Adults 18 to 70, any sex, with Chronic Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to TreatmentPrimary· 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.
Group
Value
95% CI
BKZ All Participants (SS)
76.00
53.8 – 104.3
Plasma Concentration of Bimekizumab During the StudySecondary· 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.
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (PK-PPS)
NA
± NA
Week 4
Group
Value
95% CI
BKZ All Participants (PK-PPS)
5.309
± 47.8
Week 8
Group
Value
95% CI
BKZ All Participants (PK-PPS)
7.304
± 60.7
Week 12
Group
Value
95% CI
BKZ All Participants (PK-PPS)
7.994
± 53.9
Week 16
Group
Value
95% CI
BKZ All Participants (PK-PPS)
8.700
± 53.7
Week 28
Group
Value
95% CI
BKZ All Participants (PK-PPS)
9.285
± 49.7
Week 40
Group
Value
95% CI
BKZ All Participants (PK-PPS)
9.238
± 51.3
Week 48/ Withdrawal
Group
Value
95% CI
BKZ All Participants (PK-PPS)
9.056
± 52.5
Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study TreatmentSecondary· 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
Group
Value
95% CI
BKZ All Participants (SS)
2.3
Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study TreatmentSecondary· 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
Group
Value
95% CI
BKZ All Participants (SS)
25.6
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the StudySecondary· 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
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
60.5
45.6 – 73.6
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
95.3
84.5 – 98.7
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
95.3
84.5 – 98.7
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
95.3
84.5 – 98.7
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
97.7
87.9 – 99.6
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
95.3
84.5 – 98.7
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
93.0
81.4 – 97.6
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
93.0
81.4 – 97.6
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the StudySecondary· 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
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
44.2
30.4 – 58.9
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
88.4
75.5 – 94.9
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
95.3
84.5 – 98.7
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
90.7
78.4 – 96.3
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
93.0
81.4 – 97.6
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
90.7
78.4 – 96.3
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
90.7
78.4 – 96.3
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
88.4
75.5 – 94.9
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the StudySecondary· 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
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
20.9
11.4 – 35.2
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
53.5
38.9 – 67.5
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
86.0
72.7 – 93.4
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
81.4
67.4 – 90.3
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the StudySecondary· 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 o
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
4.7
1.3 – 15.5
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
23.3
13.2 – 37.7
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
37.2
24.4 – 52.1
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
46.5
32.5 – 61.1
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
39.5
26.4 – 54.4
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
48.8
34.6 – 63.2
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
41.9
28.4 – 56.7
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
46.5
32.5 – 61.1
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 StudySecondary· 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.
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
18.6
9.7 – 32.6
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
62.8
47.9 – 75.6
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
81.4
67.4 – 90.3
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
76.7
62.3 – 86.8
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
79.1
64.8 – 88.6
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the StudySecondary· 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.
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
-11.21
± 9.13
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
-16.79
± 6.72
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
-18.12
± 7.41
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
-18.70
± 7.89
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
-19.01
± 8.70
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
-18.91
± 8.70
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
-19.08
± 8.66
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
-19.13
± 8.79
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the StudySecondary· 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.
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
-56.45
± 38.26
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
-87.71
± 15.52
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
-93.28
± 12.13
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
-94.50
± 8.22
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
-95.15
± 8.43
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
-94.84
± 9.02
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
-95.69
± 6.77
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
-95.72
± 7.35
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the StudySecondary· 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.
PS0018 Week 0
Group
Value
95% CI
BKZ All Participants (FAS)
4.7
Week 4
Group
Value
95% CI
BKZ All Participants (FAS)
23.3
Week 8
Group
Value
95% CI
BKZ All Participants (FAS)
37.2
Week 12
Group
Value
95% CI
BKZ All Participants (FAS)
44.2
Week 16
Group
Value
95% CI
BKZ All Participants (FAS)
34.9
Week 20
Group
Value
95% CI
BKZ All Participants (FAS)
41.9
Week 24
Group
Value
95% CI
BKZ All Participants (FAS)
37.2
Week 28
Group
Value
95% CI
BKZ All Participants (FAS)
39.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)].
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma SRL
Last refreshed: 22 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03230292.