Overall trial status: Ongoing, recruiting
Trial title: 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.
Medical conditions: Psoriatic arthritis, Moderate to Severe Plaque Psoriasis
Status in each country: Poland:Ongoing, recruiting, Germany:Ongoing, recruiting
Trial phase: Phase III and phase IV (Integrated)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Baseline and Week 48 using preselected genes based on Bimekizumab mechanism of action and PSO disease biology pathways
Secondary end point: 1. Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU) 2. Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU 3. TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 46
Sponsor: UCB Biopharma
Sponsor type: Pharmaceutical company
Trial product: bimekizumab
Results posted: No
Overall decision date: 15/08/2024
Countries decision date: DE: 15/08/2024, PL: 26/08/2024
Last updated date: 07/03/2026
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