A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo

NCT07251595 | Recruiting Phase 2

• 1 other identifier: SHR0302-202
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of SHR0302 tablets as single therapy or in combination with SHR0302 Base gel for patients with non-segmental vitiligo.

Conditions

Non-segmental Vitiligo

Outcome Measures

Primary Outcomes (1)

• The percentage change in the facial vitiligo area score index (F-VASI) from the baseline.

  At Week 24.

Secondary Outcomes (23)

• The percentage change in F-VASI compared to the baseline.

  Up to 48 weeks.

• The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline.

  Up to 48 weeks.

• The proportion of subjects who achieved an improvement of at least 50%/75%/90% compared to the baseline on the F-VASI (F-VASI 50/75/90 response).

  Up to 48 weeks.

• The proportion of subjects who achieved at least a 50%/75%/90% improvement in T-VASI compared to the baseline (T-VASI 50/75/90 response).

  Up to 48 weeks.

• The absolute change in facial vitiligo area (F-BSA) compared to the baseline.

  Up to 48 weeks.

Study Arms (4)

SHR0302 tablets in low dose group

EXPERIMENTAL

Drug: SHR0302 Tablets; Drug: SHR0302 Base Placebo Gel

SHR0302 tablets in high dose group

EXPERIMENTAL

Drug: SHR0302 Tablets; Drug: SHR0302 Base Placebo Gel

SHR0302 tablets + SHR0302 Base gel group

EXPERIMENTAL

Drug: SHR0302 Tablets; Drug: SHR0302 Base Gel

SHR0302 placebo tablets + SHR0302 Base placebo gel group

PLACEBO COMPARATOR

Drug: SHR0302 Placebo Tablets; Drug: SHR0302 Base Placebo Gel

Interventions

SHR0302 Tablets DRUG

SHR0302 tablets.

SHR0302 tablets + SHR0302 Base gel group; SHR0302 tablets in high dose group; SHR0302 tablets in low dose group

SHR0302 Base Gel DRUG

SHR0302 Base gel.

SHR0302 tablets + SHR0302 Base gel group

SHR0302 Placebo Tablets DRUG

SHR0302 placebo tablets.

SHR0302 placebo tablets + SHR0302 Base placebo gel group

SHR0302 Base Placebo Gel DRUG

SHR0302 Base placebo gel.

SHR0302 placebo tablets + SHR0302 Base placebo gel group; SHR0302 tablets in high dose group; SHR0302 tablets in low dose group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before the clinical trial.
• On the day of signing the informed consent form, the age must be between 18 and 75 years old (inclusive), and it can be either male or female.
• The subjects and their partners had no intention of having children during the study period and within one month after the administration of the drug, did not donate sperm or eggs, and voluntarily adopted effective contraceptive measures. The serum pregnancy test results of the female subjects must be negative and they must not be in the lactation period.
• During the screening process, it was clinically diagnosed as non-segmental vitiligo.
• Throughout the entire research process, the participants agreed to stop using all treatments related to vitiligo as well as any cosmetic products with therapeutic effects.

You may not qualify if:

• Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders.
• When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair.
• During the screening period or at the baseline, there were other active skin lesions or skin infections that might interfere with the use of the study drug or the evaluation of the drug's efficacy.
• Subjects with a history of related infections/communicable diseases or infection/contagion history.
• Known or suspected history of immunosuppression.
• Tuberculosis (TB) or latent tuberculosis infection.
• Positive for human immunodeficiency virus antibody HIV-Ab, positive for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis B virus (HBV) infection.
• Subjects who have malignant tumors or have a history of malignant tumors.
• Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event that required hospitalization within the previous 12 months.
• There are serious abnormalities in the cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine or hematological systems.
• Pregnant women, lactating women, or female participants who plan to become pregnant during the study period.
• Those who are known to be allergic to the test drug or any component of the test drug.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, 250022, China

RECRUITING

MeSH Terms

Interventions

ivarmacitinib

Central Study Contacts

Hui Wang

CONTACT

+86-0518-82342973; hui.wang.hw119@hengrui.com

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: November 19, 2025
• First Posted: November 26, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)