A phase 2/3 trial will test brepocitinib, an oral Janus kinase (JAK) inhibitor, in patients with moderate to severe lichen planopilaris — a form of inflammatory scarring alopecia that has never had an FDA-approved systemic therapy.

Dermatology Times reported the trial announcement. If the drug succeeds, it could become the first FDA-approved systemic treatment for the condition.

Why LPP Is Hard to Treat

Lichen planopilaris (LPP) causes pain, burning and itching on the scalp. It also produces permanent scarring and permanent hair loss. Because the scarring destroys follicles, treatment delays carry real consequences — a point that shapes how dermatologists talk about the disease.

The trial targets patients whose disease is moderate to severe and, in many cases, extensive or unresponsive to other options. Because brepocitinib is taken by mouth, it could treat the disease "from the inside out," according to Kristen Lo Sicco, MD, associate professor of dermatology at the Ronald O. Perelman Department of Dermatology at NYU Langone Health.

The Mechanism

Lo Sicco explained that the JAK-STAT pathway plays a key role in the inflammation behind LPP. Brepocitinib is designed to calm that pathway. Earlier research supports the approach, including studies of topical JAK inhibitors in frontal fibrosing alopecia, a related condition.

The drug has already shown success in two other rare conditions: dermatomyositis and cutaneous sarcoidosis.

Who Qualifies, and How Success Gets Measured

The study enrolls patients with both symptoms — itching, pain, burning or abnormal scalp sensations — and visible signs of inflammation, such as redness and scaling around hair follicles. Investigators confirm those signs through clinical exam and trichoscopy, a magnified view of the scalp.

The primary endpoint is a new, validated Investigator Global Assessment (IGA) built specifically for LPP. The goal: patients reach quiet or nearly quiet disease, along with real symptom relief, after six months of treatment. Researchers developed the IGA to meet FDA standards for a possible approval. The Lichen Planopilaris Activity Index will serve as a secondary measure.

The Boxed-Warning Question

Oral JAK inhibitors carry boxed warnings, so safety is part of the conversation. Lo Sicco cited a meta-analysis that found no statistically significant increase in major heart-related events or blood-clot risk among dermatology patients taking JAK inhibitors. She added two caveats: choosing the right patients still matters, and longer-term data is needed.

A Practical Upside: Insurance

Beyond the science, Lo Sicco sees an administrative benefit. Physicians prescribing JAK inhibitors for alopecia areata have already run into insurance delays, and an FDA approval for LPP could shorten them.

"I'm really hoping that the FDA approval will help to break down some barriers regarding timely insurance approval," she said. "So that means a short period of time between me putting in the prescription and the patient actually getting the medication in their hands. Like we said, time is of the essence."

While the trial runs, Lo Sicco points patients to the Scarring Alopecia Foundation as a resource for information on LPP and treatments in development. For a disease where follicular scarring is irreversible, the pace of both the trial and the approvals that follow will determine how many patients keep their hair.