004 10^12 red blood cells per liter Standard Deviation 0.213	0.047 10^12 red blood cells per liter Standard Deviation 0.238	-0.095 10^12 red blood cells per liter Standard Deviation 0.184	-0.029 10^12 red blood cells per liter Standard Deviation 0.259	-0.026 10^12 red blood cells per liter Standard Deviation 0.178
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) Week 2	-0.088 10^12 red blood cells per liter Standard Deviation 0.220	0.010 10^12 red blood cells per liter Standard Deviation 0.193	0.014 10^12 red blood cells per liter Standard Deviation 0.215	-0.060 10^12 red blood cells per liter Standard Deviation 0.282	-0.041 10^12 red blood cells per liter Standard Deviation 0.231	-0.001 10^12 red blood cells per liter Standard Deviation 0.232
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) Week 4	-0.085 10^12 red blood cells per liter Standard Deviation 0.274	0.019 10^12 red blood cells per liter Standard Deviation 0.217	-0.018 10^12 red blood cells per liter Standard Deviation 0.193	-0.066 10^12 red blood cells per liter Standard Deviation 0.215	-0.053 10^12 red blood cells per liter Standard Deviation 0.281	-0.015 10^12 red blood cells per liter Standard Deviation 0.216
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) Week 6	-0.053 10^12 red blood cells per liter Standard Deviation 0.277	0.038 10^12 red blood cells per liter Standard Deviation 0.218	0.011 10^12 red blood cells per liter Standard Deviation 0.243	-0.019 10^12 red blood cells per liter Standard Deviation 0.145	-0.060 10^12 red blood cells per liter Standard Deviation 0.278	0.035 10^12 red blood cells per liter Standard Deviation 0.224
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) Week 8	-0.062 10^12 red blood cells per liter Standard Deviation 0.320	0.022 10^12 red blood cells per liter Standard Deviation 0.245	0.048 10^12 red blood cells per liter Standard Deviation 0.219	0.009 10^12 red blood cells per liter Standard Deviation 0.224	-0.028 10^12 red blood cells per liter Standard Deviation 0.240	0.056 10^12 red blood cells per liter Standard Deviation 0.238
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) Week 12	-0.007 10^12 red blood cells per liter Standard Deviation 0.314	0.092 10^12 red blood cells per liter Standard Deviation 0.258	0.011 10^12 red blood cells per liter Standard Deviation 0.271	-0.005 10^12 red blood cells per liter Standard Deviation 0.297	-0.036 10^12 red blood cells per liter Standard Deviation 0.297	0.039 10^12 red blood cells per liter Standard Deviation 0.228
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) SFU	-0.090 10^12 red blood cells per liter Standard Deviation 0.346	-0.135 10^12 red blood cells per liter Standard Deviation 0.184	-0.195 10^12 red blood cells per liter Standard Deviation 0.165	-0.215 10^12 red blood cells per liter Standard Deviation 0.035	0.080 10^12 red blood cells per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.123 10^12 red blood cells per liter Standard Deviation 0.491

