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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Study participants receive bimekizumab (BKZ) administered subcutaneously at pre-specified timepoints during study.
Ps0039 50140
Birmingham, Alabama, United States
RECRUITINGPs0039 50162
Fountain Valley, California, United States
RECRUITINGPs0039 50642
Santa Monica, California, United States
WITHDRAWNPs0039 50283
Tampa, Florida, United States
RECRUITINGPs0039 50110
Ann Arbor, Michigan, United States
RECRUITINGPs0039 50643
Rochester, New York, United States
RECRUITINGPs0039 50491
Pittsburgh, Pennsylvania, United States
RECRUITINGPs0039 40515
Berlin, Germany
RECRUITINGPs0039 40287
Frankfurt am Main, Germany
RECRUITINGPs0039 40072
Freiburg im Breisgau, Germany
RECRUITING...and 6 more locations
Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48
Composite gene expression score using RT-PCR in lesional skin at Baseline and Week 48 using preselected genes based on bimekizumab mechanism of action and PSO disease biology pathways.
Time frame: Week 48, compared to Baseline
Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs are defined as those AEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy).
Time frame: From Baseline to End of SFU (up to Week 100)
Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU
A serious adverse event (SAE) must meet 1 or more of the following criteria: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. TESAEs are defined as those SAEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy).
Time frame: From Baseline to End of SFU (up to Week 100)
TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU
This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.
Time frame: From Baseline to End of SFU (up to Week 100)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.