Brepocitinib Demonstrates Superior Efficacy in Phase 2 BEACON Trial for Cutaneous Sarcoidosis

Priovant Therapeutics has announced positive phase 2 results for brepocitinib in cutaneous sarcoidosis (CS), marking a significant milestone in a disease area with substantial unmet need and no approved therapies.¹ The findings come from the BEACON study, the first industry-sponsored, randomized, placebo-controlled clinical trial in CS to demonstrate clear efficacy. A pivotal phase 3 program is planned to begin later in 2026, following FDA engagement.

Background and Study Design

Cutaneous sarcoidosis is a chronic granulomatous inflammatory skin disease affecting an estimated 40,000 adults in the US.² Lesions are frequently persistent, disfiguring, and psychologically distressing, with a major negative impact on quality of life. In the absence of approved treatments, management typically relies on prolonged off-label use of systemic corticosteroids, immunosuppressants, or biologics, which often provide incomplete control and are associated with cumulative toxicity.

The BEACON study was designed to address this therapeutic gap by rigorously evaluating brepocitinib, a dual selective TYK2 and JAK1 inhibitor, in this underserved population. BEACON was a multicenter, 16-week phase 2 trial enrolling 31 patients across 15 US sites. Participants were randomized in a 3:2:2 ratio to once-daily brepocitinib 45 mg, brepocitinib 15 mg, or placebo. Notably, the 45 mg cohort represented the most treatment-refractory population, with higher proportions of patients with longstanding disease, established damage, and plaque-predominant morphology, which is typically more difficult to treat.

Efficacy and Safety Results

The primary efficacy assessment was based on the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity score (CSAMI-A), a validated clinician-rated measure of disease activity. At week 16, patients receiving brepocitinib 45 mg achieved a mean improvement of 22.3 points in CSAMI-A, compared with a 0.7-point improvement in the placebo group, yielding a treatment difference of 21.6 points (p < 0.0001). Statistically significant separation from placebo was observed as early as week 4 and was maintained throughout the treatment period. Importantly, 100% of patients in the 45 mg arm achieved a clinically meaningful response defined as at least a 10-point reduction in CSAMI-A, compared with 14% of placebo-treated patients. Functional remission (CSAMI-A <5) was achieved by 62% of patients in the 45 mg group, whereas no placebo-treated patients reached this threshold.

Patients treated with brepocitinib 15 mg also demonstrated substantial improvement. Mean CSAMI-A reduction at week 16 was 22.2 points, numerically similar to the 45 mg arm on lower-bar endpoints, with 73% achieving a ≥10-point reduction and 46% achieving functional remission. Dose-dependent effects were more apparent on higher-bar endpoints and across patient-reported outcomes, supporting a dose–response relationship.

Physician global assessments reinforced the CSAMI findings. On the Investigator’s Global Assessment (IGA), 69% of patients receiving brepocitinib 45 mg achieved the gold-standard two-point improvement to “Clear” (0) or “Almost Clear” (1), compared with 0% in the placebo group (p = 0.0047). Improvements were also reflected in multiple patient-reported outcome measures, including the King’s Sarcoidosis Questionnaire (KSQ) Skin Domain, Skindex-16, and the Patient’s Global Impression of Change (PGI-C). On PGI-C, all patients treated with brepocitinib 45 mg reported improvement from baseline, compared with 29% of placebo-treated patients (p = 0.0014).

Additionally, brepocitinib was well-tolerated over the 16-week treatment period. No serious adverse effects were reported, and all adverse events were mild or moderate in severity. The observed safety profile is consistent with prior experience in more than 1,500 patients and subjects treated with brepocitinib across clinical programs.

Expert Perspectives

“The BEACON study is a watershed moment for the sarcoidosis field, and most importantly, for our patients,” said 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 an incredible milestone for a historically neglected disease – the study drug showed a clear difference in patients who received the medication compared to placebo, both from the patient and the physician perspective, and appeared to be well tolerated. This is the sort of data you dream of seeing when you look at trial results – and I would call this a transformational moment for sarcoidosis.”¹

Ben Zimmer, CEO of Priovant, shared a similar sentiment in the press release. “We are thrilled with the results of the BEACON study and are excited to rapidly move brepocitinib into Phase 3 development for cutaneous sarcoidosis, I would like to thank all of the patients, investigators, and site staff who participated in the study and made this result possible. With the brepocitinib CS program now moving into Phase 3 alongside the dermatomyositis and non-infectious uveitis programs, Priovant continues to advance our goal of developing brepocitinib as a potentially transformational therapy for patients with highly morbid autoimmune diseases underserved by existing treatment options.”¹

References

1. Priovant Announces Positive Phase 2 Results for Brepocitinib in Cutaneous Sarcoidosis (CS). News release. Globe Newswire. Published February 6, 2026. Accessed February 6, 2026. https://www.globenewswire.com/news-release/2026/02/06/3233726/34323/en/Priovant-Announces-Positive-Phase-2-Results-for-Brepocitinib-in-Cutaneous-Sarcoidosis-CS.html

2. Ungprasert P, Wetter DA, Crowson CS, Matteson EL. Epidemiology of cutaneous sarcoidosis, 1976-2013: a population-based study from Olmsted County, Minnesota. J Eur Acad Dermatol Venereol. 2016;30(10):1799-1804. doi:10.1111/jdv.13760