Vitiligo
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.
Detailed description
This study is a phase II/Ⅲ seamless adaptive clinical trial to evaluate the efficacy and safety of SHR0302 ointment in adult patients with non-segmental vitiligo.
Interventions
DRUGLow Dose SHR0302 Ointment BID
Low Dose SHR0302 Ointment BID
DRUGHigh Dose SHR0302 Ointment BID
High Dose SHR0302 Ointment BID
Placebo
Sponsors
Reistone Biopharma Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who voluntarily signed an informed consent form. 2. Ages at ≥18 and ≤ 65 years 3. Clinical diagnosis of non-segmental vitiligo. 4. All women and men who are likely to give birth must be willing to use at least one efficient method of contraception from the signing of the informed consent form to 1 month after the last dose of IP. 5. Subjects who agree to discontinue all vitiligo-related treatments and camouflage cosmetics with therapeutic effect between screening visit and the last follow-up visit. 6. Subjects who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.
Exclusion criteria
1. Subjects who were diagnosed with segmental vitiligo, mixed vitiligo or unclassified vitiligo. 2. Subjects with historical or current evidence of clinically significant disease or lab test abnormalities or with disease that require the administration of prohibited drugs in this study. 3. Subjects with a malignant tumor or a history of malignant tumor (except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma). 4. Pregnant or lactating female subjects; 5. Subjects who have previously received JAK inhibitors therapy, systemic or oral 6. Subjects who had used any biologics within12 weeks before the baseline or 5 half-lives (whichever is longer). 7. Subjects who participated in other interventional clinical studies within 4 weeks before the baseline visit, or who were still within 5 half-lives of the last dose of the intervention clinical study drug at baseline. 8. Subjects who received a live or live-attenuated vaccination within 8 weeks before the baseline visit. 9. Any other condition that causes the subject to be unfit for the study as per discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 | 24 weeks | Phase 2: Percentage of change in face and neck vitiligo area scoring index (F-VASI) compared with baseline at week 24. |
| Phase 3 | 24 weeks | Phase 3: Percentage of subjects whose face and neck vitiligo area scoring index improved by at least 75% (F-VASI75) compared with the baseline at week 24. |
Countries
China
Outcome results
None listed