Brepocitinib Phase 2 trial doses first cutaneous sarcoidosis patients
Sites are still recruiting for proof-of-concept study, primarily testing safety
The first participants in a Phase 2 clinical trial testing brepocitinib, Roivant’s experimental oral treatment, in adults with cutaneous sarcoidosis have been dosed, and top-line results are expected in the second half of 2026.
The company had this year announced plans to launch this proof-of-concept trial, called BEACON (NCT06978725), which is recruiting up to 28 adult patients across four locations across the U.S. The study is designed to evaluate the safety and efficacy of two doses of brepocitinib against a placebo.
“I am incredibly proud of the progress we reported in the final [three months] of this past fiscal year,” Matt Gline, Roivant’s CEO, said in a company press release reporting latest financial results. “We remain focused on building value in our late-stage clinical pipeline.”
Sarcoidosis causes granulomas, which are clumps of inflammatory cells that can damage the involved tissue. When these form in the skin, it is called cutaneous sarcoidosis. This type of sarcoidosis usually manifests as red-brown or purple bumps or raised patches that can appear anywhere on the body.
Brepocitinib is an orally available, small molecule designed to selectively suppress TYK2 and JAK1, two proteins that play a key role in driving the inflammatory response. As such, brepocitinib is expected to reduce inflammation and ease symptoms of sarcoidosis and other inflammatory diseases.
The therapy was licensed in 2021 by Pfizer to Priovant Therapeutics, a Roivant subsidiary of which Pfizer owns 25%.
Brepocitinib is currently in Phase 3 clinical testing for dermatomyositis and noninfectious uveitis, two inflammatory diseases, after Phase 2 clinical data showed it could ease disease activity while being safe.
Priovant launched the BEACON study to test whether brepocitinib can also ease disease activity in people with cutaneous sarcoidosis. Eligible participants must have a diagnosis of cutaneous sarcoidosis confirmed by examining a sample of skin under a microscope, where the tissue shows characteristic features.
Participants must weigh more than 40 kg (about 88 lbs.) and less than 130 kg (about 286 lbs.) and have a Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) activity score of 10 or higher. The CSAMI rates disease activity on a scale from 0-165 points, with higher scores indicating worse disease.
Participants will be randomly assigned to receive either one of two doses of brepocitinib or a placebo, taken once daily for 16 weeks, or about four months.
BEACON’s main goal is to test how safe brepocitinib is. That will be done by monitoring participants for adverse events and serious adverse events from the time of screening up to about one month after the last dose of brepocitinib or the placebo.
The secondary goal is to evaluate changes in CSAMI activity scores after the 16-week treatment period.
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