• At Week 16, 69% of participants receiving brepocitinib 45 mg achieved "Clear" or "Almost Clear" skin, with at least a 2-category improvement, compared with 0% receiving placebo
• Improvements in skin disease activity were evident as early as Week 4, increased over time, and were accompanied by benefits on skin-related quality of life
• Brepocitinib was well tolerated during the 16-week study period, with no serious adverse events (SAEs)
• Findings support ongoing Phase 3 BEACON+ study in cutaneous sarcoidosis; topline data expected in calendar year 2028
• Results of the study will be shared by Dr. Misha Rosenbach, MD, in an oral presentation at ACR Convergence 2026 today, November 10
  
  

DURHAM, N.C., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics today announced the publication in JAMA Dermatology of results from the Phase 2 portion of the BEACON study, a randomized, double-blind, placebo-controlled trial evaluating oral brepocitinib in adults with cutaneous sarcoidosis (CS). The publication describes improvements in skin disease activity and skin-related quality of life over 16 weeks of treatment, with 69.2% of participants receiving brepocitinib 45 mg once daily achieving “Clear” or “Almost Clear” skin with at least a 2-category improvement, compared with none of the participants receiving placebo (P = 0.0047).

CS is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. The condition disproportionately impacts Black Americans, and unlike most inflammatory skin diseases, 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 CS.

“Cutaneous sarcoidosis is often on the face and severely impacts patients, and there are no approved treatments,” said Dr. Misha Rosenbach, MD, Professor of Dermatology and Rheumatology and Director of the Cutaneous Sarcoidosis Program at the Hospital of the University of Pennsylvania. “This is the largest study in skin sarcoidosis to date, and the result were striking – seeing clear or almost clear skin in more than two-thirds of patients on brepocitinib demonstrates dramatic improvement and was backed by multiple metrics showing this improved patients’ symptoms and quality of life. These published findings bring rigorous clinical evidence to a historically neglected disease and patient population and offer a compelling reason to believe that a fundamentally different future with more targeted, effective treatments may be possible for our patients.”

The publication, “Efficacy and Safety of Brepocitinib in Cutaneous Sarcoidosis: A Phase 2 Randomized Clinical Trial,” reports results from the Phase 2 dose-ranging portion of BEACON. Thirty-one adults were randomized to brepocitinib 45 mg (n=13), brepocitinib 15 mg (n=11), or placebo (n=7), administered once daily, for 16 weeks of double-blinded treatment.

Both brepocitinib doses demonstrated improvement on the primary endpoint, change from baseline in the Cutaneous Sarcoidosis Activity and Morphology Instrument-Activity (CSAMI-A) score at Week 16. Mean reductions were 22.3 points with 45 mg and 22.2 points with 15 mg, compared with 0.7 points with placebo (P<0.0001 for each comparison). Improvements were evident by Week 4 and increased through Week 16. Across increasingly stringent responder-based and cutaneous remission-oriented endpoints, efficacy consistently favored brepocitinib 45 mg, supporting a dose-dependent treatment effect.

Additional Week 16 findings for brepocitinib 45 mg included:

• Clear or Almost Clear skin: 69.2% achieved a Cutaneous Sarcoidosis Activity-Investigator Global Assessment score of “Clear” or “Almost Clear,” with at least a two-category improvement, compared with 0% on placebo.
• At least 50% improvement in skin disease activity: 76.9% achieved a reduction of at least 50% in CSAMI-A, compared with 0% on placebo.
• At least a 10-point improvement in CSAMI-A: 100% achieved a reduction of at least 10 points in CSAMI-A, compared with 14.3% on placebo.
• Low residual skin disease activity: 61.5% achieved a CSAMI-A score less than 5, compared with 0% on placebo.
  
  

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

Brepocitinib was well tolerated during the study treatment period, with no serious adverse events (SAEs).

Priovant is evaluating brepocitinib 45 mg once daily for CS in the ongoing Phase 3 portion of the BEACON study (BEACON+). Topline data from BEACON+ is expected in calendar year 2028.

About BEACON +

BEACON+ is the Phase 3 portion of the BEACON trial evaluating brepocitinib in patients with cutaneous sarcoidosis. BEACON+ is enrolling approximately 140 patients with cutaneous sarcoidosis across ~70 sites globally. Patients will be randomized 3:2 between brepocitinib 45mg 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.

About Priovant

Priovant Therapeutics is a biotechnology company dedicated to developing and commercializing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company’s commercial product, LISRAYA™ (brepocitinib), is the first and only targeted oral therapy approved for the treatment of adults with dermatomyositis. See important LISRAYA safety information, including boxed warning, at lisrayahcp.com/pi. Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, recently generated positive Phase 3 data in non-infectious uveitis (NIU). In addition to the phase 3 program in cutaneous sarcoidosis, brepocitinib is also under evaluation in a Phase 2b/3 program in lichen planopilaris. These potential indications have not been approved by the FDA. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.

Contact

Stephanie Lee: stephanie.lee@priovant.com