Roivant and Priovant report positive Phase 3 results for brepocitinib in uveitis

Roivant Sciences and Priovant Therapeutics announced on October 21, 2026 that brepocitinib met its goals in both Phase 3 trials of the CLARITY program for non-infectious uveitis (NIU). Brepocitinib met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies, and also achieved statistically significant and clinically meaningful benefit on all key secondary endpoints, including measurements of sustained steroid-free quiescence at Week 48, chorioretinal vascular leakage, resolution of macular edema and patient-reported visual functioning.¹

The companies said the CLARITY program enrolled 371 patients across two identical studies, CLARITY-1 and CLARITY-2.¹ Patients were assigned in equal numbers to either daily brepocitinib at 45 mg or placebo across a 48-week period in which treatment assignment was masked.¹ All participants also received an eight-week course of oral corticosteroids, starting at 60 mg per day for two weeks, then stepping down over six additional weeks until reaching zero.¹ The primary endpoint was time to treatment failure, assessed from Week 6 through Week 48.¹

On efficacy, the hazard ratio for treatment failure versus placebo was 0.27 in CLARITY-1 and 0.22 in CLARITY-2 (both p<0.0001), with steroid-free quiescence in both eyes reached by 58.8% of brepocitinib patients versus 19.8% on placebo in CLARITY-1, and 64.4% versus 19.4% in CLARITY-2.¹

On safety, brepocitinib was generally well tolerated, with most adverse events mild or moderate and only 3% of participants discontinuing treatment due to an adverse event, with no new safety signals observed compared to prior studies.¹

Priovant intends to file a supplemental New Drug Application for brepocitinib in NIU during the first half of calendar year 2027.¹ Priovant Therapeutics is described in the filing as a Roivant company.¹