Phase 2 trial of brepocitinib in cutaneous sarcoidosis planned
Roivant Sciences said study should begin between April and June
Roivant Sciences is planning to launch a Phase 2 clinical trial this year to test its experimental oral therapy brepocitinib in adults with cutaneous sarcoidosis.
The company said it expects to start the trial between April and June, and that the study’s results should become available in the second half of 2026. Roivant didn’t provide further details about the study’s design.
“Roivant has broadened our clinical pipeline with the newly announced trial of brepocitinib in cutaneous sarcoidosis,” Matt Gline, CEO of Roivant, said in a company press release.
In sarcoidosis, inflammatory clumps of immune cells called granulomas form in tissues. In cutaneous sarcoidosis, these inflammatory cell clumps specifically affect the skin. According to Roivant, there are 30,000 to 50,000 people with cutaneous sarcoidosis in the U.S. and no approved treatment.
Testing brepocitinib
Brepocitinib works by blocking the activity of two proteins, TYK2 and JAK1, that are integral to the inflammatory activation of certain types of immune cells. By blocking them, the therapy should reduce immune cell activity, thereby dampening the inflammation that drives the disease.
The experimental therapy is already being tested in people with two other inflammatory disorders: dermatomyositis, a condition marked by inflammation of the muscles and skin, and non-infectious uveitis, a disease characterized by eye inflammation. Brepocitinib was being tested in lupus, an autoimmune disease, but its development in that condition was stopped following poor results from a clinical trial.
“As with dermatomyositis and non-infectious uveitis, brepocitinib has the potential to be a first-in-class agent for [cutaneous sarcoidosis] and expands the treatment options for patients suffering from an indication with high unmet need,” Gline said.
The study will not be Roivant’s first foray into sarcoidosis. Through its subsidiary Kinevant Sciences, the company was developing namilumab as a possible treatment for pulmonary sarcoidosis, a form of the disease that affects the lungs.
The development of namilumab for sarcoidosis was discontinued last year after disappointing results from a Phase 2 trial called RESOLVE-Lung study (NCT05314517), which failed to show that the treatment yielded any benefit to patients.
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