This is a multicenter extension study to assess the long-term safety, tolerability and
efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque
psoriasis

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

Chronic Plaque Psoriasis

Bimekizumab

Placebo

A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on
or after the date of first dose of PS0011 investigational medicinal product (IMP), or
events in which severity worsened on or after the date of first dose of PS0011 study
medication. The exposure adjusted incidence rate (EAIR) is defined as the number of
subjects (n) with a specific AE adjusted for the exposure and was scaled to 100
subject-years: where the numerator is the total number of subjects experiencing the AE
and the denominator is the total time at risk scaled to 100 subject-years; that is, the
total summation of individual subject-years at risk up to the first occurrence of the AE
for subjects with that AE, and the total subject-years at risk for those subjects not
experiencing that AE, divided by 100.

The PASI90 response assessments are based on at least 90% improvement in the PASI score
from Baseline. It averages the redness, thickness, and scaliness of the psoriatic lesions
(on a 0-4 scale) and weights the resulting score by the area of skin involved. Body
divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment
of an average score for the redness, thickness, and scaling for each of the 4 body areas
with a score of 0 (clear) to 4 (very marked). The PASI score ranges from 0 to 72 with a
higher score indicating increased disease severity. PASI90 response is defined to be
equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or
greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome
Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by
PS0010 Week 12 response status.

The Investigator's Global Assessment (IGA) measures the overall severity following a
5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of
post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink
coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red
coloration and predominately fine scaling, 3= moderate, clearly distinguishable to
moderate thickening; dull to bright red, clearly distinguishable to moderate thickening;
moderate scaling and 4= severe thickening with hard edges; bright to deep dark red
coloration; severe/coarse scaling covering almost all or all lesions. IGA response is
defined as clear (0) or almost clear (1) with at least a two category improvement from
Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at
PS0011 Baseline by PS0010 Week 12 response status.

Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering
PS0011 will receive Placebo.

Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering
PS0011 will receive the same dosing regimen.

Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in
PS0010 will be assigned to a higher dosing regimen.

Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering
PS0011 will receive the same dosing regimen.

Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in
PS0010 will be assigned to a higher dosing regimen.

Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in
PS0010 will receive bimekizumab dosing regimen 3.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status