Treatment for vitiligo using a new medication

Vitiligo Treatment by Targeting TYK2 Mediated Responses Prospective Multicentric Double Blind Interventional Study

This study is testing a new medication to see if it can help people with vitiligo stop skin color loss and encourage their skin to regain its color.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Drugs / interventions: Deucravacitinib
• Locations: 5 sites (Nice, Alpes-Maritimes and 4 other locations)
• Trial ID: NCT06327321 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of deucravacitinib, an allosteric TYK2 inhibitor, to treat generalized vitiligo by targeting the autoimmune inflammatory response that leads to skin depigmentation. The study aims to halt the depigmentation process and promote repigmentation by inhibiting specific immune responses associated with vitiligo. Participants will either receive the treatment or volunteer without treatment, allowing for a comparison of outcomes. The trial focuses on individuals with significant vitiligo lesions and evaluates the effectiveness and safety of the intervention.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 to 75 with non-segmental vitiligo and specific lesion characteristics.

Not a fit: Patients with segmental or mixed vitiligo or those currently using immunosuppressive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with vitiligo by restoring skin pigmentation.

How similar studies have performed: Other studies have shown success with similar immune-targeting approaches in treating autoimmune conditions, suggesting potential for this novel treatment.

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

Where this trial is running

Nice, Alpes-Maritimes and 4 other locations

• CHU de Nice - Hôpital de l'Archet — Nice, Alpes-Maritimes, France (Recruiting)
• APHP, Henri Mondor — Paris, Creteil, France (Recruiting)
• CHU de Bordeaux — Bordeaux, Talence, France (Recruiting)
• CHU de Lille — Lille, France (Recruiting)
• Hcl — Lyon, France (Recruiting)

Study contacts

• Principal investigator: PASSERON Thierry, PhD — CHU de Nice, Service de Dermatologie
• Study coordinator: Passeron Thierry, PhD

Conditions Vitiligo, Generalized