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

• ClinicalTrials.gov Identifier: NCT03248531
• Recruitment Status: Completed
• First Posted: August 14, 2017
• Results First Posted: February 9, 2022
• Last Update Posted: April 11, 2022
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hidradenitis Suppurativa
• Interventions: Drug: Bimekizumab; Drug: Adalimumab; Other: Placebo
• Enrollment: 90

Participant Flow

Recruitment Details	The study started to enroll patients in September 2017 and concluded in February 2019.
Pre-assignment Details	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.

Arm/Group Title	Placebo	Adalimumab	Bimekizumab
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
Started [1]	22	22	46
Completed Week 12 [2]	19	18	42
Completed [3]	18	17	38
Not Completed	4	5	8
Reason Not Completed
Adverse Event	0	0	1
Lost to Follow-up	1	0	5
Withdrawal by Subject	3	3	2
Sponsor Request	0	2	0
[1] Completed screening period (2-4 Weeks) and Randomized; [2] Completed treatment period (12 Weeks); [3] Study completed (including safety follow-up period [20 weeks after last dose])

Baseline Characteristics

Arm/Group Title		Placebo	Adalimumab	Bimekizumab	Total Title
Arm/Group Description		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.	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.	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.	[Not Specified]
Overall Number of Baseline Participants		22	22	46	90
Baseline Analysis Population Description		Baseline Characteristics refer to the Randomized Set (RS) which consisted of all study participants randomized into the study.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	22 participants	46 participants	90 participants
	<=18 years	0 0.0%	0 0.0%	2 4.3%	2 2.2%
	Between 18 and 65 years	21 95.5%	22 100.0%	44 95.7%	87 96.7%
	>=65 years	1 4.5%	0 0.0%	0 0.0%	1 1.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	22 participants	22 participants	46 participants	90 participants
		40.7 (12.5)	31.0 (9.2)	37.4 (11.9)	36.6 (11.9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	22 participants	46 participants	90 participants
	Female	15 68.2%	18 81.8%	30 65.2%	63 70.0%
	Male	7 31.8%	4 18.2%	16 34.8%	27 30.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	22 participants	46 participants	90 participants
	American Indian or Alaskan Native	1 4.5%	0 0.0%	0 0.0%	1 1.1%
	Asian	1 4.5%	3 13.6%	0 0.0%	4 4.4%
	Black or African American	6 27.3%	5 22.7%	10 21.7%	21 23.3%
	White	12 54.5%	14 63.6%	35 76.1%	61 67.8%
	Other or Mixed	2 9.1%	0 0.0%	1 2.2%	3 3.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo (PPS)	Adalimumab (PPS)	Bimekizumab (PPS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	20	20	44
Mean (95% Confidence Interval); Unit of Measure: Percentage of responders
	26.1; (13.8 to 40.5)	59.5; (44.2 to 73.9)	57.3; (42.4 to 71.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (PPS), Bimekizumab (PPS)
	Comments	Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean posterior difference
	Estimated Value	31.2
	Confidence Interval	(2-Sided) 95%; 11.0 to 50.4
	Parameter Dispersion	Type: Standard Deviation; Value: 10.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (PPS), Bimekizumab (PPS)
	Comments	Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean posterior difference
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 60%; -11.2 to 6.6
	Parameter Dispersion	Type: Standard Deviation; Value: 10.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo (PPS), Bimekizumab (PPS)
	Comments	Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Pr [Diff>0%] (%)
	Estimated Value	99.8
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Adalimumab (PPS), Bimekizumab (PPS)
	Comments	Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Pr[Diff > 0%](%)
	Estimated Value	42.1
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
Description	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).
Time Frame	Day 1 (Prior to first dose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 Pharmacokinetic Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	46
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng/mL
	NA [1]; (NA%)

[1]

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).

