Vitiligo Treatment by Targeting TYK2 Mediated Responses

NCT06327321 | Recruiting Phase 2

• 1 other identifier: 23-PP-08
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Vitiligo, Generalized

Outcome Measures

Primary Outcomes (1)

• rate of depigmentation

  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)

  at week 24

Secondary Outcomes (1)

• number of patient with the T-VASI 50

  at 48 weeks

Study Arms (2)

Drug group

EXPERIMENTAL

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.

Drug: Deucravacitinib

Placebo group

PLACEBO COMPARATOR

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.

Other: Volunteer without treatment

Interventions

Deucravacitinib DRUG

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.

Drug group

Volunteer without treatment OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Affiliation to a social security system
• Signed informed consent
• Patient willing and able to attend all study visits

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (5)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-Maritimes, 06200, France

RECRUITING

APHP, Henri Mondor

Paris, Creteil, France

RECRUITING

CHU de Bordeaux

Bordeaux, Talence, 33000, France

RECRUITING

CHU de Lille

Lille, France

RECRUITING

HCL

Lyon, France

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

deucravacitinib; Therapeutics

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• PASSERON Thierry, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Passeron Thierry, PhD

CONTACT

+33492036488; passeron.t@chu-nice.fr

Pradelli Emmanuelle

CONTACT

+33492036488; pradelli.e@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: May 5, 2024
• Primary Completion: May 5, 2026
• Study Completion (Estimated): November 5, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

FR (5)