Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327321
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-18
Brief Title:
Vitiligo Treatment by Targeting TYK2 Mediated Responses
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Vitiligo Treatment by Targeting TYK2 Mediated Responses Prospective Multicentric Double Blind Interventional Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ViTYK
Brief Summary:
Vitiligo affects approximately 1 to 2 of the global population and significantly impacts peoples 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None