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Study on the Safety and Effectiveness of Ritlecitinib in Adults and Adolescents 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 Ritlecitinib on a skin condition known as nonsegmental vitiligo. Nonsegmental vitiligo is a condition where patches of skin lose their color, leading to white spots on various parts of the body. The study will use two different doses of Ritlecitinib, 50 mg and 100 mg, taken as capsules. The purpose of the study is to evaluate the long-term safety and how well people tolerate these doses of Ritlecitinib.

Participants in the study will be adults and adolescents who have nonsegmental vitiligo. The study will involve a period where participants will take the medication, and their response to the treatment will be monitored. Some participants may receive a placebo, which is a capsule that looks like the medication but does not contain the active ingredient. The study will help researchers understand how effective Ritlecitinib is in treating nonsegmental vitiligo and whether it is safe for long-term use.

Throughout the study, participants will be regularly checked for any side effects or changes in their condition. The study aims to provide valuable information on the potential benefits and risks of using Ritlecitinib for treating nonsegmental vitiligo, contributing to better treatment options for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing 52 weeks in a previous study for nonsegmental vitiligo.

    The first dose in this study must be taken within 30 days after the last visit in the previous study.

  2. Step 2

    Medication administration

    The study involves taking ritlecitinib tosilate orally.

    Two dosages are used: 100 mg once daily and 50 mg once daily.

    The medication is provided in capsule form.

  3. Step 3

    Monitoring and assessments

    Regular assessments are conducted to monitor safety and effectiveness.

    The study evaluates the incidence of side effects and any significant changes in laboratory results.

  4. Step 4

    Response evaluation

    The response to treatment is measured using the Total Vitiligo Area Scoring Index (T-VASI) and Facial Vitiligo Area Scoring Index (F-VASI).

    Improvement is assessed at various time points throughout the study.

  5. Step 5

    Study duration

    The study is expected to continue until August 2026.

    Participants are required to refrain from using other treatments for vitiligo during the study period.

Who can join the trial?

4 criteria

  • Participants must be **18 years or older** at the time of screening in a previous study. Adolescents aged **12 to less than 18 years** can also join if approved by local authorities. If not approved, only those **18 years or older** can participate.
  • Participants must have completed **52 weeks** of study treatment for **nonsegmental vitiligo** in a previous study. This means they have either stable or active vitiligo, as defined in that study.
  • Participants must agree not to use any other treatments for vitiligo from the start of the study until the final follow-up visit.
  • The first visit and dose in the new study must be within **30 days** after the last visit in the previous study.

Who cannot join the trial?

8 criteria

  • Participants who have a different type of vitiligo other than non-segmental vitiligo. Non-segmental vitiligo is a condition where patches of skin lose their color.
  • Participants who are not within the specified age range for the study.
  • Participants who are not able to follow the study procedures or take the study medication as required.
  • Participants who have any other medical condition that might interfere with the study or pose a risk to their health.
  • Participants who are pregnant or breastfeeding.
  • Participants who are taking other medications that might interfere with the study treatment.
  • Participants who have a history of allergic reactions to similar medications.
  • Participants who have participated in another clinical trial recently.
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Investigated drugs

Ritlecitinib is a medication being studied for its safety, effectiveness, and how well it is tolerated in people with nonsegmental vitiligo. Nonsegmental vitiligo is a condition where the skin loses its color in patches. This study is looking at how well this medication works over a long period.

What is already known about the treatment

Ritlecitinib – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its safety, efficacy, and tolerability in treating nonsegmental vitiligo, a condition characterized by loss of skin color in patches. Ritlecitinib works by inhibiting specific enzymes involved in the immune response, which may help in restoring skin pigmentation. It belongs to the pharmacological class of Janus kinase (JAK) inhibitors, which are known for their role in modulating immune system activity.

Investigated diseases

Nonsegmental Vitiligo – Nonsegmental vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on the skin. It occurs when the cells responsible for skin color, called melanocytes, are destroyed. This type of vitiligo often appears symmetrically on both sides of the body and can affect any skin area. The progression of the condition is unpredictable, with some individuals experiencing rapid changes, while others may have stable patches for years. The exact cause is not fully understood, but it is believed to involve genetic and autoimmune factors. The condition can also affect hair and the inside of the mouth.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505804-42-00Protocol codeB7981041Estimated enrolment468 patientsSponsorPfizer Inc.

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