A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

• Sponsor: UCB Biopharma SRL (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03230292
• Collaborator: (none)
• Enrollment: 43
• Locations: 10
• Arm: 1
• Actual Duration (Months): 20.1
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.

Condition or Disease	Intervention/Treatment	Phase
Chronic Plaque Psoriasis	Drug: Bimekizumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, 48-week, Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis.
• Actual Study Start Date: Jul 3, 2017
• Actual Primary Completion Date: Mar 6, 2019
• Actual Study Completion Date: Mar 6, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Cohort 1 Subjects in this cohort will receive dose 1 every four weeks (Q4W) subcutaneously (sc) during the 48-week open-label Treatment Period. There will be an option to increase the dose to dose 2 Q4W at the discretion of the Investigator if the subject's Psoriasis Area and Severity Index (PASI) response is >=50% to <75% reduction from the Baseline of PS0016 at Week 12 or later. If the subject's disease is adequately controlled on dose 2 Q4W, they may return to dose 1 Q4W at the discretion of the Investigator.

Drug: Bimekizumab; Bimekizumab will be administered subcutaneously in 2 different doses.; Other Names: UCB4940

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment [From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)]

   TEAEs were events that had a start date on or after the first administration of study treatment in PS0018 until the last received dose of investigational medicinal product (IMP) +140 days [which covered the 20-week Safety Follow-Up (SFU) Visit]. The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.

Secondary Outcome Measures

1. Plasma Concentration of Bimekizumab During the Study [From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)]

   Plasma concentration of Bimekizumab was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (=0.075 μg/mL) in calculations of Means and Coefficient of Variations (CVs). Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.

2. Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment [Baseline of study PS0016 [NCT03025542]]

   For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

3. Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

   For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

4. Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

   The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI50 responses were based on at least 50% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

5. Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

   The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI75 responses were based on at least 75% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

6. Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

   The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI90 responses were based on at least 90% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

7. Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

   The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI100 responses were based on 100% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

8. Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

   A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0=Clear to 4=Severe. The response was defined as clear [0] or almost clear [1] with at least 2 category improvement from PS0016 Baseline. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

9. Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

   The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

10. Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A negative percentage change from PS0016 baseline indicated improvement in Total PASI score. The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

11. Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Clear IGA was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

12. Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

13. Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

14. Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

15. Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Severe was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

16. Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

17. Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

18. Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

19. Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Moderate was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

20. Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

21. Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant's flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last Observation Carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

22. Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study [From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018]

    The percentage BSA (0 to 100%) affected by PSO was listed by PS0016 randomized treatment, by study participant and visit including the percentage change from PS0016 Baseline. The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant's flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

23. Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study [Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]]

    HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

24. Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study [Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]]

    HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

25. Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study [Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018]

    HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

26. Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study [Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018]

    HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subject must have completed all dosing requirements in PS0016 without meeting any withdrawal criteria

• 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 with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)

Exclusion Criteria:

• Subjects previously participating in this study

• Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subject's entry into PS0018

• Subject has any current sign or symptom that may indicate a medically significant infection

• Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed.

• Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ps0018 701	High Point	North Carolina	United States	27265
2	Ps0018 704	Bexley	Ohio	United States	43209
3	Ps0018 101	Carlton		Australia
4	Ps0018 103	East Melbourne		Australia
5	Ps0018 102	Kogarah		Australia
6	Ps0018 104	Woolloongabba		Australia
7	Ps0018 201	Ajax		Canada
8	Ps0018 203	London		Canada
9	Ps0018 202	Windsor		Canada
10	Ps0018 501	Chisinau		Moldova, Republic of

Sponsors and Collaborators

• UCB Biopharma SRL

Investigators

• Study Director: UCB Cares, UCB (001 844 599 2273)

Study Documents (Full-Text)

• Study Protocol - Feb 16, 2018
• Statistical Analysis Plan - Oct 29, 2018

More Information

Additional Information:

• Product Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT03230292
• Other Study ID Numbers: PS0018; 2016-002934-57
• First Posted: Jul 26, 2017
• Last Update Posted: Jul 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by UCB Biopharma SRL: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Recruitment Details	The study started to enroll patients in July 2017 and concluded in March 2019.
Pre-assignment Detail	Participant Flow refers to the Safety Set.

