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A study of upadacitinib in adults with erosive mucosal lichen planus and lichen planopilaris.

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What is this trial about?

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

This study focuses on individuals living with Lichen Planus, specifically the erosive mucosal type which affects the lining of the mouth, and Lichen Planopilaris, a condition that causes hair loss and scalp inflammation. The purpose of the study is to evaluate the effectiveness of a medication called upadacitinib. Participants will be assigned to receive either 30 mg of rinovq, which is a prolonged-release tablet designed to release the medicine slowly into the body, or a placebo.

During the study, participants will take one tablet daily. The process involves monitoring the condition over a period of time to see how the medication affects the symptoms and the overall health of the affected areas. The evaluation of the treatment continues through various stages to observe changes in the skin, hair, or mouth over several weeks.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    A daily dose of either 30 mg of upadacitinib (given as a prolonged-release tablet taken by mouth) or a placebo (a substance that looks identical to the medication but contains no active medicine) is administered.

    The medication is taken once every day.

  2. Step 2

    <b>first assessment period</b>

    After 16 weeks of taking the daily dose, an evaluation is conducted to check for an iga response. the iga (investigator global assessment) is a method used to score the severity of the skin or mucosal condition, where a score of 2 or less indicates improvement.

    During this time, various measurements are recorded, including vital signs (such as blood pressure), laboratory values (blood tests), and scores from questionnaires like the dlqi (dermatology life quality index) to assess how the condition affects daily life.

  3. Step 3

    <b>second assessment period</b>

    The medication administration and monitoring continue until week 32.

    At the 32-week mark, additional assessments are performed to check for a 2-point improvement in the iga score and to evaluate other metrics such as the pgis (patient global impression of severity) and pgic (patient global impression of change) to determine how the condition has changed from the start.

Who can join the trial?

6 criteria

  • You must provide written informed consent, which means you sign a document agreeing to participate in the study after being told all the details.
  • You must be between 18 and 64 years old at the start of the study.
  • You must have a confirmed diagnosis of mucosal lichen planus (a condition affecting the moist linings of the mouth or other areas) or lichen planopilaris (a condition that affects the scalp and hair follicles) through a biopsy, which is a small sample of skin taken for testing.
  • Your skin condition must be rated as moderate or severe by a doctor using a specific scoring system called IGA.
  • You must have not had a good result from using topical corticosteroids, which are strong creams used to reduce swelling and redness.
  • All women who could potentially become pregnant must have a negative pregnancy test in their blood during the screening phase and a negative pregnancy test in their urine before taking the first dose of the study medicine.

Who cannot join the trial?

7 criteria

  • A history that suggests you may have had a lichenoid drug eruption, which is a skin rash that looks similar to lichen planus caused by a reaction to a medication.
  • Signs or a medical history that suggest paraneoplastic mucosal lichen planus, which is a type of mouth irritation that may be linked to an underlying cancer.
  • Having mucosal lichen planus (sores or irritation in the mouth or digestive tract) that is so severe you must use parenteral nutrition (liquid nutrition delivered through a vein) or a feeding tube.
  • Having burnt-out cicatricial alopecia, which is a stage of permanent hair loss where the hair follicles have been replaced by scar tissue.
  • A diagnosis of frontal fibrosing alopecia (a specific pattern of hair loss at the front of the scalp) if there are no active areas of lichen planopilaris (an inflammatory condition that causes hair loss).
  • Testing positive for Hepatitis C (a virus that affects the liver) unless the viral load (the amount of virus present in your blood) is zero.
  • Having an active TB (tuberculosis) infection or a latent TB infection (where the bacteria are in your body but are not currently causing illness) without a history of taking prophylaxis (preventative medicine to stop the disease from becoming active).
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Investigated drugs

Upadacitinib is a medication taken by mouth that is being studied to see if it can help treat specific skin and mouth conditions. It works by targeting certain parts of the immune system to help reduce inflammation.

What is already known about the treatment

Upadacitinib - This medication is taken as a tablet by mouth once a day and is used to treat certain skin conditions like lichen planus. It belongs to a group of drugs called Janus kinase inhibitors, which work by blocking specific proteins inside cells that trigger inflammation. By stopping these signals, the medicine helps to calm down the body's overactive immune response and reduce skin irritation. Currently, this substance is an established treatment used in medical practice for various inflammatory diseases.

Investigated diseases

  • Erosive Lichen Planus

    This is a condition that causes inflammation of the mucous membranes, most commonly inside the mouth. It often begins with painful sores or ulcers that can develop on the gums, tongue, or inner cheeks. As the condition progresses, the lining of the mouth may appear red, raw, or develop white patches. The inflammation can lead to continuous discomfort and changes in the appearance of the oral tissue.

  • Lichen Planus Pigmentosus

    This condition is characterized by the appearance of dark or brownish patches on the skin. It primarily affects areas that are frequently exposed to sunlight or in skin folds. The progression typically involves the gradual darkening of the skin without causing significant itching or pain. These pigmented areas can appear in various patterns across different parts of the body.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522870-35-00Protocol code25-PP-10Estimated enrolment56 patientsSponsorCentre Hospitalier Universitaire De Nice

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