Vitiligo Treatment by Targeting TYK2 Mediated Responses

Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. Achieving the best treatment outcomes for vitiligo involves addressing the autoimmune inflammatory response to stop the depigmentation process and promoting the differentiation of melanocyte stem cells to induce repigmentation. The loss of melanocytes in vitiligo is a result of an autoimmune process. While the IFN gamma pathway plays a crucial role in the adaptive immune response in vitiligo, there is increasing evidence highlighting the importance of the innate immune response. Deucravacitinib, an allosteric TYK2 inhibitor, has shown effectiveness and safety in treating psoriasis. It inhibits the responses of IFN alpha (IFNα), IFN beta (IFNβ), and IL12, and may also have an impact on the Th1 response. The hypothesis is that by targeting the IFN type I response and IL12, deucravacitinib could effectively halt the depigmentation process and facilitate repigmentation of vitiligo lesions. When combined with NB-UVB, the process of repigmentation should be significantly enhanced. The primary objective is to compare the proportion of patients treated with deucravacitinib versus placebo achieving VITIL-IA 50 at week 24.

Interventions Following central randomization, patients will be assigned to receive either deucravacitinib 12mg daily (QD) or a placebo daily (QD) for a duration of 24 weeks. At the end of this period, patients will be re-randomized to receive either deucravacitinib 12mg QD alone or deucravacitinib 12mg QD + twice weekly narrowband UVB treatment twice weekly for an additional 24 weeks.

Throughout the study, there will be a total of six visits conducted: selection, inclusion, Week 12, Week 24, Week 36, and Week 48. In patients who volunteer, a skin biopsy will be performed on both the lesional and peri-lesional areas at baseline, Week 12 and Week 36. Serum and plasma samples will be collected at the screening visit, Week 12, Week 24, Week 36, and Week 48.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Vitiligo, Generalized Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Nice - Hôpital de l'Archet, Nice, Alpes-Maritimes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women with non-segmental vitiligo.
≥ 18 and <75 years
Patient with at least one lesion of more than 2 cm² not located on the face, hands or feet.
Patients with Vitil-IA score above 5% and T-VASI above 5% (not taking into account the involvement of hands and feet)
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.
Affiliation to a social security system
Signed informed consent
Patient willing and able to attend all study visits

Exclusion criteria

Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration.
Segmental or mixed vitiligo
Concomitant use of topical or systemic immunosuppressive medication or steroids
Patients suffering from photodermatosis or taking photosensitive drugs
Personal history of skin cancer
Personal history of cancer of less than 5 years
Patients with active infection
Tuberculosis or latent tuberculosis
Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom
Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation

Treatment and study plan

Deucravacitinib

Drug

Volunteer without treatment

Other

Primary outcomes

rate of depigmentation

Time frame: at week 24

Improvement of at least 50% of the depigmentation of the face assessed by the Vitil-IA algorithm on UV pictures performed on ColorFace (Vitil-IA 50)

Secondary outcomes

number of patient with the T-VASI 50

Time frame: at 48 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: ViTYK

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Mar 25, 2024
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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