NCT06506916
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatmentUCB Biopharma SRL
~89 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:bimekizumab
At a glance
Recruiting sites
0 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48
Measured over Week 48, compared to Baseline
Conditions
Where it's being run
14 sites across 8 statesPoland5
Germany3
Alabama1
California1
Florida1
Michigan1
New York1
Pennsylvania1
Study leadership
- UCB Cares · STUDY_DIRECTOR · 001 844 599 2273
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Study participant must be at least 18 years of age inclusive at the time of signing the Informed Consent Form (ICF)
Study participant must have:
Study participant must have Psoriasis Area and Severity Index (PASI) score ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on a 5 point scale
Study participant must be a candidate for systemic PSO therapy and/or phototherapy
Study participant agrees not to change their usual sun exposure during the course of the study and to use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs
Study participant has body weight \<120 kg
A female study participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Study participant must be ≥18 years of age at the time of signing the informed consent
Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs
Study participant has body weight \<120 kg
Female study participant is eligible to participate if they are not pregnant and not breastfeeding
Exclusion
Study participant has a form of PSO other than plaque type (eg, pustular, erythrodermic and guttate PSO, or drug induced PSO)
Study participant has an active infection or history of infection(s) as follows:
At investigator's discretion, study participant with chronic (medically controlled) viral hepatitis B or C or human immunodeficiency virus (HIV) infection, or history of hepatitis B.
Study participant has any of the following:
Study participant has a verified diagnosis of inflammatory conditions other than PSO or PsA, including but not limited to rheumatoid arthritis (RA), sarcoidosis, inflammatory bowel diseases (IBD), or systemic lupus erythematosus. Note: Study participants with a diagnosis of IBD are allowed if they have no active symptomatic disease at Screening or Baseline
Study participant has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Study participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
Study participant has a known hypersensitivity to any components of the IMP as stated in this protocol
Study participant has a history of primary failure to any biologic (ie, no response within the first 12 weeks of treatment)
Study participant has laboratory abnormalities at Screening
Study participant has a current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM) V, within the previous 6 months prior to Screening, as evaluated by the investigator based on medical history, and/or site interview
What this trial measures
- Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48Week 48, compared to Baseline
Composite gene expression score using RT-PCR in lesional skin at Baseline and Week 48 using preselected genes based on bimekizumab mechanism of action and PSO disease biology pathways.