VitiligoPhase 2NCT06790862
A Trial of SHR0302Base in Patients With Vitiligo
A Phase 2 study testing SHR0302Base gel in people with Vitiligo, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- SHR0302Base gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2025to Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Clinically diagnosis of non-segmental vitiligo.
- The disease has been stable for more than 3 months (90 days) (stable disease is defined as no expansion of the original lesion and no new lesions).
- Subjects and their partners do not plan to have children, do not donate sperm/eggs, and voluntarily use highly effective contraception during the study period until 6 months (female subjects) or 3 months (male subjects) after dosing. Female subjects must have a negative serum pregnancy test and be non-lactating.
Who cannot join
- Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; Or previously diagnosed with other skin pigmentation disorders (except nevus halos).
- Conditions at baseline that would interfere with evaluation of vitiligo.
- Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
- Use of protocol-defined treatments within the indicated washout period before baseline.
Trial locations and contacts
1 site in 1 country.
China1 site
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong, 250022
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Excipient-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR0302Base in Subjects With Nonsegmental Vitiligo
The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo.
- Conditions
- Vitiligo
- Being tested
- SHR0302Base gel, SHR0302Base gel placebo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302Base gelDrug
SHR0302Base gel.
SHR0302Base gel placeboDrug
SHR0302Base gel placebo.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | Not described Receives: Drug: SHR0302Base gel |
| Treatment group 2 | Experimental | Not described Receives: Drug: SHR0302Base gel |
| Treatment group 3 | Experimental | Not described Receives: Drug: SHR0302Base gel |
| Treatment group 4 | Placebo comparator | Not described Receives: Drug: SHR0302Base gel placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieved at least a 50% improvement from baseline in the facial-neck vitiligo area score (F-VASI 50 response).
Measured: At week 24.
Secondary outcomes (5)
The proportion of subjects who achieved at least a 75% improvement from baseline in the facial-neck vitiligo area score (F-VASI 75 response).
Measured: At week 24.
The proportion of subjects who achieved at least a 90% improvement from baseline in the facial-neck vitiligo area score (F-VASI 90 response).
Measured: At week 24.
The proportion of subjects who achieved at least a 50% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 50 response).
Measured: At week 24.
The proportion of subjects who achieved at least a 75% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 75 response).
Measured: At week 24.
The proportion of subjects who achieved at least a 90% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 90 response).
Measured: At week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start13 Feb 2025
- Primary completion3 Mar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- SHR0302Base compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
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
- NCT06790862
- Sponsor's protocol ID
- SHR0302Base-201
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Excipient-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR0302Base in Subjects With Nonsegmental Vitiligo
- ClinicalTrials.gov ID
- NCT06790862
- Acronym / sponsor ID
- SHR0302Base-201
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 3 Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- SHR0302Base compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: SHR0302Base gel |
| Treatment group 2 | Experimental | Drug: SHR0302Base gel |
| Treatment group 3 | Experimental | Drug: SHR0302Base gel |
| Treatment group 4 | Placebo comparator | Drug: SHR0302Base gel placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically diagnosis of non-segmental vitiligo.
- The disease has been stable for more than 3 months (90 days) (stable disease is defined as no expansion of the original lesion and no new lesions).
- Subjects and their partners do not plan to have children, do not donate sperm/eggs, and voluntarily use highly effective contraception during the study period until 6 months (female subjects) or 3 months (male subjects) after dosing. Female subjects must have a negative serum pregnancy test and be non-lactating.
Key exclusion criteria (4 listed)
- Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; Or previously diagnosed with other skin pigmentation disorders (except nevus halos).
- Conditions at baseline that would interfere with evaluation of vitiligo.
- Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
- Use of protocol-defined treatments within the indicated washout period before baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR0302Base gelSHR0302Base gel. | Drug | Treatment group 1, Treatment group 2, Treatment group 3 |
| SHR0302Base gel placeboSHR0302Base gel placebo. | Drug | Treatment group 4 |
Primary outcome
The proportion of subjects who achieved at least a 50% improvement from baseline in the facial-neck vitiligo area score (F-VASI 50 response).
Time frame: At week 24.
5 secondary outcomes
The proportion of subjects who achieved at least a 75% improvement from baseline in the facial-neck vitiligo area score (F-VASI 75 response).
Time frame: At week 24.
The proportion of subjects who achieved at least a 90% improvement from baseline in the facial-neck vitiligo area score (F-VASI 90 response).
Time frame: At week 24.
The proportion of subjects who achieved at least a 50% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 50 response).
Time frame: At week 24.
The proportion of subjects who achieved at least a 75% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 75 response).
Time frame: At week 24.
The proportion of subjects who achieved at least a 90% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 90 response).
Time frame: At week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR0302Base gel in people with Vitiligo, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieved at least a 50% improvement from baseline in the facial-neck vitiligo area score (F-VASI 50 response). (time frame: At week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.