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Safety and Efficacy of Oral Brepocitinib in Adults with Lichen Planopilaris: A Randomized, Double‑Blind, Placebo‑Controlled Phase 2/3 Study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at adults with Lichen Planopilaris, a rare condition that causes inflammation and scarring that leads to permanent hair loss on the scalp. The medication being tested is an oral tablet called brepocitinib, taken by mouth once daily. A matching placebo tablet is also used for comparison.

The purpose of the study is to see whether the medication is safe and works better than the placebo in reducing disease activity. Participants will be randomly assigned (placed into groups by chance) to receive either the medication or the placebo for several months, with regular visits to check for side effects, basic health measurements such as blood pressure and heart rate, and any changes in the condition. The study will collect information on how the scalp improves and how participants feel during the trial.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Randomization

    After joining the study you will be randomly assigned to receive either the active medication or a matching placebo tablet.

    Randomization ensures that the assignment is unbiased and that the study can compare the effects of the drug with no active treatment.

  2. Step 2

    Receive Study Medication

    You will be given a tablet to take by mouth (oral use) each day.

    The active tablet contains a dose of 45 mg of brepocitinib tosylate; the placebo tablet contains no active drug but looks the same.

  3. Step 3

    Daily Medication Administration

    Take one tablet every day for the entire treatment period defined by the study protocol.

    The tablet should be swallowed with water and taken at the same time each day to maintain a consistent level of medication in the body.

  4. Step 4

    Regular Study Visits

    Attend scheduled clinic visits throughout the trial (for example, at weeks 4, 12, 24, and so on).

    During each visit your vital signs, a heart test called an electrocardiogram (ECG), and laboratory blood tests will be checked.

  5. Step 5

    Disease Activity Assessments

    At each visit the doctor will evaluate the activity of your Lichen Planopilaris (LPP) skin condition.

    You may also be asked to complete simple questionnaires about your symptoms and how the condition affects you.

  6. Step 6

    Safety Monitoring

    Any side effects or changes in your health will be recorded at every visit.

    Serious side effects, known as serious adverse events, will be reported immediately to the study team.

  7. Step 7

    End of Treatment

    After the planned treatment period you will stop taking the tablet.

    A final assessment will be performed to evaluate your condition and any remaining side effects.

  8. Step 8

    Follow‑Up Period

    A post‑treatment visit may be scheduled to check for any lasting effects after you have stopped the medication.

    This visit helps the study determine the long‑term safety of the treatment.

Who can join the trial?

4 criteria

  • Be 18 years old or older, regardless of gender.
  • Have a tissue sample (a biopsy) that shows signs of Lichen Planopilaris, the condition being studied.
  • Currently have active disease, meaning the condition is still present and not completely resolved.
  • Weigh more than 40 kilograms but less than 130 kilograms, and have a body mass index (BMI) of 45 or lower (BMI is a measure that compares weight to height).

Who cannot join the trial?

6 criteria

  • Having a history of or currently having lymphoproliferative disorder, which means a disease where the immune system makes too many certain white blood cells.
  • Having an active malignancy, meaning a cancer that is currently present and growing.
  • Having any cancer in the past five years, except for certain skin cancers (basal cell carcinoma, squamous cell carcinoma), early‑stage breast cancer (ductal carcinoma in situ), early‑stage cervical cancer (carcinoma in situ of the uterine cervix), or thyroid cancer.
  • Having had a blood clot (thrombosis) or a stroke or similar brain blood‑flow problem (cerebrovascular ischemic event) in the last 12 months.
  • Being at high risk for herpes zoster reactivation, which is the return of shingles.
  • Having an active infection or a recent infection.
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Investigated drugs

brepocitinib is an oral tablet being studied as a potential treatment for adults with lichen planopilaris, a condition that causes scarring hair loss on the scalp. In this trial, participants take the tablet by mouth to see if the medicine can safely reduce the signs and symptoms of the disease and improve hair health. The study is looking at both how well the drug works and whether it is tolerated without serious side effects.

What is already known about the treatment

  • Placebo tablet to match 45 mg brepocitinib tablet.

    This is an oral tablet that contains no active drug and is made to look the same as the brepocitinib tablet. It is used only in clinical studies as a control to compare the effects of the real medicine. The tablet has no therapeutic use and does not affect the body, so it has no mechanism of action or drug class. It is not a marketed medication and exists solely for research purposes.

  • brepocitinib

    This is a 45 mg oral tablet taken by mouth, formulated as a small solid pill. The drug is still under investigation and has not yet received full market approval, although it is designated as an orphan drug for a rare skin condition. It is being studied to treat lichen planopilaris, a disease that causes scarring hair loss. Brepocitinib works by blocking two proteins called JAK1 and TYK2, which helps reduce abnormal inflammation in the skin. It belongs to the class of medicines known as Janus kinase (JAK) inhibitors.

Investigated diseases

Lichen Planopilaris - It is a chronic inflammatory condition that causes scarring hair loss on the scalp. The disease starts with redness, itching, and small bumps around hair follicles. Over time the inflammation destroys the follicles, leading to permanent loss of hair in the affected areas. New patches can appear, and the affected skin may become smooth and shiny. Symptoms may fluctuate, with periods of worsening followed by relative calm.
Trial detailsLast updated 8 Nov 2026
Age18+ yearsPhasePhase IVTrial ID2025-524656-56-01Protocol codePVT-2201-304Estimated enrolment273 patientsSponsorPriovant Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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