Overview

Assess the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo

Status:
Recruiting
Trial end date:
2024-08-10
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Reistone Biopharma Company Limited
Criteria
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.