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A Phase 2/3 Study of the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis

Verified siteInvestigational
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What is this trial about?

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

Cutaneous Sarcoidosis is a rare condition in which small clusters of immune cells form in the skin, causing bumps, redness, or patches that can be uncomfortable or affect appearance. The study is testing an oral medication called brepocitinib, which is taken as a tablet once a day, and it will be compared with a matching placebo tablet that contains no active drug.

The goal of the research is to find out whether the medication can safely reduce the skin symptoms of the disease. Participants will be randomly assigned to receive either the active tablet or the placebo, and neither the participants nor the study staff will know which one is given. Over several months, volunteers will take the assigned tablet each day, attend a few clinic visits for basic health checks, and report any changes in their skin condition. The study will track how the skin lesions change from the start of treatment to the end of the study period.

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

    Baseline Assessment

    After joining the study, you will undergo an initial assessment that includes a review of your medical history, physical examination of the skin, and laboratory tests to establish baseline disease activity of cutaneous sarcoidosis.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either brepocitinib 45 mg tablet or a matching placebo tablet. The study is double‑blind, meaning neither you nor the investigators will know which treatment you receive.

  3. Step 3

    Medication Dispensing

    A supply of tablets will be provided for home use. Instructions will specify taking one tablet by mouth each day as directed by the study protocol.

  4. Step 4

    Daily Treatment

    You will take one tablet daily, at the same time each day, without altering the dose or schedule unless instructed by the study team.

  5. Step 5

    Scheduled Clinic Visits

    At regular intervals during the trial (for example, every four weeks), you will return to the clinic for safety evaluations, blood tests, and examination of skin lesions to monitor progress.

  6. Step 6

    Outcome Assessments

    During each visit, you will complete questionnaires about your symptoms, and the physician will assess disease activity to determine any change from the baseline measurement.

  7. Step 7

    End of Treatment

    After the predetermined treatment period, you will stop taking the study tablets and undergo a final assessment of safety and disease activity.

  8. Step 8

    Post‑Treatment Follow‑up

    A follow‑up visit may be scheduled after treatment ends to observe any lasting effects and to ensure your health remains stable.

Who can join the trial?

4 criteria

  • Be 18 years of age or older, regardless of gender.
  • Have a tissue sample (a biopsy) that shows the signs of Cutaneous Sarcoidosis.
  • Have currently active disease, meaning symptoms are present at the time of screening.
  • Weigh more than 40 kilograms but less than 130 kilograms, and have a body mass index (BMI) of 45 or lower; BMI is a number that relates weight to height.

Who cannot join the trial?

5 criteria

  • Having a history of or currently having a lymphoproliferative disorder, which means a condition where certain white blood cells grow too much.
  • Having an active malignancy (cancer) or having had any cancer in the past 5 years, except for specific early‑stage skin cancers (basal cell carcinoma, squamous cell carcinoma) or early‑stage breast, cervical, or thyroid cancers.
  • Having had a blood clot (thrombosis) or a stroke or mini‑stroke (cerebrovascular ischemic event) within the last 12 months.
  • Being at high risk for shingles, also called herpes zoster, coming back.
  • Having an active infection or a recent infection.
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Investigated drugs

brepocitinib is an experimental oral tablet being tested as a possible treatment for cutaneous sarcoidosis, a skin condition that causes inflammatory lesions. In this study, participants take the tablet by mouth to see if it can safely reduce the skin symptoms and improve overall health. The drug is designed to target specific parts of the immune system that are thought to contribute to the disease, and researchers are evaluating how well it works compared with not receiving the active medication.

What is already known about the treatment

  • brepocitinib

    Brepocitinib is taken as a 45 mg tablet that you swallow by mouth. It is an investigational drug currently being studied in a Phase 2/3 trial and has received orphan‑drug status for a rare skin condition. The medication is being tested to treat cutaneous sarcoidosis, which causes skin lesions. It works by blocking the JAK1 and TYK2 enzymes, lowering the signals that cause inflammation, and it belongs to the class of Janus kinase (JAK) inhibitors.

  • Placebo tablet

    The placebo tablet is a pill that looks like the brepocitinib tablet and is taken orally, but it contains no active drug. It is used only as an inactive control in the clinical trial and has no therapeutic effect or classification.

Investigated diseases

Cutaneous Sarcoidosis - Cutaneous sarcoidosis is a condition where small clusters of inflammatory cells form in the skin, creating patches, nodules, or plaques. These skin lesions may start as isolated spots and can gradually increase in number or size over time. In some people the skin changes remain limited, while in others they persist or spread, sometimes indicating involvement of other body parts. The disease course can vary, with periods of activity followed by relative calm, and lesions may change in appearance as the condition evolves.
Trial detailsLast updated 6 Nov 2026
Age18+ yearsPhasePhase IVTrial ID2026-526437-25-00Protocol codePVT-2201-203Estimated enrolment131 patientsSponsorPriovant Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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