Trial Outcomes & Findings for A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. (NCT NCT03248531)

NCT ID: NCT03248531

Last Updated: 2022-04-11

Results Overview

HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2022-04-11

Participant Flow

The study started to enroll patients in September 2017 and concluded in February 2019.

The study included a Screening Period (≥ 2 weeks up to a maximum of 4 weeks prior to randomization), a Treatment Period (12 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the last dose of investigational medicinal product (IMP)). Participant Flow refers to the Randomized Set.

Participant milestones

Measure	Placebo Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.	Adalimumab Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.	Bimekizumab Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.
Overall Study STARTED	22	22	46
Overall Study Completed Week 12	19	18	42
Overall Study COMPLETED	18	17	38
Overall Study NOT COMPLETED	4	5	8

Reasons for withdrawal

Measure	Placebo Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.	Adalimumab Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.	Bimekizumab Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.
Overall Study Adverse Event	0	0	1
Overall Study Lost to Follow-up	1	0	5
Overall Study Withdrawal by Subject	3	3	2
Overall Study Sponsor Request	0	2	0

Baseline Characteristics

A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

Baseline characteristics by cohort

Measure	Placebo n=22 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding.	Adalimumab n=22 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding.	Bimekizumab n=46 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.	Total Title n=90 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants	87 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	40.7 years STANDARD_DEVIATION 12.5 • n=5 Participants	31.0 years STANDARD_DEVIATION 9.2 • n=7 Participants	37.4 years STANDARD_DEVIATION 11.9 • n=5 Participants	36.6 years STANDARD_DEVIATION 11.9 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants	63 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants	61 Participants n=4 Participants
Race/Ethnicity, Customized Other or Mixed	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The Per-Protocol Set (PPS) was a subset of the Full Analysis Set (FAS), consisting of those study participants who had no important protocol deviations affecting the primary efficacy variable, as confirmed during a pre-analysis review prior to unblinding of the data (at each of the interim and final analyses).

HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.

Outcome measures

Measure	Placebo (PPS) n=20 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=20 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=44 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12	26.1 Percentage of responders Interval 13.8 to 40.5	59.5 Percentage of responders Interval 44.2 to 73.9	57.3 Percentage of responders Interval 42.4 to 71.4

SECONDARY outcome

Timeframe: Day 1 (Prior to first dose)

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.

Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).

Outcome measures

Measure	Placebo (PPS) n=46 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)	NA ng/mL Geometric Coefficient of Variation NA Here, NA signifies that geometric means and geometric CVs were only calculated if at least 2/3 of the concentrations were above lower limit of quantification (LLOQ).	—	—

SECONDARY outcome

Timeframe: Week 2

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.

Outcome measures

Measure	Placebo (PPS) n=45 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Bimekizumab Plasma Concentration at Week 2	24086.4 ng/mL Geometric Coefficient of Variation 56.4	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.

Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.

Outcome measures

Measure	Placebo (PPS) n=46 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Bimekizumab Plasma Concentration at Week 4	26572.6 ng/mL Geometric Coefficient of Variation 57.6	—	—

SECONDARY outcome

Timeframe: Week 8

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.

Outcome measures

Measure	Placebo (PPS) n=43 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Bimekizumab Plasma Concentration at Week 8	30222.6 ng/mL Geometric Coefficient of Variation 54.5	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.

Outcome measures

Measure	Placebo (PPS) n=42 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Bimekizumab Plasma Concentration at Week 12	25319.0 ng/mL Geometric Coefficient of Variation 116.8	—	—

SECONDARY outcome

Timeframe: Week 30

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.

Outcome measures

Measure	Placebo (PPS) n=35 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Bimekizumab Plasma Concentration at Week 30	NA ng/mL Geometric Coefficient of Variation NA Here, NA signifies that geometric means and geometric CVs were only calculated if at least 2/3 of the concentrations were above lower limit of quantification (LLOQ).	—	—

SECONDARY outcome

Timeframe: From Screening to Safety Follow-Up (Week 30)

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

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Measure	Placebo (PPS) n=21 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=21 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=46 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With at Least One Adverse Event During the Study	61.9 percentage of participants	71.4 percentage of participants	71.7 percentage of participants

SECONDARY outcome

Timeframe: From Screening to Safety Follow-Up (Week 30)

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

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.