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Hematocrit was measured in volume percentage (%) of red blood cells in blood.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) Week 1	-0.88 volume % of red blood cells Standard Deviation 2.49	0.27 volume % of red blood cells Standard Deviation 2.07	0.33 volume % of red blood cells Standard Deviation 2.31	-0.58 volume % of red blood cells Standard Deviation 2.14	-0.36 volume % of red blood cells Standard Deviation 2.31	-0.23 volume % of red blood cells Standard Deviation 1.62
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) Week 2	-0.86 volume % of red blood cells Standard Deviation 2.02	0.00 volume % of red blood cells Standard Deviation 1.65	-0.04 volume % of red blood cells Standard Deviation 2.15	-0.42 volume % of red blood cells Standard Deviation 2.61	-0.65 volume % of red blood cells Standard Deviation 2.09	-0.02 volume % of red blood cells Standard Deviation 2.03
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) Week 4	-0.81 volume % of red blood cells Standard Deviation 2.40	0.24 volume % of red blood cells Standard Deviation 2.07	-0.26 volume % of red blood cells Standard Deviation 1.86	-0.26 volume % of red blood cells Standard Deviation 1.80	-0.48 volume % of red blood cells Standard Deviation 2.57	-0.03 volume % of red blood cells Standard Deviation 2.02
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) Week 6	-0.33 volume % of red blood cells Standard Deviation 2.46	0.41 volume % of red blood cells Standard Deviation 1.88	-0.04 volume % of red blood cells Standard Deviation 2.18	0.02 volume % of red blood cells Standard Deviation 1.73	-0.51 volume % of red blood cells Standard Deviation 2.59	0.44 volume % of red blood cells Standard Deviation 1.90
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) Week 8	-0.52 volume % of red blood cells Standard Deviation 2.37	0.55 volume % of red blood cells Standard Deviation 2.51	0.18 volume % of red blood cells Standard Deviation 1.84	0.14 volume % of red blood cells Standard Deviation 2.61	-0.22 volume % of red blood cells Standard Deviation 2.46	0.67 volume % of red blood cells Standard Deviation 2.03
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) Week 12	0.32 volume % of red blood cells Standard Deviation 2.87	1.25 volume % of red blood cells Standard Deviation 2.29	0.18 volume % of red blood cells Standard Deviation 2.57	0.30 volume % of red blood cells Standard Deviation 2.99	-0.05 volume % of red blood cells Standard Deviation 2.75	0.59 volume % of red blood cells Standard Deviation 2.02
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) SFU	0.20 volume % of red blood cells Standard Deviation 1.44	1.98 volume % of red blood cells Standard Deviation 6.92	-1.20 volume % of red blood cells Standard Deviation 1.90	-1.50 volume % of red blood cells Standard Deviation 0.14	2.10 volume % of red blood cells Standard Deviation NA Value was not evaluable because only one participant was analyzed.	1.00 volume % of red blood cells Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10\^9/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Eosinophils SFU	0.05 10^9 white blood cells per liter Standard Deviation 0.06	0.08 10^9 white blood cells per liter Standard Deviation 0.10	0.10 10^9 white blood cells per liter Standard Deviation 0.00	0.00 10^9 white blood cells per liter Standard Deviation 0.00	-0.10 10^9 white blood cells per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.07 10^9 white blood cells per liter Standard Deviation 0.06
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Monocytes SFU	0.10 10^9 white blood cells per liter Standard Deviation 0.22	0.10 10^9 white blood cells per liter Standard Deviation 0.22	0.03 10^9 white blood cells per liter Standard Deviation 0.10	0.00 10^9 white blood cells per liter Standard Deviation 0.00	-0.30 10^9 white blood cells per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.07 10^9 white blood cells per liter Standard Deviation 0.21
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Neutrophils Week 2	0.09 10^9 white blood cells per liter Standard Deviation 1.29	-0.43 10^9 white blood cells per liter Standard Deviation 1.05	-0.31 10^9 white blood cells per liter Standard Deviation 1.33	-0.59 10^9 white blood cells per liter Standard Deviation 1.09	-0.41 10^9 white blood cells per liter Standard Deviation 1.64	-0.36 10^9 white blood cells per liter Standard Deviation 1.13
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Basophils Week 1	0.01 10^9 white blood cells per liter Standard Deviation 0.03	0.01 10^9 white blood cells per liter Standard Deviation 0.03	0.00 10^9 white blood cells per liter Standard Deviation 0.03	0.01 10^9 white blood cells per liter Standard Deviation 0.03	0.00 10^9 white blood cells per liter Standard Deviation 0.04	0.01 10^9 white blood cells per liter Standard Deviation 0.03
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Basophils Week 2	0.00 10^9 white blood cells per liter Standard Deviation 0.02	0.00 10^9 white blood cells per liter Standard Deviation 0.04	0.01 10^9 white blood cells per liter Standard Deviation 0.04	0.01 10^9 white blood cells per liter Standard Deviation 0.04	0.01 10^9 white blood cells per liter Standard Deviation 0.04	0.00 10^9 white blood cells per liter Standard Deviation 0.03
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Basophils Week 4	0.00 10^9 white blood cells per liter Standard Deviation 0.03	0.00 10^9 white blood cells per liter Standard Deviation 0.05	0.00 10^9 white blood cells per liter Standard Deviation 0.03	0.01 10^9 white blood cells per liter Standard Deviation 0.02	0.01 10^9 white blood cells per liter Standard Deviation 0.05	0.00 10^9 white blood cells per liter Standard Deviation 0.04
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Basophils Week 6	0.01 10^9 white blood cells per liter Standard Deviation 0.03	0.00 10^9 white blood cells per liter Standard Deviation 0.04	0.00 10^9 white blood cells per liter Standard Deviation 0.04	0.01 10^9 white blood cells per liter Standard Deviation 0.02	0.00 10^9 white blood cells per liter Standard Deviation 0.04	0.00 10^9 white blood cells per liter Standard Deviation 0.04
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Basophils Week 8	0.00 10^9 white blood cells per liter Standard Deviation 0.04	-0.01 10^9 white blood cells per liter Standard Deviation 0.04	0.02 10^9 white blood cells per liter Standard Deviation 0.01	0.00 10^9 white blood cells per liter Standard Deviation 0.00	0.02 10^9 white blood cells per liter Standard Deviation 0.04	0.00 10^9 white blood cells per liter Standard Deviation 0.05
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Basophils Week 12	0.00 10^9 white blood cells per liter Standard Deviation 0.03	0.00 10^9 white blood cells per liter Standard Deviation 0.04	0.01 10^9 white blood cells per liter Standard Deviation 0.03	0.00 10^9 white blood cells per liter Standard Deviation 0.02	0.01 10^9 white blood cells per liter Standard Deviation 0.04	0.00 10^9 white blood cells per liter Standard Deviation 0.04
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Basophils SFU	0.03 10^9 white blood cells per liter Standard Deviation 0.05	-0.03 10^9 white blood cells per liter Standard Deviation 0.05	0.00 10^9 white blood cells per liter Standard Deviation 0.00	0.00 10^9 white blood cells per liter Standard Deviation 0.00	0.00 10^9 white blood cells per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.03 10^9 white blood cells per liter Standard Deviation 0.06
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Eosinophils Week 1	0.02 10^9 white blood cells per liter Standard Deviation 0.06	0.02 10^9 white blood cells per liter Standard Deviation 0.12	0.01 10^9 white blood cells per liter Standard Deviation 0.07	0.04 10^9 white blood cells per liter Standard Deviation 0.10	0.02 10^9 white blood cells per liter Standard Deviation 0.11	-0.02 10^9 white blood cells per liter Standard Deviation 0.12
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Eosinophils Week 2	0.02 10^9 white blood cells per liter Standard Deviation 0.08	0.04 10^9 white blood cells per liter Standard Deviation 0.26	0.00 10^9 white blood cells per liter Standard Deviation 0.08	0.05 10^9 white blood cells per liter Standard Deviation 0.11	0.00 10^9 white blood cells per liter Standard Deviation 0.11	0.01 10^9 white blood cells per liter Standard Deviation 0.11
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Eosinophils Week 4	0.03 10^9 white blood cells per liter Standard Deviation 0.09	0.04 10^9 white blood cells per liter Standard Deviation 0.26	0.01 10^9 white blood cells per liter Standard Deviation 0.08	0.02 10^9 white blood cells per liter Standard Deviation 0.11	0.03 10^9 white blood cells per liter Standard Deviation 0.09	0.00 10^9 white blood cells per liter Standard Deviation 0.18
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Eosinophils Week 6	0.04 10^9 white blood cells per liter Standard Deviation 0.10	0.02 10^9 white blood cells per liter Standard Deviation 0.19	0.00 10^9 white blood cells per liter Standard Deviation 0.08	0.01 10^9 white blood cells per liter Standard Deviation 0.09	0.05 10^9 white blood cells per liter Standard Deviation 0.16	-0.01 10^9 white blood cells per liter Standard Deviation 0.17
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Eosinophils Week 8	0.01 10^9 white blood cells per liter Standard Deviation 0.09	0.01 10^9 white blood cells per liter Standard Deviation 0.18	0.01 10^9 white blood cells per liter Standard Deviation 0.08	0.04 10^9 white blood cells per liter Standard Deviation 0.17	0.05 10^9 white blood cells per liter Standard Deviation 0.18	-0.03 10^9 white blood cells per liter Standard Deviation 0.16
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Eosinophils Week 12	0.02 10^9 white blood cells per liter Standard Deviation 0.09	0.03 10^9 white blood cells per liter Standard Deviation 0.22	0.00 10^9 white blood cells per liter Standard Deviation 0.09	0.00 10^9 white blood cells per liter Standard Deviation 0.08	0.03 10^9 white blood cells per liter Standard Deviation 0.13	-0.03 10^9 white blood cells per liter Standard Deviation 0.11
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Leukocytes Week 1	0.16 10^9 white blood cells per liter Standard Deviation 1.30	-0.59 10^9 white blood cells per liter Standard Deviation 1.34	-0.15 10^9 white blood cells per liter Standard Deviation 1.43	-0.63 10^9 white blood cells per liter Standard Deviation 1.82	-0.19 10^9 white blood cells per liter Standard Deviation 1.51	-0.48 10^9 white blood cells per liter Standard Deviation 0.90
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Leukocytes Week 2	0.18 10^9 white blood cells per liter Standard Deviation 1.36	-0.56 10^9 white blood cells per liter Standard Deviation 1.31	-0.22 10^9 white blood cells per liter Standard Deviation 1.43	-0.42 10^9 white blood cells per liter Standard Deviation 1.34	-0.31 10^9 white blood cells per liter Standard Deviation 1.80	-0.46 10^9 white blood cells per liter Standard Deviation 1.29
