US biotechnology company Priovant Therapeutics announced on Monday that the first patients have been enrolled in CLARITY, a Phase 3 study assessing brepocitinib in non-anterior non-infectious uveitis (NIU).

Brepocitinib has also received Fast Track Designation for NIU from the US Food and Drug Administration (FDA). A potential first-in-class dual selective inhibitor of TYK2 and JAK1 under evaluation for multiple highly morbid orphan autoimmune diseases, brepocitinib is administered as an oral therapy dosed once daily.

CLARITY, a global multi-centre Phase 3 programme, compares brepocitinib 45mg to placebo in patients with non-anterior NIU. It includes two sub-studies under a single protocol with 150 patients in each sub-study (300 subjects total) randomised 1:1 to brepocitinib 45mg and placebo, with a primary endpoint of Time to Treatment Failure. Patients will be enrolled at sites in the United States, Europe, Asia, Australia and South America. The commencement of CLARITY follows an End of Phase 2 Meeting with the FDA.

Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, CLARITY investigator and Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Paediatrics at Stanford University School of Medicine, said: "Non-infectious uveitis is a devastating disease that, if inadequately managed, often leads to irreversible visual impairment or blindness. Current treatment options fail to meet many patients' needs, and brepocitinib's striking Phase 2 results from the NEPTUNE Study suggest that it has the potential to serve as a transformative therapy in controlling inflammation and improving visual acuity."