A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
NCT Number: NCT06511739
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-segmental Vitiligo
Interventions: DRUG: SYHX1901|DRUG: placebo
Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborators: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-27
Completion Date: 2025-10-01
Locations: Clinical Trials Information Group, Shijiazhuang, China

Summary:
A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.

Primary Outcome Measures: Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI), The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5., At 24 weeks
Secondary Outcome Measures: Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline), The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5., At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks|Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline), The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5., At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks|Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline), The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100., At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks|Percent Change From Baseline in F-VASI, The VASI is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100., At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks|Percent Change From Baseline in BSA, The BSA is measured by the number of hand units (palm plus 5 digits = 1% body surface area)., At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks|Change from baseline in Overall Dermatology Life Quality Index (DLQI) score, The DLQI is a validated questionnaire used in dermatology clinical trials as patient reported outcome measure. The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week., At 8、16、24、32、40、48、52、56 weeks|Change from baseline in Hospital Anxiety and Depression Scale (HADS) score, The HADS is a self-rating patient reported outcome measure (PROM) to assess depression and anxiety in patients. Fourteen items are equally divided in two subscales: anxiety (HADS-A) and depression (HADS-D)., At 8、16、24、32、40、48、52、56 weeks