Chronic Plaque Psoriasis
Conditions
Keywords
Psoriasis, Chronic Plaque Psoriasis, Bimekizumab
Brief summary
This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.
Interventions
DRUGBimekizumab
Bimekizumab will be administered subcutaneously in 2 different doses.
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Australia, Canada, Moldova, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| BKZ All Participants 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. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | BKZ All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 45.0 years STANDARD_DEVIATION 12.8 |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White | 37 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 27 / 43 |
| serious Total, serious adverse events | 3 / 43 |
Outcome results
Primary
Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment
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)
Population: The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BKZ All Participants (SS) | Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment | 76.00 no. of new events per 100 subject-years |
Secondary
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study
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]
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study | PS0018 Week 0 | -1.5 score on a scale | Standard Deviation 2.3 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study | Week 12 | -2.0 score on a scale | Standard Deviation 1.8 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study | Week 24 | -2.0 score on a scale | Standard Deviation 2.4 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study | Week 36 | -2.0 score on a scale | Standard Deviation 2.4 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study | Week 48/ Withdrawal | -1.5 score on a scale | Standard Deviation 2.2 |
Secondary
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study
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]
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study | PS0018 Week 0 | -1.0 score on a scale | Standard Deviation 1.4 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study | Week 12 | -0.8 score on a scale | Standard Deviation 2.1 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study | Week 24 | -1.0 score on a scale | Standard Deviation 1.7 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study | Week 36 | -1.1 score on a scale | Standard Deviation 1.7 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study | Week 48/ Withdrawal | -1.0 score on a scale | Standard Deviation 1.8 |
Secondary
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | PS0018 Week 0 | -11.21 score on a scale | Standard Deviation 9.13 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 4 | -16.79 score on a scale | Standard Deviation 6.72 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 8 | -18.12 score on a scale | Standard Deviation 7.41 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 12 | -18.70 score on a scale | Standard Deviation 7.89 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 16 | -19.01 score on a scale | Standard Deviation 8.7 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 20 | -18.91 score on a scale | Standard Deviation 8.7 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 24 | -19.08 score on a scale | Standard Deviation 8.66 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 28 | -19.13 score on a scale | Standard Deviation 8.79 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 32 | -19.30 score on a scale | Standard Deviation 8.66 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 36 | -19.27 score on a scale | Standard Deviation 8.68 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 44 | -19.32 score on a scale | Standard Deviation 8.68 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 48/ Withdrawal | -19.20 score on a scale | Standard Deviation 8.76 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Follow-up | -15.93 score on a scale | Standard Deviation 9.29 |
| BKZ All Participants (SS) | Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 40 | -19.22 score on a scale | Standard Deviation 8.82 |
Secondary
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Follow-Up | -81.98 percentage change | Standard Deviation 25.45 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | PS0018 Week 0 | -56.45 percentage change | Standard Deviation 38.26 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 4 | -87.71 percentage change | Standard Deviation 15.52 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 8 | -93.28 percentage change | Standard Deviation 12.13 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 12 | -94.50 percentage change | Standard Deviation 8.22 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 16 | -95.15 percentage change | Standard Deviation 8.43 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 20 | -94.84 percentage change | Standard Deviation 9.02 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 24 | -95.69 percentage change | Standard Deviation 6.77 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 28 | -95.72 percentage change | Standard Deviation 7.35 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 32 | -96.85 percentage change | Standard Deviation 4.81 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 36 | -96.66 percentage change | Standard Deviation 4.88 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 40 | -96.13 percentage change | Standard Deviation 6.38 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 44 | -96.98 percentage change | Standard Deviation 4.14 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study | Week 48/ Withdrawal | -96.10 percentage change | Standard Deviation 7.45 |
Secondary
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | PS0018 Week 0 | -61.0 percentage change | Standard Deviation 41.5 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 4 | -83.0 percentage change | Standard Deviation 23.7 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 8 | -91.1 percentage change | Standard Deviation 15.9 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 12 | -92.9 percentage change | Standard Deviation 10.9 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 16 | -95.5 percentage change | Standard Deviation 7.4 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 20 | -94.4 percentage change | Standard Deviation 9.1 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 24 | -94.8 percentage change | Standard Deviation 7.8 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 28 | -95.4 percentage change | Standard Deviation 8.7 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 32 | -96.1 percentage change | Standard Deviation 6.7 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 36 | -96.5 percentage change | Standard Deviation 5.7 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 40 | -95.8 percentage change | Standard Deviation 8.5 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 44 | -96.3 percentage change | Standard Deviation 6.2 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 48/ Withdrawal | -95.6 percentage change | Standard Deviation 10 |
| BKZ All Participants (SS) | Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Follow-Up | -81.5 percentage change | Standard Deviation 33.9 |
Secondary
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 40 | 0.8 percentage of BSA | Standard Deviation 1.2 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | PS0016 Baseline | 25.8 percentage of BSA | Standard Deviation 17.5 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | PS0018 Week 0 | 8.6 percentage of BSA | Standard Deviation 10.7 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 4 | 5.2 percentage of BSA | Standard Deviation 12.6 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 8 | 3.0 percentage of BSA | Standard Deviation 10.9 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 12 | 2.0 percentage of BSA | Standard Deviation 4.8 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 16 | 1.0 percentage of BSA | Standard Deviation 1.6 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 20 | 1.2 percentage of BSA | Standard Deviation 2.2 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 24 | 1.2 percentage of BSA | Standard Deviation 1.9 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 28 | 0.9 percentage of BSA | Standard Deviation 1.6 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 32 | 0.8 percentage of BSA | Standard Deviation 1.1 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 44 | 0.7 percentage of BSA | Standard Deviation 1 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 48/ Withdrawal | 0.7 percentage of BSA | Standard Deviation 1.2 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Follow-Up | 4.8 percentage of BSA | Standard Deviation 13 |
