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Trial record 1 of 1 for:    PS0018
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A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03230292
Recruitment Status : Completed
First Posted : July 26, 2017
Results First Posted : March 31, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Plaque Psoriasis
Intervention Drug: Bimekizumab
Enrollment 43
Recruitment Details The study started to enroll patients in July 2017 and concluded in March 2019.
Pre-assignment Details Participant Flow refers to the Safety Set.
Arm/Group Title BKZ All Participants
Hide 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
Reason Not Completed
Adverse Event             1
Protocol Violation             1
Lost to Follow-up             1
Withdrawal by Subject             3
Arm/Group Title BKZ All Participants
Hide 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 Number of Baseline Participants 43
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set which consisted of all study participants who received at least 1 dose of investigational medicinal product (IMP) in PS0018.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  93.0%
>=65 years
3
   7.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
45.0  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
20
  46.5%
Male
23
  53.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Asian
4
   9.3%
Black or African American
1
   2.3%
Native Hawaiian or Other Pacific Islander
1
   2.3%
White
37
  86.0%
1.Primary Outcome
Title Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: no. of new events per 100 subject-years
76.00
(53.8 to 104.3)
2.Secondary Outcome
Title Plasma Concentration of Bimekizumab During the Study
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
PS0018 Week 0 Number Analyzed 43 participants
NA [1] 
(NA%)
Week 4 Number Analyzed 42 participants
5.309
(47.8%)
Week 8 Number Analyzed 40 participants
7.304
(60.7%)
Week 12 Number Analyzed 39 participants
7.994
(53.9%)
Week 16 Number Analyzed 37 participants
8.700
(53.7%)
Week 28 Number Analyzed 37 participants
9.285
(49.7%)
Week 40 Number Analyzed 36 participants
9.238
(51.3%)
Week 48/ Withdrawal Number Analyzed 36 participants
9.056
(52.5%)
Follow-up Number Analyzed 35 participants
0.310
(164.8%)
[1]
Participants had no prior BKZ treatment and thus no BKZ levels at Baseline.
3.Secondary Outcome
Title Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment
Hide 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]
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
2.3
4.Secondary Outcome
Title Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: percentage of participants
25.6
5.Secondary Outcome
Title Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PS0018 Week 0
60.5
(45.6 to 73.6)
Week 4
95.3
(84.5 to 98.7)
Week 8
95.3
(84.5 to 98.7)
Week 12
95.3
(84.5 to 98.7)
Week 16
97.7
(87.9 to 99.6)
Week 20
95.3
(84.5 to 98.7)
Week 24
93.0
(81.4 to 97.6)
Week 28
93.0
(81.4 to 97.6)
Week 32
90.7
(78.4 to 96.3)
Week 36
90.7
(78.4 to 96.3)
Week 40
88.4
(75.5 to 94.9)
Week 44
90.7
(78.4 to 96.3)
Week 48/ Withdrawal
88.4
(75.5 to 94.9)
Follow-Up
79.1
(64.8 to 88.6)
6.Secondary Outcome
Title Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PS0018 Week 0
44.2
(30.4 to 58.9)
Week 4
88.4
(75.5 to 94.9)
Week 8
95.3
(84.5 to 98.7)
Week 12
90.7
(78.4 to 96.3)
Week 16
93.0
(81.4 to 97.6)
Week 20
90.7
(78.4 to 96.3)
Week 24
90.7
(78.4 to 96.3)
Week 28
88.4
(75.5 to 94.9)
Week 32
90.7
(78.4 to 96.3)
Week 36
90.7
(78.4 to 96.3)
Week 40
86.0
(72.7 to 93.4)
Week 44
90.7
(78.4 to 96.3)
Week 48/ Withdrawal
86.0
(72.7 to 93.4)
Follow-Up
65.1
(50.2 to 77.6)
7.Secondary Outcome
Title Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PS0018 Week 0
20.9
(11.4 to 35.2)
Week 4
53.5
(38.9 to 67.5)
Week 8
79.1
(64.8 to 88.6)
Week 12
79.1
(64.8 to 88.6)
Week 16
86.0
(72.7 to 93.4)
Week 20
79.1
(64.8 to 88.6)
Week 24
79.1
(64.8 to 88.6)
Week 28
81.4
(67.4 to 90.3)
Week 32
81.4
(67.4 to 90.3)
Week 36
86.0
(72.7 to 93.4)
Week 40
76.7
(62.3 to 86.8)
Week 44
86.0
(72.7 to 93.4)
Week 48/ Withdrawal
79.1
(64.8 to 88.6)
Follow-Up
58.1
(43.3 to 71.6)
8.Secondary Outcome
Title Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PS0018 Week 0
4.7
(1.3 to 15.5)
Week 4
23.3
(13.2 to 37.7)
Week 8
37.2
(24.4 to 52.1)
Week 12
46.5
(32.5 to 61.1)
Week 16
39.5
(26.4 to 54.4)
Week 20
48.8
(34.6 to 63.2)
Week 24
41.9
(28.4 to 56.7)
Week 28
46.5
(32.5 to 61.1)
Week 32
41.9
(28.4 to 56.7)
Week 36
41.9
(28.4 to 56.7)
Week 40
46.5
(32.5 to 61.1)
Week 44
46.5
(32.5 to 61.1)
Week 48/ Withdrawal
46.5
(32.5 to 61.1)
Follow-Up
18.6
(9.7 to 32.6)
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PS0018 Week 0
18.6
(9.7 to 32.6)
Week 4
62.8
(47.9 to 75.6)
Week 8
79.1
(64.8 to 88.6)
Week 12
79.1
(64.8 to 88.6)
Week 16
81.4
(67.4 to 90.3)
Week 20
79.1
(64.8 to 88.6)
Week 24
76.7
(62.3 to 86.8)
Week 28
79.1
(64.8 to 88.6)
Week 32
86.0
(72.7 to 93.4)
Week 36
81.4
(67.4 to 90.3)
Week 40
79.1
(64.8 to 88.6)
Week 44
83.7
(70.0 to 91.9)
Week 48/ Withdrawal
79.1
(64.8 to 88.6)
Follow-Up
51.2
(36.8 to 65.4)
10.Secondary Outcome
Title Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: score on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percentage change
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 4.7
Week 4 23.3
Week 8 37.2
Week 12 44.2
Week 16 34.9
Week 20 41.9
Week 24 37.2
Week 28 39.5
Week 32 37.2
Week 36 37.2
Week 40 37.2
Week 44 37.2
Week 48/ Withdrawal 39.5
Follow-Up 18.6
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 11.6
Week 4 37.2
Week 8 32.6
Week 12 23.3
Week 16 37.2
Week 20 23.3
Week 24 30.2
Week 28 30.2
Week 32 37.2
Week 36 30.2
Week 40 27.9
Week 44 32.6
Week 48/ Withdrawal 25.6
Follow-Up 30.2
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 25.6
Week 4 18.6
Week 8 14.0
Week 12 11.6
Week 16 9.3
Week 20 14.0
Week 24 9.3
Week 28 7.0
Week 32 2.3
Week 36 9.3
Week 40 9.3
Week 44 2.3
Week 48/ Withdrawal 7.0
Follow-Up 11.6
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 25.6
Week 4 4.7
Week 8 0
Week 12 2.3
Week 16 2.3
Week 20 2.3
Week 24 2.3
Week 28 2.3
Week 32 0
Week 36 0
Week 40 2.3
Week 44 4.7
Week 48/ Withdrawal 4.7
Follow-Up 11.6
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 16.3
Week 4 0
Week 8 0
Week 12 0
Week 16 0
Week 20 0
Week 24 0
Week 28 0
Week 32 0
Week 36 0
Week 40 0
Week 44 0
Week 48/ Withdrawal 0
Follow-Up 4.7
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 0
Week 4 0
Week 8 0
Week 12 2.3
Week 16 4.7
Week 20 7.0
Week 24 4.7
Week 28 7.0
Week 32 4.7
Week 36 7.0
Week 40 11.6
Week 44 9.3
Week 48/ Withdrawal 9.3
Follow-Up 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 2.3
Week 4 2.3
Week 8 9.3
Week 12 9.3
Week 16 4.7
Week 20 7.0
Week 24 4.7
Week 28 2.3
Week 32 7.0
