Non-segmental VitiligoPhase 2NCT07251595
A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo
A Phase 2 study testing SHR0302 Tablets and SHR0302 Base Gel in people with Non-segmental Vitiligo, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- SHR0302 Tablets and SHR0302 Base Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to Sep 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong, 250022
Furen Zhang, +86-0531-87298847, zhangfuren@hotmail.com
Furen Zhang
About this study
Official 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
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
- Being tested
- SHR0302 Tablets, SHR0302 Base Gel, SHR0302 Placebo Tablets, SHR0302 Base Placebo Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302 TabletsDrug
SHR0302 tablets.
SHR0302 Base GelDrug
SHR0302 Base gel.
SHR0302 Placebo TabletsDrug
SHR0302 placebo tablets.
SHR0302 Base Placebo GelDrug
SHR0302 Base placebo gel.
| Study group | Role | What they receive |
|---|---|---|
| SHR0302 tablets in low dose group | Experimental | Not described Receives: Drug: SHR0302 Tablets; Drug: SHR0302 Base Placebo Gel |
| SHR0302 tablets in high dose group | Experimental | Not described Receives: Drug: SHR0302 Tablets; Drug: SHR0302 Base Placebo Gel |
| SHR0302 tablets + SHR0302 Base gel group | Experimental | Not described Receives: Drug: SHR0302 Tablets; Drug: SHR0302 Base Gel |
| SHR0302 placebo tablets + SHR0302 Base placebo gel group | Placebo comparator | Not described Receives: Drug: SHR0302 Placebo Tablets; Drug: SHR0302 Base Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in the facial vitiligo area score index (F-VASI) from the baseline.
Measured: At Week 24.
Secondary outcomes (23)
The percentage change in F-VASI compared to the baseline.
Except for Week 24.
Measured: Up to 48 weeks.
The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline.
Measured: 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).
Measured: 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).
Measured: Up to 48 weeks.
The absolute change in facial vitiligo area (F-BSA) compared to the baseline.
Measured: Up to 48 weeks.
The percentage change in facial vitiligo area (F-BSA) compared to the baseline.
Measured: Up to 48 weeks.
The percentage change the total body vitiligo area (T-BSA) compared to the baseline.
Measured: Up to 48 weeks.
The absolute change the total body vitiligo area (T-BSA) compared to the baseline.
Measured: Up to 48 weeks.
The proportion of subjects who achieved a significant improvement (4) on the Vitiligo Visual Scale (VNS).
Measured: Up to 48 weeks.
The proportion of subjects who achieved a complete improvement (5) on the Vitiligo Visual Scale (VNS).
Measured: Up to 48 weeks.
The absolute values of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.
Measured: Up to 48 weeks.
The percentages of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.
Measured: Up to 48 weeks.
The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of no depigmentation (0).
Measured: Up to 48 weeks.
The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of almost no depigmentation (1).
Measured: Up to 48 weeks.
The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as no depigmentation (0).
Measured: Up to 48 weeks.
The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as almost no depigmentation (1).
Measured: 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).
Measured: 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).
Measured: Up to 48 weeks.
The proportion of subjects who achieved a significant improvement (1) in the overall impression (T-PaGIC-V) of generalized vitiligo.
Measured: Up to 48 weeks.
The proportion of subjects who achieved a moderate improvement (2) in the overall impression (T-PaGIC-V) of generalized vitiligo.
Measured: Up to 48 weeks.
The plasma concentration of SHR0302.
Measured: Week 12 and Week 24.
The relative change in serum CXCL-9 level before administration compared to the baseline value.
Measured: At Week 4, 12, 24, 32, and 48.
The relative change in serum CXCL-10 level before administration compared to the baseline value.
Measured: At Week 4, 12, 24, 32, and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start5 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental VitiligoStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251595
- Sponsor's protocol ID
- SHR0302-202
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided