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

Reistone Biopharma

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Vitiligo

Treatments: Drug: Low Dose SHR0302 Ointment BID; Other: Placebo Comparator: Vehicle; Drug: High Dose SHR0302 Ointment BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT04774809

RSJ10828

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

SHR0302 Low Dose

Active Comparator group

Description:

Drug: SHR0302 SHR0302 Ointment BID Low Dose

Treatment:

Drug: Low Dose SHR0302 Ointment BID

SHR0302 High Dose

Active Comparator group

Description:

Drug: SHR0302 SHR0302 Ointment BID High Dose

Treatment:

Drug: High Dose SHR0302 Ointment BID

Placebo Comparator: Vehicle

Placebo Comparator group

Description:

Drug: vehicle Vehicle BID Placebo

Treatment:

Other: Placebo Comparator: Vehicle