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Study on the Effects of Upadacitinib in Adults and Adolescents with Non-Segmental Vitiligo Eligible for Systemic Treatment

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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 Upadacitinib in treating a skin condition known as non-segmental vitiligo. Non-segmental vitiligo is a condition where patches of skin lose their color. The study will involve adult and adolescent participants who are eligible for systemic therapy, which means they can receive treatment that affects the entire body, not just the skin.

The purpose of the study is to evaluate how effective, safe, and tolerable Upadacitinib is for treating non-segmental vitiligo. Participants will be randomly assigned to receive either the medication or a placebo, which is a substance with no active ingredients. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased.

Throughout the study, participants will take the medication in the form of modified-release tablets, which are designed to release the drug slowly over time. The study will last for a period of time, during which participants will be monitored for any changes in their condition and any side effects they may experience. The goal is to determine if Upadacitinib can significantly improve the skin condition of those with non-segmental vitiligo.

The research process

The trial runs in 7 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 an informed consent form. This document confirms understanding and agreement to follow the study's requirements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying age, weight, and a clinical diagnosis of non-segmental vitiligo.

    Participants must have previously tried at least one topical treatment for vitiligo without success or have signs of actively progressing vitiligo.

  3. Step 3

    Medication administration

    Participants will receive either upadacitinib or a placebo. Upadacitinib is administered as a modified-release tablet taken orally.

    The dosage and frequency of administration will be determined by the study protocol.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor the effectiveness and safety of the treatment.

    These assessments will include measurements of vitiligo area and severity index (VASI) to track changes in skin condition.

  5. Step 5

    Primary evaluation

    The primary evaluation will occur at Week 48. The goal is to achieve a significant reduction in vitiligo severity, measured by T-VASI 50 and F-VASI 75.

  6. Step 6

    Secondary evaluation

    Secondary evaluations will also be conducted, focusing on additional improvements in vitiligo severity and participant-reported outcomes.

    These evaluations will occur at various points, including Week 24 and Week 48.

  7. Step 7

    Study completion

    The study is expected to conclude by February 2028. Participants will receive a final assessment to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

11 criteria

  • The person or their legal representative must understand and agree to follow all study requirements and sign a consent form before any study procedures begin.
  • Participants must be adults or adolescents who are 12 years of age or older at the time of screening.
  • For participants aged 12 to 17, their body weight must be at least 30 kg at the start of the study.
  • Participants must have certain laboratory test results that meet the study's requirements before starting the study medication.
  • Participants must have a confirmed diagnosis of non-segmental vitiligo (NSV), which is a type of skin condition.
  • At the screening and start of the study, participants must meet at least one of the following conditions:
    • Have a certain level of skin involvement measured by F-VASI and T-VASI scores, and have not responded to at least one topical corticosteroid or calcineurin inhibitor treatment for vitiligo.
    • Have a certain level of skin involvement measured by F-VASI and T-VASI scores, and show signs of vitiligo that is actively getting worse.
    • Have a certain level of skin involvement measured by F-VASI and T-VASI scores.
    • Participants must not have segmental or localized vitiligo, which are other types of skin conditions.
    • Participants must not have any other active skin diseases that could affect the assessment of vitiligo.
    • Participants must not have more than 33% leukotrichia (white hair) in the areas of vitiligo on the face or body.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of vitiligo than non-segmental vitiligo cannot participate. Non-segmental vitiligo is a condition where the skin loses its color in patches.
  • Patients who are not eligible for systemic therapy cannot participate. Systemic therapy is a treatment that affects the entire body, not just one part.
  • Patients who are outside the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

Upadacitinib is a medication being studied for its effectiveness, safety, and tolerability in treating non-segmental vitiligo in adults and adolescents. This condition causes patches of skin to lose their color. Upadacitinib is being tested to see if it can help improve the appearance of the skin by restoring its natural color.

What is already known about the treatment

Upadacitinib – Upadacitinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating non-segmental vitiligo, a condition characterized by loss of skin color in patches. The medication works by inhibiting specific enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process that contributes to the condition. Upadacitinib is classified as a JAK inhibitor and is being evaluated for its safety and tolerability in patients eligible for systemic therapy.

Investigated diseases

Non-segmental vitiligo – Non-segmental 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 this condition is unpredictable, with patches often appearing symmetrically on both sides of the body. These patches can increase in size and spread over time, affecting larger areas of the skin. The condition can also impact hair, turning it white or gray in the affected areas. Non-segmental vitiligo can start at any age and may progress slowly or rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506195-27-00Protocol codeM19-044Estimated enrolment620 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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