3. Secondary Outcome

Title	Bimekizumab Plasma Concentration at Week 2
Description	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.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	45
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng/mL
	24086.4; (56.4%)

4. Secondary Outcome

Title	Bimekizumab Plasma Concentration at Week 4
Description	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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	46
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng/mL
	26572.6; (57.6%)

5. Secondary Outcome

Title	Bimekizumab Plasma Concentration at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	43
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng/mL
	30222.6; (54.5%)

6. Secondary Outcome

Title	Bimekizumab Plasma Concentration at Week 12
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	42
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng/mL
	25319.0; (116.8%)

7. Secondary Outcome

Title	Bimekizumab Plasma Concentration at Week 30
Description	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.
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	35
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng/mL
	NA [1]; (NA%)

[1]

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).

8. Secondary Outcome

Title	Percentage of Participants With at Least One Adverse Event During the Study
Description	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.
Time Frame	From Screening to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	21	21	46
Measure Type: Number; Unit of Measure: percentage of participants
	61.9	71.4	71.7

9. Secondary Outcome

Title	Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study
Description	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.
Time Frame	From Screening to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	21	21	46
Measure Type: Number; Unit of Measure: percentage of participants
Mild	47.6	66.7	63.0
Moderate	33.3	42.9	39.1
Severe	4.8	9.5	6.5

10. Secondary Outcome

Title	Percentage of Participants With at Least One Serious Adverse Event During the Study
Description	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.
Time Frame	From Screening to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	21	21	46
Measure Type: Number; Unit of Measure: percentage of participants
	9.5	4.8	4.3

11. Secondary Outcome

Title	Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study
Description	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.
Time Frame	From Screening to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	21	21	46
Measure Type: Number; Unit of Measure: percentage of participants
Mild	0	4.8	0
Moderate	4.8	0	0
Severe	4.8	4.8	4.3

12. Secondary Outcome

Title	Percentage of Participants That Withdrew Due to Adverse Events During the Study
Description	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.
Time Frame	From Screening to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	21	21	46
Measure Type: Number; Unit of Measure: percentage of participants
	0	0	2.2

13. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Description	Blood pressure was measured in millimeters of mercury (mmHg).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	18	19	38
Mean (Standard Deviation); Unit of Measure: mmHg
Systolic Blood Pressure	-2.9 (14.8)	4.5 (14.5)	-0.4 (13.8)
Diastolic Blood Pressure	-1.8 (8.4)	-0.6 (9.1)	-2.2 (11.2)

14. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Description	Pulse rate was measured in beats per minute (beats/min).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	18	19	38
Mean (Standard Deviation); Unit of Measure: beats/min
	-1.4 (10.2)	-1.8 (10.8)	-1.6 (10.8)

15. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Body Weight
Description	Body weight was measured in kilograms (kg).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	18	19	38
Mean (Standard Deviation); Unit of Measure: kg
	0.90 (7.39)	1.82 (3.94)	0.42 (6.89)

16. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
Description	Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	18	15	37
Mean (Standard Deviation); Unit of Measure: beats/min
	-2.1 (12.4)	-2.1 (11.1)	1.5 (10.1)

17. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
Description	PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	18	15	37
Mean (Standard Deviation); Unit of Measure: msec
PR Interval	0.8 (18.8)	2.4 (10.5)	3.6 (18.7)
QRS duration	-0.3 (7.1)	0.2 (5.2)	0.6 (7.4)
QT interval	4.8 (20.2)	4.2 (26.7)	1.8 (27.7)
QTcF Interval	-11.7 (49.9)	-0.3 (14.4)	2.4 (12.7)

18. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Description	Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: 10^12 red blood cells per liter
	0.144 (0.349)	-0.151 (0.416)	-0.013 (0.274)

19. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Description	Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: volume % of red blood cells
	2.01 (2.83)	-0.81 (4.30)	0.39 (2.69)

20. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
Description	Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: g/L
Hemoglobin	5.3 (11.6)	-3.7 (11.6)	1.1 (7.6)
Erythrocytes mean corpuscular HGB	-1.4 (16.2)	-2.6 (13.4)	-0.2 (13.2)

21. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Description	Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: picograms (pg)
	0.29 (0.76)	0.21 (0.78)	0.30 (0.99)

22. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Description	Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: femtoliters (fL)
	1.49 (2.95)	1.36 (3.21)	1.04 (4.03)

23. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Description	Platelets was measured in number of platelets per liter (10^9/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: 10^9 platelets per liter
	-17.4 (38.7)	2.3 (61.6)	-19.2 (51.4)

24. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
Description	Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: 10^9 white blood cells per liter
Leukocytes	-0.281 (2.621)	-0.114 (2.997)	-0.122 (2.308)
Basophils	0.009 (0.026)	0.033 (0.077)	0.015 (0.048)
Eosinophils	0.007 (0.077)	-0.012 (0.100)	0.002 (0.056)
Lymphocytes	0.029 (0.812)	0.241 (0.682)	0.038 (0.570)
Monocytes	0.072 (0.420)	-0.032 (0.322)	0.060 (0.192)
Neutrophils	-0.396 (2.076)	-0.341 (2.460)	-0.240 (2.234)

25. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
Description	Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	18	33
Mean (Standard Deviation); Unit of Measure: % of white blood cells per leukocytes
Basophils/leukocytes	0.13 (0.23)	0.42 (0.93)	0.13 (0.65)
Eosinophils/leukocytes	-0.12 (1.92)	-0.03 (1.09)	0.12 (1.12)
Lymphocytes/leukocytes	1.43 (5.47)	2.04 (6.73)	2.04 (8.07)
Monocytes/leukocytes	0.49 (4.35)	-0.20 (2.79)	1.00 (2.17)
Neutrophils/leukocytes	-1.93 (6.84)	-2.24 (7.50)	-3.29 (9.55)

26. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
Description	Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	15	19	36
Mean (Standard Deviation); Unit of Measure: mmol/L
Bicarbonate	-0.1 (2.1)	0.7 (2.8)	0.6 (2.3)
Chloride	0.9 (1.5)	1.3 (2.4)	0.1 (2.2)
Potassium	-0.13 (0.79)	-0.09 (0.37)	0.03 (0.41)
Sodium	0.4 (1.5)	0.4 (1.6)	0.1 (2.2)
Calcium	0.027 (0.065)	0.008 (0.144)	0.067 (0.095)
Magnesium	-0.029 (0.087)	-0.027 (0.052)	-0.009 (0.081)
Urea nitrogen	0.00 (1.46)	-0.43 (1.37)	0.29 (1.79)
Cholesterol	-0.311 (0.667)	-0.177 (0.634)	0.157 (0.585)
Glucose	1.049 (1.835)	0.436 (2.990)	0.439 (2.212)

27. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
Description	Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:		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).	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.	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.
Overall Number of Participants Analyzed		15	19	36
Mean (Standard Deviation); Unit of Measure: μmol/L
Creatinine	Number Analyzed	15 participants	19 participants	36 participants
		-1.73 (9.92)	-1.72 (9.04)	3.84 (9.22)
Bilirubin	Number Analyzed	15 participants	19 participants	34 participants
		0.17 (3.48)	-1.38 (3.04)	0.18 (4.35)
Urate	Number Analyzed	15 participants	19 participants	34 participants
		8.7 (52.2)	-8.9 (50.5)	1.5 (43.1)

28. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
Description	C reactive protein high sensitivity was measured in milligrams per liter (mg/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	15	19	36
Mean (Standard Deviation); Unit of Measure: mg/L
	-2.801 (16.851)	-4.865 (21.863)	-2.810 (10.853)

29. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Description	Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:		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).	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.	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.
Overall Number of Participants Analyzed		15	19	36
Mean (Standard Deviation); Unit of Measure: U/L
Alanine aminotransferase	Number Analyzed	15 participants	19 participants	34 participants
		-3.3 (8.3)	-3.6 (9.8)	3.6 (23.8)
Alkaline phosphatase	Number Analyzed	15 participants	19 participants	36 participants
		-2.0 (12.2)	-2.4 (13.5)	-3.4 (11.6)
Aspartate aminotransferase	Number Analyzed	15 participants	19 participants	36 participants
		-0.6 (3.6)	-1.0 (5.8)	2.0 (13.3)
Gamma glutamyl transferase	Number Analyzed	15 participants	19 participants	36 participants
		-2.0 (9.5)	1.8 (14.2)	2.3 (10.1)
Lactate dehydrogenase	Number Analyzed	15 participants	19 participants	36 participants
		-17.0 (29.9)	-16.3 (35.6)	-12.8 (61.8)

30. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
Description	Urine pH was measured on a pH scale.
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	16	31
Mean (Standard Deviation); Unit of Measure: pH
	-0.43 (0.98)	-0.25 (0.55)	-0.03 (0.69)

31. Secondary Outcome

Title	Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
Description	Urine albumin was measured in milligrams per liter (mg/L).
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	15	18	34
Mean (Standard Deviation); Unit of Measure: mg/L
	50.80 (211.30)	-28.25 (121.29)	0.49 (19.92)

32. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
Description	[Not Specified]
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	16	31
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline Low - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 Normal	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 High	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Normal	12 85.7%	14 87.5%	28 90.3%
Baseline Normal - Week 30 High	1 7.1%	1 6.3%	0 0.0%
Baseline High - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 Normal	0 0.0%	1 6.3%	1 3.2%
Baseline High - Week 30 High	1 7.1%	0 0.0%	2 6.5%

33. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
Description	[Not Specified]
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	14	16	31
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline Low - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 Normal	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 High	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Normal	8 57.1%	9 56.3%	19 61.3%
Baseline Normal - Week 30 High	2 14.3%	0 0.0%	6 19.4%
Baseline High - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 Normal	2 14.3%	3 18.8%	6 19.4%
Baseline High - Week 30 High	2 14.3%	4 25.0%	0 0.0%

34. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
Description	[Not Specified]
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	3	6	2
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline Low - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 Normal	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 High	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Normal	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 High	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 Normal	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 High	3 100.0%	6 100.0%	2 100.0%

35. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
Description	[Not Specified]
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	3	1	1
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline Low - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 Normal	0 0.0%	0 0.0%	0 0.0%
Baseline Low - Week 30 High	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline Normal - Week 30 Normal	1 33.3%	0 0.0%	1 100.0%
Baseline Normal - Week 30 High	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 Low	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 Normal	0 0.0%	0 0.0%	0 0.0%
Baseline High - Week 30 High	2 66.7%	1 100.0%	0 0.0%

36. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
Description	[Not Specified]
Time Frame	From Baseline to Safety Follow-Up (Week 30)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo (SS)	Adalimumab (SS)	Bimekizumab (SS)
Arm/Group Description:	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).	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.	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.
Overall Number of Participants Analyzed	18	19	38
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline Normal - Week 30 Normal	14 77.8%	15 78.9%	28 73.7%
Baseline Normal - Week 30 Abnormal	1 5.6%	2 10.5%	5 13.2%
Baseline Abnormal - Week 30 Normal	1 5.6%	1 5.3%	1 2.6%
Baseline Abnormal - Week 30 Abnormal	2 11.1%	1 5.3%	4 10.5%

37. Secondary Outcome

Title	Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	46
Measure Type: Number; Unit of Measure: percentage of participants
	4.3

38. Secondary Outcome

Title	Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
Description	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.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	45
Measure Type: Number; Unit of Measure: percentage of participants
	4.4

39. Secondary Outcome

Title	Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
Description	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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	46
Measure Type: Number; Unit of Measure: percentage of participants
	4.3

40. Secondary Outcome

Title	Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	42
Measure Type: Number; Unit of Measure: percentage of participants
	0

41. Secondary Outcome

Title	Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	42
Measure Type: Number; Unit of Measure: percentage of participants
	9.5

42. Secondary Outcome

Title	Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30
Description	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.
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab (PK-PPS)
Arm/Group Description:	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 PK-PPS.
Overall Number of Participants Analyzed	36
Measure Type: Number; Unit of Measure: percentage of participants
	13.9

