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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire de la Réunion	La Réunion	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

Vitiligo

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 ID:

2025-521504-22-00

Protocol code:

25-PP-03

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?