Outcome measures

Measure	Placebo (PPS) n=21 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=21 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=46 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study Mild	47.6 percentage of participants	66.7 percentage of participants	63.0 percentage of participants
Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study Moderate	33.3 percentage of participants	42.9 percentage of participants	39.1 percentage of participants
Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study Severe	4.8 percentage of participants	9.5 percentage of participants	6.5 percentage of participants

SECONDARY outcome

Timeframe: From Screening to Safety Follow-Up (Week 30)

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

A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.

Outcome measures

Measure	Placebo (PPS) n=21 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=21 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=46 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With at Least One Serious Adverse Event During the Study	9.5 percentage of participants	4.8 percentage of participants	4.3 percentage of participants

SECONDARY outcome

Timeframe: From Screening to Safety Follow-Up (Week 30)

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

A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.

Outcome measures

Measure	Placebo (PPS) n=21 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=21 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=46 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study Mild	0 percentage of participants	4.8 percentage of participants	0 percentage of participants
Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study Moderate	4.8 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study Severe	4.8 percentage of participants	4.8 percentage of participants	4.3 percentage of participants

SECONDARY outcome

Timeframe: From Screening to Safety Follow-Up (Week 30)

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

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Measure	Placebo (PPS) n=21 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=21 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=46 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants That Withdrew Due to Adverse Events During the Study	0 percentage of participants	0 percentage of participants	2.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=18 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=38 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Systolic Blood Pressure	-2.9 mmHg Standard Deviation 14.8	4.5 mmHg Standard Deviation 14.5	-0.4 mmHg Standard Deviation 13.8
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) Diastolic Blood Pressure	-1.8 mmHg Standard Deviation 8.4	-0.6 mmHg Standard Deviation 9.1	-2.2 mmHg Standard Deviation 11.2

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=18 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=38 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)	-1.4 beats/min Standard Deviation 10.2	-1.8 beats/min Standard Deviation 10.8	-1.6 beats/min Standard Deviation 10.8

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Body weight was measured in kilograms (kg).

Outcome measures

Measure	Placebo (PPS) n=18 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=38 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Body Weight	0.90 kg Standard Deviation 7.39	1.82 kg Standard Deviation 3.94	0.42 kg Standard Deviation 6.89

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.

Outcome measures

Measure	Placebo (PPS) n=18 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=15 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=37 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)	-2.1 beats/min Standard Deviation 12.4	-2.1 beats/min Standard Deviation 11.1	1.5 beats/min Standard Deviation 10.1

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).

Outcome measures

Measure	Placebo (PPS) n=18 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=15 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=37 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) PR Interval	0.8 msec Standard Deviation 18.8	2.4 msec Standard Deviation 10.5	3.6 msec Standard Deviation 18.7
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) QRS duration	-0.3 msec Standard Deviation 7.1	0.2 msec Standard Deviation 5.2	0.6 msec Standard Deviation 7.4
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) QT interval	4.8 msec Standard Deviation 20.2	4.2 msec Standard Deviation 26.7	1.8 msec Standard Deviation 27.7
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) QTcF Interval	-11.7 msec Standard Deviation 49.9	-0.3 msec Standard Deviation 14.4	2.4 msec Standard Deviation 12.7

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)	0.144 10^12 red blood cells per liter Standard Deviation 0.349	-0.151 10^12 red blood cells per liter Standard Deviation 0.416	-0.013 10^12 red blood cells per liter Standard Deviation 0.274

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)	2.01 volume % of red blood cells Standard Deviation 2.83	-0.81 volume % of red blood cells Standard Deviation 4.30	0.39 volume % of red blood cells Standard Deviation 2.69

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration) Hemoglobin	5.3 g/L Standard Deviation 11.6	-3.7 g/L Standard Deviation 11.6	1.1 g/L Standard Deviation 7.6
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration) Erythrocytes mean corpuscular HGB	-1.4 g/L Standard Deviation 16.2	-2.6 g/L Standard Deviation 13.4	-0.2 g/L Standard Deviation 13.2

