Combination approach with ritlecitinib and nbUVB compared to ritlecitinib alone for treating vitiligo
EU CTIS ID: 2025-521504-22-00
What this study is testing
To compare between the groups, the mean percentage change of F-VASI and T-VASI between the baseline and week 52.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Men and women with non-segmental vitiligo.
- 2. Age ≥ 18 age old
- 3. BSA involvement between 4% and 60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet
- 4. BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids)
- 5. F-VASI ≥0.5 and T-VASI ≥3
- 6. Active and stable vitiligo
You likely can't join if
- 1. Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration,
- 10. Patients with active infection or other systemic/ inflammatory disease
- 11. Tuberculosis or latent tuberculosis
- 12. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition
- 13. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.
- 2. Segmental or mixed vitiligo
See the full eligibility criteria
- 1. Men and women with non-segmental vitiligo.
- 2. Age ≥ 18 age old
- 3. BSA involvement between 4% and 60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet
- 4. BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids)
- 5. F-VASI ≥0.5 and T-VASI ≥3
- 6. Active and stable vitiligo
- 7. For Women of childbearing potential (WOCBP), an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study; Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at baseline;
- 8. Affiliation to a social security system;
- 9. Signed informed consent.
- 1. Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration,
- 10. Patients with active infection or other systemic/ inflammatory disease
- 11. Tuberculosis or latent tuberculosis
- 12. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition
- 13. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.
- 2. Segmental or mixed vitiligo
- 3. Contraindication to nbUVB phototherapy
- 4. Concomitant use of topical or systemic immunosuppressive medication or steroids
- 5. Patients treated before with oral JAK inhibitor, topical treatments (including JAK inhibitors) that could affect vitiligo (eg, corticosteroids, vitamin D3 and calcineurin inhibitor) within 2 Weeks of Day 1 (Baseline) and during the study
- 6. Patients suffering from photodermatosis or taking photosensitive drugs
- 7. Patients with more than 33% of leucotrichia on the lesions (Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions),
- 8. Personal history of skin cancer
- 9. Personal history of any malignancies or a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ will be excluded from the study
The study team makes the final eligibility decision.
Where it's taking place
- France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.