Vitiligo Treatment by Targeting TYK2 Mediated Responses

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for vitiligo, a skin condition that causes loss of color in patches on the skin. The treatment being tested is a medication called deucravacitinib, which aims to stop the skin from losing its color and help restore it by targeting specific immune responses. The trial will involve participants receiving either deucravacitinib or a placebo (a harmless pill with no active medication) for 24 weeks, followed by a chance to continue with the medication alone or combined with a type of light therapy for an additional 24 weeks. The main goal is to see how many patients experience significant improvement in their skin color after 24 weeks of treatment.

To participate, individuals must be at least 18 years old and not older than 75, with non-segmental vitiligo and at least one lesion larger than 2 cm² that is not on the face, hands, or feet. Participants must also be willing to attend all study visits and provide informed consent. Throughout the study, participants will have several check-ins, including skin evaluations and blood tests, to monitor their progress. This trial is currently recruiting, and it offers a potential new option for individuals who are struggling with vitiligo.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and women with non-segmental vitiligo.
• • 2. ≥ 18 and \<75 years
• • 3. Patient with at least one lesion of more than 2 cm² not located on the face, hands or feet.
• • 4. Patients with Vitil-IA score above 5% and T-VASI above 5% (not taking into account the involvement of hands and feet)
• • 5. For women of child-bearing age, 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. A urine pregnancy test (βHCG in urines) will be performed.
• • 6. Affiliation to a social security system
• • 7. Signed informed consent
• • 8. Patient willing and able to attend all study visits
• Exclusion Criteria:
• • 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.
• • 2. Segmental or mixed vitiligo
• • 3. Concomitant use of topical or systemic immunosuppressive medication or steroids
• • 4. Patients suffering from photodermatosis or taking photosensitive drugs
• • 5. Personal history of skin cancer
• • 6. Personal history of cancer of less than 5 years
• • 7. Patients with active infection
• • 8. Tuberculosis or latent tuberculosis
• • 9. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom
• • 10. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation