A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)
Status:
Not yet recruiting
Trial end date:
2025-01-25
Target enrollment:
Participant gender:
Summary
Thyroid eye disease (TED) is a rare autoimmune, inflammatory disorder of the orbit and
represents the most common extra-thyroidal manifestation of Graves' disease (GD). Several
lines of evidence suggest an important role of interleukin-17A (IL-17A) in the pathogenesis
of TED; increased levels of IL-17A have been detected in the serum and tears of patients with
TED and IL-17A levels correlate with clinical activity of the disease. Th17 cells (as well as
other cellular sources of IL-17A, e.g. Tc17 cells)have been shown to infiltrate the orbital
tissue of affected patients, producing IL-17A. IL-17A stimulates fibroblast activation,
leading to retrobulbar tissue expansion and orbital fibrosis, which causes significant
functional impairment. Secukinumab is a recombinant high-affinity fully human monoclonal
anti-IL-17A antibody currently approved for the treatment of 3 inflammatory/ autoimmune
diseases: moderate to severe plaque psoriasis (PsO), psoriatic arthritis (PsA), and axial
spondyloarthritis (axSpA) (ankylosing spondylitis (AS) and non-radiographic axSpA). The
purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 mg s.c. in
adults with active, moderate to severe TED.