Arm/Group Title	BKZ All Participants
Arm/Group Description	Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
Period Title: Overall Study
STARTED	43
COMPLETED	37
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	BKZ All Participants
Arm/Group Description	Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
Overall Participants	43
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 93%
>=65 years	3 7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.0 (12.8)
Sex: Female, Male (Count of Participants)
Female	20 46.5%
Male	23 53.5%
Race/Ethnicity, Customized (Count of Participants)
Asian	4 9.3%
Black or African American	1 2.3%
Native Hawaiian or Other Pacific Islander	1 2.3%
White	37 86%

Outcome Measures

1. Primary Outcome

Title	Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment
Description	TEAEs were events that had a start date on or after the first administration of study treatment in PS0018 until the last received dose of investigational medicinal product (IMP) +140 days [which covered the 20-week Safety Follow-Up (SFU) Visit]. The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.
Time Frame	From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.

Arm/Group Title	BKZ All Participants (SS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Measure Participants	43
Number (95% Confidence Interval) [no. of new events per 100 subject-years]	76.00

2. Secondary Outcome

Title	Plasma Concentration of Bimekizumab During the Study
Description	Plasma concentration of Bimekizumab was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (=0.075 μg/mL) in calculations of Means and Coefficient of Variations (CVs). Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.
Time Frame	From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set consisted of all enrolled participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration postdose in PS0018. Here, 'number analyzed' signifies participants who were evaluable at specified time points.

Arm/Group Title	BKZ All Participants (PK-PPS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Pharmacokinetic-Per Protocol Set (PK-PPS).
Measure Participants	43
PS0018 Week 0	NA (NA)
Week 4	5.309 (47.8)
Week 8	7.304 (60.7)
Week 12	7.994 (53.9)
Week 16	8.700 (53.7)
Week 28	9.285 (49.7)
Week 40	9.238 (51.3)
Week 48/ Withdrawal	9.056 (52.5)
Follow-up	0.310 (164.8)

3. Secondary Outcome

Title	Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment
Description	For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	Baseline of study PS0016 [NCT03025542]

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.

Arm/Group Title	BKZ All Participants (SS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Measure Participants	43
Number [percentage of participants]	2.3 5.3%

4. Secondary Outcome

Title	Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment
Description	For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018. The number of participants analyzed reflects participants with a non-missing measurement.

Arm/Group Title	BKZ All Participants (SS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Measure Participants	39
Number [percentage of participants]	25.6 59.5%

5. Secondary Outcome

Title	Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Description	The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI50 responses were based on at least 50% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	60.5 140.7%
Week 4	95.3 221.6%
Week 8	95.3 221.6%
Week 12	95.3 221.6%
Week 16	97.7 227.2%
Week 20	95.3 221.6%
Week 24	93.0 216.3%
Week 28	93.0 216.3%
Week 32	90.7 210.9%
Week 36	90.7 210.9%
Week 40	88.4 205.6%
Week 44	90.7 210.9%
Week 48/ Withdrawal	88.4 205.6%
Follow-Up	79.1 184%

6. Secondary Outcome

Title	Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Description	The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI75 responses were based on at least 75% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	44.2 102.8%
Week 4	88.4 205.6%
Week 8	95.3 221.6%
Week 12	90.7 210.9%
Week 16	93.0 216.3%
Week 20	90.7 210.9%
Week 24	90.7 210.9%
Week 28	88.4 205.6%
Week 32	90.7 210.9%
Week 36	90.7 210.9%
Week 40	86.0 200%
Week 44	90.7 210.9%
Week 48/ Withdrawal	86.0 200%
Follow-Up	65.1 151.4%

7. Secondary Outcome

Title	Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Description	The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI90 responses were based on at least 90% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	20.9 48.6%
Week 4	53.5 124.4%
Week 8	79.1 184%
Week 12	79.1 184%
Week 16	86.0 200%
Week 20	79.1 184%
Week 24	79.1 184%
Week 28	81.4 189.3%
Week 32	81.4 189.3%
Week 36	86.0 200%
Week 40	76.7 178.4%
Week 44	86.0 200%
Week 48/ Withdrawal	79.1 184%
Follow-Up	58.1 135.1%