Week 36 7.0
Week 40 2.3
Week 44 4.7
Week 48/ Withdrawal 4.7
Follow-Up 2.3
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 2.3
Week 4 9.3
Week 8 2.3
Week 12 0
Week 16 4.7
Week 20 0
Week 24 4.7
Week 28 4.7
Week 32 2.3
Week 36 0
Week 40 0
Week 44 0
Week 48/ Withdrawal 0
Follow-Up 7.0
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 2.3
Week 4 2.3
Week 8 0
Week 12 2.3
Week 16 0
Week 20 0
Week 24 0
Week 28 0
Week 32 0
Week 36 0
Week 40 0
Week 44 0
Week 48/ Withdrawal 0
Follow-Up 2.3
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0018 Week 0 9.3
Week 4 2.3
Week 8 2.3
Week 12 0
Week 16 0
Week 20 0
Week 24 0
Week 28 0
Week 32 0
Week 36 0
Week 40 0
Week 44 0
Week 48/ Withdrawal 0
Follow-Up 2.3
22.Secondary Outcome
Title Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percentage change
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
Hide 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]
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: score on a scale
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
Hide 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]
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: score on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0016 Baseline Number Analyzed 43 participants
83.7
PS0018 Week 0 Number Analyzed 43 participants
88.4
Week 12 Number Analyzed 42 participants
95.2
Week 24 Number Analyzed 42 participants
90.5
Week 36 Number Analyzed 39 participants
89.7
Week 48/ Withdrawal Number Analyzed 39 participants
87.2
27.Secondary Outcome
Title Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
PS0016 Baseline Number Analyzed 43 participants
93.0
PS0018 Week 0 Number Analyzed 43 participants
97.7
Week 12 Number Analyzed 42 participants
95.2
Week 24 Number Analyzed 42 participants
97.6
Week 36 Number Analyzed 39 participants
94.9
Week 48/ Withdrawal Number Analyzed 39 participants
97.4
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)]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BKZ All Participants (SS)
Hide 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 (%)
Total   0/43 (0.00%)    
Hide Serious Adverse Events
BKZ All Participants (SS)
Affected / at Risk (%) # Events
Total   3/43 (6.98%)    
Cardiac disorders   
Acute myocardial infarction * 1  1/43 (2.33%)  1
Injury, poisoning and procedural complications   
Anaemia postoperative * 1  1/43 (2.33%)  1
Nervous system disorders   
Syncope * 1  1/43 (2.33%)  1
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BKZ All Participants (SS)
Affected / at Risk (%) # Events
Total   27/43 (62.79%)    
Infections and infestations   
Upper respiratory tract infection * 1  8/43 (18.60%)  12
Nasopharyngitis * 1  7/43 (16.28%)  10
Viral upper respiratory tract infection * 1  5/43 (11.63%)  6
Oral candidiasis * 1  4/43 (9.30%)  6
Pharyngitis * 1  3/43 (6.98%)  3
Staphylococcal pharyngitis * 1  3/43 (6.98%)  3
Investigations   
Gamma-glutamyltransferase increased * 1  5/43 (11.63%)  7
Alanine aminotransferase increased * 1  4/43 (9.30%)  5
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: 001 844 599 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03230292    
Other Study ID Numbers: PS0018
2016-002934-57 ( EudraCT Number )
First Submitted: July 24, 2017
First Posted: July 26, 2017
Results First Submitted: March 3, 2022
Results First Posted: March 31, 2022
Last Update Posted: July 22, 2022