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Leukocytes Week 4	0.17 10^9 white blood cells per liter Standard Deviation 1.51	-0.36 10^9 white blood cells per liter Standard Deviation 1.31	-0.23 10^9 white blood cells per liter Standard Deviation 1.38	-0.54 10^9 white blood cells per liter Standard Deviation 1.14	-0.36 10^9 white blood cells per liter Standard Deviation 1.73	-0.34 10^9 white blood cells per liter Standard Deviation 1.24
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Leukocytes Week 6	-0.22 10^9 white blood cells per liter Standard Deviation 1.25	-0.50 10^9 white blood cells per liter Standard Deviation 1.95	-0.47 10^9 white blood cells per liter Standard Deviation 1.49	-0.57 10^9 white blood cells per liter Standard Deviation 1.34	-0.45 10^9 white blood cells per liter Standard Deviation 2.02	-0.45 10^9 white blood cells per liter Standard Deviation 1.12
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Leukocytes Week 8	-0.10 10^9 white blood cells per liter Standard Deviation 1.34	-0.67 10^9 white blood cells per liter Standard Deviation 1.55	-0.24 10^9 white blood cells per liter Standard Deviation 1.94	-0.37 10^9 white blood cells per liter Standard Deviation 1.55	-0.30 10^9 white blood cells per liter Standard Deviation 1.76	-0.45 10^9 white blood cells per liter Standard Deviation 0.87
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Leukocytes Week 12	0.00 10^9 white blood cells per liter Standard Deviation 1.37	-0.28 10^9 white blood cells per liter Standard Deviation 1.68	-0.47 10^9 white blood cells per liter Standard Deviation 1.67	-0.51 10^9 white blood cells per liter Standard Deviation 1.41	-0.50 10^9 white blood cells per liter Standard Deviation 1.44	-0.48 10^9 white blood cells per liter Standard Deviation 1.09
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Leukocytes SFU	-0.05 10^9 white blood cells per liter Standard Deviation 0.98	1.15 10^9 white blood cells per liter Standard Deviation 2.54	0.95 10^9 white blood cells per liter Standard Deviation 1.43	-0.65 10^9 white blood cells per liter Standard Deviation 0.78	0.20 10^9 white blood cells per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.30 10^9 white blood cells per liter Standard Deviation 0.40
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Lymphocytes Week 1	0.12 10^9 white blood cells per liter Standard Deviation 0.36	-0.05 10^9 white blood cells per liter Standard Deviation 0.30	0.15 10^9 white blood cells per liter Standard Deviation 0.42	0.13 10^9 white blood cells per liter Standard Deviation 0.34	0.14 10^9 white blood cells per liter Standard Deviation 0.46	0.00 10^9 white blood cells per liter Standard Deviation 0.45
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Lymphocytes Week 2	0.08 10^9 white blood cells per liter Standard Deviation 0.32	-0.11 10^9 white blood cells per liter Standard Deviation 0.30	0.09 10^9 white blood cells per liter Standard Deviation 0.34	0.09 10^9 white blood cells per liter Standard Deviation 0.40	0.12 10^9 white blood cells per liter Standard Deviation 0.34	-0.08 10^9 white blood cells per liter Standard Deviation 0.37
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Lymphocytes Week 4	0.06 10^9 white blood cells per liter Standard Deviation 0.40	-0.04 10^9 white blood cells per liter Standard Deviation 0.33	0.15 10^9 white blood cells per liter Standard Deviation 0.43	0.08 10^9 white blood cells per liter Standard Deviation 0.42	0.11 10^9 white blood cells per liter Standard Deviation 0.36	0.06 10^9 white blood cells per liter Standard Deviation 0.36
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Lymphocytes Week 6	0.08 10^9 white blood cells per liter Standard Deviation 0.46	-0.08 10^9 white blood cells per liter Standard Deviation 0.43	0.03 10^9 white blood cells per liter Standard Deviation 0.31	0.04 10^9 white blood cells per liter Standard Deviation 0.43	0.05 10^9 white blood cells per liter Standard Deviation 0.37	-0.05 10^9 white blood cells per liter Standard Deviation 0.40
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Lymphocytes Week 8	0.02 10^9 white blood cells per liter Standard Deviation 0.37	-0.04 10^9 white blood cells per liter Standard Deviation 0.31	0.09 10^9 white blood cells per liter Standard Deviation 0.40	0.11 10^9 white blood cells per liter Standard Deviation 0.33	0.15 10^9 white blood cells per liter Standard Deviation 0.45	0.06 10^9 white blood cells per liter Standard Deviation 0.42
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Lymphocytes Week 12	0.08 10^9 white blood cells per liter Standard Deviation 0.38	0.01 10^9 white blood cells per liter Standard Deviation 0.35	0.06 10^9 white blood cells per liter Standard Deviation 0.38	0.07 10^9 white blood cells per liter Standard Deviation 0.48	0.14 10^9 white blood cells per liter Standard Deviation 0.38	-0.04 10^9 white blood cells per liter Standard Deviation 0.37
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Lymphocytes SFU	0.25 10^9 white blood cells per liter Standard Deviation 0.24	0.25 10^9 white blood cells per liter Standard Deviation 0.40	0.23 10^9 white blood cells per liter Standard Deviation 0.19	0.25 10^9 white blood cells per liter Standard Deviation 0.21	0.00 10^9 white blood cells per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.50 10^9 white blood cells per liter Standard Deviation 0.44
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Monocytes Week 1	0.02 10^9 white blood cells per liter Standard Deviation 0.16	-0.01 10^9 white blood cells per liter Standard Deviation 0.12	0.02 10^9 white blood cells per liter Standard Deviation 0.15	0.02 10^9 white blood cells per liter Standard Deviation 0.11	0.02 10^9 white blood cells per liter Standard Deviation 0.17	-0.03 10^9 white blood cells per liter Standard Deviation 0.14
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Monocytes Week 2	0.00 10^9 white blood cells per liter Standard Deviation 0.14	-0.04 10^9 white blood cells per liter Standard Deviation 0.13	0.00 10^9 white blood cells per liter Standard Deviation 0.14	0.04 10^9 white blood cells per liter Standard Deviation 0.15	-0.04 10^9 white blood cells per liter Standard Deviation 0.17	-0.03 10^9 white blood cells per liter Standard Deviation 0.15
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Monocytes Week 4	0.03 10^9 white blood cells per liter Standard Deviation 0.16	-0.01 10^9 white blood cells per liter Standard Deviation 0.11	0.01 10^9 white blood cells per liter Standard Deviation 0.15	0.03 10^9 white blood cells per liter Standard Deviation 0.13	-0.01 10^9 white blood cells per liter Standard Deviation 0.17	0.02 10^9 white blood cells per liter Standard Deviation 0.17
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Monocytes Week 6	0.01 10^9 white blood cells per liter Standard Deviation 0.15	-0.01 10^9 white blood cells per liter Standard Deviation 0.18	0.02 10^9 white blood cells per liter Standard Deviation 0.15	0.00 10^9 white blood cells per liter Standard Deviation 0.11	-0.02 10^9 white blood cells per liter Standard Deviation 0.22	-0.03 10^9 white blood cells per liter Standard Deviation 0.18
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Monocytes Week 8	-0.02 10^9 white blood cells per liter Standard Deviation 0.15	-0.03 10^9 white blood cells per liter Standard Deviation 0.11	0.00 10^9 white blood cells per liter Standard Deviation 0.16	-0.01 10^9 white blood cells per liter Standard Deviation 0.14	-0.04 10^9 white blood cells per liter Standard Deviation 0.17	-0.02 10^9 white blood cells per liter Standard Deviation 0.15
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Monocytes Week 12	0.01 10^9 white blood cells per liter Standard Deviation 0.16	0.00 10^9 white blood cells per liter Standard Deviation 0.14	-0.02 10^9 white blood cells per liter Standard Deviation 0.15	-0.01 10^9 white blood cells per liter Standard Deviation 0.18	-0.07 10^9 white blood cells per liter Standard Deviation 0.17	-0.01 10^9 white blood cells per liter Standard Deviation 0.14
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Neutrophils Week 1	-0.02 10^9 white blood cells per liter Standard Deviation 1.16	-0.55 10^9 white blood cells per liter Standard Deviation 1.12	-0.32 10^9 white blood cells per liter Standard Deviation 1.25	-0.81 10^9 white blood cells per liter Standard Deviation 1.81	-0.37 10^9 white blood cells per liter Standard Deviation 1.20	-0.44 10^9 white blood cells per liter Standard Deviation 0.76
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Neutrophils Week 4	0.04 10^9 white blood cells per liter Standard Deviation 1.30	-0.35 10^9 white blood cells per liter Standard Deviation 1.07	-0.39 10^9 white blood cells per liter Standard Deviation 1.31	-0.68 10^9 white blood cells per liter Standard Deviation 1.02	-0.48 10^9 white blood cells per liter Standard Deviation 1.60	-0.40 10^9 white blood cells per liter Standard Deviation 1.18
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Neutrophils Week 6	-0.36 10^9 white blood cells per liter Standard Deviation 0.98	-0.43 10^9 white blood cells per liter Standard Deviation 1.64	-0.49 10^9 white blood cells per liter Standard Deviation 1.38	-0.54 10^9 white blood cells per liter Standard Deviation 1.16	-0.50 10^9 white blood cells per liter Standard Deviation 1.78	-0.36 10^9 white blood cells per liter Standard Deviation 1.01
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Neutrophils Week 8	-0.13 10^9 white blood cells per liter Standard Deviation 1.18	-0.61 10^9 white blood cells per liter Standard Deviation 1.40	-0.34 10^9 white blood cells per liter Standard Deviation 1.72	-0.57 10^9 white blood cells per liter Standard Deviation 1.28	-0.45 10^9 white blood cells per liter Standard Deviation 1.61	-0.47 10^9 white blood cells per liter Standard Deviation 0.80
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Neutrophils Week 12	-0.11 10^9 white blood cells per liter Standard Deviation 1.17	-0.33 10^9 white blood cells per liter Standard Deviation 1.50	-0.49 10^9 white blood cells per liter Standard Deviation 1.50	-0.57 10^9 white blood cells per liter Standard Deviation 1.20	-0.59 10^9 white blood cells per liter Standard Deviation 1.28	-0.39 10^9 white blood cells per liter Standard Deviation 0.93
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) Neutrophils SFU	-0.45 10^9 white blood cells per liter Standard Deviation 0.79	0.75 10^9 white blood cells per liter Standard Deviation 1.88	0.65 10^9 white blood cells per liter Standard Deviation 1.20	-0.95 10^9 white blood cells per liter Standard Deviation 0.49	0.50 10^9 white blood cells per liter Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.13 10^9 white blood cells per liter Standard Deviation 0.38