8. Secondary Outcome

Title	Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Description	The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI100 responses were based on 100% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	4.7 10.9%
Week 4	23.3 54.2%
Week 8	37.2 86.5%
Week 12	46.5 108.1%
Week 16	39.5 91.9%
Week 20	48.8 113.5%
Week 24	41.9 97.4%
Week 28	46.5 108.1%
Week 32	41.9 97.4%
Week 36	41.9 97.4%
Week 40	46.5 108.1%
Week 44	46.5 108.1%
Week 48/ Withdrawal	46.5 108.1%
Follow-Up	18.6 43.3%

9. Secondary Outcome

Title	Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0=Clear to 4=Severe. The response was defined as clear [0] or almost clear [1] with at least 2 category improvement from PS0016 Baseline. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	18.6 43.3%
Week 4	62.8 146%
Week 8	79.1 184%
Week 12	79.1 184%
Week 16	81.4 189.3%
Week 20	79.1 184%
Week 24	76.7 178.4%
Week 28	79.1 184%
Week 32	86.0 200%
Week 36	81.4 189.3%
Week 40	79.1 184%
Week 44	83.7 194.7%
Week 48/ Withdrawal	79.1 184%
Follow-Up	51.2 119.1%

10. Secondary Outcome

Title	Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study
Description	The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	-11.21 (9.13)
Week 4	-16.79 (6.72)
Week 8	-18.12 (7.41)
Week 12	-18.70 (7.89)
Week 16	-19.01 (8.70)
Week 20	-18.91 (8.70)
Week 24	-19.08 (8.66)
Week 28	-19.13 (8.79)
Week 32	-19.30 (8.66)
Week 36	-19.27 (8.68)
Week 40	-19.22 (8.82)
Week 44	-19.32 (8.68)
Week 48/ Withdrawal	-19.20 (8.76)
Follow-up	-15.93 (9.29)

11. Secondary Outcome

Title	Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study
Description	A negative percentage change from PS0016 baseline indicated improvement in Total PASI score. The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	-56.45 (38.26)
Week 4	-87.71 (15.52)
Week 8	-93.28 (12.13)
Week 12	-94.50 (8.22)
Week 16	-95.15 (8.43)
Week 20	-94.84 (9.02)
Week 24	-95.69 (6.77)
Week 28	-95.72 (7.35)
Week 32	-96.85 (4.81)
Week 36	-96.66 (4.88)
Week 40	-96.13 (6.38)
Week 44	-96.98 (4.14)
Week 48/ Withdrawal	-96.10 (7.45)
Follow-Up	-81.98 (25.45)

12. Secondary Outcome

Title	Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Clear IGA was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	4.7 10.9%
Week 4	23.3 54.2%
Week 8	37.2 86.5%
Week 12	44.2 102.8%
Week 16	34.9 81.2%
Week 20	41.9 97.4%
Week 24	37.2 86.5%
Week 28	39.5 91.9%
Week 32	37.2 86.5%
Week 36	37.2 86.5%
Week 40	37.2 86.5%
Week 44	37.2 86.5%
Week 48/ Withdrawal	39.5 91.9%
Follow-Up	18.6 43.3%

13. Secondary Outcome

Title	Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	11.6 27%
Week 4	37.2 86.5%
Week 8	32.6 75.8%
Week 12	23.3 54.2%
Week 16	37.2 86.5%
Week 20	23.3 54.2%
Week 24	30.2 70.2%
Week 28	30.2 70.2%
Week 32	37.2 86.5%
Week 36	30.2 70.2%
Week 40	27.9 64.9%
Week 44	32.6 75.8%
Week 48/ Withdrawal	25.6 59.5%
Follow-Up	30.2 70.2%

