A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.
Willing to sign an ICF, able to comprehend and comply with the study procedures.
Male or female subjects aged 18 to 65，inclusive.
Subjects with a clinical diagnosis of non-segmental vitiligo.
Agree to stop all other treatments for vitiligo during the study period.
Diagnosed as other active depigmentation disease.
At screening or baseline visits, subject exhibits active inflammatory dermatologic disease or symptoms that in the opinion of investigators would interfere of vitiligo evaluation or response to treatment.
Uncontrolled thyroid function at screening as determined by the investigator.
Use of permanent depigmentation treatment or skin grafts.
Parallel
SYHX1901
DrugSYHX1901 tablet
placebo
DrugOral tablet
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.
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.
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.
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.
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.
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CSPC Ouyi Pharmaceutical Co., Ltd.
Lead sponsor
Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
Collaborator
