Actively Recruiting
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Led by UCB Biopharma SRL · Updated on 2026-04-24
90
Participants Needed
16
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR).
CONDITIONS
Official Title
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old when signing consent
- Diagnosed with plaque psoriasis for at least 6 months before screening (Cohort A and B)
- For Cohort B only: diagnosis of adult-onset psoriatic arthritis meeting CASPAR criteria for at least 6 months before screening, with at least 1 tender joint and 1 swollen joint
- Psoriasis Area and Severity Index (PASI) score of 12 or higher
- Body surface area affected by psoriasis of 10% or more
- Investigator's Global Assessment (IGA) score of 3 or higher on a 5-point scale
- Candidate for systemic psoriasis therapy and/or phototherapy
- Agree to maintain usual sun exposure and use UVA/UVB sunscreen if exposure occurs
- Body weight less than 120 kg
- Female participants must not be pregnant or breastfeeding and either not be women of childbearing potential or agree to follow contraceptive guidance during and after the study period
- Control cohort participants must be 18 years or older, overtly healthy, body weight less than 120 kg, and females not pregnant or breastfeeding
You will not qualify if you...
- Having any form of psoriasis other than plaque type (e.g., pustular, erythrodermic, guttate, or drug-induced psoriasis)
- Active systemic infection within 14 days prior to baseline
- Serious infection requiring hospitalization or intravenous treatment within 2 months prior to baseline
- History of opportunistic, recurrent, or chronic infections that might be harmful
- Chronic viral hepatitis B or C, HIV infection, or history of hepatitis B (per investigator discretion)
- Known active tuberculosis or history of active tuberculosis unless treated
- High risk for acquiring tuberculosis
- Diagnosed with inflammatory conditions other than psoriasis or psoriatic arthritis, except inactive inflammatory bowel disease
- Active malignancy or history of malignancy within 5 years except treated skin or cervical cancers
- Medical or psychiatric conditions that could compromise participation
- Known allergy to study medication components
- History of primary failure to any biologic treatment
- Laboratory abnormalities at screening
- Current history of alcohol or drug use disorder within 6 months prior to screening
- Control cohort participants with uncontrolled or unstable systemic diseases likely to worsen during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Ps0039 50140
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Ps0039 50162
Fountain Valley, California, United States, 92708
Actively Recruiting
3
Ps0039 50642
Santa Monica, California, United States, 90404
Withdrawn
4
Ps0039 50283
Tampa, Florida, United States, 33613
Actively Recruiting
5
Ps0039 50110
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Ps0039 50643
Rochester, New York, United States, 14623
Actively Recruiting
7
Ps0039 50491
Pittsburgh, Pennsylvania, United States, 15213-2536
Actively Recruiting
8
Ps0039 40515
Berlin, Germany
Active, Not Recruiting
9
Ps0039 40287
Frankfurt am Main, Germany
Active, Not Recruiting
10
Ps0039 40072
Freiburg im Breisgau, Germany
Active, Not Recruiting
11
Ps0039 40775
Witten, Germany
Withdrawn
12
Ps0039 40347
Lodz, Poland
Active, Not Recruiting
13
Ps0039 40757
Poznan, Poland
Active, Not Recruiting
14
Ps0039 40625
Warsaw, Poland
Active, Not Recruiting
15
Ps0039 40761
Warsaw, Poland
Active, Not Recruiting
16
Ps0039 40773
Wroclaw, Poland
Active, Not Recruiting
Research Team
U
UCB Cares
CONTACT
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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