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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04774809
• Other study ID #: RSJ10828
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 29, 2020
• Est. completion date: March 21, 2022

Study information

• Verified date: June 2022
• Source: Reistone Biopharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Low Dose SHR0302 Ointment BID
Low Dose SHR0302 Ointment BID
• High Dose SHR0302 Ointment BID
High Dose SHR0302 Ointment BID

Other:
• Placebo Comparator: Vehicle
Placebo

Locations

Country	Name	City	State
China	The First Hospital of Jillin University	Changchun
China	West China School of Medicine	Chengdu	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun. Yai- Sen Memorial Hospital, Sun. Yai- Sen University	Guangzhou
China	Hangzhou Third Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou
China	Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jiangsu Province Hospital	Nanjing
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Huashan Hospital Affiliated To Fudan University	Shanghai
China	Shanghai Skin Disease Hospital	Shanghai	Shanghai
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin
China	Wuhan No.1 Hospital	Wuhan	Hubei
China	Xijing Hospital, Air Force Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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