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

A Randomized, Double-blind, Vehicle-Controlled, Phase II/Ⅲ Seamless Adaptive Clinical Trail to Evaluate the Efficacy and Safety of SHR0302 Ointment in Adult Patients With Vitiligo

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

Study Overview

• Status: Terminated
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Low Dose SHR0302 Ointment BID; Drug: High Dose SHR0302 Ointment BID; Other: Placebo Comparator: Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Changchun, China, 130021
    • The First Hospital of Jillin University
  • Guangzhou, China, 51000
    • Sun. Yai- Sen Memorial Hospital, Sun. Yai- Sen University
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital
  • Nanjing, China, 210006
    • Jiangsu Province Hospital
  • Shanghai, China
    • Huashan Hospital affiliated to Fudan University
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Dermatology Hospital of Southern Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan No.1 hospital
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Xijing Hospital, Air Force Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Shanghai Skin Disease Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China School of Medicine
  • Tianjin
    • Tianjin, Tianjin, China, 300120
      • Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou Third Hospital
    • Hangzhou, Zhejiang, China
      • Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China
      • Ningbo No.2 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SHR0302 Low Dose; Drug: SHR0302 SHR0302 Ointment BID Low Dose	Drug: Low Dose SHR0302 Ointment BID; Low Dose SHR0302 Ointment BID
Active Comparator: SHR0302 High Dose; Drug: SHR0302 SHR0302 Ointment BID High Dose	Drug: High Dose SHR0302 Ointment BID; High Dose SHR0302 Ointment BID
Placebo Comparator: Placebo Comparator: Vehicle; Drug: vehicle Vehicle BID Placebo	Other: Placebo Comparator: Vehicle; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2	Phase 2: Percentage of change in face and neck vitiligo area scoring index (F-VASI) compared with baseline at week 24.	24 weeks
Phase 3	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.	24 weeks

Collaborators and Investigators

• Sponsor: Reistone Biopharma Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: RSJ10828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No