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30)
Adverse Event Reporting Description	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.
Arm/Group Title	Placebo (SS)		Adalimumab (SS)		Bimekizumab (SS)
Arm/Group Description	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).		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.		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.
All-Cause Mortality
	Placebo (SS)		Adalimumab (SS)		Bimekizumab (SS)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/21 (0.00%)		0/21 (0.00%)		0/46 (0.00%)
Serious Adverse Events
	Placebo (SS)		Adalimumab (SS)		Bimekizumab (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.52%)		1/21 (4.76%)		2/46 (4.35%)
Blood and lymphatic system disorders
Anaemia * 1	0/21 (0.00%)	0	0/21 (0.00%)	0	1/46 (2.17%)	1
Cardiac disorders
Myocardial infarction * 1	1/21 (4.76%)	1	0/21 (0.00%)	0	0/46 (0.00%)	0
Infections and infestations
Empyema * 1	0/21 (0.00%)	0	0/21 (0.00%)	0	1/46 (2.17%)	1
Nervous system disorders
Headache * 1	1/21 (4.76%)	1	0/21 (0.00%)	0	0/46 (0.00%)	0
Dizziness * 1	1/21 (4.76%)	1	0/21 (0.00%)	0	0/46 (0.00%)	0
Hypoaesthesia * 1	1/21 (4.76%)	1	0/21 (0.00%)	0	0/46 (0.00%)	0
Skin and subcutaneous tissue disorders
Hidradenitis * 1	0/21 (0.00%)	0	1/21 (4.76%)	2	0/46 (0.00%)	0
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo (SS)		Adalimumab (SS)		Bimekizumab (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/21 (23.81%)		12/21 (57.14%)		21/46 (45.65%)
Gastrointestinal disorders
Diarrhoea * 1	0/21 (0.00%)	0	1/21 (4.76%)	2	3/46 (6.52%)	5
Nausea * 1	0/21 (0.00%)	0	1/21 (4.76%)	1	3/46 (6.52%)	3
General disorders
Fatigue * 1	0/21 (0.00%)	0	2/21 (9.52%)	2	4/46 (8.70%)	4
Pyrexia * 1	0/21 (0.00%)	0	2/21 (9.52%)	2	1/46 (2.17%)	2
Injection site reaction * 1	0/21 (0.00%)	0	0/21 (0.00%)	0	3/46 (6.52%)	4
Injection site pain * 1	0/21 (0.00%)	0	0/21 (0.00%)	0	3/46 (6.52%)	3
Injection site pruritus * 1	0/21 (0.00%)	0	2/21 (9.52%)	2	2/46 (4.35%)	2
Infections and infestations
Oral candidiasis * 1	0/21 (0.00%)	0	1/21 (4.76%)	1	3/46 (6.52%)	4
Influenza * 1	0/21 (0.00%)	0	3/21 (14.29%)	3	0/46 (0.00%)	0
Nasopharyngitis * 1	0/21 (0.00%)	0	1/21 (4.76%)	1	3/46 (6.52%)	4
Upper respiratory tract infection * 1	0/21 (0.00%)	0	2/21 (9.52%)	2	2/46 (4.35%)	2
Musculoskeletal and connective tissue disorders
Arthralgia * 1	1/21 (4.76%)	1	2/21 (9.52%)	2	1/46 (2.17%)	3
Nervous system disorders
Headache * 1	3/21 (14.29%)	4	0/21 (0.00%)	0	3/46 (6.52%)	4
Skin and subcutaneous tissue disorders
Hidradenitis * 1	3/21 (14.29%)	3	6/21 (28.57%)	6	8/46 (17.39%)	9
Intertrigo * 1	0/21 (0.00%)	0	1/21 (4.76%)	1	3/46 (6.52%)	3
Vascular disorders
Hypertension * 1	0/21 (0.00%)	0	0/21 (0.00%)	0	3/46 (6.52%)	3
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1-844-599-2273
• EMail: UCBCares@ucb.com

Publications of Results:

Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G, Weisman J, Rolleri R, Seegobin S, Baeten D, Ionescu L, Zouboulis CC, Shaw S. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905. Erratum In: JAMA Dermatol. 2021 Nov 1;157(11):1384.

• Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• ClinicalTrials.gov Identifier: NCT03248531
• Other Study ID Numbers: HS0001; 2017-000892-10 ( EudraCT Number )
• First Submitted: August 2, 2017
• First Posted: August 14, 2017
• Results First Submitted: November 22, 2021
• Results First Posted: February 9, 2022
• Last Update Posted: April 11, 2022