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Calcium Week 8	-0.023 mmol/L Standard Deviation 0.084	0.001 mmol/L Standard Deviation 0.106	-0.027 mmol/L Standard Deviation 0.099	0.019 mmol/L Standard Deviation 0.089	-0.002 mmol/L Standard Deviation 0.089	-0.016 mmol/L Standard Deviation 0.084
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Calcium Week 6	-0.033 mmol/L Standard Deviation 0.070	0.009 mmol/L Standard Deviation 0.079	-0.019 mmol/L Standard Deviation 0.091	-0.008 mmol/L Standard Deviation 0.092	-0.026 mmol/L Standard Deviation 0.086	-0.027 mmol/L Standard Deviation 0.100
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Urea Nitrogen Week 1	-0.16 mmol/L Standard Deviation 1.09	0.11 mmol/L Standard Deviation 1.12	0.27 mmol/L Standard Deviation 1.19	0.34 mmol/L Standard Deviation 1.22	0.27 mmol/L Standard Deviation 1.24	0.21 mmol/L Standard Deviation 0.88
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Calcium Week 12	-0.011 mmol/L Standard Deviation 0.095	0.025 mmol/L Standard Deviation 0.092	-0.038 mmol/L Standard Deviation 0.120	0.001 mmol/L Standard Deviation 0.093	-0.019 mmol/L Standard Deviation 0.121	-0.001 mmol/L Standard Deviation 0.092
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Calcium SFU	-0.095 mmol/L Standard Deviation 0.083	-0.050 mmol/L Standard Deviation 0.109	-0.073 mmol/L Standard Deviation 0.045	-0.125 mmol/L Standard Deviation 0.134	0.020 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.020 mmol/L Standard Deviation 0.193
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Chloride Week 1	0.5 mmol/L Standard Deviation 1.8	0.6 mmol/L Standard Deviation 2.0	0.6 mmol/L Standard Deviation 2.3	0.6 mmol/L Standard Deviation 2.5	0.3 mmol/L Standard Deviation 2.1	0.1 mmol/L Standard Deviation 1.8
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Potassium Week 1	0.08 mmol/L Standard Deviation 0.45	0.08 mmol/L Standard Deviation 0.33	0.05 mmol/L Standard Deviation 0.41	0.02 mmol/L Standard Deviation 0.36	-0.03 mmol/L Standard Deviation 0.32	0.04 mmol/L Standard Deviation 0.29
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Chloride Week 2	0.0 mmol/L Standard Deviation 2.3	0.1 mmol/L Standard Deviation 2.4	-0.3 mmol/L Standard Deviation 2.2	0.4 mmol/L Standard Deviation 2.3	0.5 mmol/L Standard Deviation 2.1	0.1 mmol/L Standard Deviation 1.9
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Chloride Week 4	0.1 mmol/L Standard Deviation 1.8	0.8 mmol/L Standard Deviation 2.1	0.0 mmol/L Standard Deviation 2.5	0.2 mmol/L Standard Deviation 2.3	-0.1 mmol/L Standard Deviation 2.6	-0.1 mmol/L Standard Deviation 1.9
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Chloride Week 6	-0.1 mmol/L Standard Deviation 2.1	0.0 mmol/L Standard Deviation 2.3	-0.6 mmol/L Standard Deviation 1.7	0.0 mmol/L Standard Deviation 2.4	-0.1 mmol/L Standard Deviation 3.0	0.1 mmol/L Standard Deviation 2.0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Chloride Week 8	0.2 mmol/L Standard Deviation 2.1	0.3 mmol/L Standard Deviation 2.3	0.3 mmol/L Standard Deviation 2.0	-0.1 mmol/L Standard Deviation 2.9	0.1 mmol/L Standard Deviation 2.4	0.1 mmol/L Standard Deviation 2.3
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Chloride Week 12	0.3 mmol/L Standard Deviation 1.7	-0.1 mmol/L Standard Deviation 2.5	-0.2 mmol/L Standard Deviation 2.0	0.2 mmol/L Standard Deviation 2.3	0.8 mmol/L Standard Deviation 2.4	0.1 mmol/L Standard Deviation 2.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Chloride SFU	1.0 mmol/L Standard Deviation 1.6	3.0 mmol/L Standard Deviation 2.7	0.5 mmol/L Standard Deviation 5.4	2.0 mmol/L Standard Deviation 0.0	0.0 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.3 mmol/L Standard Deviation 2.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Potassium Week 2	0.03 mmol/L Standard Deviation 0.30	0.08 mmol/L Standard Deviation 0.33	0.02 mmol/L Standard Deviation 0.32	-0.06 mmol/L Standard Deviation 0.29	0.05 mmol/L Standard Deviation 0.37	-0.03 mmol/L Standard Deviation 0.39
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Potassium Week 4	0.09 mmol/L Standard Deviation 0.40	0.12 mmol/L Standard Deviation 0.41	0.09 mmol/L Standard Deviation 0.38	0.01 mmol/L Standard Deviation 0.34	0.05 mmol/L Standard Deviation 0.40	0.03 mmol/L Standard Deviation 0.33
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Potassium Week 6	-0.04 mmol/L Standard Deviation 0.32	0.11 mmol/L Standard Deviation 0.35	-0.03 mmol/L Standard Deviation 0.31	-0.07 mmol/L Standard Deviation 0.33	-0.07 mmol/L Standard Deviation 0.34	-0.02 mmol/L Standard Deviation 0.35
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Potassium Week 8	0.01 mmol/L Standard Deviation 0.39	0.07 mmol/L Standard Deviation 0.36	0.12 mmol/L Standard Deviation 0.38	-0.06 mmol/L Standard Deviation 0.38	-0.12 mmol/L Standard Deviation 0.40	0.02 mmol/L Standard Deviation 0.35
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Potassium Week 12	-0.05 mmol/L Standard Deviation 0.35	0.08 mmol/L Standard Deviation 0.34	0.08 mmol/L Standard Deviation 0.37	-0.06 mmol/L Standard Deviation 0.37	-0.07 mmol/L Standard Deviation 0.37	-0.06 mmol/L Standard Deviation 0.33
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Potassium SFU	0.10 mmol/L Standard Deviation 0.36	0.10 mmol/L Standard Deviation 0.37	-0.10 mmol/L Standard Deviation 0.29	-0.45 mmol/L Standard Deviation 0.07	0.20 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.20 mmol/L Standard Deviation 0.30
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Urea Nitrogen Week 2	0.00 mmol/L Standard Deviation 1.16	-0.03 mmol/L Standard Deviation 1.25	0.24 mmol/L Standard Deviation 1.16	0.16 mmol/L Standard Deviation 1.17	0.27 mmol/L Standard Deviation 1.17	0.37 mmol/L Standard Deviation 1.03
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Urea Nitrogen Week 4	-0.14 mmol/L Standard Deviation 1.16	0.48 mmol/L Standard Deviation 1.52	0.50 mmol/L Standard Deviation 1.31	-0.03 mmol/L Standard Deviation 1.20	-0.11 mmol/L Standard Deviation 1.08	0.15 mmol/L Standard Deviation 1.04
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Urea Nitrogen Week 6	-0.12 mmol/L Standard Deviation 0.96	0.21 mmol/L Standard Deviation 1.40	0.41 mmol/L Standard Deviation 1.14	0.19 mmol/L Standard Deviation 1.31	0.29 mmol/L Standard Deviation 1.14	0.12 mmol/L Standard Deviation 0.93
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Urea Nitrogen Week 8	-0.28 mmol/L Standard Deviation 1.29	0.14 mmol/L Standard Deviation 1.33	0.32 mmol/L Standard Deviation 1.08	-0.08 mmol/L Standard Deviation 1.58	0.33 mmol/L Standard Deviation 1.30	0.35 mmol/L Standard Deviation 0.88
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Urea Nitrogen Week 12	-0.17 mmol/L Standard Deviation 1.35	-0.04 mmol/L Standard Deviation 1.37	0.39 mmol/L Standard Deviation 1.14	0.08 mmol/L Standard Deviation 1.13	0.13 mmol/L Standard Deviation 1.08	0.01 mmol/L Standard Deviation 0.85
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Urea Nitrogen SFU	0.65 mmol/L Standard Deviation 1.74	0.80 mmol/L Standard Deviation 1.19	0.78 mmol/L Standard Deviation 3.27	-0.65 mmol/L Standard Deviation 2.05	-0.30 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.77 mmol/L Standard Deviation 1.27
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol Week 1	-0.04 mmol/L Standard Deviation 0.47	-0.06 mmol/L Standard Deviation 0.54	0.00 mmol/L Standard Deviation 0.65	-0.09 mmol/L Standard Deviation 0.59	0.12 mmol/L Standard Deviation 0.65	0.06 mmol/L Standard Deviation 0.34
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol Week 2	-0.13 mmol/L Standard Deviation 0.71	0.03 mmol/L Standard Deviation 0.63	0.12 mmol/L Standard Deviation 0.58	-0.11 mmol/L Standard Deviation 0.52	0.12 mmol/L Standard Deviation 1.04	0.05 mmol/L Standard Deviation 0.57
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol Week 4	-0.06 mmol/L Standard Deviation 0.59	0.04 mmol/L Standard Deviation 0.63	0.17 mmol/L Standard Deviation 0.55	-0.31 mmol/L Standard Deviation 0.88	0.00 mmol/L Standard Deviation 1.30	0.05 mmol/L Standard Deviation 0.66
