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

February 14, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250022
        • Recruiting
        • Dermatology Hospital Affiliated to Shandong First Medical University
        • Principal Investigator:
          • Furen Zhang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sign the informed consent form before the clinical trial.
  2. 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.
  3. 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.
  4. During the screening process, it was clinically diagnosed as non-segmental vitiligo.
  5. 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:

  1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders.
  2. When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair.
  3. 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.
  4. Subjects with a history of related infections/communicable diseases or infection/contagion history.
  5. Known or suspected history of immunosuppression.
  6. Tuberculosis (TB) or latent tuberculosis infection.
  7. 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.
  8. Subjects who have malignant tumors or have a history of malignant tumors.
  9. 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.
  10. There are serious abnormalities in the cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine or hematological systems.
  11. Pregnant women, lactating women, or female participants who plan to become pregnant during the study period.
  12. Those who are known to be allergic to the test drug or any component of the test drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SHR0302 tablets in low dose group
Drug: SHR0302 Tablets
SHR0302 tablets.
Drug: SHR0302 Base Placebo Gel
SHR0302 Base placebo gel.
Experimental: SHR0302 tablets in high dose group
Drug: SHR0302 Tablets
SHR0302 tablets.
Drug: SHR0302 Base Placebo Gel
SHR0302 Base placebo gel.
Experimental: SHR0302 tablets + SHR0302 Base gel group
Drug: SHR0302 Tablets
SHR0302 tablets.
Drug: SHR0302 Base Gel
SHR0302 Base gel.
Placebo Comparator: SHR0302 placebo tablets + SHR0302 Base placebo gel group
Drug: SHR0302 Base Placebo Gel
SHR0302 Base placebo gel.
Drug: SHR0302 Placebo Tablets
SHR0302 placebo tablets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The percentage change in the facial vitiligo area score index (F-VASI) from the baseline.
Time Frame: At Week 24.
At Week 24.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The percentage change in F-VASI compared to the baseline.
Time Frame: Up to 48 weeks.
Except for Week 24.
Up to 48 weeks.
The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline.
Time Frame: Up to 48 weeks.
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).
Time Frame: Up to 48 weeks.
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).
Time Frame: Up to 48 weeks.
Up to 48 weeks.
The absolute change in facial vitiligo area (F-BSA) compared to the baseline.
Time Frame: Up to 48 weeks.
Up to 48 weeks.
The percentage change in facial vitiligo area (F-BSA) compared to the baseline.
Time Frame: Up to 48 weeks.
Up to 48 weeks.
The percentage change the total body vitiligo area (T-BSA) compared to the baseline.
Time Frame: Up to 48 weeks.
Up to 48 weeks.
The absolute change the total body vitiligo area (T-BSA) compared to the baseline.
Time Frame: Up to 48 weeks.
Up to 48 weeks.
The proportion of subjects who achieved a significant improvement (4) on the Vitiligo Visual Scale (VNS).
Time Frame: Up to 48 weeks.
Up to 48 weeks.
The proportion of subjects who achieved a complete improvement (5) on the Vitiligo Visual Scale (VNS).
Time Frame: Up to 48 weeks.
Up to 48 weeks.
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.
Up to 48 weeks.
The percentages of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.
Time Frame: Up to 48 weeks.
Up to 48 weeks.
The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of no depigmentation (0).
Time Frame: Up to 48 weeks.
Up to 48 weeks.
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.
Up to 48 weeks.
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.
Up to 48 weeks.
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.
Up to 48 weeks.
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.
Up to 48 weeks.
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.
Up to 48 weeks.
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.
Up to 48 weeks.
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.
Up to 48 weeks.
The plasma concentration of SHR0302.
Time Frame: Week 12 and Week 24.
Week 12 and Week 24.
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.
At Week 4, 12, 24, 32, and 48.
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.
At Week 4, 12, 24, 32, and 48.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR0302-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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