Roivant and Priovant Announce Positive Results in CLARITY-1 and CLARITY-2 Phase 3 Trials for Brepocitinib in Non-Infectious Uveitis (NIU)
Roivant and subsidiary Priovant announced that brepocitinib met the primary endpoint in both Phase 3 CLARITY trials in non-infectious uveitis, with statistically significant benefit on all key secondary endpoints (p<0.0001). Median time to treatment failure exceeded 48 weeks on brepocitinib versus roughly 12 weeks on placebo, and 62% of pooled patients achieved steroid-free quiescence at Week 48 versus 20% on placebo. Macular edema resolution was 42% versus 4.8% on placebo.
Key figures
- Drug Name
- brepocitinib (LISRAYA)
- Phase Of Trial
- Phase 3
- Nda filing window
- H1 2027
- Niu us prevalence
- 70,000 to 190,000 adults
- Patients enrolled
- 371
- Ae discontinuations
- 3%
- Hazard ratio treatment failure
- 0.27 (CLARITY-1), 0.22 (CLARITY-2), p<0.0001 both
- Median time to treatment failure
- >48 weeks brepocitinib vs ~12 weeks placebo
- Pooled steroid free quiescence week48
- 62% vs 20% placebo (p<0.0001)
- Pooled macular edema resolution week48
- 42% vs 4.8% placebo (p<0.0001)
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.