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Study of Ritlecitinib Combined with Narrow Band UVB Light Therapy Compared to Ritlecitinib Alone in Adults with Vitiligo

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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 treating patients with vitiligo, a condition where patches of skin lose their color. The research evaluates a new medication called ritlecitinib (Litfulo), given as oral capsules, both alone and in combination with narrowband ultraviolet B light therapy (nbUVB). The purpose is to determine if combining these two treatments works better than using the medication by itself.

The treatment involves taking ritlecitinib capsules daily for 72 weeks, with some patients also receiving light therapy sessions. The maximum daily dose of the medication is 100 milligrams. During the study, doctors will measure changes in the skin's appearance, particularly focusing on improvements in facial and total body areas affected by vitiligo.

Throughout the study, healthcare providers will monitor how well the treatment works by examining changes in the skin's pigmentation. They will assess both the face and other body areas affected by vitiligo, and track any changes in the condition over time. The study will also evaluate how the treatment affects patients' quality of life and their satisfaction with the results.

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 treatment phase start

    You will begin taking Litfulo (ritlecitinib) 50 mg capsules by mouth

    Your current skin condition will be documented and measured using special assessment tools that track the areas affected by vitiligo on your face and body

  2. Step 2

    12-week assessment

    Your skin condition will be evaluated to measure any changes

    The activity of your condition will be assessed at three different areas of your body

    You will be asked to rate your impression of the treatment effects

  3. Step 3

    24-week assessment

    Your skin will be examined to check if there is at least 50% improvement in the affected areas

    The stability of your condition will be evaluated

    You will continue taking the oral medication as prescribed

  4. Step 4

    36-week assessment

    A thorough evaluation of your skin condition will be performed

    You will complete a quality of life questionnaire

    You will use a mirror to compare your current skin condition with initial photographs

  5. Step 5

    52-week main assessment

    This is the primary evaluation point of the study

    Your skin condition will be thoroughly assessed to measure the percentage of improvement

    The effectiveness of the treatment will be evaluated on both facial and total body affected areas

    You will complete another quality of life assessment

  6. Step 6

    Final assessment at 72 weeks

    Final evaluation of your skin condition will be performed

    You will complete a final quality of life questionnaire

    All changes in your condition throughout the study period will be documented

Who can join the trial?

10 criteria

  • Must be diagnosed with non-segmental vitiligo (a type of vitiligo that appears on both sides of the body in a symmetrical pattern)
  • Must be 18 years or older
  • Must have vitiligo affecting between 4% and 60% of body surface area, not including hands, feet, or top of feet
  • Must have at least 0.5% of face affected by vitiligo (including forehead up to hairline, cheeks to jawline, area from mouth corners to ear area, nose and eyelids, but not including scalp, ears, neck, or lips)
  • Must have minimum scores of 0.5 on F-VASI (Face Vitiligo Area Scoring Index) and 3 on T-VASI (Total Vitiligo Area Scoring Index)
  • Must have active and stable vitiligo condition
  • Women who can become pregnant must:
    • Use effective birth control (such as birth control pills, implants, IUD, condoms, or tubal ligation) for at least one month before joining the study
    • Have a negative pregnancy test at the start of the study
    • Must be enrolled in a social security system
    • Must sign an informed consent form

Who cannot join the trial?

14 criteria

  • Individuals under 12 years of age
  • Anyone who has had phototherapy (light therapy) within 30 days before starting the study
  • People using topical treatments for vitiligo in the past 2 weeks
  • Those with a history of skin cancer
  • Pregnant or breastfeeding women
  • People with severe autoimmune conditions (diseases where the immune system attacks healthy cells)
  • Individuals who have participated in another clinical trial within the past 30 days
  • Those with known allergies to the study medication ingredients
  • People with active skin infections in the treatment areas
  • Individuals with a history of photosensitivity (unusual reactions to sunlight)
  • Those currently using medications that increase sensitivity to light
  • People with unstable medical conditions that could interfere with the study
  • Individuals with extensive scarring in the areas to be treated
  • Those unable to follow the study protocol or attend regular visits
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Investigated drugs

Ritlecitinib is a medication taken by mouth that works by blocking specific proteins in the body that contribute to the immune system's attack on pigment-producing cells. It is being studied as a treatment for vitiligo, a condition where patches of skin lose their color. Narrow-band UVB (nbUVB) is a type of light therapy that uses a specific wavelength of ultraviolet light. This treatment is delivered through special light panels or boxes, and it helps stimulate melanocytes (pigment-producing cells) in the skin to produce melanin, potentially helping to restore skin color in vitiligo patches. The study compares using these treatments together versus using ritlecitinib alone to determine which approach is more effective in treating vitiligo.

What is already known about the treatment

  • Ritlecitinib

    An oral medication administered in tablet form that represents a new class of JAK inhibitors specifically developed for treating vitiligo, an autoimmune condition causing loss of skin pigmentation. This medication works by blocking specific enzymes called Janus kinases (JAK), which are involved in the immune response that attacks melanocytes in vitiligo patients, helping to restore normal skin pigmentation. Ritlecitinib is currently being evaluated in clinical trials as both a standalone treatment and in combination with narrow-band UVB phototherapy, showing promising results in repigmentation of affected skin areas.

  • Narrow-band UVB (nbUVB)

    A specialized form of phototherapy that uses a specific wavelength of ultraviolet light to treat vitiligo through controlled exposure of affected skin areas. This treatment works by stimulating melanocytes (pigment-producing cells) to become more active and produce melanin, while also modulating the immune response in the skin. nbUVB is a well-established treatment for vitiligo that has been used successfully for many years, with documented evidence of effectiveness in medical literature, particularly when combined with other therapeutic approaches.

Investigated diseases

Vitiligo - A skin condition where patches of skin lose their color due to the destruction of melanocytes, the cells that produce pigment. It develops when the immune system mistakenly attacks and destroys the melanocytes, resulting in white or light patches on various parts of the body. The condition typically begins as small, pale areas that gradually enlarge over time. Vitiligo can affect any area of the skin, but it commonly appears on the face, hands, arms, and areas around body openings and folds. The depigmented patches are more noticeable in people with darker skin tones. The condition can develop at any age and affects all races and genders equally.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521504-22-00Protocol code25-PP-03Estimated enrolment80 patientsSponsorCentre Hospitalier Universitaire De Nice

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