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
UCB Biopharma SRL
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Cohort A and Cohort B * Study participant must be at least 18 years of age inclusive at the time of signing the Informed Consent Form (ICF) * Study participant must have: 1. Cohort A and Cohort B: Plaque psoriasis (PSO) diagnosed for at least 6 months prior to the Screening Visit 2. 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)…
Interventions
- Drugbimekizumab
Study participants receive bimekizumab (BKZ) administered subcutaneously at pre-specified timepoints during study.
Locations (16)
- Ps0039 50140Birmingham, Alabama
- Ps0039 50162Fountain Valley, California
- Ps0039 50642Santa Monica, California
- Ps0039 50283Tampa, Florida
- Ps0039 50110Ann Arbor, Michigan
- Ps0039 50643Rochester, New York