Priovant Starts Phase 3 Study of Brepocitinib in Cutaneous Sarcoidosis

First Patients Enrolled in BEACON+ Study

Priovant Therapeutics has started its phase 3 clinical study evaluating brepocitinib in adults with cutaneous sarcoidosis (CS), a rare inflammatory skin disease that can cause permanent skin and tissue damage.

The first patients have now been enrolled in the BEACON+ study. The trial follows positive results from the earlier phase 2 BEACON study, which was the first placebo-controlled study in cutaneous sarcoidosis to report positive results.

The earlier findings also supported the US Food and Drug Administration's decision to grant brepocitinib Breakthrough Therapy Designation for cutaneous sarcoidosis.

What Is the BEACON+ Study?

BEACON+ is a global phase 3 study that will evaluate the safety and effectiveness of brepocitinib in approximately 140 patients with cutaneous sarcoidosis.

The study will be conducted at around 70 sites worldwide. Patients will be randomly assigned in a 3:2 ratio to receive either brepocitinib 45 mg once daily or placebo.

The main goal of the study is to see how many patients achieve at least a 50% reduction in their Cutaneous Sarcoidosis Activity and Morphology Instrument–Activity Score, known as CSAMI-A, by Week 16.

The trial is being conducted as Part B of the earlier BEACON study.

Priovant currently expects to report topline results from BEACON+ in 2028.

Earlier Phase 2 Results Showed a Clear Treatment Difference

The decision to move brepocitinib into phase 3 development follows encouraging results from the phase 2 BEACON trial.

In that study, 77% of patients receiving brepocitinib 45 mg achieved at least a 50% reduction in the CSAMI-A score.

In comparison, none of the patients receiving placebo achieved the same endpoint.

These results provided the clinical basis for continuing the development program in a larger phase 3 study.

Cutaneous Sarcoidosis Can Cause Permanent Damage

Cutaneous sarcoidosis is an inflammatory granulomatous disease that affects the skin.

The condition affects approximately 40,000 adults in the United States and disproportionately affects Black Americans.

For some patients, the disease is more than a skin problem. If it is not treated properly, cutaneous sarcoidosis can progress quickly and cause permanent scarring.

It can also damage structures such as bone, cartilage and hair follicles.

Despite the burden of the disease, there are currently no FDA-approved treatments specifically for cutaneous sarcoidosis.

This leaves many patients with limited treatment options and a significant unmet medical need.

Priovant Is Expanding Brepocitinib Into Several Rare Diseases

The BEACON+ study is part of a broader development program for brepocitinib.

Priovant is studying the drug across several rare autoimmune and inflammatory diseases where patients have significant disease burden and limited treatment options.

In dermatomyositis, brepocitinib's New Drug Application is currently under Priority Review by the FDA. The application follows positive results from the phase 3 VALOR study, with a Prescription Drug User Fee Act target action date expected later this quarter.

The company is also developing brepocitinib for non-infectious uveitis. The phase 3 CLARITY study is expected to report results later in 2026.

Another phase 2/3 study is evaluating brepocitinib in lichen planopilaris, a condition that can cause inflammation and permanent hair loss.

With the start of BEACON+, brepocitinib's orphan disease development program now includes four indications with ongoing or completed registrational studies.

Priovant Sees Brepocitinib as a Potential Treatment Across Rare Diseases

Priovant CEO Ben Zimmer said the company wants to establish brepocitinib as an important treatment option for several rare diseases where patients have a high disease burden and few available therapies.

The company is also preparing for a potential approval and launch of brepocitinib in dermatomyositis, which could become an important milestone for the broader development program.

The company plans to continue developing brepocitinib in additional diseases where patients face serious complications and limited treatment choices.

How Brepocitinib Works

Brepocitinib is an oral therapy designed to block two signaling proteins involved in autoimmune inflammation: TYK2 and JAK1.

By targeting both pathways, brepocitinib is designed to reduce the activity of several cytokines that are involved in autoimmune diseases.

These include type I interferon, type II interferon, IL-6, IL-12 and IL-23.

The drug is being developed as a once-daily oral treatment, which could provide a simpler treatment option for patients compared with some injectable or more complex therapies.

What Comes Next for BEACON+

The BEACON+ study will now continue enrolling patients across its global clinical trial sites.

Researchers will evaluate whether brepocitinib can produce meaningful improvements in skin disease activity compared with placebo while continuing to assess its safety and tolerability.

The primary assessment will take place at Week 16, with topline results currently expected in 2028.

The data from BEACON+ will help determine whether the positive findings from the phase 2 BEACON study can be confirmed in a larger phase 3 patient population.

About Priovant Therapeutics

Priovant Therapeutics is a biotechnology company focused on developing treatments for autoimmune diseases that can cause serious disability and have limited treatment options.

The company's lead drug candidate is brepocitinib, a selective TYK2 and JAK1 inhibitor being studied across multiple rare autoimmune and inflammatory diseases.

Through its development program, Priovant is targeting conditions where uncontrolled inflammation can lead to significant disease progression, permanent tissue damage and major impacts on patients' daily lives.

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