Non-segmental Vitiligo
Conditions
Brief summary
A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.
Detailed description
SYHX1901 tablet is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 144 participants aged 18-65 with non-segmental vitiligo in 4 treatment arms. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.
Interventions
DRUGSYHX1901
SYHX1901 tablet
DRUGplacebo
Oral tablet
Sponsors
Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
CSPC Ouyi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel assigned
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Willing to sign an ICF, able to comprehend and comply with the study procedures. 2. Male or female subjects aged 18 to 65，inclusive. 3. Subjects with a clinical diagnosis of non-segmental vitiligo. 4. Agree to stop all other treatments for vitiligo during the study period. 5. Women of child-bearing potential must have a negative serum pregnancy test within 3 days prior to the first study agent administration.
Exclusion criteria
1. Diagnosed as other active depigmentation disease. 2. 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. 3. Uncontrolled thyroid function at screening as determined by the investigator. 4. Use of permanent depigmentation treatment or skin grafts. 5. Use of phototherapy, topical or systemic treatments within certain time frame prior to Day1. 6. Have active bacterial/virus/other pathogens infection or infestation that require medical intervention. 7. Have progressive or uncontrolled systemic disease, or other concomitant chronic disease that the investigators believe unsuitable to participate the study. 8. History of alcohol and drug abuse within one year prior to screening; History of neurological or mental disorders with diagnosis records, such as severe depression, suicidal tendencies, epilepsy, dementia, etc. 9. Have any other reasons determined by the investigator that the subject is not eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) | At 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks | 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) | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks | 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 | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks | 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. |
| Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks | 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. |
| Change from baseline in Overall Dermatology Life Quality Index (DLQI) score | At 8、16、24、32、40、48、52、56 weeks | 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. |
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) score | At 8、16、24、32、40、48、52、56 weeks | 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). |
| Percent Change From Baseline in BSA | At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks | The BSA is measured by the number of hand units (palm plus 5 digits = 1% body surface area). |
Countries
China
Outcome results
None listed