| BKZ All Participants (SS) | Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study | Week 36 | 0.7 percentage of BSA | Standard Deviation 1.1 |
Secondary
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | PS0018 Week 0 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 4 | 23.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 8 | 37.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 12 | 46.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 16 | 39.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 20 | 48.8 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 24 | 41.9 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 28 | 46.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 32 | 41.9 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 36 | 41.9 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 40 | 46.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 44 | 46.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 48/ Withdrawal | 46.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Follow-Up | 18.6 percentage of participants |
Secondary
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 4 | 95.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 8 | 95.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 12 | 95.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 16 | 97.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 20 | 95.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 24 | 93.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 28 | 93.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 32 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 36 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 40 | 88.4 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 44 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 48/ Withdrawal | 88.4 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Follow-Up | 79.1 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | PS0018 Week 0 | 60.5 percentage of participants |
Secondary
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | PS0018 Week 0 | 44.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 4 | 88.4 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 8 | 95.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 12 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 16 | 93.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 20 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 24 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 28 | 88.4 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 32 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 36 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 44 | 90.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 40 | 86.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 48/ Withdrawal | 86.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Follow-Up | 65.1 percentage of participants |
Secondary
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | PS0018 Week 0 | 20.9 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 4 | 53.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 8 | 79.1 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 12 | 79.1 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 16 | 86.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 20 | 79.1 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 24 | 79.1 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 28 | 81.4 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 32 | 81.4 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 36 | 86.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 40 | 76.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 44 | 86.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Week 48/ Withdrawal | 79.1 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study | Follow-Up | 58.1 percentage of participants |
Secondary
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | 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 | PS0018 Week 0 | 11.6 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 4 | 37.2 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 8 | 32.6 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 12 | 23.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 16 | 37.2 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 20 | 23.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 24 | 30.2 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 28 | 30.2 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 32 | 37.2 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 36 | 30.2 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 40 | 27.9 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 44 | 32.6 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 48/ Withdrawal | 25.6 percentage of participants |
| BKZ All Participants (SS) | 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 | Follow-Up | 30.2 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | PS0018 Week 0 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 4 | 23.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 8 | 37.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 12 | 44.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 16 | 34.9 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 20 | 41.9 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 24 | 37.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 28 | 39.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 32 | 37.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 36 | 37.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 40 | 37.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 44 | 37.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 48/ Withdrawal | 39.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Follow-Up | 18.6 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | PS0018 Week 0 | 25.6 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 4 | 18.6 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 8 | 14.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 12 | 11.6 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 16 | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 20 | 14.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 24 | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 28 | 7.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 32 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 36 | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 40 | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 44 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 48/ Withdrawal | 7.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Follow-Up | 11.6 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | PS0018 Week 0 | 25.6 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 4 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 8 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 12 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 16 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 20 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 24 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 28 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 32 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 36 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 40 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 44 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 48/ Withdrawal | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Follow-Up | 11.6 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | PS0018 Week 0 | 16.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 4 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 8 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 12 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 16 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 20 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 24 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 28 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 32 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 36 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 40 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 44 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 48/ Withdrawal | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Follow-Up | 4.7 percentage of participants |
