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Combination Approach With Ritlecitinib and nbUVB Compared to Ritlecitinib Alone for Treating Vitiligo Prospective Multicentric Evaluator Blinded Interventional Study
Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-05-20
56
Participants Needed
5
Research Sites
21 weeks
Total Duration
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AI-Summary
What this Trial Is About
Vitiligo affects about 1 to 2% of people worldwide and can greatly reduce quality of life. Researchers are studying how the drug ritlecitinib, which blocks certain enzymes involved in the immune response, works alone or combined with narrowband UVB light therapy to treat vitiligo. This study aims to compare the improvement in vitiligo severity on the face and body after 52 weeks between these two treatment approaches. Participants will be randomly assigned to receive either ritlecitinib 100 mg once daily by mouth alone or combined with narrowband UVB light therapy twice weekly for 52 weeks. After this period, all participants will continue taking ritlecitinib 100 mg daily in an open-label phase. The study will include patients with different skin types and vitiligo that is either active or stable. Treatment effects will be evaluated across these groups. Participants will attend eight study visits over about 72 weeks for assessments including skin evaluations, blood sample collection, and pregnancy tests every four weeks for women who can become pregnant. Some volunteers will have skin biopsies at baseline, week 4, and week 52. Researchers will measure changes in vitiligo severity using scoring indexes focused on the face and total body. Safety and quality of life will also be monitored throughout the study.
CONDITIONS
Brief Title
Combination Approach With Ritlecitinib and nbUVB Compared to Ritlecitinib Alone for Treating Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women with non-segmental vitiligo
- Age 18 years or older
- Body surface area (BSA) involvement between 4% and 60%, excluding palms and soles
- At least 0.5% BSA involvement on the face as defined in the study
- Facial Vitiligo Area Scoring Index (F-VASI) of 0.5 or higher and Total Body Vitiligo Scoring Index (T-VASI) of 3 or higher
- Active or stable vitiligo
- Women of childbearing potential must use effective contraception and have a negative pregnancy test at baseline
- Women not of childbearing potential must meet specific criteria (e.g., hysterectomy, menopause)
- Affiliation to a social security system
- Signed informed consent
You will not qualify if you...
- Pregnant or breastfeeding women, or women planning pregnancy without contraceptives
- Segmental or mixed vitiligo
- Contraindications to narrowband UVB phototherapy
- Use of topical or systemic immunosuppressive medications or steroids
- Previous treatment with oral JAK inhibitors or topical treatments affecting vitiligo within 2 weeks before baseline
- Use of permanent depigmentation treatments
- Prior systemic JAK inhibitor use for any disease
- Use of lymphocyte depleting agents or certain immunomodulatory biologics within specified timeframes
- Recent phototherapy treatments within 8 weeks before baseline
- Use of TNF inhibitors and interferon therapy within 8 weeks before baseline
- Use of systemic treatments affecting vitiligo or immune suppressants within 8 weeks before baseline
- Vaccination with live attenuated vaccines within 6 weeks before baseline
- Use of prohibited medications affecting drug metabolism
- Severe allergic reactions to kinase inhibitors
- Hearing loss or ear diseases with progression
- History of lymphoproliferative disorders
- Abnormal chest imaging indicating risk
- Long QT syndrome or family history
- History of malignancies except certain treated skin or cervical cancers
- Recent significant trauma or surgery
- Severe hepatic impairment
- Photodermatosis or photosensitive drug use
- Leukotrichia affecting more than 33% of lesions
- Active infection or systemic inflammatory diseases
- Tuberculosis or latent tuberculosis
- Psychiatric conditions including recent suicidal behavior
- Other skin diseases interfering with vitiligo evaluation
- History of systemic infections requiring significant treatment within 6 months
- Hepatitis B or C infection without clearance
- Immunodeficiency disorders
- Participation in other clinical trials with interfering drugs
- Vulnerable populations such as minors, adults under guardianship, or deprived of freedom
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive ritlecitinib 100mg daily alone or combined with twice weekly narrowband UVB treatment for 52 weeks.
Twice weekly visits for UVB treatment; daily medication taken at home
Duration - Duration not specified
After the initial 52 weeks, all participants continue receiving open-label ritlecitinib 100mg daily.
Ongoing medication with follow-up visits as scheduled by the study
Trial Site Locations
Total: 5 locations
1
CHu de Nice, Hôpital Archet
Nice, Alpes-Maritime, France, 06200
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2
APHP
Paris, Creteil, France, 94010
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3
CHU de Bordeaux
Bordeaux, France, 33000
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4
CHU La Réunion
La Réunion, France
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5
HCL
Lyon, France, 69000
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Research Team
T
Thierry Passeron, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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