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))	0.29 picograms (pg) Standard Deviation 0.76	0.21 picograms (pg) Standard Deviation 0.78	0.30 picograms (pg) Standard Deviation 0.99

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)	1.49 femtoliters (fL) Standard Deviation 2.95	1.36 femtoliters (fL) Standard Deviation 3.21	1.04 femtoliters (fL) Standard Deviation 4.03

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)	-17.4 10^9 platelets per liter Standard Deviation 38.7	2.3 10^9 platelets per liter Standard Deviation 61.6	-19.2 10^9 platelets per liter Standard Deviation 51.4

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) Basophils	0.009 10^9 white blood cells per liter Standard Deviation 0.026	0.033 10^9 white blood cells per liter Standard Deviation 0.077	0.015 10^9 white blood cells per liter Standard Deviation 0.048
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) Leukocytes	-0.281 10^9 white blood cells per liter Standard Deviation 2.621	-0.114 10^9 white blood cells per liter Standard Deviation 2.997	-0.122 10^9 white blood cells per liter Standard Deviation 2.308
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) Eosinophils	0.007 10^9 white blood cells per liter Standard Deviation 0.077	-0.012 10^9 white blood cells per liter Standard Deviation 0.100	0.002 10^9 white blood cells per liter Standard Deviation 0.056
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) Lymphocytes	0.029 10^9 white blood cells per liter Standard Deviation 0.812	0.241 10^9 white blood cells per liter Standard Deviation 0.682	0.038 10^9 white blood cells per liter Standard Deviation 0.570
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) Monocytes	0.072 10^9 white blood cells per liter Standard Deviation 0.420	-0.032 10^9 white blood cells per liter Standard Deviation 0.322	0.060 10^9 white blood cells per liter Standard Deviation 0.192
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) Neutrophils	-0.396 10^9 white blood cells per liter Standard Deviation 2.076	-0.341 10^9 white blood cells per liter Standard Deviation 2.460	-0.240 10^9 white blood cells per liter Standard Deviation 2.234

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=33 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) Basophils/leukocytes	0.13 % of white blood cells per leukocytes Standard Deviation 0.23	0.42 % of white blood cells per leukocytes Standard Deviation 0.93	0.13 % of white blood cells per leukocytes Standard Deviation 0.65
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) Eosinophils/leukocytes	-0.12 % of white blood cells per leukocytes Standard Deviation 1.92	-0.03 % of white blood cells per leukocytes Standard Deviation 1.09	0.12 % of white blood cells per leukocytes Standard Deviation 1.12
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) Lymphocytes/leukocytes	1.43 % of white blood cells per leukocytes Standard Deviation 5.47	2.04 % of white blood cells per leukocytes Standard Deviation 6.73	2.04 % of white blood cells per leukocytes Standard Deviation 8.07
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) Monocytes/leukocytes	0.49 % of white blood cells per leukocytes Standard Deviation 4.35	-0.20 % of white blood cells per leukocytes Standard Deviation 2.79	1.00 % of white blood cells per leukocytes Standard Deviation 2.17
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) Neutrophils/leukocytes	-1.93 % of white blood cells per leukocytes Standard Deviation 6.84	-2.24 % of white blood cells per leukocytes Standard Deviation 7.50	-3.29 % of white blood cells per leukocytes Standard Deviation 9.55

