Brepocitinib Shows Promising Results in Treating Cutaneous Sarcoidosis

Priovant Therapeutics announced the publication of Phase 2 BEACON results for brepocitinib in cutaneous sarcoidosis in JAMA Dermatology. The study showed that at Week 16, 69% of participants receiving brepocitinib 45 mg achieved "Clear" or "Almost Clear" skin, with at least a 2-category improvement, compared to none of the participants receiving placebo. This result was statistically significant (P = 0.0047).

Improvements in skin disease activity were evident as early as Week 4 and increased over time. At Week 16, 76.9% of participants receiving brepocitinib 45 mg achieved at least a 50% improvement in skin disease activity, compared to 0% on placebo. Additionally, 100% of participants receiving brepocitinib 45 mg achieved at least a 10-point improvement in the Cutaneous Sarcoidosis Activity and Morphology Instrument-Activity (CSAMI-A) score, compared to 14.3% on placebo. Furthermore, 61.5% of participants receiving brepocitinib 45 mg achieved a CSAMI-A score less than 5, compared to 0% on placebo.

Participants receiving brepocitinib 45 mg also reported improvements in skin-related quality of life. Mean improvement on the Skindex-16 was 23.5 points, compared to an 8.9-point worsening on placebo. All participants receiving brepocitinib 45 mg reported improvement on the Patient Global Impression of Change, compared to 29% receiving placebo. Post hoc analyses also suggested dose-dependent benefit in participants with lupus pernio, a particularly difficult-to-treat form of cutaneous sarcoidosis.

Brepocitinib was well tolerated during the 16-week study period, with no serious adverse events (SAEs). The findings support ongoing Phase 3 BEACON+ study in cutaneous sarcoidosis, with topline data expected in calendar year 2028. The results of the study will be shared by Dr. Misha Rosenbach, MD, in an oral presentation at ACR Convergence 2026 today, November 10.

Cutaneous sarcoidosis is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. The condition disproportionately impacts Black Americans and can rapidly cause permanent scarring and destruction of bone, cartilage, and hair follicles. Despite this significant unmet therapeutic need, there are currently no FDA-approved therapies for cutaneous sarcoidosis.

The BEACON+ study, the Phase 3 portion of the BEACON trial, is evaluating brepocitinib 45 mg once daily for cutaneous sarcoidosis. The study is enrolling approximately 140 patients with cutaneous sarcoidosis across approximately 70 sites globally. Patients will be randomized 3:2 between brepocitinib 45 mg once daily and placebo. The primary endpoint is the proportion of patients achieving a 50% or greater reduction in the Cutaneous Sarcoidosis Activity and Morphology Instrument, Activity Score (CSAMI-A) at Week 16. Topline data from the BEACON+ study is expected in calendar year 2028.