Priovant Therapeutics has dosed the first patients in CLARITY, a phase 3 trial investigating brepocitinib for non-anterior non-infectious uveitis (NIU). The US Food and Drug Administration (FDA) has granted fast track designation to brepocitinib for NIU, aiming to speed up its development.
The CLARITY trial follows a successful phase 2 study (NEPTUNE), which demonstrated dose-dependent improvements in retinal vascular leakage. These findings, presented at the EURETINA conference in September, highlight brepocitinib’s potential as a first-in-class dual TYK2 and JAK1 inhibitor to treat this severe condition.
The CLARITY trial will enroll 300 patients worldwide, comparing brepocitinib 45 mg to placebo, with the primary endpoint being time to treatment failure. If successful, brepocitinib could offer a new therapeutic option for patients suffering from NIU, a disease that can lead to blindness if not properly treated.