Clinical Trial Results:
A multicenter, 48-week, open-label extension study to assess the long-term safety, tolerability, and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
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Summary
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EudraCT number |
2016-002934-57 |
Trial protocol |
DE |
Global end of trial date |
06 Mar 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Oct 2022
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First version publication date |
11 Oct 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PS0018
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03230292 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB Biopharma SRL
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Sponsor organisation address |
Allée de la Recherche 60, Brussels, Belgium, B-1070
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Public contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Scientific contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 May 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
06 Mar 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Mar 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study is to assess the long-term safety and tolerability of bimekizumab.
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Protection of trial subjects |
During the conduct of the study all participants were closely monitored.
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Background therapy |
Background therapy as permitted in the protocol. | ||
Evidence for comparator |
Not Applicable | ||
Actual start date of recruitment |
03 Jul 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Australia: 17
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Country: Number of subjects enrolled |
Canada: 12
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Country: Number of subjects enrolled |
Moldova, Republic of: 13
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Country: Number of subjects enrolled |
United States: 1
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Worldwide total number of subjects |
43
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
40
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
The study started to enroll patients in July 2017 and concluded in March 2019. | ||||||||||||||||
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Pre-assignment
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Screening details |
Participant Flow refers to the Safety Set. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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BKZ All participants | ||||||||||||||||
Arm description |
Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Bimekizumab
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Investigational medicinal product code |
UCB4940
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Bimekizumab (BKZ) was administered as one sc injection for 160 mg Q4W or as 2 sc injections for 320 mg Q4W. Suitable areas for sc injections were the lateral abdominal wall and upper outer thigh.
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Baseline characteristics reporting groups
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Reporting group title |
BKZ All participants
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Reporting group description |
Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
BKZ All participants
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Reporting group description |
Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (>=) 50% to less than (<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. | ||
Subject analysis set title |
BKZ All participants (SS)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
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Subject analysis set title |
BKZ All participants (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Pharmacokinetic-Per Protocol Set (PK-PPS).
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Subject analysis set title |
BKZ All participants (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Full Analysis Set (FAS).
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End point title |
Incidence of Treatment Emergent Adverse Event (TEAE) adjusted by duration of participant exposure to treatment [1] | ||||||||
End point description |
TEAEs were events that had a start date on or after the first administration of study treatment in PS0018 until the last received dose of investigational medicinal product (IMP) +140 days [which covered the 20-week Safety Follow-Up (SFU) Visit]. The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used. The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.
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End point type |
Primary
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End point timeframe |
From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this outcome. Results were summarized as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma concentration of bimekizumab during the study | ||||||||||||||||||||||||||
End point description |
Plasma concentration of Bimekizumab was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (=0.075 μg/mL) in calculations of Means and Coefficient of Variations (CVs). Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. 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, 'n' signifies participants who were evaluable at specified time points. Note: 999 was used a placeholder for the value that was not calculated (Participants had no prior BKZ treatment and thus no BKZ levels at Baseline).
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End point type |
Secondary
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End point timeframe |
From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of participants with positive anti-bimekizumab (BZK) antibody levels prior to study treatment | ||||||||
End point description |
For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.
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End point type |
Secondary
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End point timeframe |
Baseline of study PS0016 [NCT03025542]
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with overall positive anti-bimekizumab (BZK) antibody levels following study treatment | ||||||||
End point description |
For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants achieving a 50% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study | ||||||||||||||||||||||||||||||||||||
End point description |
The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI50 responses were based on at least 50% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of participants achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study | ||||||||||||||||||||||||||||||||||||
End point description |
The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI75 responses were based on at least 75% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of participants achieving a 90% or higher improvement in Psoriasis Area and Severity Index (PASI) during the study | ||||||||||||||||||||||||||||||||||||
End point description |
The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI90 responses were based on at least 90% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI) during the study | ||||||||||||||||||||||||||||||||||||
End point description |
The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI100 responses were based on 100% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of participants with Investigator´s Global Assessment response (Clear or Almost clear with at least a 2 category improvement from Baseline on a 5-point scale) during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0=Clear to 4=Severe. The response was defined as clear [0] or almost clear [1] with at least 2 category improvement from PS0016 Baseline. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Mean change from PS0016 [NCT03025542] Baseline in PASI score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Mean percentage change from PS0016 [NCT03025542] Baseline in PASI score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A negative percentage change from PS0016 baseline indicated improvement in Total PASI score. The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to clear IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Clear IGA was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to almost clear IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
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End point type |
Secondary
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End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to mild IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to moderate IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from moderate Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to severe IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Severe was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to clear IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to almost clear IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to mild IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to moderate IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Moderate was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of participants who shifted from severe Investigator´s Global Assessment (IGA) score at PS0016 [NCT03025542] Baseline to severe IGA score during the study | ||||||||||||||||||||||||||||||||||||
End point description |
A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||
End point title |
Mean percentage in the Body Surface Area (BSA) affected by psoriasis during the study | ||||||||||||||||||||||||||||||||||||||
End point description |
The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant’s flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last Observation Carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Mean percentage change from PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) affected by psoriasis during the study | ||||||||||||||||||||||||||||||||||||
End point description |
The percentage BSA (0 to 100 %) affected by PSO was listed by PS0016 randomized treatment, by study participant and visit including the percentage change from PS0016 Baseline. The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant’s flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Mean change from PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale – Anxiety (HADS-A) score during the study | ||||||||||||||||||
End point description |
HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||
End point title |
Mean change from PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale – Depression (HADS-D) score during the study | ||||||||||||||||||
End point description |
HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Percentage of participants with scores below 8 in HADS-A (participants with normal scores) during the study | ||||||||||||||||||||
End point description |
HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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, 'n' signifies participants who were evaluable at specified time points.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Percentage of participants with scores below 8 in HADS-D (participants with normal scores) during the study | ||||||||||||||||||||
End point description |
HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study. 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, 'n' signifies participants who were evaluable at specified time points.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
BKZ All participants (SS)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's PASI response was >= 50% to < 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant’s disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
16 Feb 2018 |
Protocol amendment 3, dated 16 Feb 2018, was implemented to make the following changes: • Revised the withdrawal criteria to provide instructions for the management of study participants with newly diagnosed inflammatory bowel disease or with inflammatory bowel disease flares during the study • Updated the study contact information. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| PS0018 has not been conducted in the European Economic Area (EEA) and therefore did not meet the criteria for the results posting on EudraCT. Nevertheless, due to data transparency reason, UCB decided to post the respective results. | |||
