Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07251595

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, 250022, China

Location status: Recruiting

Location contact

Furen Zhang

CONTACT

[email protected]

+86-0531-87298847

Furen Zhang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR0302 Tablets

Drug

SHR0302 tablets.

SHR0302 Base Gel

Drug

SHR0302 Base gel.

SHR0302 Placebo Tablets

Drug

SHR0302 placebo tablets.

SHR0302 Base Placebo Gel

Drug

SHR0302 Base placebo gel.

Primary outcomes

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

    Time frame: At Week 24.

Secondary outcomes

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

    Time frame: Up to 48 weeks.

    Except for Week 24.

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

    Time frame: Up to 48 weeks.

  3. 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).

    Time frame: Up to 48 weeks.

  4. 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).

    Time frame: Up to 48 weeks.

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

    Time frame: Up to 48 weeks.

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

    Time frame: Up to 48 weeks.

  7. The percentage change the total body vitiligo area (T-BSA) compared to the baseline.

    Time frame: Up to 48 weeks.

  8. The absolute change the total body vitiligo area (T-BSA) compared to the baseline.

    Time frame: Up to 48 weeks.

  9. The proportion of subjects who achieved a significant improvement (4) on the Vitiligo Visual Scale (VNS).

    Time frame: Up to 48 weeks.

  10. The proportion of subjects who achieved a complete improvement (5) on the Vitiligo Visual Scale (VNS).

    Time frame: Up to 48 weeks.

  11. The absolute values of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.

    Time frame: Up to 48 weeks.

  12. The percentages of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.

    Time frame: Up to 48 weeks.

  13. The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of no depigmentation (0).

    Time frame: Up to 48 weeks.

  14. The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of almost no depigmentation (1).

    Time frame: Up to 48 weeks.

  15. The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as no depigmentation (0).

    Time frame: Up to 48 weeks.

  16. The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as almost no depigmentation (1).

    Time frame: Up to 48 weeks.

  17. The proportion of subjects who achieved a significant improvement (1) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V).

    Time frame: Up to 48 weeks.

  18. The proportion of subjects who achieved a moderate improvement (2) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V).

    Time frame: Up to 48 weeks.

  19. The proportion of subjects who achieved a significant improvement (1) in the overall impression (T-PaGIC-V) of generalized vitiligo.

    Time frame: Up to 48 weeks.

  20. The proportion of subjects who achieved a moderate improvement (2) in the overall impression (T-PaGIC-V) of generalized vitiligo.

    Time frame: Up to 48 weeks.

  21. The plasma concentration of SHR0302.

    Time frame: Week 12 and Week 24.

  22. The relative change in serum CXCL-9 level before administration compared to the baseline value.

    Time frame: At Week 4, 12, 24, 32, and 48.

  23. The relative change in serum CXCL-10 level before administration compared to the baseline value.

    Time frame: At Week 4, 12, 24, 32, and 48.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR0302 Tablets as Single Therapy or in Combination With SHR0302 Base Gel in the Treatment of Patients With Non-segmental Vitiligo

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.