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol Week 6	0.05 mmol/L Standard Deviation 0.46	-0.02 mmol/L Standard Deviation 0.73	0.17 mmol/L Standard Deviation 0.56	-0.24 mmol/L Standard Deviation 0.70	-0.24 mmol/L Standard Deviation 1.32	0.08 mmol/L Standard Deviation 0.60
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol Week 8	-0.08 mmol/L Standard Deviation 0.67	-0.17 mmol/L Standard Deviation 0.68	0.16 mmol/L Standard Deviation 0.64	-0.13 mmol/L Standard Deviation 0.83	-0.17 mmol/L Standard Deviation 1.22	0.01 mmol/L Standard Deviation 0.48
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol Week 12	-0.20 mmol/L Standard Deviation 0.88	-0.07 mmol/L Standard Deviation 0.62	0.11 mmol/L Standard Deviation 0.62	-0.18 mmol/L Standard Deviation 0.77	0.01 mmol/L Standard Deviation 1.29	-0.05 mmol/L Standard Deviation 0.76
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol SFU	-0.28 mmol/L Standard Deviation 0.30	-0.83 mmol/L Standard Deviation 1.56	0.38 mmol/L Standard Deviation 0.52	-0.80 mmol/L Standard Deviation 0.14	0.20 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.40 mmol/L Standard Deviation 0.44
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Magnesium Week 1	-0.010 mmol/L Standard Deviation 0.074	-0.002 mmol/L Standard Deviation 0.052	-0.020 mmol/L Standard Deviation 0.069	0.005 mmol/L Standard Deviation 0.079	-0.007 mmol/L Standard Deviation 0.077	-0.009 mmol/L Standard Deviation 0.064
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Magnesium Week 2	-0.012 mmol/L Standard Deviation 0.063	-0.004 mmol/L Standard Deviation 0.064	-0.010 mmol/L Standard Deviation 0.065	0.001 mmol/L Standard Deviation 0.068	-0.017 mmol/L Standard Deviation 0.086	0.005 mmol/L Standard Deviation 0.075
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Magnesium Week 4	-0.023 mmol/L Standard Deviation 0.077	-0.004 mmol/L Standard Deviation 0.062	-0.017 mmol/L Standard Deviation 0.046	0.008 mmol/L Standard Deviation 0.071	-0.017 mmol/L Standard Deviation 0.067	-0.013 mmol/L Standard Deviation 0.070
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Magnesium Week 6	-0.013 mmol/L Standard Deviation 0.054	-0.014 mmol/L Standard Deviation 0.053	-0.013 mmol/L Standard Deviation 0.057	-0.008 mmol/L Standard Deviation 0.065	-0.020 mmol/L Standard Deviation 0.073	-0.017 mmol/L Standard Deviation 0.063
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Magnesium Week 8	-0.026 mmol/L Standard Deviation 0.070	-0.023 mmol/L Standard Deviation 0.042	-0.023 mmol/L Standard Deviation 0.063	0.003 mmol/L Standard Deviation 0.071	-0.019 mmol/L Standard Deviation 0.072	-0.021 mmol/L Standard Deviation 0.058
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Magnesium Week 12	-0.014 mmol/L Standard Deviation 0.093	0.007 mmol/L Standard Deviation 0.074	-0.025 mmol/L Standard Deviation 0.069	0.009 mmol/L Standard Deviation 0.074	-0.017 mmol/L Standard Deviation 0.075	-0.008 mmol/L Standard Deviation 0.056
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Magnesium SFU	0.053 mmol/L Standard Deviation 0.093	0.110 mmol/L Standard Deviation 0.295	-0.035 mmol/L Standard Deviation 0.047	-0.050 mmol/L Standard Deviation 0.057	-0.060 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.023 mmol/L Standard Deviation 0.025
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Sodium Week 1	-0.1 mmol/L Standard Deviation 1.8	0.2 mmol/L Standard Deviation 1.7	0.3 mmol/L Standard Deviation 2.7	0.1 mmol/L Standard Deviation 1.9	0.0 mmol/L Standard Deviation 2.2	0.0 mmol/L Standard Deviation 1.4
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Sodium Week 2	-0.3 mmol/L Standard Deviation 1.7	-0.2 mmol/L Standard Deviation 1.4	-0.4 mmol/L Standard Deviation 1.8	0.0 mmol/L Standard Deviation 2.0	0.2 mmol/L Standard Deviation 2.3	0.0 mmol/L Standard Deviation 1.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Sodium Week 4	-0.2 mmol/L Standard Deviation 1.7	0.2 mmol/L Standard Deviation 1.7	0.2 mmol/L Standard Deviation 1.7	-0.2 mmol/L Standard Deviation 1.7	-0.1 mmol/L Standard Deviation 2.3	-0.2 mmol/L Standard Deviation 1.7
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Sodium Week 6	-0.5 mmol/L Standard Deviation 2.0	-0.1 mmol/L Standard Deviation 2.1	-0.8 mmol/L Standard Deviation 1.6	-0.1 mmol/L Standard Deviation 1.9	-0.1 mmol/L Standard Deviation 2.9	-0.3 mmol/L Standard Deviation 1.7
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Sodium Week 8	-0.6 mmol/L Standard Deviation 2.0	0.0 mmol/L Standard Deviation 2.8	-0.2 mmol/L Standard Deviation 1.8	-0.2 mmol/L Standard Deviation 2.0	-0.1 mmol/L Standard Deviation 2.2	-0.6 mmol/L Standard Deviation 2.0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Sodium Week 12	-0.4 mmol/L Standard Deviation 2.0	-0.2 mmol/L Standard Deviation 1.7	-0.1 mmol/L Standard Deviation 1.7	-0.2 mmol/L Standard Deviation 2.0	-0.2 mmol/L Standard Deviation 2.4	-0.3 mmol/L Standard Deviation 1.9
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Sodium SFU	-0.5 mmol/L Standard Deviation 2.1	0.8 mmol/L Standard Deviation 1.7	-2.0 mmol/L Standard Deviation 2.2	-2.0 mmol/L Standard Deviation 2.8	-1.0 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-1.7 mmol/L Standard Deviation 1.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Glucose Week 1	0.50 mmol/L Standard Deviation 1.59	0.12 mmol/L Standard Deviation 0.82	-0.14 mmol/L Standard Deviation 1.00	-0.06 mmol/L Standard Deviation 1.14	0.07 mmol/L Standard Deviation 1.10	0.22 mmol/L Standard Deviation 0.70
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Glucose Week 2	0.29 mmol/L Standard Deviation 1.62	0.17 mmol/L Standard Deviation 1.23	-0.05 mmol/L Standard Deviation 0.92	-0.20 mmol/L Standard Deviation 1.13	0.03 mmol/L Standard Deviation 1.09	0.05 mmol/L Standard Deviation 0.67
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Glucose Week 4	0.37 mmol/L Standard Deviation 1.42	0.25 mmol/L Standard Deviation 1.22	-0.12 mmol/L Standard Deviation 1.03	-0.09 mmol/L Standard Deviation 1.24	0.37 mmol/L Standard Deviation 1.20	0.19 mmol/L Standard Deviation 0.92
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Glucose Week 6	0.44 mmol/L Standard Deviation 1.42	0.30 mmol/L Standard Deviation 1.15	-0.04 mmol/L Standard Deviation 1.26	0.02 mmol/L Standard Deviation 1.60	0.21 mmol/L Standard Deviation 1.30	0.29 mmol/L Standard Deviation 1.27
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Glucose Week 8	0.37 mmol/L Standard Deviation 1.48	0.22 mmol/L Standard Deviation 1.48	-0.15 mmol/L Standard Deviation 0.87	-0.06 mmol/L Standard Deviation 1.43	0.11 mmol/L Standard Deviation 1.10	0.03 mmol/L Standard Deviation 0.97
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Glucose Week 12	0.22 mmol/L Standard Deviation 1.27	0.01 mmol/L Standard Deviation 1.08	0.02 mmol/L Standard Deviation 1.35	-0.17 mmol/L Standard Deviation 1.23	-0.15 mmol/L Standard Deviation 0.88	0.04 mmol/L Standard Deviation 0.95
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Glucose SFU	-0.40 mmol/L Standard Deviation 0.48	0.75 mmol/L Standard Deviation 0.89	-0.33 mmol/L Standard Deviation 0.67	-0.25 mmol/L Standard Deviation 0.49	0.20 mmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.17 mmol/L Standard Deviation 0.61
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Calcium Week 1	-0.010 mmol/L Standard Deviation 0.076	0.011 mmol/L Standard Deviation 0.088	-0.021 mmol/L Standard Deviation 0.126	-0.017 mmol/L Standard Deviation 0.076	0.000 mmol/L Standard Deviation 0.077	-0.010 mmol/L Standard Deviation 0.080
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Calcium Week 2	-0.003 mmol/L Standard Deviation 0.082	0.034 mmol/L Standard Deviation 0.094	-0.007 mmol/L Standard Deviation 0.092	0.004 mmol/L Standard Deviation 0.074	0.006 mmol/L Standard Deviation 0.088	-0.006 mmol/L Standard Deviation 0.085
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) Calcium Week 4	-0.029 mmol/L Standard Deviation 0.073	0.012 mmol/L Standard Deviation 0.099	-0.020 mmol/L Standard Deviation 0.106	-0.008 mmol/L Standard Deviation 0.074	0.005 mmol/L Standard Deviation 0.099	-0.010 mmol/L Standard Deviation 0.084

