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Study of Ritlecitinib (50 mg and 100 mg daily) compared to placebo in adults with nonsegmental vitiligo

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on studying the effectiveness and safety of ritlecitinib in adults with nonsegmental vitiligo, a condition where patches of skin lose their color due to the destruction of pigment-producing cells. The study will test two different doses of ritlecitinib (50 mg and 100 mg) taken as oral capsules, comparing them with placebo to determine how well they work in treating vitiligo.

The study will involve taking either ritlecitinib or placebo daily for 52 weeks, followed by another 52-week extension period where dose adjustments may be made. During the study, participants may also receive dexamethasone, which is a type of steroid medication. The main goal is to see if ritlecitinib can improve the appearance of vitiligo patches, particularly on the face and other areas of the body.

Throughout the study, doctors will monitor how well the treatment works by measuring the improvement in vitiligo-affected areas and checking for any side effects. They will pay special attention to changes in the face area and overall body surface affected by vitiligo. The study will also look at how the treatment affects participants' quality of life and emotional well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive either ritlecitinib (100 mg or 50 mg) or a placebo in the form of oral capsules.

    This phase lasts for 52 weeks (approximately one year).

  2. Step 2

    Assessment at week 24

    Your face and total body vitiligo will be evaluated using special measurement tools.

    The doctor will assess the improvement in your condition using the F-VASI (face measurement) and T-VASI (total body measurement) scales.

  3. Step 3

    Evaluations at week 36

    You will complete questionnaires about changes in your facial and total body vitiligo.

    The doctor will evaluate the improvement in your condition.

  4. Step 4

    52-week assessment

    A comprehensive evaluation of your condition will be performed.

    Your quality of life and emotional well-being will be assessed through questionnaires.

    The doctor will measure the improvement in both facial and total body vitiligo.

  5. Step 5

    Extension period

    This phase lasts for another 52 weeks.

    Your medication dose may be adjusted up or down during this period.

    Regular evaluations of your condition will continue throughout this phase.

  6. Step 6

    Final assessment

    A final comprehensive evaluation will be conducted at week 104 (end of the second year).

    The doctor will assess the overall improvement in your condition.

    Final questionnaires about your vitiligo and quality of life will be completed.

Who can join the trial?

12 criteria

  • Must be 18 years or older at the time of screening
  • Must have been diagnosed with nonsegmental vitiligo for at least 3 months before screening
  • Must have vitiligo affecting between 4% and 60% of body surface area, not including:
    • palms of hands
    • soles of feet
    • top surface of feet
    • Must have vitiligo affecting at least 0.5% of the face area, including:
      • forehead up to hairline
      • cheeks down to jawline
      • area from mouth corners to ear area
      • nose and eyelids
      • Must have a minimum score of:
        • 0.5 on F-VASI (Face Vitiligo Area Scoring Index)
        • 3 on T-VASI (Total Vitiligo Area Scoring Index)
        • Must have either active or stable nonsegmental vitiligo during both screening and baseline visits

Who cannot join the trial?

15 criteria

  • Age below 18 years or over 65 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Current participation in other clinical trials
  • Presence of other types of vitiligo (other than nonsegmental vitiligo)
  • Active skin infections in affected areas
  • Use of other treatments for vitiligo in the past 4 weeks
  • History of skin cancer
  • Significant medical conditions that could interfere with study participation
  • Inability to follow study procedures or attend scheduled visits
  • Use of medications that could interact with the study drug
  • History of immunosuppressive conditions (conditions that weaken the immune system)
  • Major surgery planned during the study period
  • Current substance abuse or mental health conditions that could affect participation
  • Previous treatment with ritlecitinib or similar medications
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Investigated drugs

  • Ritlecitinib

    is a medication being studied for the treatment of nonsegmental vitiligo, a condition where patches of skin lose their color. This medication works by targeting specific enzymes in the body that are involved in the immune system response. It is taken as an oral medication (by mouth) and is being tested to see if it can help restore skin pigmentation and prevent further loss of skin color in people with vitiligo.

  • Placebo

    is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used as a comparison to determine if the active medication (ritlecitinib) is effective.

What is already known about the treatment

Ritlecitinib – An oral medication administered once daily that is currently being investigated in Phase 3 clinical trials for the treatment of nonsegmental vitiligo, an autoimmune condition causing loss of skin pigmentation. The drug belongs to the class of Janus kinase (JAK) inhibitors and works by modulating the immune system response at the molecular level, specifically targeting the JAK-STAT signaling pathway that is involved in the autoimmune attack on melanocytes. Being tested in doses of 50mg and 100mg daily, this investigational therapy aims to potentially provide a new treatment option for patients with vitiligo, with ongoing studies evaluating both its efficacy and long-term safety profile.

Investigated diseases

Nonsegmental Vitiligo - A chronic skin condition where patches of skin lose their color due to the destruction of melanocytes, the cells that produce pigment. Unlike segmental vitiligo, this form affects both sides of the body in roughly symmetrical patterns and can appear on any part of the body. The depigmented patches typically start small and gradually enlarge over time. The condition can affect people of any age, gender, or skin type. The white patches may be more noticeable in people with darker skin tones.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502518-98-00Protocol codeB7981080Estimated enrolment1 450 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).