14. Secondary Outcome

Title	Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	25.6 59.5%
Week 4	18.6 43.3%
Week 8	14.0 32.6%
Week 12	11.6 27%
Week 16	9.3 21.6%
Week 20	14.0 32.6%
Week 24	9.3 21.6%
Week 28	7.0 16.3%
Week 32	2.3 5.3%
Week 36	9.3 21.6%
Week 40	9.3 21.6%
Week 44	2.3 5.3%
Week 48/ Withdrawal	7.0 16.3%
Follow-Up	11.6 27%

15. Secondary Outcome

Title	Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	25.6 59.5%
Week 4	4.7 10.9%
Week 8	0 0%
Week 12	2.3 5.3%
Week 16	2.3 5.3%
Week 20	2.3 5.3%
Week 24	2.3 5.3%
Week 28	2.3 5.3%
Week 32	0 0%
Week 36	0 0%
Week 40	2.3 5.3%
Week 44	4.7 10.9%
Week 48/ Withdrawal	4.7 10.9%
Follow-Up	11.6 27%

16. Secondary Outcome

Title	Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Severe was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	16.3 37.9%
Week 4	0 0%
Week 8	0 0%
Week 12	0 0%
Week 16	0 0%
Week 20	0 0%
Week 24	0 0%
Week 28	0 0%
Week 32	0 0%
Week 36	0 0%
Week 40	0 0%
Week 44	0 0%
Week 48/ Withdrawal	0 0%
Follow-Up	4.7 10.9%

17. Secondary Outcome

Title	Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	0 0%
Week 4	0 0%
Week 8	0 0%
Week 12	2.3 5.3%
Week 16	4.7 10.9%
Week 20	7.0 16.3%
Week 24	4.7 10.9%
Week 28	7.0 16.3%
Week 32	4.7 10.9%
Week 36	7.0 16.3%
Week 40	11.6 27%
Week 44	9.3 21.6%
Week 48/ Withdrawal	9.3 21.6%
Follow-Up	0 0%

18. Secondary Outcome

Title	Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	2.3 5.3%
Week 4	2.3 5.3%
Week 8	9.3 21.6%
Week 12	9.3 21.6%
Week 16	4.7 10.9%
Week 20	7.0 16.3%
Week 24	4.7 10.9%
Week 28	2.3 5.3%
Week 32	7.0 16.3%
Week 36	7.0 16.3%
Week 40	2.3 5.3%
Week 44	4.7 10.9%
Week 48/ Withdrawal	4.7 10.9%
Follow-Up	2.3 5.3%

19. Secondary Outcome

Title	Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	2.3 5.3%
Week 4	9.3 21.6%
Week 8	2.3 5.3%
Week 12	0 0%
Week 16	4.7 10.9%
Week 20	0 0%
Week 24	4.7 10.9%
Week 28	4.7 10.9%
Week 32	2.3 5.3%
Week 36	0 0%
Week 40	0 0%
Week 44	0 0%
Week 48/ Withdrawal	0 0%
Follow-Up	7.0 16.3%

20. Secondary Outcome

Title	Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Moderate was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	2.3 5.3%
Week 4	2.3 5.3%
Week 8	0 0%
Week 12	2.3 5.3%
Week 16	0 0%
Week 20	0 0%
Week 24	0 0%
Week 28	0 0%
Week 32	0 0%
Week 36	0 0%
Week 40	0 0%
Week 44	0 0%
Week 48/ Withdrawal	0 0%
Follow-Up	2.3 5.3%

21. Secondary Outcome

Title	Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study
Description	A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	9.3 21.6%
Week 4	2.3 5.3%
Week 8	2.3 5.3%
Week 12	0 0%
Week 16	0 0%
Week 20	0 0%
Week 24	0 0%
Week 28	0 0%
Week 32	0 0%
Week 36	0 0%
Week 40	0 0%
Week 44	0 0%
Week 48/ Withdrawal	0 0%
Follow-Up	2.3 5.3%

