Bimekizumab
DrugStudy participants receive bimekizumab (BKZ) administered subcutaneously at pre-specified timepoints during study.
Other names: BKZ
NCT Number: NCT06506916
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Ps0039 40515, Berlin, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cohort A and Cohort B
Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Run In Treatment Period, the Randomized Treatment Extension Period, theTreatment Extension Period, the Escape Treatment Period, and for 17 weeks after the final dose of investigational medicinal product (IMP)
Control Cohort
Exclusion criteria
Cohort A and Cohort B
Control Cohort
Study participants receive bimekizumab (BKZ) administered subcutaneously at pre-specified timepoints during study.
Other names: BKZ
Time frame: Week 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.
Time frame: From Baseline to End of SFU (up to Week 100)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs are defined as those AEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy).
Time frame: From Baseline to End of SFU (up to Week 100)
A serious adverse event (SAE) must meet 1 or more of the following criteria:
TESAEs are defined as those SAEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy).
Time frame: From Baseline to End of SFU (up to Week 100)
This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.
UCB Biopharma SRL
Industry
A Phase 3b Exploratory Multicenter Open-Label Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Acronym: BE UNIQUE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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