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

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

Outcome measures

Measure	Placebo (PPS) n=15 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=36 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Bicarbonate	-0.1 mmol/L Standard Deviation 2.1	0.7 mmol/L Standard Deviation 2.8	0.6 mmol/L Standard Deviation 2.3
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Chloride	0.9 mmol/L Standard Deviation 1.5	1.3 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 (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Potassium	-0.13 mmol/L Standard Deviation 0.79	-0.09 mmol/L Standard Deviation 0.37	0.03 mmol/L Standard Deviation 0.41
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Sodium	0.4 mmol/L Standard Deviation 1.5	0.4 mmol/L Standard Deviation 1.6	0.1 mmol/L Standard Deviation 2.2
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Calcium	0.027 mmol/L Standard Deviation 0.065	0.008 mmol/L Standard Deviation 0.144	0.067 mmol/L Standard Deviation 0.095
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Magnesium	-0.029 mmol/L Standard Deviation 0.087	-0.027 mmol/L Standard Deviation 0.052	-0.009 mmol/L Standard Deviation 0.081
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Urea nitrogen	0.00 mmol/L Standard Deviation 1.46	-0.43 mmol/L Standard Deviation 1.37	0.29 mmol/L Standard Deviation 1.79
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Cholesterol	-0.311 mmol/L Standard Deviation 0.667	-0.177 mmol/L Standard Deviation 0.634	0.157 mmol/L Standard Deviation 0.585
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) Glucose	1.049 mmol/L Standard Deviation 1.835	0.436 mmol/L Standard Deviation 2.990	0.439 mmol/L Standard Deviation 2.212

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.

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

Outcome measures

Measure	Placebo (PPS) n=15 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=36 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) Urate	8.7 μmol/L Standard Deviation 52.2	-8.9 μmol/L Standard Deviation 50.5	1.5 μmol/L Standard Deviation 43.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) Creatinine	-1.73 μmol/L Standard Deviation 9.92	-1.72 μmol/L Standard Deviation 9.04	3.84 μmol/L Standard Deviation 9.22
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) Bilirubin	0.17 μmol/L Standard Deviation 3.48	-1.38 μmol/L Standard Deviation 3.04	0.18 μmol/L Standard Deviation 4.35

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

C reactive protein high sensitivity was measured in milligrams per liter (mg/L).

Outcome measures

Measure	Placebo (PPS) n=15 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=36 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)	-2.801 mg/L Standard Deviation 16.851	-4.865 mg/L Standard Deviation 21.863	-2.810 mg/L Standard Deviation 10.853

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.

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

Outcome measures

Measure	Placebo (PPS) n=15 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=36 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) Alanine aminotransferase	-3.3 U/L Standard Deviation 8.3	-3.6 U/L Standard Deviation 9.8	3.6 U/L Standard Deviation 23.8
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) Alkaline phosphatase	-2.0 U/L Standard Deviation 12.2	-2.4 U/L Standard Deviation 13.5	-3.4 U/L Standard Deviation 11.6
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) Aspartate aminotransferase	-0.6 U/L Standard Deviation 3.6	-1.0 U/L Standard Deviation 5.8	2.0 U/L Standard Deviation 13.3
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) Gamma glutamyl transferase	-2.0 U/L Standard Deviation 9.5	1.8 U/L Standard Deviation 14.2	2.3 U/L Standard Deviation 10.1
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) Lactate dehydrogenase	-17.0 U/L Standard Deviation 29.9	-16.3 U/L Standard Deviation 35.6	-12.8 U/L Standard Deviation 61.8

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Urine pH was measured on a pH scale.

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=16 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=31 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)	-0.43 pH Standard Deviation 0.98	-0.25 pH Standard Deviation 0.55	-0.03 pH Standard Deviation 0.69

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.

Urine albumin was measured in milligrams per liter (mg/L).

Outcome measures

Measure	Placebo (PPS) n=15 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=18 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=34 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)	50.80 mg/L Standard Deviation 211.30	-28.25 mg/L Standard Deviation 121.29	0.49 mg/L Standard Deviation 19.92

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=16 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=31 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline Low - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline Low - Week 30 Normal	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline Low - Week 30 High	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline Normal - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline Normal - Week 30 Normal	12 Participants	14 Participants	28 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline Normal - Week 30 High	1 Participants	1 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline High - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline High - Week 30 Normal	0 Participants	1 Participants	1 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) Baseline High - Week 30 High	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.

Outcome measures

Measure	Placebo (PPS) n=14 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=16 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=31 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline Low - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline Low - Week 30 Normal	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline Low - Week 30 High	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline Normal - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline Normal - Week 30 Normal	8 Participants	9 Participants	19 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline Normal - Week 30 High	2 Participants	0 Participants	6 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline High - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline High - Week 30 Normal	2 Participants	3 Participants	6 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) Baseline High - Week 30 High	2 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.