22. Secondary Outcome

Title	Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study
Description	The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant's flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last Observation Carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0016 Baseline	25.8 (17.5)
PS0018 Week 0	8.6 (10.7)
Week 4	5.2 (12.6)
Week 8	3.0 (10.9)
Week 12	2.0 (4.8)
Week 16	1.0 (1.6)
Week 20	1.2 (2.2)
Week 24	1.2 (1.9)
Week 28	0.9 (1.6)
Week 32	0.8 (1.1)
Week 36	0.7 (1.1)
Week 40	0.8 (1.2)
Week 44	0.7 (1.0)
Week 48/ Withdrawal	0.7 (1.2)
Follow-Up	4.8 (13.0)

23. Secondary Outcome

Title	Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study
Description	The percentage BSA (0 to 100%) affected by PSO was listed by PS0016 randomized treatment, by study participant and visit including the percentage change from PS0016 Baseline. The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant's flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	-61.0 (41.5)
Week 4	-83.0 (23.7)
Week 8	-91.1 (15.9)
Week 12	-92.9 (10.9)
Week 16	-95.5 (7.4)
Week 20	-94.4 (9.1)
Week 24	-94.8 (7.8)
Week 28	-95.4 (8.7)
Week 32	-96.1 (6.7)
Week 36	-96.5 (5.7)
Week 40	-95.8 (8.5)
Week 44	-96.3 (6.2)
Week 48/ Withdrawal	-95.6 (10.0)
Follow-Up	-81.5 (33.9)

24. Secondary Outcome

Title	Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study
Description	HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	-1.5 (2.3)
Week 12	-2.0 (1.8)
Week 24	-2.0 (2.4)
Week 36	-2.0 (2.4)
Week 48/ Withdrawal	-1.5 (2.2)

25. Secondary Outcome

Title	Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study
Description	HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0018 Week 0	-1.0 (1.4)
Week 12	-0.8 (2.1)
Week 24	-1.0 (1.7)
Week 36	-1.1 (1.7)
Week 48/ Withdrawal	-1.0 (1.8)

26. Secondary Outcome

Title	Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study
Description	HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018. Here, 'number analyzed' signifies participants who were evaluable at specified time points.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0016 Baseline	83.7 194.7%
PS0018 Week 0	88.4 205.6%
Week 12	95.2 221.4%
Week 24	90.5 210.5%
Week 36	89.7 208.6%
Week 48/ Withdrawal	87.2 202.8%

27. Secondary Outcome

Title	Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study
Description	HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.
Time Frame	Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018

Outcome Measure Data

Analysis Population Description

The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018. Here, 'number analyzed' signifies participants who were evaluable at specified time points.

Arm/Group Title	BKZ All Participants (FAS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
Measure Participants	43
PS0016 Baseline	93.0 216.3%
PS0018 Week 0	97.7 227.2%
Week 12	95.2 221.4%
Week 24	97.6 227%
Week 36	94.9 220.7%
Week 48/ Withdrawal	97.4 226.5%

Adverse Events

Time Frame	Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Arm/Group Title	BKZ All Participants (SS)
Arm/Group Description	Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
All Cause Mortality
	BKZ All Participants (SS)
	Affected / at Risk (%)	# Events
Total	0/43 (0%)
Serious Adverse Events
	BKZ All Participants (SS)
	Affected / at Risk (%)	# Events
Total	3/43 (7%)
Cardiac disorders
Acute myocardial infarction	1/43 (2.3%)	1
Injury, poisoning and procedural complications
Anaemia postoperative	1/43 (2.3%)	1
Nervous system disorders
Syncope	1/43 (2.3%)	1
Other (Not Including Serious) Adverse Events
	BKZ All Participants (SS)
	Affected / at Risk (%)	# Events
Total	27/43 (62.8%)
Infections and infestations
Upper respiratory tract infection	8/43 (18.6%)	12
Nasopharyngitis	7/43 (16.3%)	10
Viral upper respiratory tract infection	5/43 (11.6%)	6
Oral candidiasis	4/43 (9.3%)	6
Pharyngitis	3/43 (7%)	3
Staphylococcal pharyngitis	3/43 (7%)	3
Investigations
Gamma-glutamyltransferase increased	5/43 (11.6%)	7
Alanine aminotransferase increased	4/43 (9.3%)	5

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.