RecruitingPhase 3

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

United States90 participantsStarted 2024-07-29

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Cohort A and Cohort B: Plaque psoriasis (PSO) diagnosed for at least 6 months prior to the Screening Visit
✓. Cohort B only: In addition to the criteria specified above, study participant has a documented diagnosis of adult-onset psoriatic arthritis (PsA) and meets the CASPAR classification criteria for at least 6 months prior to Screening for active PsA and must have ≥1 tender joint count (TJC) out of 68 and ≥1 swollen joint count (SJC) out of 66 at Screening or up to 3 months before Screening (documented evidence)

Exclusion criteria

✕. Any active systemic infection within 14 days prior to Baseline
✕. A serious infection, defined as requiring hospitalization or intravenous anti-infective(s) within 2 months prior to the Baseline Visit
✕. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause this study to be detrimental to the study participant
✕. Known active tuberculosis (TB) disease.
✕. History of active TB involving any organ system unless adequately treated
✕. High risk of acquiring TB infection

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

Timeframe: Week 48, compared to Baseline

Trial details

NCT IDNCT06506916

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-09

Contact for this trial

UCB Cares

1-844-599-2273 (USA) ucbcares@ucb.com

View on ClinicalTrials.gov More Moderate to Severe Plaque Psoriasis trials