Secondary
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | 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 | PS0018 Week 0 | 2.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 4 | 2.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 8 | 9.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 12 | 9.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 16 | 4.7 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 20 | 7.0 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 24 | 4.7 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 28 | 2.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 32 | 7.0 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 36 | 7.0 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 40 | 2.3 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 44 | 4.7 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 48/ Withdrawal | 4.7 percentage of participants |
| BKZ All Participants (SS) | 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 | Follow-Up | 2.3 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 24 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 28 | 7.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 32 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 36 | 7.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 40 | 11.6 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 44 | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 48/ Withdrawal | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Follow-Up | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | PS0018 Week 0 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 4 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 8 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 12 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 16 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study | Week 20 | 7.0 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | PS0018 Week 0 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 4 | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 8 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 12 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 16 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 20 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 24 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 28 | 4.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 32 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 36 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 40 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 44 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Week 48/ Withdrawal | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study | Follow-Up | 7.0 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | PS0018 Week 0 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 4 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 8 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 12 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 16 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 20 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 24 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 28 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 32 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 36 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 40 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 44 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Week 48/ Withdrawal | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study | Follow-Up | 2.3 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | PS0018 Week 0 | 9.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 4 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 8 | 2.3 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 12 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 16 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 20 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 24 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 28 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 32 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 36 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 40 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 44 | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Week 48/ Withdrawal | 0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study | Follow-Up | 2.3 percentage of participants |
Secondary
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | 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 | PS0018 Week 0 | 18.6 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 4 | 62.8 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 8 | 79.1 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 12 | 79.1 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 16 | 81.4 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 20 | 79.1 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 24 | 76.7 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 28 | 79.1 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 32 | 86.0 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 36 | 81.4 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 40 | 79.1 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 44 | 83.7 percentage of participants |
| BKZ All Participants (SS) | 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 | Week 48/ Withdrawal | 79.1 percentage of participants |
| BKZ All Participants (SS) | 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 | Follow-Up | 51.2 percentage of participants |
Secondary
Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment | 25.6 percentage of participants |
Secondary
Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment
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]
Population: The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment | 2.3 percentage of participants |
Secondary
Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study | PS0016 Baseline | 83.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study | PS0018 Week 0 | 88.4 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study | Week 12 | 95.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study | Week 24 | 90.5 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study | Week 36 | 89.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study | Week 48/ Withdrawal | 87.2 percentage of participants |
Secondary
Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study | PS0016 Baseline | 93.0 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study | PS0018 Week 0 | 97.7 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study | Week 12 | 95.2 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study | Week 24 | 97.6 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study | Week 36 | 94.9 percentage of participants |
| BKZ All Participants (SS) | Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study | Week 48/ Withdrawal | 97.4 percentage of participants |
Secondary
Plasma Concentration of Bimekizumab During the Study
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)
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | PS0018 Week 0 | NA μg/mL | — |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Week 4 | 5.309 μg/mL | Geometric Coefficient of Variation 47.8 |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Week 8 | 7.304 μg/mL | Geometric Coefficient of Variation 60.7 |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Week 12 | 7.994 μg/mL | Geometric Coefficient of Variation 53.9 |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Week 16 | 8.700 μg/mL | Geometric Coefficient of Variation 53.7 |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Week 28 | 9.285 μg/mL | Geometric Coefficient of Variation 49.7 |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Week 40 | 9.238 μg/mL | Geometric Coefficient of Variation 51.3 |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Week 48/ Withdrawal | 9.056 μg/mL | Geometric Coefficient of Variation 52.5 |
| BKZ All Participants (SS) | Plasma Concentration of Bimekizumab During the Study | Follow-up | 0.310 μg/mL | Geometric Coefficient of Variation 164.8 |