Outcome measures

Measure	Placebo (PPS) n=3 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=6 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=2 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline Low - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline Low - Week 30 Normal	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline Low - Week 30 High	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline Normal - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline Normal - Week 30 Normal	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline Normal - Week 30 High	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline High - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline High - Week 30 Normal	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) Baseline High - Week 30 High	3 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.

Outcome measures

Measure	Placebo (PPS) n=3 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=1 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=1 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline Low - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline Low - Week 30 Normal	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline Low - Week 30 High	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline Normal - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline Normal - Week 30 Normal	1 Participants	0 Participants	1 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline Normal - Week 30 High	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline High - Week 30 Low	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline High - Week 30 Normal	0 Participants	0 Participants	0 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) Baseline High - Week 30 High	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline to Safety Follow-Up (Week 30)

Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with a normal/at least one abnormal physical examination assessment and with non-missing physical examination assessment results at Baseline and at Week 30 for this outcome measure.

Outcome measures

Measure	Placebo (PPS) n=18 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) n=19 Participants Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) n=38 Participants Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination Baseline Normal - Week 30 Normal	14 Participants	15 Participants	28 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination Baseline Normal - Week 30 Abnormal	1 Participants	2 Participants	5 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination Baseline Abnormal - Week 30 Normal	1 Participants	1 Participants	1 Participants
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination Baseline Abnormal - Week 30 Abnormal	2 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 1

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.

The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.

Outcome measures

Measure	Placebo (PPS) n=46 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1	4.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 2

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.

The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.

Outcome measures

Measure	Placebo (PPS) n=45 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2	4.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 4

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.

The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.

Outcome measures

Measure	Placebo (PPS) n=46 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4	4.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 8

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.

The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.

Outcome measures

Measure	Placebo (PPS) n=42 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8	0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.

The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.

Outcome measures

Measure	Placebo (PPS) n=42 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12	9.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 30

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.

The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.

Outcome measures

Measure	Placebo (PPS) n=36 Participants Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).	Adalimumab (PPS) Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.	Bimekizumab (PPS) Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30	13.9 percentage of participants	—	—

Adverse Events

Placebo (SS)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Adalimumab (SS)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Bimekizumab (SS)

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (SS) n=21 participants at risk Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).	Adalimumab (SS) n=21 participants at risk Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.	Bimekizumab (SS) n=46 participants at risk Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Blood and lymphatic system disorders Anaemia	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	2.2% 1/46 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Cardiac disorders Myocardial infarction	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/46 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Infections and infestations Empyema	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	2.2% 1/46 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Nervous system disorders Headache	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/46 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Nervous system disorders Dizziness	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/46 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Nervous system disorders Hypoaesthesia	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/46 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.8% 1/21 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/46 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

Other adverse events

Measure	Placebo (SS) n=21 participants at risk Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).	Adalimumab (SS) n=21 participants at risk Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.	Bimekizumab (SS) n=46 participants at risk Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Gastrointestinal disorders Diarrhoea	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.8% 1/21 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Gastrointestinal disorders Nausea	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
General disorders Fatigue	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	8.7% 4/46 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
General disorders Pyrexia	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	2.2% 1/46 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
General disorders Injection site reaction	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
General disorders Injection site pain	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
General disorders Injection site pruritus	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.3% 2/46 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Infections and infestations Oral candidiasis	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Infections and infestations Influenza	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	14.3% 3/21 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/46 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Infections and infestations Nasopharyngitis	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Infections and infestations Upper respiratory tract infection	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.3% 2/46 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	2.2% 1/46 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Nervous system disorders Headache	14.3% 3/21 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Skin and subcutaneous tissue disorders Hidradenitis	14.3% 3/21 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	28.6% 6/21 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	17.4% 8/46 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Vascular disorders Hypertension	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	0.00% 0/21 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.	6.5% 3/46 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30) A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

Additional Information

UCB

Cares

Phone: +1-844-599-2273

Email: UCBCares@ucb.com

Results disclosure agreements

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

Restriction type: GT60