The study is being conducted to evaluate the efficacy, and safety of SHR0302 tablets as single therapy or in combination with SHR0302 Base gel for patients with non-segmental vitiligo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
176
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China
RECRUITINGThe percentage change in the facial vitiligo area score index (F-VASI) from the baseline.
Time frame: At Week 24.
The percentage change in F-VASI compared to the baseline.
Except for Week 24.
Time frame: Up to 48 weeks.
The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline.
Time frame: Up to 48 weeks.
The proportion of subjects who achieved an improvement of at least 50%/75%/90% compared to the baseline on the F-VASI (F-VASI 50/75/90 response).
Time frame: Up to 48 weeks.
The proportion of subjects who achieved at least a 50%/75%/90% improvement in T-VASI compared to the baseline (T-VASI 50/75/90 response).
Time frame: Up to 48 weeks.
The absolute change in facial vitiligo area (F-BSA) compared to the baseline.
Time frame: Up to 48 weeks.
The percentage change in facial vitiligo area (F-BSA) compared to the baseline.
Time frame: Up to 48 weeks.
The percentage change the total body vitiligo area (T-BSA) compared to the baseline.
Time frame: Up to 48 weeks.
The absolute change the total body vitiligo area (T-BSA) compared to the baseline.
Time frame: Up to 48 weeks.
The proportion of subjects who achieved a significant improvement (4) on the Vitiligo Visual Scale (VNS).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SHR0302 Base placebo gel.
Time frame: Up to 48 weeks.
The proportion of subjects who achieved a complete improvement (5) on the Vitiligo Visual Scale (VNS).
Time frame: Up to 48 weeks.
The absolute values of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.
Time frame: Up to 48 weeks.
The percentages of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.
Time frame: Up to 48 weeks.
The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of no depigmentation (0).
Time frame: Up to 48 weeks.
The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of almost no depigmentation (1).
Time frame: Up to 48 weeks.
The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as no depigmentation (0).
Time frame: Up to 48 weeks.
The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as almost no depigmentation (1).
Time frame: Up to 48 weeks.
The proportion of subjects who achieved a significant improvement (1) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V).
Time frame: Up to 48 weeks.
The proportion of subjects who achieved a moderate improvement (2) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V).
Time frame: Up to 48 weeks.
The proportion of subjects who achieved a significant improvement (1) in the overall impression (T-PaGIC-V) of generalized vitiligo.
Time frame: Up to 48 weeks.
The proportion of subjects who achieved a moderate improvement (2) in the overall impression (T-PaGIC-V) of generalized vitiligo.
Time frame: Up to 48 weeks.
The plasma concentration of SHR0302.
Time frame: Week 12 and Week 24.
The relative change in serum CXCL-9 level before administration compared to the baseline value.
Time frame: At Week 4, 12, 24, 32, and 48.
The relative change in serum CXCL-10 level before administration compared to the baseline value.
Time frame: At Week 4, 12, 24, 32, and 48.