Roivant reports positive Phase 3 CLARITY-1 and CLARITY-2 results for brepocitinib in non-infectious uveitis, with 62% achieving steroid-free quiescence at Week 48.
Written By: Khushi Patel, PharmD
Reviewed By: Pharmacally Editorial Team
Roivant Sciences and Priovant Therapeutics have reported positive topline results from the Phase 3 CLARITY program evaluating brepocitinib in adults with non-infectious uveitis (NIU). The oral TYK2/JAK1 inhibitor met the primary endpoint of time to treatment failure in both CLARITY-1 and CLARITY-2 and achieved statistically significant improvements across all key secondary endpoints, including steroid-free disease control, chorioretinal vascular leakage, macular edema resolution and patient-reported visual functioning.
The findings support Priovant’s plan to submit a supplemental New Drug Application (sNDA) for NIU in the first half of 2027. If approved, brepocitinib could offer another systemic, non-steroid treatment option for patients with this potentially vision-threatening inflammatory condition.
CLARITY Trials Show Consistent Efficacy
The CLARITY program enrolled 371 patients across two identical Phase 3 studies. Participants were randomized to receive brepocitinib 45 mg once daily or placebo during a 48-week double-masked treatment period. All participants received an eight-week oral corticosteroid regimen, including a mandatory six-week taper to zero.
The primary endpoint was time to treatment failure, assessed from Week 6 through Week 48. Median time to treatment failure exceeded 48 weeks with brepocitinib in both trials, compared with approximately 12 weeks with placebo. The hazard ratios were 0.27 in CLARITY-1 and 0.22 in CLARITY-2, with p values below 0.0001 in both studies.
These results indicate a substantially lower hazard of treatment failure with brepocitinib during the study period. The separation between treatment groups also suggests that disease control was maintained longer despite the planned withdrawal of corticosteroids.
Steroid-Free Quiescence and Other Secondary Endpoints
Across the pooled studies, 62% of patients receiving brepocitinib achieved steroid-free quiescence in both eyes at Week 48, compared with 20% receiving placebo (p<0.0001). Trial-level response rates were 58.8% versus 19.8% in CLARITY-1 and 64.4% versus 19.4% in CLARITY-2.
Brepocitinib also improved measures of ocular inflammation and visual functioning:
- Chorioretinal vascular leakage: Among eyes with elevated baseline fluorescein angiography scores, 39.4% in CLARITY-1 and 54.9% in CLARITY-2 achieved a reduction of at least 30%, compared with 8.6% and 7.2%, respectively, with placebo.
- Macular edema resolution: Among eyes with macular edema at baseline, resolution at Week 48 occurred in 40.4% and 42.6% of brepocitinib-treated eyes in CLARITY-1 and CLARITY-2, respectively. The corresponding placebo rates were 2.1% and 7.0%.
- Patient-reported visual functioning: At least a five-point improvement in the NEI VFQ-25 overall composite score occurred in 36.4% of eligible participants in CLARITY-1 and 40.4% in CLARITY-2, compared with 13.7% and 14.1% with placebo.
Together, these findings extend the efficacy signal beyond time to treatment failure to measures of inflammatory control, macular edema and vision-related quality of life. However, the reported results are topline findings, and their interpretation remains subject to the detailed clinical dataset and subsequent regulatory review.
Safety Profile and Regulatory Outlook
Brepocitinib was generally well tolerated during the treatment period. Most adverse events were mild or moderate, and 3% of participants discontinued treatment because of an adverse event. The company reported no new safety signals compared with previous clinical experience.
Brepocitinib inhibits TYK2 and JAK1, two kinases involved in inflammatory signalling. The dual mechanism provides the rationale for evaluating the drug across autoimmune and inflammatory conditions.
The drug is marketed in the United States as LISRAYA for adults with dermatomyositis. NIU remains a potential additional indication and is not yet an approved use.
What the Results Mean for NIU Treatment
The consistency of the primary endpoint across two Phase 3 trials, alongside improvements in steroid-free quiescence and other secondary measures, strengthens the evidence supporting brepocitinib’s development for NIU. The corticosteroid taper is also clinically relevant because sustained disease control after steroid withdrawal is an important treatment objective.
Nevertheless, the company-reported findings do not establish superiority over all existing treatments or demonstrate that brepocitinib will become a new standard of care. The planned sNDA submission in the first half of 2027 represents the next regulatory milestone, with the eventual indication and prescribing information dependent on FDA review.
Reference
Roivant and Priovant Announce Positive Results in CLARITY-1 and CLARITY-2 Phase 3 Trials for Brepocitinib in Non-Infectious Uveitis (NIU), Roivant, 21 October 2026
A Study of Brepocitinib in Adults with Active, Non-Infectious, Non-Anterior Uveitis (CLARITY), ClinicalTrials.gov ID NCT06431373
About the Writer
Khushi Patel is a Pharm.D (Linkedin) professional with a strong foundation in clinical pharmacy, patient-centered care, regulatory affairs, and pharmacovigilance, with published work on Brugada syndrome.
Her interests include regulatory affairs, pharmacovigilance, guideline integration, multimodal therapy, pharmacogenomics, and antibiogram utilization, with a focus on evidence-based clinical decision-making and medication safety.
As a Pharmacally healthcare writer, she translates clinical and scientific evidence into clear, accurate, and clinically relevant healthcare content, while continuously developing her expertise in evolving pharmacy practice.