Brepocitinib clears Phase 3 uveitis trials for Priovant and Roivant

Pooled data from the CLARITY-1 and CLARITY-2 studies show 62% of patients on the drug reached steroid-free quiescence at Week 48, versus 20% on placebo

Roivant Sciences and its subsidiary Priovant Therapeutics said brepocitinib met its primary endpoint and all key secondary endpoints in both Phase 3 trials of the drug in non-infectious uveitis, an inflammatory eye condition.

Across the pooled CLARITY-1 and CLARITY-2 studies, 62% of patients on brepocitinib reached steroid-free quiescence at Week 48, compared with 20% on placebo. Median time to treatment failure exceeded 48 weeks in patients on the drug, versus roughly 12 weeks on placebo in each study.

Priovant plans to file a supplemental New Drug Application for brepocitinib in uveitis in the first half of 2027.

The result marks the third positive pivotal readout for brepocitinib in just over a year, after a priority-reviewed filing in dermatomyositis with a decision due in the third quarter of 2026, and positive Phase 2 data in cutaneous sarcoidosis that is moving into a pivotal study. Adding uveitis extends the drug's label ambitions beyond its lead indication before any approval has been granted, and strengthens the case that its mechanism works across several inflammatory conditions rather than just one. The uveitis filing timeline sits about a year behind the dermatomyositis one, so the nearest catalyst for investors remains that late-2026 decision.