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

• Sponsor: UCB Biopharma SRL (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03248531
• Collaborator: (none)
• Enrollment: 90
• Locations: 31
• Arms: 3
• Actual Duration (Months): 17
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa	Drug: Bimekizumab; Drug: Adalimumab; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
• Actual Study Start Date: Sep 22, 2017
• Actual Primary Completion Date: Nov 23, 2018
• Actual Study Completion Date: Feb 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimekizumab Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.	Drug: Bimekizumab; Bimekizumab in different dosages (dose 1 and 2).; Other Names: UCB4940
Active Comparator: Adalimumab Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.	Drug: Adalimumab; Adalimumab in different dosages (dose 1, 2 and 3).; Other Names: Humira®
Placebo Comparator: Placebo Subjects will receive several placebo applications to keep the blinding.	Other: Placebo; Placebo will be provided matching Bimekizumab.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [Week 12]

   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.

Secondary Outcome Measures

1. Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose) [Day 1 (Prior to first dose)]

   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).

2. Bimekizumab Plasma Concentration at Week 2 [Week 2]

   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.

3. Bimekizumab Plasma Concentration at Week 4 [Week 4]

   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.

4. Bimekizumab Plasma Concentration at Week 8 [Week 8]

   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.

5. Bimekizumab Plasma Concentration at Week 12 [Week 12]

   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.

6. Bimekizumab Plasma Concentration at Week 30 [Week 30]

   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.

7. Percentage of Participants With at Least One Adverse Event During the Study [From Screening to Safety Follow-Up (Week 30)]

   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.

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

   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.

9. Percentage of Participants With at Least One Serious Adverse Event During the Study [From Screening to Safety Follow-Up (Week 30)]

   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.

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

    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.

11. Percentage of Participants That Withdrew Due to Adverse Events During the Study [From Screening to Safety Follow-Up (Week 30)]

    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.

12. Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) [From Baseline to Safety Follow-Up (Week 30)]

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

13. Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) [From Baseline to Safety Follow-Up (Week 30)]

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

14. Change From Baseline Until Safety Follow-up Visit in Body Weight [From Baseline to Safety Follow-Up (Week 30)]

    Body weight was measured in kilograms (kg).

15. Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate) [From Baseline to Safety Follow-Up (Week 30)]

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

16. Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) [From Baseline to Safety Follow-Up (Week 30)]

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

17. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) [From Baseline to Safety Follow-Up (Week 30)]

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

18. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) [From Baseline to Safety Follow-Up (Week 30)]

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

19. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration) [From Baseline to Safety Follow-Up (Week 30)]

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

20. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) [From Baseline to Safety Follow-Up (Week 30)]

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

21. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) [From Baseline to Safety Follow-Up (Week 30)]

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

22. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) [From Baseline to Safety Follow-Up (Week 30)]

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

23. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) [From Baseline to Safety Follow-Up (Week 30)]

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

24. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) [From Baseline to Safety Follow-Up (Week 30)]

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

25. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) [From Baseline to Safety Follow-Up (Week 30)]

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

26. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) [From Baseline to Safety Follow-Up (Week 30)]

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

27. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity) [From Baseline to Safety Follow-Up (Week 30)]

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

28. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) [From Baseline to Safety Follow-Up (Week 30)]

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

29. Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH) [From Baseline to Safety Follow-Up (Week 30)]

    Urine pH was measured on a pH scale.

30. Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin) [From Baseline to Safety Follow-Up (Week 30)]

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

31. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) [From Baseline to Safety Follow-Up (Week 30)]

32. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) [From Baseline to Safety Follow-Up (Week 30)]

33. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) [From Baseline to Safety Follow-Up (Week 30)]

34. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) [From Baseline to Safety Follow-Up (Week 30)]

35. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination [From Baseline to Safety Follow-Up (Week 30)]

36. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1 [Day 1]

    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.

37. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2 [Week 2]

    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.

38. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4 [Week 4]

    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.

39. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8 [Week 8]

    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.

40. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12 [Week 12]

    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.

41. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30 [Week 30]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least

1 year prior to Baseline

• Stable HS for at least 2 months prior to Screening and also at the Baseline Visit

• Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS

• Total abscess and inflammatory nodule count >=3 at the Baseline Visit

• Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their HS lesions

• Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose

• Male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication

Exclusion Criteria:

• Prior treatment with anti-IL17s or participation in an anti-IL17 study

• Previously received anti-TNFs

• Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol)

• Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit

• Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit

• Draining fistula count >20 at the Baseline Visit

• Diagnosis of inflammatory conditions other than HS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hs0001 121	Los Angeles	California	United States	90033
2	Hs0001 119	Coral Gables	Florida	United States	33134
3	Hs0001 111	Orange	Florida	United States	32073
4	Hs0001 117	Tampa	Florida	United States	33624
5	Hs0001 112	Sandy Springs	Georgia	United States	30328
6	Hs0001 113	Boston	Massachusetts	United States	02215
7	Hs0001 115	Las Vegas	Nevada	United States	89074
8	Hs0001 126	Manhasset	New York	United States	11030
9	Hs0001 125	Chapel Hill	North Carolina	United States	27599
10	Hs0001 123	Hershey	Pennsylvania	United States	17033
11	Hs0001 120	Nashville	Tennessee	United States	37215
12	Hs0001 103	East Melbourne		Australia
13	Hs0001 101	Fremantle		Australia
14	Hs0001 104	Saint Leonards		Australia
15	Hs0001 100	Westmead		Australia
16	Hs0001 102	Woolloongabba		Australia
17	Hs0001 203	Brussels		Belgium
18	Hs0001 202	Liège		Belgium
19	Hs0001 300	Copenhagen		Denmark
20	Hs0001 408	Berlin		Germany
21	Hs0001 405	Bochum		Germany
22	Hs0001 407	Darmstadt		Germany
23	Hs0001 400	Dessau		Germany
24	Hs0001 404	Erlangen		Germany
25	Hs0001 406	Würzburg		Germany
26	Hs0001 503	Athens		Greece
27	Hs0001 701	Harstad		Norway
28	Hs0001 700	Tromsø		Norway
29	Hs0001 901	Moscow		Russian Federation
30	Hs0001 903	Saint Petersburg		Russian Federation
31	Hs0001 900	Yaroslavl		Russian Federation

Sponsors and Collaborators

• UCB Biopharma SRL

Investigators

• Study Director: UCB Cares, [phone] (UCB)

Study Documents (Full-Text)

• Study Protocol - Mar 8, 2018
• Statistical Analysis Plan - Feb 19, 2019

More Information

Publications

None provided.

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT03248531
• Other Study ID Numbers: HS0001; 2017-000892-10
• First Posted: Aug 14, 2017
• Last Update Posted: Apr 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by UCB Biopharma SRL: Hidradenitis Suppurativa; Bimekizumab; HS; Moderate to Severe HS
• Additional relevant MeSH terms: Hidradenitis Suppurativa; Hidradenitis; Adalimumab

Study Results

Participant Flow

Recruitment Details	The study started to enroll patients in September 2017 and concluded in February 2019.
Pre-assignment Detail	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	22	22	46
Completed Week 12	19	18	42
COMPLETED	18	17	38
NOT COMPLETED	4	5	8

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.
Overall Participants	22	22	46	90
Age (Count of Participants)
<=18 years	0 0%	0 0%	2 4.3%	2 2.2%
Between 18 and 65 years	21 95.5%	22 100%	44 95.7%	87 96.7%
>=65 years	1 4.5%	0 0%	0 0%	1 1.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.7 (12.5)	31.0 (9.2)	37.4 (11.9)	36.6 (11.9)
Sex: Female, Male (Count of Participants)
Female	15 68.2%	18 81.8%	30 65.2%	63 70%
Male	7 31.8%	4 18.2%	16 34.8%	27 30%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native	1 4.5%	0 0%	0 0%	1 1.1%
Asian	1 4.5%	3 13.6%	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%	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.
Measure Participants	20	20	44
Mean (95% Confidence Interval) [Percentage of responders]	26.1	59.5	57.3

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Pr [Diff>0%] (%)
	Estimated Value	99.8
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Pr[Diff > 0%](%)
	Estimated Value	42.1
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

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).
Measure Participants	46
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	NA (NA)

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.
Measure Participants	45
Geometric Mean (Geometric Coefficient of Variation) [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.
Measure Participants	46
Geometric Mean (Geometric Coefficient of Variation) [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.
Measure Participants	43
Geometric Mean (Geometric Coefficient of Variation) [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.
Measure Participants	42
Geometric Mean (Geometric Coefficient of Variation) [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.
Measure Participants	35
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	NA (NA)

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.
Measure Participants	21	21	46
Number [percentage of participants]	61.9 281.4%	71.4 324.5%	71.7 155.9%