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Aspartate Aminotransferase Week 1	0.5 U/L Standard Deviation 6.1	2.0 U/L Standard Deviation 10.8	-3.0 U/L Standard Deviation 15.2	1.9 U/L Standard Deviation 11.5	0.3 U/L Standard Deviation 6.3	-0.5 U/L Standard Deviation 7.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Aspartate Aminotransferase Week 2	-1.0 U/L Standard Deviation 3.8	0.4 U/L Standard Deviation 4.9	-1.9 U/L Standard Deviation 19.1	-0.9 U/L Standard Deviation 4.7	-0.5 U/L Standard Deviation 6.1	0.9 U/L Standard Deviation 13.4
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Aspartate Aminotransferase Week 4	-1.1 U/L Standard Deviation 4.8	-0.1 U/L Standard Deviation 5.8	-2.5 U/L Standard Deviation 17.5	-0.4 U/L Standard Deviation 5.9	0.6 U/L Standard Deviation 8.2	-0.4 U/L Standard Deviation 7.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Aspartate Aminotransferase Week 6	1.5 U/L Standard Deviation 10.6	0.8 U/L Standard Deviation 6.0	-0.9 U/L Standard Deviation 9.5	4.0 U/L Standard Deviation 15.7	-1.4 U/L Standard Deviation 7.0	-1.4 U/L Standard Deviation 6.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Aspartate Aminotransferase Week 8	0.0 U/L Standard Deviation 5.1	0.2 U/L Standard Deviation 6.7	-1.4 U/L Standard Deviation 5.4	-1.4 U/L Standard Deviation 4.6	-0.4 U/L Standard Deviation 8.3	-0.8 U/L Standard Deviation 6.3
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Aspartate Aminotransferase Week 12	-1.3 U/L Standard Deviation 5.5	1.1 U/L Standard Deviation 7.9	-1.4 U/L Standard Deviation 8.3	-0.3 U/L Standard Deviation 4.8	-0.5 U/L Standard Deviation 7.3	-0.9 U/L Standard Deviation 5.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Aspartate Aminotransferase SFU	-2.8 U/L Standard Deviation 1.7	-0.3 U/L Standard Deviation 2.1	11.5 U/L Standard Deviation 23.5	-4.0 U/L Standard Deviation 2.8	9.0 U/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.7 U/L Standard Deviation 2.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Gamma Glutamyl Transferase Week 1	0.6 U/L Standard Deviation 6.4	-0.8 U/L Standard Deviation 14.1	-2.0 U/L Standard Deviation 10.7	-7.5 U/L Standard Deviation 42.1	1.6 U/L Standard Deviation 22.9	-0.8 U/L Standard Deviation 6.3
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Gamma Glutamyl Transferase Week 2	0.2 U/L Standard Deviation 8.7	-1.6 U/L Standard Deviation 11.1	0.2 U/L Standard Deviation 14.2	-1.2 U/L Standard Deviation 8.0	-1.9 U/L Standard Deviation 6.5	0.4 U/L Standard Deviation 15.0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Gamma Glutamyl Transferase Week 4	-0.7 U/L Standard Deviation 8.5	-1.9 U/L Standard Deviation 11.8	1.8 U/L Standard Deviation 18.6	-2.6 U/L Standard Deviation 12.8	-0.4 U/L Standard Deviation 8.4	-1.4 U/L Standard Deviation 14.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Gamma Glutamyl Transferase Week 6	1.8 U/L Standard Deviation 10.5	-1.8 U/L Standard Deviation 13.8	-2.9 U/L Standard Deviation 13.1	-2.9 U/L Standard Deviation 7.3	-2.1 U/L Standard Deviation 9.3	-1.1 U/L Standard Deviation 12.9
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Gamma Glutamyl Transferase Week 8	2.4 U/L Standard Deviation 13.7	-1.9 U/L Standard Deviation 14.9	-0.9 U/L Standard Deviation 18.4	-2.6 U/L Standard Deviation 13.6	-2.5 U/L Standard Deviation 9.4	3.1 U/L Standard Deviation 29.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Gamma Glutamyl Transferase Week 12	-0.4 U/L Standard Deviation 10.9	-2.2 U/L Standard Deviation 13.3	-1.1 U/L Standard Deviation 21.7	-0.6 U/L Standard Deviation 11.2	-0.4 U/L Standard Deviation 11.1	-0.9 U/L Standard Deviation 12.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Gamma Glutamyl Transferase SFU	-8.0 U/L Standard Deviation 13.4	1.3 U/L Standard Deviation 3.9	19.8 U/L Standard Deviation 23.3	-16.5 U/L Standard Deviation 24.7	37.0 U/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	3.0 U/L Standard Deviation 3.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Lactate Dehydrogenase Week 1	-2.0 U/L Standard Deviation 29.4	1.1 U/L Standard Deviation 24.8	-5.0 U/L Standard Deviation 24.1	-0.3 U/L Standard Deviation 21.4	-4.6 U/L Standard Deviation 18.9	-3.4 U/L Standard Deviation 19.7
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Lactate Dehydrogenase Week 2	-4.9 U/L Standard Deviation 26.4	-2.5 U/L Standard Deviation 25.2	-3.5 U/L Standard Deviation 22.1	0.4 U/L Standard Deviation 27.6	-7.6 U/L Standard Deviation 27.4	-5.1 U/L Standard Deviation 20.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Lactate Dehydrogenase Week 4	-4.9 U/L Standard Deviation 22.4	1.7 U/L Standard Deviation 31.9	-8.1 U/L Standard Deviation 16.7	5.0 U/L Standard Deviation 43.5	-4.5 U/L Standard Deviation 37.7	-4.4 U/L Standard Deviation 15.4
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Lactate Dehydrogenase Week 6	-5.0 U/L Standard Deviation 27.7	-1.4 U/L Standard Deviation 25.2	-7.3 U/L Standard Deviation 20.3	2.0 U/L Standard Deviation 16.2	-11.0 U/L Standard Deviation 27.5	-3.5 U/L Standard Deviation 22.6
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Lactate Dehydrogenase Week 8	-5.5 U/L Standard Deviation 27.4	0.5 U/L Standard Deviation 25.2	-12.3 U/L Standard Deviation 22.2	-0.8 U/L Standard Deviation 18.9	-10.7 U/L Standard Deviation 33.1	-3.7 U/L Standard Deviation 27.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Lactate Dehydrogenase Week 12	-4.9 U/L Standard Deviation 28.1	2.9 U/L Standard Deviation 26.7	-7.5 U/L Standard Deviation 25.1	-0.3 U/L Standard Deviation 20.6	-5.6 U/L Standard Deviation 33.1	-4.4 U/L Standard Deviation 24.8
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Lactate Dehydrogenase SFU	-1.5 U/L Standard Deviation 12.9	-5.0 U/L Standard Deviation 18.4	3.3 U/L Standard Deviation 81.2	-45.5 U/L Standard Deviation 16.3	15.0 U/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	32.3 U/L Standard Deviation 34.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alkaline Phosphatase Week 1	-1.8 U/L Standard Deviation 6.3	-0.5 U/L Standard Deviation 6.0	-3.5 U/L Standard Deviation 8.2	-3.8 U/L Standard Deviation 7.7	-1.9 U/L Standard Deviation 5.3	-2.3 U/L Standard Deviation 5.7
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alkaline Phosphatase Week 2	-3.0 U/L Standard Deviation 12.7	0.0 U/L Standard Deviation 7.4	-2.5 U/L Standard Deviation 10.5	-2.7 U/L Standard Deviation 8.2	-1.6 U/L Standard Deviation 6.5	-1.7 U/L Standard Deviation 7.7
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alkaline Phosphatase Week 4	-2.4 U/L Standard Deviation 8.7	-1.9 U/L Standard Deviation 9.2	-6.2 U/L Standard Deviation 9.8	-4.3 U/L Standard Deviation 9.4	-2.6 U/L Standard Deviation 8.1	-1.7 U/L Standard Deviation 7.8
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alkaline Phosphatase Week 6	-3.0 U/L Standard Deviation 8.3	-1.8 U/L Standard Deviation 9.0	-5.5 U/L Standard Deviation 10.0	-2.4 U/L Standard Deviation 8.6	-2.1 U/L Standard Deviation 9.6	-1.4 U/L Standard Deviation 7.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alkaline Phosphatase Week 8	-4.3 U/L Standard Deviation 12.2	-1.7 U/L Standard Deviation 8.0	-4.2 U/L Standard Deviation 11.2	-2.1 U/L Standard Deviation 10.0	-1.1 U/L Standard Deviation 11.3	-1.9 U/L Standard Deviation 7.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alkaline Phosphatase Week 12	-2.0 U/L Standard Deviation 8.1	0.3 U/L Standard Deviation 7.2	-2.4 U/L Standard Deviation 11.8	-0.4 U/L Standard Deviation 9.0	-0.5 U/L Standard Deviation 10.4	-0.4 U/L Standard Deviation 8.4
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alkaline Phosphatase SFU	-0.5 U/L Standard Deviation 7.4	9.8 U/L Standard Deviation 8.9	7.8 U/L Standard Deviation 15.3	-3.0 U/L Standard Deviation 5.7	3.0 U/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	3.0 U/L Standard Deviation 1.0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alanine Aminotransferase Week 1	2.0 U/L Standard Deviation 7.7	2.1 U/L Standard Deviation 10.4	-1.7 U/L Standard Deviation 13.7	1.6 U/L Standard Deviation 12.2	0.7 U/L Standard Deviation 8.9	1.2 U/L Standard Deviation 9.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alanine Aminotransferase Week 2	0.3 U/L Standard Deviation 6.5	1.9 U/L Standard Deviation 9.0	2.0 U/L Standard Deviation 29.8	-0.9 U/L Standard Deviation 7.7	-0.2 U/L Standard Deviation 10.2	1.6 U/L Standard Deviation 11.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alanine Aminotransferase Week 4	-0.2 U/L Standard Deviation 7.0	1.1 U/L Standard Deviation 8.6	0.8 U/L Standard Deviation 18.7	-0.4 U/L Standard Deviation 10.2	0.4 U/L Standard Deviation 14.7	1.0 U/L Standard Deviation 13.3
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alanine Aminotransferase Week 6	3.9 U/L Standard Deviation 18.9	1.1 U/L Standard Deviation 8.9	-0.6 U/L Standard Deviation 11.7	3.5 U/L Standard Deviation 20.9	-1.7 U/L Standard Deviation 13.7	1.1 U/L Standard Deviation 12.5
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alanine Aminotransferase Week 8	1.8 U/L Standard Deviation 10.8	2.2 U/L Standard Deviation 10.2	0.1 U/L Standard Deviation 10.5	-0.4 U/L Standard Deviation 9.7	-1.1 U/L Standard Deviation 14.5	0.8 U/L Standard Deviation 9.0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alanine Aminotransferase Week 12	-1.3 U/L Standard Deviation 7.5	1.8 U/L Standard Deviation 9.9	-1.0 U/L Standard Deviation 10.8	-0.9 U/L Standard Deviation 9.1	-0.9 U/L Standard Deviation 14.6	-0.4 U/L Standard Deviation 10.6
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) Alanine Aminotransferase SFU	-3.8 U/L Standard Deviation 3.0	4.3 U/L Standard Deviation 3.4	26.5 U/L Standard Deviation 42.1	-6.0 U/L Standard Deviation 8.5	16.0 U/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-3.3 U/L Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Creatinine and bilirubin were measured in micromols per liter (μmol/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Creatinine Week 1	0.6 μmol/L Standard Deviation 7.0	2.7 μmol/L Standard Deviation 10.1	1.4 μmol/L Standard Deviation 8.6	0.6 μmol/L Standard Deviation 8.1	0.7 μmol/L Standard Deviation 8.4	-0.7 μmol/L Standard Deviation 7.7
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Creatinine Week 2	0.0 μmol/L Standard Deviation 7.1	-0.8 μmol/L Standard Deviation 8.2	-0.4 μmol/L Standard Deviation 10.1	-0.7 μmol/L Standard Deviation 8.5	-0.1 μmol/L Standard Deviation 8.3	0.0 μmol/L Standard Deviation 7.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Creatinine Week 4	0.0 μmol/L Standard Deviation 5.8	1.3 μmol/L Standard Deviation 9.1	0.6 μmol/L Standard Deviation 7.9	-1.7 μmol/L Standard Deviation 8.1	0.6 μmol/L Standard Deviation 8.1	1.6 μmol/L Standard Deviation 7.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Creatinine Week 6	-1.1 μmol/L Standard Deviation 7.8	1.6 μmol/L Standard Deviation 10.5	-0.1 μmol/L Standard Deviation 10.6	-0.6 μmol/L Standard Deviation 7.9	-0.1 μmol/L Standard Deviation 8.1	-0.5 μmol/L Standard Deviation 11.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Creatinine Week 8	-1.1 μmol/L Standard Deviation 6.2	-0.4 μmol/L Standard Deviation 7.4	-1.0 μmol/L Standard Deviation 9.6	-2.6 μmol/L Standard Deviation 8.4	-0.1 μmol/L Standard Deviation 7.6	0.1 μmol/L Standard Deviation 8.3
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Creatinine Week 12	-1.6 μmol/L Standard Deviation 7.8	-0.2 μmol/L Standard Deviation 7.0	0.7 μmol/L Standard Deviation 12.0	-0.7 μmol/L Standard Deviation 9.1	0.1 μmol/L Standard Deviation 9.0	-0.7 μmol/L Standard Deviation 7.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Creatinine SFU	1.5 μmol/L Standard Deviation 4.4	6.0 μmol/L Standard Deviation 4.3	-6.5 μmol/L Standard Deviation 4.4	-10.5 μmol/L Standard Deviation 16.3	9.0 μmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	1.3 μmol/L Standard Deviation 6.4
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Bilirubin Week 1	-0.53 μmol/L Standard Deviation 3.10	-1.79 μmol/L Standard Deviation 4.50	-0.52 μmol/L Standard Deviation 2.81	-0.55 μmol/L Standard Deviation 4.49	0.57 μmol/L Standard Deviation 5.73	0.14 μmol/L Standard Deviation 4.16
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Bilirubin Week 2	-0.35 μmol/L Standard Deviation 2.85	-0.86 μmol/L Standard Deviation 5.05	-0.48 μmol/L Standard Deviation 3.40	-0.38 μmol/L Standard Deviation 3.60	-0.99 μmol/L Standard Deviation 2.98	0.27 μmol/L Standard Deviation 3.69
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Bilirubin Week 4	-0.70 μmol/L Standard Deviation 3.26	-1.70 μmol/L Standard Deviation 4.92	-0.26 μmol/L Standard Deviation 3.53	-0.04 μmol/L Standard Deviation 2.74	0.76 μmol/L Standard Deviation 4.27	0.70 μmol/L Standard Deviation 4.52
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Bilirubin Week 6	-0.51 μmol/L Standard Deviation 3.13	-1.15 μmol/L Standard Deviation 4.59	0.35 μmol/L Standard Deviation 3.44	-0.33 μmol/L Standard Deviation 3.94	0.11 μmol/L Standard Deviation 4.19	-0.30 μmol/L Standard Deviation 4.28
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Bilirubin Week 8	-0.21 μmol/L Standard Deviation 3.81	-0.98 μmol/L Standard Deviation 4.68	-0.30 μmol/L Standard Deviation 3.20	-0.43 μmol/L Standard Deviation 4.52	-0.15 μmol/L Standard Deviation 3.79	-0.02 μmol/L Standard Deviation 4.41
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Bilirubin Week 12	-0.74 μmol/L Standard Deviation 3.43	-1.02 μmol/L Standard Deviation 5.24	-0.73 μmol/L Standard Deviation 2.98	-1.20 μmol/L Standard Deviation 3.37	-0.43 μmol/L Standard Deviation 3.68	-0.34 μmol/L Standard Deviation 3.45
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) Bilirubin SFU	2.05 μmol/L Standard Deviation 2.16	-1.23 μmol/L Standard Deviation 2.62	-0.30 μmol/L Standard Deviation 3.87	-0.25 μmol/L Standard Deviation 0.78	-1.50 μmol/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	1.40 μmol/L Standard Deviation 2.96

