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Study on the Effectiveness of Povorcitinib for Adults with Nonsegmental Vitiligo

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Povorcitinib in individuals with a skin condition known as vitiligo. Vitiligo is a condition where patches of skin lose their color, leading to lighter areas on the body. The study will specifically look at a type of vitiligo called nonsegmental vitiligo, which is the most common form and can appear on both sides of the body. Participants in the study will receive either Povorcitinib or a placebo, which is a substance with no active medication, to compare the effectiveness of the treatment.

The purpose of the study is to evaluate how well Povorcitinib works in improving the skin condition over a period of 52 weeks. Participants will take the medication in the form of a tablet by mouth. Throughout the study, researchers will monitor changes in the skin, particularly looking for improvements in the color of the skin on the face and body. The study aims to see if participants experience at least a 75% improvement in their skin condition by the end of the study period.

Participants will be involved in the study for about a year, during which they will have regular check-ups to assess their progress. The study will help determine if Povorcitinib is a safe and effective treatment option for people with nonsegmental vitiligo. This research could potentially lead to new treatment options for those affected by this skin condition.

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

    Joining the study

    Upon joining the study, the participant will be required to sign a consent form, confirming understanding and willingness to participate.

    The participant must be at least 18 years old and have a clinical diagnosis of nonsegmental vitiligo.

  2. Step 2

    Discontinuation of current treatments

    The participant must stop using any treatments or procedures for vitiligo from the start of the study until the final safety follow-up visit.

  3. Step 3

    Medication administration

    The participant will receive either Povorcitinib or a placebo in the form of a tablet, taken orally.

    The treatment will last for 52 weeks.

  4. Step 4

    Regular assessments

    Throughout the study, the participant will undergo regular assessments to monitor the progress of the treatment.

    These assessments will include photography to document changes in vitiligo.

  5. Step 5

    Evaluation of treatment effectiveness

    The main goal is to evaluate the effectiveness of Povorcitinib compared to the placebo after 52 weeks.

    The primary measure of success is achieving at least a 75% improvement in the Face Vitiligo Area Scoring Index (F-VASI75).

  6. Step 6

    Secondary evaluations

    Secondary evaluations include changes in the Total Body Vitiligo Area Scoring Index (T-VASI) and the Vitiligo Noticeability Scale (VNS).

    These evaluations will also occur at the 52-week mark.

Who can join the trial?

6 criteria

  • Ability to understand and willingness to sign a written consent form for the study.
  • Must be at least 18 years old at the time of giving consent.
  • Have a clinical diagnosis of nonsegmental vitiligo, which is a type of skin condition that causes loss of skin color in patches.
  • Agree to stop using all treatments for vitiligo from the start of the study until the final safety follow-up visit.
  • Willingness to avoid becoming pregnant or fathering children during the study, following specific guidelines.
  • Willing and able to follow the study rules and procedures, including having photographs taken as part of the study.

Who cannot join the trial?

7 criteria

  • Participants with any other skin condition that might interfere with the study.
  • Individuals who have used certain medications that could affect the study results.
  • People with a history of severe allergic reactions to similar treatments.
  • Participants with any serious health conditions that could make the study unsafe for them.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Participants who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Povorcitinib is a medication being studied for its effectiveness in treating nonsegmental vitiligo, a condition that causes loss of skin color in patches. The trial aims to determine how well this medication works over a 52-week period. Participants in the study receive this medication to see if it can help improve their skin condition by restoring color to the affected areas.

What is already known about the treatment

Povorcitinib – Povorcitinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating nonsegmental vitiligo, a condition characterized by loss of skin pigmentation. The medication is in the Phase 3 stage of clinical trials, indicating it is being evaluated for safety and efficacy before potential approval for widespread use. Povorcitinib works by inhibiting specific enzymes involved in the immune response, which may help restore skin color in affected areas. It is classified as a Janus kinase (JAK) inhibitor, a type of medication that targets pathways involved in inflammation and immune regulation.

Investigated diseases

Vitiligo – Vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on various parts of the body. It occurs when the cells responsible for skin color, called melanocytes, are destroyed. The progression of vitiligo can vary; some people may experience slow and gradual spreading of the patches, while others might see rapid changes. The condition can affect any skin area, including the face, hands, and feet, and may also impact hair and the inside of the mouth. The exact cause of vitiligo is not fully understood, but it is believed to involve genetic, autoimmune, and environmental factors. It is not contagious and does not cause physical discomfort, but it can have significant psychological and social effects.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505782-86-00Protocol codeINCB 54707-303Estimated enrolment444 patientsSponsorIncyte Corp.

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