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.
Measure Participants	21	21	46
Mild	47.6 216.4%	66.7 303.2%	63.0 137%
Moderate	33.3 151.4%	42.9 195%	39.1 85%
Severe	4.8 21.8%	9.5 43.2%	6.5 14.1%

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.
Measure Participants	21	21	46
Number [percentage of participants]	9.5 43.2%	4.8 21.8%	4.3 9.3%

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.
Measure Participants	21	21	46
Mild	0 0%	4.8 21.8%	0 0%
Moderate	4.8 21.8%	0 0%	0 0%
Severe	4.8 21.8%	4.8 21.8%	4.3 9.3%

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.
Measure Participants	21	21	46
Number [percentage of participants]	0 0%	0 0%	2.2 4.8%

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.
Measure Participants	18	19	38
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.
Measure Participants	18	19	38
Mean (Standard Deviation) [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.
Measure Participants	18	19	38
Mean (Standard Deviation) [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.
Measure Participants	18	15	37
Mean (Standard Deviation) [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.
Measure Participants	18	15	37
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.
Measure Participants	14	18	33
Mean (Standard Deviation) [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.
Measure Participants	14	18	33
Mean (Standard Deviation) [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.
Measure Participants	14	18	33
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.
Measure Participants	14	18	33
Mean (Standard Deviation) [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.
Measure Participants	14	18	33
Mean (Standard Deviation) [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.
Measure Participants	14	18	33
Mean (Standard Deviation) [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.
Measure Participants	14	18	33
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.
Measure Participants	14	18	33
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.
Measure Participants	15	19	36
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.
Measure Participants	15	19	36
Creatinine	-1.73 (9.92)	-1.72 (9.04)	3.84 (9.22)
Bilirubin	0.17 (3.48)	-1.38 (3.04)	0.18 (4.35)
Urate	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.
Measure Participants	15	19	36
Mean (Standard Deviation) [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.
Measure Participants	15	19	36
Alanine aminotransferase	-3.3 (8.3)	-3.6 (9.8)	3.6 (23.8)
Alkaline phosphatase	-2.0 (12.2)	-2.4 (13.5)	-3.4 (11.6)
Aspartate aminotransferase	-0.6 (3.6)	-1.0 (5.8)	2.0 (13.3)
Gamma glutamyl transferase	-2.0 (9.5)	1.8 (14.2)	2.3 (10.1)
Lactate dehydrogenase	-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.
Measure Participants	14	16	31
Mean (Standard Deviation) [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.
Measure Participants	15	18	34
Mean (Standard Deviation) [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)
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.
Measure Participants	14	16	31
Baseline Low - Week 30 Low	0 0%	0 0%	0 0%
Baseline Low - Week 30 Normal	0 0%	0 0%	0 0%
Baseline Low - Week 30 High	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Low	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Normal	12 54.5%	14 63.6%	28 60.9%
Baseline Normal - Week 30 High	1 4.5%	1 4.5%	0 0%
Baseline High - Week 30 Low	0 0%	0 0%	0 0%
Baseline High - Week 30 Normal	0 0%	1 4.5%	1 2.2%
Baseline High - Week 30 High	1 4.5%	0 0%	2 4.3%

33. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
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.
Measure Participants	14	16	31
Baseline Low - Week 30 Low	0 0%	0 0%	0 0%
Baseline Low - Week 30 Normal	0 0%	0 0%	0 0%
Baseline Low - Week 30 High	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Low	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Normal	8 36.4%	9 40.9%	19 41.3%
Baseline Normal - Week 30 High	2 9.1%	0 0%	6 13%
Baseline High - Week 30 Low	0 0%	0 0%	0 0%
Baseline High - Week 30 Normal	2 9.1%	3 13.6%	6 13%
Baseline High - Week 30 High	2 9.1%	4 18.2%	0 0%

34. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
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.
Measure Participants	3	6	2
Baseline Low - Week 30 Low	0 0%	0 0%	0 0%
Baseline Low - Week 30 Normal	0 0%	0 0%	0 0%
Baseline Low - Week 30 High	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Low	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Normal	0 0%	0 0%	0 0%
Baseline Normal - Week 30 High	0 0%	0 0%	0 0%
Baseline High - Week 30 Low	0 0%	0 0%	0 0%
Baseline High - Week 30 Normal	0 0%	0 0%	0 0%
Baseline High - Week 30 High	3 13.6%	6 27.3%	2 4.3%

35. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
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.
Measure Participants	3	1	1
Baseline Low - Week 30 Low	0 0%	0 0%	0 0%
Baseline Low - Week 30 Normal	0 0%	0 0%	0 0%
Baseline Low - Week 30 High	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Low	0 0%	0 0%	0 0%
Baseline Normal - Week 30 Normal	1 4.5%	0 0%	1 2.2%
Baseline Normal - Week 30 High	0 0%	0 0%	0 0%
Baseline High - Week 30 Low	0 0%	0 0%	0 0%
Baseline High - Week 30 Normal	0 0%	0 0%	0 0%
Baseline High - Week 30 High	2 9.1%	1 4.5%	0 0%

36. Secondary Outcome

Title	Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
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.
Measure Participants	18	19	38
Baseline Normal - Week 30 Normal	14 63.6%	15 68.2%	28 60.9%
Baseline Normal - Week 30 Abnormal	1 4.5%	2 9.1%	5 10.9%
Baseline Abnormal - Week 30 Normal	1 4.5%	1 4.5%	1 2.2%
Baseline Abnormal - Week 30 Abnormal	2 9.1%	1 4.5%	4 8.7%

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.
Measure Participants	46
Number [percentage of participants]	4.3 19.5%

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.
Measure Participants	45
Number [percentage of participants]	4.4 20%

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.
Measure Participants	46
Number [percentage of participants]	4.3 19.5%

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.
Measure Participants	42
Number [percentage of participants]	0 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.
Measure Participants	42
Number [percentage of participants]	9.5 43.2%

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.
Measure Participants	36
Number [percentage of participants]	13.9 63.2%

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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)		0/46 (0%)
Serious Adverse Events
	Placebo (SS)		Adalimumab (SS)		Bimekizumab (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		1/21 (4.8%)		2/46 (4.3%)
Blood and lymphatic system disorders
Anaemia	0/21 (0%)	0	0/21 (0%)	0	1/46 (2.2%)	1
Cardiac disorders
Myocardial infarction	1/21 (4.8%)	1	0/21 (0%)	0	0/46 (0%)	0
Infections and infestations
Empyema	0/21 (0%)	0	0/21 (0%)	0	1/46 (2.2%)	1
Nervous system disorders
Headache	1/21 (4.8%)	1	0/21 (0%)	0	0/46 (0%)	0
Dizziness	1/21 (4.8%)	1	0/21 (0%)	0	0/46 (0%)	0
Hypoaesthesia	1/21 (4.8%)	1	0/21 (0%)	0	0/46 (0%)	0
Skin and subcutaneous tissue disorders
Hidradenitis	0/21 (0%)	0	1/21 (4.8%)	2	0/46 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo (SS)		Adalimumab (SS)		Bimekizumab (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/21 (23.8%)		12/21 (57.1%)		21/46 (45.7%)
Gastrointestinal disorders
Diarrhoea	0/21 (0%)	0	1/21 (4.8%)	2	3/46 (6.5%)	5
Nausea	0/21 (0%)	0	1/21 (4.8%)	1	3/46 (6.5%)	3
General disorders
Fatigue	0/21 (0%)	0	2/21 (9.5%)	2	4/46 (8.7%)	4
Pyrexia	0/21 (0%)	0	2/21 (9.5%)	2	1/46 (2.2%)	2
Injection site reaction	0/21 (0%)	0	0/21 (0%)	0	3/46 (6.5%)	4
Injection site pain	0/21 (0%)	0	0/21 (0%)	0	3/46 (6.5%)	3
Injection site pruritus	0/21 (0%)	0	2/21 (9.5%)	2	2/46 (4.3%)	2
Infections and infestations
Oral candidiasis	0/21 (0%)	0	1/21 (4.8%)	1	3/46 (6.5%)	4
Influenza	0/21 (0%)	0	3/21 (14.3%)	3	0/46 (0%)	0
Nasopharyngitis	0/21 (0%)	0	1/21 (4.8%)	1	3/46 (6.5%)	4
Upper respiratory tract infection	0/21 (0%)	0	2/21 (9.5%)	2	2/46 (4.3%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	1/21 (4.8%)	1	2/21 (9.5%)	2	1/46 (2.2%)	3
Nervous system disorders
Headache	3/21 (14.3%)	4	0/21 (0%)	0	3/46 (6.5%)	4
Skin and subcutaneous tissue disorders
Hidradenitis	3/21 (14.3%)	3	6/21 (28.6%)	6	8/46 (17.4%)	9
Intertrigo	0/21 (0%)	0	1/21 (4.8%)	1	3/46 (6.5%)	3
Vascular disorders
Hypertension	0/21 (0%)	0	0/21 (0%)	0	3/46 (6.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.