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.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506333-29-00

Acronym

PS0039

Enrollment

Registered

2024-08-15

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Plaque Psoriasis, Psoriatic arthritis

Brief summary

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

Detailed description

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

Interventions

DRUGbimekizumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026