A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
405 patients around the world
Available in Argentina
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and
axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin
(Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of
interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23
receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine
production. This study will consist of a screening phase (up to 6 weeks), a treatment
phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and
an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up
phase (up to Week 60). The efficacy assessments will include assessment such as Bath
Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments
will include evaluations of physical examinations, vital signs, electrocardiograms,
clinical laboratory tests, and adverse events. The overall duration of the study will be
up to 14 months.