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A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis

Study acronym: BE UNIQUE
StatusActive, Not Recruiting
PhasePhase 3
Started2024-07-29
View on ClinicalTrials.gov ↗

Amendment history

2026-07-16
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 14 sites
2026-05-19
Study Status, Study Design, Contacts/Locations v11
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment targetestimated 90→confirmed 89
Study sites16→14
2026-04-23
Study Status, Contacts/Locations v10
Study sitesdetails revised at 8 of 16 sites
2026-02-26
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 16 sites
2026-01-28
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 16 sites
Show 7 earlier versions
2026-01-05
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 16 sites
2025-11-27
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 16 sites
2025-09-18
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 16 sites
2025-07-24
Study Status v4
Primary completion date2026-04-16→2027-03-09
2025-05-27
Study Status, Eligibility v3
Eligibility criteria+22 characters
[...] reatment Period, the Randomized Treatment Extension Period, theTreatment Extension Period, the Escape Treatment Period, and for at least 1217 weeks after the final dose of investigational medicinal pro [...]
2025-04-17
Study Status v2
Re-verified, no change to tracked fields
2025-03-12
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-01-16→2026-04-16
Completion date2027-01-18→2028-03-14
Start dateestimated 2024-07-12→confirmed 2024-07-29
Study sites0→16
2024-07-09
Original filing
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).
Trial Details
NCT Number NCT06506916
Lead Sponsor UCB Biopharma SRL
Conditions Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
Enrollment 89 participants
Start Date 2024-07-29
Primary Completion 2027-03-09 (estimated)
Study Completion 2028-03-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-17