Roivant Sciences Ltd. announced on October 21, 2026, that its subsidiary, Priovant Therapeutics, Inc., has reported positive results from the Phase 3 CLARITY program evaluating brepocitinib for the treatment of non-infectious uveitis (NIU). The program consisted of two identical trials, CLARITY-1 and CLARITY-2, which enrolled a total of 371 patients. Patients were randomized 1:1 to receive once-daily brepocitinib 45 mg or placebo for a 48-week treatment period.
The primary endpoint of the study was time to treatment failure. Brepocitinib demonstrated statistically significant benefits compared to placebo in both studies. In CLARITY-1, the hazard ratio for treatment failure was 0.27 (95% CI: 0.17–0.43), and in CLARITY-2, the ratio was 0.22 (95% CI: 0.14–0.34), with p-values less than 0.0001 in both cases. The cumulative incidence of treatment failure at Week 48 was significantly lower for brepocitinib patients in both trials.
Secondary endpoints included sustained steroid-free quiescence, improvement in chorioretinal vascular leakage, resolution of macular edema, and improvement in patient-reported visual functioning. Across the pooled studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared to 20% on placebo. Similarly, among eyes with macular edema at baseline, 42% on brepocitinib achieved resolution at Week 48, compared to 4.8% on placebo.
Safety data from the trials showed that brepocitinib was generally well tolerated. Most events were mild or moderate in severity, and only 3% of participants discontinued treatment due to adverse events. The safety profile was consistent with prior clinical trials, with no new safety signals observed.
Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib in the first half of calendar year 2027. Roivant will host an investor call on October 21, 2026, at 8:00 a.m. ET to discuss these results.
