Study Stopped
terminated by sponsor
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
1 other identifier
interventional
75
1 country
16
Brief Summary
The purpose of this study is to assess the efficacy and safety of SHR0302 ointment in adult patients with Vitiligo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2020
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2020
CompletedFirst Submitted
Initial submission to the registry
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedJuly 13, 2022
June 1, 2022
2.1 years
February 24, 2021
July 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
SHR0302 Low Dose
ACTIVE COMPARATORDrug: SHR0302 SHR0302 Ointment BID Low Dose
SHR0302 High Dose
ACTIVE COMPARATORDrug: SHR0302 SHR0302 Ointment BID High Dose
Placebo Comparator: Vehicle
PLACEBO COMPARATORDrug: vehicle Vehicle BID Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who voluntarily signed an informed consent form.
- Ages at ≥18 and ≤ 65 years
- Clinical diagnosis of non-segmental vitiligo.
- 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.
- Subjects who agree to discontinue all vitiligo-related treatments and camouflage cosmetics with therapeutic effect between screening visit and the last follow-up visit.
- Subjects who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.
You may not qualify if:
- Subjects who were diagnosed with segmental vitiligo, mixed vitiligo or unclassified vitiligo.
- 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.
- 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).
- Pregnant or lactating female subjects;
- Subjects who have previously received JAK inhibitors therapy, systemic or oral
- Subjects who had used any biologics within12 weeks before the baseline or 5 half-lives (whichever is longer).
- 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.
- Subjects who received a live or live-attenuated vaccination within 8 weeks before the baseline visit.
- Any other condition that causes the subject to be unfit for the study as per discretion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200071, China
West China School of Medicine
Chengdu, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, China
Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
The First Hospital of Jillin University
Changchun, 130021, China
Sun. Yai- Sen Memorial Hospital, Sun. Yai- Sen University
Guangzhou, 51000, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
Jiangsu Province Hospital
Nanjing, 210006, China
Huashan Hospital Affiliated To Fudan University
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2021
First Posted
March 1, 2021
Study Start
January 29, 2020
Primary Completion
March 21, 2022
Study Completion
March 21, 2022
Last Updated
July 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share