Roivant and Priovant Announce Positive Results in CLARITY-1 and CLARITY-2 Phase 3 Trials for Brepocitinib in Non-Infectious Uveitis (NIU)
Key Highlights
- ➤Brepocitinib 45 mg achieved statistically significant primary endpoint benefits in both Phase 3 NIU trials
- ➤Median treatment-failure time exceeded 48 weeks with brepocitinib versus approximately 12 weeks on placebo
- ➤Brepocitinib resolved baseline macular edema in 40.4% and 42.6% of eyes at Week 48
- ➤Only 3% of participants discontinued treatment due to adverse events; no new safety signals emerged
- ➤Priovant intends to file an NIU supplemental New Drug Application in the first half of 2027
Expert Statements
Ben Zimmer, CEO of Priovant
“The breadth and magnitude of benefit seen in the CLARITY studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis”
Ben Zimmer, CEO of Priovant
“With LISRAYA now commercially available for adults with dermatomyositis, we see NIU as the potential next pillar of a leading rare disease immunology franchise. I would like to thank all of the investigators and patients who participated in the CLARITY trials, without whom this moment would not be possible.”
* Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIU * Median time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p<0.0001 in both studies), including 40 weeks of steroid-free treatment, setting a new bar for time to failure and steroid-sparing benefit in NIU * Pooled across the CLARITY studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo (p<0.0001), with similar results in each study * Of patients that entered the CLARITY studies (pooled) with macular edema, 42% of eyes on brepocitinib achieved resolution of macular edema at Week 48, compared with 4.8% on placebo (p<0.0001), with similar results in each study * The magnitude and breadth of benefit observed across every ranked endpoint, compared with results reported in registrational trials of existing NIU therapies, suggest brepocitinib has the potential to be the most effective systemic, non-steroid treatment option for NIU * Safety data consistent with prior brepocitinib clinical trials; no new safety signals or findings * Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for the treatment of NIU in the first half of calendar year 2027 * Roivant will host an investor call to discuss these updates today, October 21, 2026, at 8:00 a.m. ET BASEL, Switzerland and LONDON and NEW YORK and DURHAM, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq:ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). Brepocitinib met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies. Brepocitinib 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. These results were achieved despite a substantially more aggressive steroid taper than precedent NIU trials.
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