Roivant Sciences (ROIV) Study result summary

Trial design

• CLARITY-1 and CLARITY-2 were identical Phase 3 trials enrolling 371 adults with active, non-anterior NIU; participants received brepocitinib 45 mg once daily or placebo for 48 weeks.

• The primary endpoint was time to treatment failure from Week 6 to Week 48; oral corticosteroids started at 60 mg, then tapered to zero by Week 8.

Primary efficacy

• Both trials met the primary endpoint; median time to treatment failure exceeded 48 weeks with brepocitinib versus 13 weeks in CLARITY-1 and 12 weeks in CLARITY-2 (HR 0.27 and 0.22; p<0.0001 in both).

• Pooled Week 48 treatment failure was 33.5% with brepocitinib versus 78.2% with placebo; among prior-TNFi patients, rates were 38.1% versus 77.5%.

Secondary outcomes

• Pooled Week 48 steroid-free quiescence was 62% with brepocitinib versus 20% with placebo; results were consistent across subgroups.

• Pooled macular edema resolution was 42% with brepocitinib versus 4.8% with placebo; FA response and VFQ-25 response also improved, and all key secondary endpoints were statistically significant in both trials.