Vitiligo Treatment by Targeting TYK2 Mediated Responses
NCT ID: NCT06327321
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
128 participants
INTERVENTIONAL
2024-05-05
2026-11-05
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Drug group
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.
Deucravacitinib
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
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.
Volunteer without treatment
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.
Interventions
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Deucravacitinib
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.
Volunteer without treatment
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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PASSERON Thierry, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Nice, Service de Dermatologie
Locations
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CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, France
APHP, Henri Mondor
Paris, Creteil, France
CHU de Bordeaux
Bordeaux, Talence, France
CHU de Lille
Lille, , France
HCL
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-PP-08
Identifier Type: -
Identifier Source: org_study_id
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