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Roivant Sciences (ROIV) investor relations material

Roivant Sciences Study result summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Study result summary21 Oct, 2026

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.

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