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

C Reactive Protein was measured in milligrams per liters (mg/L).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) Week 1	-2.110 mg/L Standard Deviation 5.255	-5.367 mg/L Standard Deviation 11.806	-0.775 mg/L Standard Deviation 2.020	-2.635 mg/L Standard Deviation 2.550	-5.108 mg/L Standard Deviation 10.013	-3.732 mg/L Standard Deviation 3.997
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) Week 2	1.821 mg/L Standard Deviation 6.974	-6.985 mg/L Standard Deviation 11.064	0.576 mg/L Standard Deviation 2.898	2.743 mg/L Standard Deviation 15.212	-6.763 mg/L Standard Deviation 13.211	-3.042 mg/L Standard Deviation 1.989
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) Week 4	1.338 mg/L Standard Deviation 11.182	-5.835 mg/L Standard Deviation 8.594	-1.722 mg/L Standard Deviation 5.596	0.929 mg/L Standard Deviation 8.047	-4.226 mg/L Standard Deviation 9.865	7.141 mg/L Standard Deviation 32.344
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) Week 6	2.978 mg/L Standard Deviation 13.162	-5.930 mg/L Standard Deviation 9.560	-4.516 mg/L Standard Deviation 11.304	-0.595 mg/L Standard Deviation 7.346	1.799 mg/L Standard Deviation 14.635	-6.598 mg/L Standard Deviation 6.278
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) Week 8	3.153 mg/L Standard Deviation 18.764	-6.891 mg/L Standard Deviation 15.192	-3.143 mg/L Standard Deviation 10.844	2.590 mg/L Standard Deviation 7.755	12.434 mg/L Standard Deviation 47.447	-1.104 mg/L Standard Deviation 5.201
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) Week 12	7.279 mg/L Standard Deviation 13.546	-5.193 mg/L Standard Deviation 10.817	0.695 mg/L Standard Deviation 6.381	-3.033 mg/L Standard Deviation 7.261	-9.890 mg/L Standard Deviation 10.729	-5.368 mg/L Standard Deviation 5.322
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) SFU	8.000 mg/L Standard Deviation NA Value was not evaluable because only one participant was analyzed.	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Urine pH was measured on a pH scale.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) Week 1	0.00 ph Standard Deviation 0.79	-0.10 ph Standard Deviation 0.79	-0.13 ph Standard Deviation 0.88	-0.20 ph Standard Deviation 0.88	-0.08 ph Standard Deviation 0.82	-0.07 ph Standard Deviation 0.90
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) Week 2	0.06 ph Standard Deviation 0.86	-0.06 ph Standard Deviation 0.86	-0.10 ph Standard Deviation 0.77	-0.23 ph Standard Deviation 0.92	-0.18 ph Standard Deviation 0.76	0.06 ph Standard Deviation 0.65
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) Week 4	0.05 ph Standard Deviation 0.87	-0.09 ph Standard Deviation 0.76	-0.11 ph Standard Deviation 0.95	-0.26 ph Standard Deviation 0.89	-0.07 ph Standard Deviation 0.73	-0.04 ph Standard Deviation 0.74
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) Week 6	-0.01 ph Standard Deviation 0.73	-0.03 ph Standard Deviation 0.68	-0.17 ph Standard Deviation 0.69	-0.18 ph Standard Deviation 0.86	-0.13 ph Standard Deviation 0.81	0.05 ph Standard Deviation 0.86
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) Week 8	-0.03 ph Standard Deviation 0.92	-0.07 ph Standard Deviation 0.83	-0.12 ph Standard Deviation 1.07	-0.34 ph Standard Deviation 0.79	-0.30 ph Standard Deviation 0.91	0.08 ph Standard Deviation 0.75
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) Week 12	-0.14 ph Standard Deviation 0.79	-0.01 ph Standard Deviation 0.85	0.01 ph Standard Deviation 0.70	-0.28 ph Standard Deviation 0.85	-0.21 ph Standard Deviation 0.99	-0.01 ph Standard Deviation 0.85
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) SFU	0.25 ph Standard Deviation 1.04	-0.25 ph Standard Deviation 0.87	0.50 ph Standard Deviation 1.22	-1.00 ph Standard Deviation 1.41	0.50 ph Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-0.17 ph Standard Deviation 0.29

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Week 12

Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP. Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.

Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=39 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=38 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=37 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=34 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline Low - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline Low - Week 12 Normal	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline Low - Week 12 High	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline Normal - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline Normal - Week 12 Normal	84.6 percentage of participants	84.2 percentage of participants	97.3 percentage of participants	88.2 percentage of participants	90.0 percentage of participants	92.3 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline Normal - Week 12 High	2.6 percentage of participants	0 percentage of participants	2.7 percentage of participants	5.9 percentage of participants	5.0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline High - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline High - Week 12 Normal	7.7 percentage of participants	15.8 percentage of participants	0 percentage of participants	2.9 percentage of participants	5.0 percentage of participants	7.7 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) Baseline High - Week 12 High	5.1 percentage of participants	0 percentage of participants	0 percentage of participants	2.9 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Week 12

Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=39 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=38 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=37 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=34 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline Low - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline Low - Week 12 Normal	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline Low - Week 12 High	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline Normal - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline Normal - Week 12 Normal	97.4 percentage of participants	97.4 percentage of participants	100 percentage of participants	100 percentage of participants	95.0 percentage of participants	94.9 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline Normal - Week 12 High	0 percentage of participants	2.6 percentage of participants	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	2.6 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline High - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline High - Week 12 Normal	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	2.6 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) Baseline High - Week 12 High	2.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Week 12

Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=39 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=38 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=37 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=34 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline Low - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline Low - Week 12 Normal	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline Low - Week 12 High	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline Normal - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline Normal - Week 12 Normal	76.9 percentage of participants	86.8 percentage of participants	83.8 percentage of participants	79.4 percentage of participants	77.5 percentage of participants	89.7 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline Normal - Week 12 High	0 percentage of participants	5.3 percentage of participants	0 percentage of participants	5.9 percentage of participants	5.0 percentage of participants	2.6 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline High - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline High - Week 12 Normal	10.3 percentage of participants	5.3 percentage of participants	5.4 percentage of participants	8.8 percentage of participants	15.0 percentage of participants	5.1 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) Baseline High - Week 12 High	12.8 percentage of participants	2.6 percentage of participants	10.8 percentage of participants	5.9 percentage of participants	2.5 percentage of participants	2.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Week 12

Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=39 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=38 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=37 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=34 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline Low - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline Low - Week 12 Normal	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline Low - Week 12 High	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline Normal - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline Normal - Week 12 Normal	94.9 percentage of participants	94.7 percentage of participants	97.3 percentage of participants	97.1 percentage of participants	95.0 percentage of participants	94.9 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline Normal - Week 12 High	0 percentage of participants	2.6 percentage of participants	2.7 percentage of participants	2.9 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline High - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline High - Week 12 Normal	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) Baseline High - Week 12 High	5.1 percentage of participants	2.6 percentage of participants	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Week 12

Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=39 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=38 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=37 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=34 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline Low - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline Low - Week 12 Normal	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline Low - Week 12 High	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline Normal - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline Normal - Week 12 Normal	94.9 percentage of participants	89.5 percentage of participants	86.5 percentage of participants	91.2 percentage of participants	95.0 percentage of participants	92.3 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline Normal - Week 12 High	0 percentage of participants	7.9 percentage of participants	2.7 percentage of participants	2.9 percentage of participants	2.5 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline High - Week 12 Low	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline High - Week 12 Normal	5.1 percentage of participants	2.6 percentage of participants	10.8 percentage of participants	5.9 percentage of participants	2.5 percentage of participants	2.6 percentage of participants
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) Baseline High - Week 12 High	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Blood pressure was measured in millimeters of mercury (mmHg).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure Week 1	1.2 mmHg Standard Deviation 10.7	2.2 mmHg Standard Deviation 7.1	-3.9 mmHg Standard Deviation 8.3	1.7 mmHg Standard Deviation 9.3	0.2 mmHg Standard Deviation 12.1	-1.0 mmHg Standard Deviation 9.9
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure Week 2	-1.1 mmHg Standard Deviation 9.7	2.1 mmHg Standard Deviation 9.4	-2.7 mmHg Standard Deviation 12.5	0.2 mmHg Standard Deviation 13.6	-0.6 mmHg Standard Deviation 8.4	-3.2 mmHg Standard Deviation 11.2
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure Week 4	-2.3 mmHg Standard Deviation 10.0	2.1 mmHg Standard Deviation 7.9	-1.9 mmHg Standard Deviation 11.3	0.1 mmHg Standard Deviation 12.4	-0.1 mmHg Standard Deviation 11.3	-0.5 mmHg Standard Deviation 10.8
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure Week 6	-1.4 mmHg Standard Deviation 9.8	-1.3 mmHg Standard Deviation 10.7	-4.3 mmHg Standard Deviation 10.6	0.1 mmHg Standard Deviation 12.8	-0.9 mmHg Standard Deviation 10.9	-2.4 mmHg Standard Deviation 9.2
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure Week 8	-0.8 mmHg Standard Deviation 12.1	-1.3 mmHg Standard Deviation 13.0	-3.4 mmHg Standard Deviation 8.0	0.1 mmHg Standard Deviation 12.3	0.5 mmHg Standard Deviation 12.5	-1.0 mmHg Standard Deviation 10.7
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure Week 12	-1.3 mmHg Standard Deviation 10.9	2.2 mmHg Standard Deviation 9.0	-2.9 mmHg Standard Deviation 10.3	-0.3 mmHg Standard Deviation 11.8	-1.2 mmHg Standard Deviation 10.4	-2.4 mmHg Standard Deviation 10.1
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure SFU	-7.0 mmHg Standard Deviation 12.7	-10.5 mmHg Standard Deviation 17.0	-1.3 mmHg Standard Deviation 10.4	4.5 mmHg Standard Deviation 7.8	-2.0 mmHg Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-2.0 mmHg Standard Deviation 2.6
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure Week 1	-0.4 mmHg Standard Deviation 7.4	0.9 mmHg Standard Deviation 10.0	-2.1 mmHg Standard Deviation 7.3	0.6 mmHg Standard Deviation 6.5	0.3 mmHg Standard Deviation 7.4	0.1 mmHg Standard Deviation 6.7
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure Week 2	-1.5 mmHg Standard Deviation 6.9	0.4 mmHg Standard Deviation 8.7	-1.2 mmHg Standard Deviation 7.1	2.1 mmHg Standard Deviation 8.3	0.0 mmHg Standard Deviation 7.2	0.2 mmHg Standard Deviation 7.0
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure Week 4	-0.3 mmHg Standard Deviation 7.8	0.6 mmHg Standard Deviation 9.2	-0.3 mmHg Standard Deviation 7.9	0.6 mmHg Standard Deviation 7.3	0.0 mmHg Standard Deviation 7.7	0.3 mmHg Standard Deviation 8.1
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure Week 6	0.3 mmHg Standard Deviation 7.6	0.0 mmHg Standard Deviation 9.7	-3.1 mmHg Standard Deviation 7.9	1.3 mmHg Standard Deviation 8.6	0.1 mmHg Standard Deviation 7.3	-1.6 mmHg Standard Deviation 7.3
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure Week 8	-1.1 mmHg Standard Deviation 8.9	-0.3 mmHg Standard Deviation 9.1	-1.2 mmHg Standard Deviation 7.3	2.8 mmHg Standard Deviation 8.7	-0.7 mmHg Standard Deviation 7.7	-0.6 mmHg Standard Deviation 8.2
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure Week 12	-2.3 mmHg Standard Deviation 5.8	0.5 mmHg Standard Deviation 6.3	-1.7 mmHg Standard Deviation 6.4	3.1 mmHg Standard Deviation 8.4	-1.1 mmHg Standard Deviation 6.7	-1.1 mmHg Standard Deviation 7.3
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure SFU	1.3 mmHg Standard Deviation 8.5	-9.0 mmHg Standard Deviation 9.1	0.8 mmHg Standard Deviation 8.8	-4.5 mmHg Standard Deviation 0.7	-9.0 mmHg Standard Deviation NA Value was not evaluable because only one participant was analyzed.	-4.0 mmHg Standard Deviation 6.6

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Pulse rate was measured in beats per minute (beats/min).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) Week 1	1.7 beats/min Standard Deviation 9.5	-1.6 beats/min Standard Deviation 9.1	3.2 beats/min Standard Deviation 8.0	-1.8 beats/min Standard Deviation 8.1	0.1 beats/min Standard Deviation 6.4	-0.4 beats/min Standard Deviation 7.7
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) Week 2	1.2 beats/min Standard Deviation 8.4	-1.3 beats/min Standard Deviation 9.9	1.1 beats/min Standard Deviation 7.8	-1.0 beats/min Standard Deviation 10.4	-2.2 beats/min Standard Deviation 7.9	0.5 beats/min Standard Deviation 9.5
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) Week 4	1.0 beats/min Standard Deviation 10.2	-3.1 beats/min Standard Deviation 9.9	0.6 beats/min Standard Deviation 7.8	-3.6 beats/min Standard Deviation 9.0	-1.6 beats/min Standard Deviation 6.5	1.6 beats/min Standard Deviation 8.0
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) Week 6	0.9 beats/min Standard Deviation 9.8	1.2 beats/min Standard Deviation 10.7	1.4 beats/min Standard Deviation 8.3	-2.6 beats/min Standard Deviation 9.7	-1.7 beats/min Standard Deviation 9.3	2.6 beats/min Standard Deviation 8.0
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) Week 8	1.7 beats/min Standard Deviation 8.9	-3.2 beats/min Standard Deviation 9.3	0.4 beats/min Standard Deviation 9.2	-1.8 beats/min Standard Deviation 8.5	0.5 beats/min Standard Deviation 8.2	0.6 beats/min Standard Deviation 6.7
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) Week 12	0.9 beats/min Standard Deviation 8.4	-1.9 beats/min Standard Deviation 6.8	1.8 beats/min Standard Deviation 11.0	-3.1 beats/min Standard Deviation 8.5	-1.7 beats/min Standard Deviation 9.1	0.0 beats/min Standard Deviation 7.5
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) SFU	-2.8 beats/min Standard Deviation 2.6	-2.5 beats/min Standard Deviation 12.0	2.3 beats/min Standard Deviation 6.0	1.5 beats/min Standard Deviation 4.9	-7.0 beats/min Standard Deviation NA Value was not evaluable because only one participant was analyzed.	7.3 beats/min Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Temperature was measured in degrees Celsius (°C).

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) Week 1	-0.07 °C Standard Deviation 0.23	-0.04 °C Standard Deviation 0.22	0.02 °C Standard Deviation 0.30	-0.11 °C Standard Deviation 0.32	-0.07 °C Standard Deviation 0.30	0.02 °C Standard Deviation 0.35
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) Week 2	0.00 °C Standard Deviation 0.26	0.02 °C Standard Deviation 0.26	0.01 °C Standard Deviation 0.33	0.01 °C Standard Deviation 0.35	-0.04 °C Standard Deviation 0.36	-0.01 °C Standard Deviation 0.35
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) Week 4	-0.05 °C Standard Deviation 0.29	0.03 °C Standard Deviation 0.24	0.00 °C Standard Deviation 0.42	-0.04 °C Standard Deviation 0.24	-0.03 °C Standard Deviation 0.26	-0.01 °C Standard Deviation 0.41
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) Week 6	-0.03 °C Standard Deviation 0.29	-0.02 °C Standard Deviation 0.25	-0.01 °C Standard Deviation 0.22	-0.06 °C Standard Deviation 0.43	-0.03 °C Standard Deviation 0.38	0.07 °C Standard Deviation 0.24
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) Week 8	0.01 °C Standard Deviation 0.24	-0.02 °C Standard Deviation 0.28	0.00 °C Standard Deviation 0.33	-0.03 °C Standard Deviation 0.41	0.00 °C Standard Deviation 0.35	0.02 °C Standard Deviation 0.31
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) Week 12	0.10 °C Standard Deviation 0.27	0.00 °C Standard Deviation 0.27	0.06 °C Standard Deviation 0.36	-0.04 °C Standard Deviation 0.28	0.00 °C Standard Deviation 0.33	0.00 °C Standard Deviation 0.30
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) SFU	0.08 °C Standard Deviation 0.22	0.15 °C Standard Deviation 0.33	-0.03 °C Standard Deviation 0.05	0.10 °C Standard Deviation 0.00	0.10 °C Standard Deviation NA Value was not evaluable because only one participant was analyzed.	0.43 °C Standard Deviation 0.31

SECONDARY outcome

Timeframe: At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)

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

The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With Clinically Significant Physical Examination Abnormalities	23.8 percentage of participants	7.7 percentage of participants	11.6 percentage of participants	10.0 percentage of participants	9.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

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

Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=42 Participants Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Full Analysis Set (FAS).	Bimekizumab 64 mg Q4W (FAS) n=39 Participants Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 160 mg w/ LD Q4W (FAS) n=40 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 320 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the FAS.	Bimekizumab 480 mg Q4W (FAS) n=43 Participants Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the FAS.
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings Baseline	0 percentage of participants	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings Week 2	0 percentage of participants	0 percentage of participants	0 percentage of participants	2.6 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings Week 4	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings Week 6	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings Week 12	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings SFU	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (SS) Treatment Period n=42 participants at risk During the Treatment Period participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).	Bimekizumab 64 mg Q4W (SS) Treatment Period n=39 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 160 mg Q4W (SS) Treatment Period n=43 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period n=40 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 320 mg Q4W (SS) Treatment Period n=43 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 480 mg Q4W (SS) Treatment Period n=43 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.	Placebo (SS) Post-Treatment Period n=42 participants at risk At Week 12, participants who were randomized to receive Placebo during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 64 mg Q4W (SS) Post-Treatment Period n=39 participants at risk At Week 12, participants who were randomized to receive 64 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 160 mg Q4W (SS) Post-Treatment Period n=43 participants at risk At Week 12, participants who were randomized to receive 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period n=40 participants at risk At Week 12, participants who were randomized to receive 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 320 mg Q4W (SS) Post-Treatment Period n=43 participants at risk At Week 12, participants who were randomized to receive 320 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 480 mg Q4W (SS) Post-Treatment Period n=43 participants at risk At Week 12, participants who were randomized to receive 480 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.
Gastrointestinal disorders Large intestine polyp	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Infections and infestations Meningitis viral	2.4% 1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Cardiac disorders Myocardial infarction	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.6% 1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.

Other adverse events

Other adverse events
Measure	Placebo (SS) Treatment Period n=42 participants at risk During the Treatment Period participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS).	Bimekizumab 64 mg Q4W (SS) Treatment Period n=39 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 160 mg Q4W (SS) Treatment Period n=43 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period n=40 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 320 mg Q4W (SS) Treatment Period n=43 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS.	Bimekizumab 480 mg Q4W (SS) Treatment Period n=43 participants at risk During the Treatment Period participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS.	Placebo (SS) Post-Treatment Period n=42 participants at risk At Week 12, participants who were randomized to receive Placebo during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 64 mg Q4W (SS) Post-Treatment Period n=39 participants at risk At Week 12, participants who were randomized to receive 64 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 160 mg Q4W (SS) Post-Treatment Period n=43 participants at risk At Week 12, participants who were randomized to receive 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period n=40 participants at risk At Week 12, participants who were randomized to receive 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 320 mg Q4W (SS) Post-Treatment Period n=43 participants at risk At Week 12, participants who were randomized to receive 320 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.	Bimekizumab 480 mg Q4W (SS) Post-Treatment Period n=43 participants at risk At Week 12, participants who were randomized to receive 480 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS.
Blood and lymphatic system disorders Neutropenia	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.5% 1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	4.7% 2/43 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Blood and lymphatic system disorders Leukopenia	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Gastrointestinal disorders Vomiting	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Infections and infestations Nasopharyngitis	4.8% 2/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	12.8% 5/39 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	7.0% 3/43 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	7.5% 3/40 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	14.0% 6/43 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	9.3% 4/43 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Infections and infestations Upper respiratory tract infection	2.4% 1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	12.8% 5/39 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	4.7% 2/43 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	7.5% 3/40 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	4.7% 2/43 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Infections and infestations Respiratory tract infection	2.4% 1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.5% 1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Infections and infestations Tonsillitis	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	4.7% 2/43 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Infections and infestations Oral candidiasis	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.5% 1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	7.0% 3/43 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Infections and infestations Rhinitis	2.4% 1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Investigations Gamma-glutamyltransferase increased	2.4% 1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	7.0% 3/43 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.0% 2/40 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.5% 1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	7.0% 3/43 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Nervous system disorders Headache	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	5.1% 2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Vascular disorders Hypertension	7.1% 3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.6% 1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.5% 1/40 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	2.3% 1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/42 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/39 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/40 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28) It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.

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