VitiligoPhase 2D2570-206NCT07625891
Study of D-2570 in Subjects With Non-Segmental Vitiligo
A Phase 2 study testing D-2570 Dose 1, D-2570 Dose 2 and D-2570 Dose 3 in people with Vitiligo and Non-Segmental Vitiligo (NSV), run by InventisBio Co., Ltd at 1 site in China.
Trial summary
This study tests D-2570, an investigational drug, in people with non-segmental vitiligo to check its safety and effect on skin discoloration. Eligible participants will take D-2570, or a placebo, once daily for 24 weeks in a double-blind setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo, Non-Segmental Vitiligo (NSV)
- What is being tested?
- D-2570 Dose 1, D-2570 Dose 2 and D-2570 Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2026to May 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signs informed consent and complies with study procedures.
- Age 18-65 years, male or female.
- Clinical diagnosis of non-segmental vitiligo at screening.
- F-VASI ≥0.25 and T-VASI ≥5 at screening and baseline, with either active or stable vitiligo.
- Women of childbearing potential have negative pregnancy tests at screening and baseline. All eligible subjects agree to effective contraception from consent through 30 days after last study drug dose.
Who cannot join
- - Segmental, mixed vitiligo or other concurrent pigmentary/active skin disorders interfering with study assessment.
- Over 33% facial or total vitiligo lesions with leukotrichia.
- Pregnant or breastfeeding females.
- Active, latent or inadequately treated tuberculosis infection.
- Positive HIV, active HBV/HCV infection, or untreated syphilis.
- Current or history of severe herpes infection.
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- Severe systemic infection requiring recent inpatient, intravenous or oral anti-infective treatment.
- Congenital or acquired immune deficiency, opportunistic infection history, or conditions requiring systemic immunosuppression during the study.
- Uncontrolled thyroid disease, severe cardiovascular/cerebrovascular disease or other unstable severe systemic disorders.
- Severe psychiatric disease, suicidal ideation, or alcohol/drug abuse within 6 months.
- Malignancy history within 5 years (excluding cured non-melanoma skin cancer and cervical intraepithelial neoplasia).
- Gastrointestinal disease affecting drug absorption or major surgery within 8 weeks prior to dosing.
- Clinically significant abnormal lab results: elevated liver/renal indices, decreased hemoglobin, WBC, platelet, lymphocyte or neutrophil counts.
- History of severe drug hypersensitivity or drug-related toxicity.
- Any condition that may impair protocol compliance or study participation per investigator judgment.
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
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201203
shilin Sha, 15601826678, shilin.sha@inventisbio.com
About this study
Official title: A Phase 2 Multicenter, Randomized, Parallel-group, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of D-2570 in Subjects With Non-Segmental Vitiligo
This study tests D-2570, an investigational drug, in people with non-segmental vitiligo to check its safety and effect on skin discoloration.
Eligible participants will take D-2570, or a placebo, once daily for 24 weeks in a double-blind setting. Most will then continue into a 24-week extension phase All participants will have a 4-week safety follow-up after treatment ends, with regular check-ups and blood tests throughout the study.
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of D-2570 in subjects with non-segmental vitiligo. The study consists of three periods: a screening period (up to 4 weeks), a 24-week double-blind treatment period, and a 24-week extension treatment period, followed by a 4-week safety follow-up period.
During the screening period, written informed consent will be obtained from each subject, and eligibility will be assessed based on predefined inclusion and exclusion criteria. Subjects who meet all eligibility criteria will be stratified according to baseline vitiligo severity (T-VASI <15 or ≥15) and disease activity (active or stable), then randomized in a 1:1:1:1 ratio to one of four treatment groups: D-2570 Group A, D-2570 Group B, D-2570 Group C, or placebo.
During the 24-week double-blind treatment period, subjects will receive once-daily oral study medication. Subjects in Groups A and B will continue the same dose in the subsequent 24-week extension period. Subjects in Group C and the placebo group will be re-randomized in a 1:1 ratio to either Group A or Group B for the extension period, maintaining the blind.
All subjects will attend study visits at protocol-specified time points, including assessments of efficacy (including T-VASI), safety (including adverse events, clinical laboratory tests, vital signs, and physical examinations), and pharmacokinetic evaluations via blood sampling. The study will conclude with an end-of-study (EOS) visit at Week 52, 4 weeks after the last dose of study medication, to collect final safety data. All subjects, investigators, and study site personnel will remain blinded to treatment assignments throughout the study.
- Conditions
- Vitiligo, Non-Segmental Vitiligo (NSV)
- Being tested
- D-2570 Dose 1, D-2570 Dose 2, Placebo, D-2570 Dose 3
- Keywords
- Non-segmental Vitiligo, D-2570, Phase 2 Clinical Trial
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-2570 Dose 1Drug
Oral D-2570 Dose 1 administered once daily for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose in the 24-week extension period
D-2570 Dose 2Drug
Oral D-2570 Dose 2 administered once daily for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose in the 24-week extension period.
PlaceboDrug
Oral placebo administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 Dose 1 or Dose 2 in the extension period.
D-2570 Dose 3Drug
Oral D-2570 Dose 3 administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 Dose 1 or Dose 2 in the extension period.
| Study group | Role | What they receive |
|---|---|---|
| D-2570 Dose 1 (experimental arm 1) | Experimental | Subjects in this arm will receive oral D-2570 Dose 1 once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 Dose 1 in the subsequent 24-week extension period. Receives: Drug: D-2570 Dose 1 |
| D-2570 Dose 2 (experimental arm 2) | Experimental | Subjects in this arm will receive oral D-2570 Dose 2 once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 Dose 2 in the subsequent 24-week extension period Receives: Drug: D-2570 Dose 2 |
| D-2570 Dose 3 (experimental arm 3) | Experimental | Subjects in this arm will receive oral D-2570 Dose 3 once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 Dose 1 or Dose 2 once daily for the extension period. Receives: Drug: D-2570 Dose 3 |
| placebo | Placebo comparator | Subjects in this arm will receive matching placebo once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 Dose 1 or Dose 2 once daily for the extension period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI)
Change rate of facial vitiligo area, measured by F-VASI score, relative to baseline
Measured: week24
Secondary outcomes (11)
Change and percentage change from baseline in F-VASI
Absolute change and percentage change in facial vitiligo area, measured by F-VASI score, relative to baseline.
Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects achieving F-VASI50/75/90
Percentage of subjects with ≥50%, ≥75%, or ≥90% reduction in F-VASI score from baseline.
Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Change and percentage change from baseline in T-VASI
Absolute change and percentage change in total vitiligo area, measured by T-VASI score, relative to baseline.
Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects achieving T-VASI50/75/90
Percentage of subjects with ≥50%, ≥75%, or ≥90% reduction in T-VASI score from baseline.
Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects with F-PhGVA score 0 or 1
Percentage of subjects with F-PhGVA score of 0 (clear) or 1 (almost clear).
Measured: Weeks 8, 16, 24, 32, 40, and 48
Proportion of subjects with T-PhGVA score 0 or 1
Percentage of subjects with T-PhGVA score of 0 (clear) or 1 (almost clear).
Measured: Weeks 8, 16, 24, 32, 40, and 48
Proportion of subjects with VNS score 4 or 5
Percentage of subjects with VNS score of 4 (hardly noticeable) or 5 (not noticeable).
Measured: Weeks 8, 16, 24, 32, 40, and 48
Change from baseline in DLQI score
Change in Dermatology Quality of Life Index (DLQI) score relative to baseline.
Measured: Weeks 8, 16, 24, 32, 40, and 48
Change from baseline in VitiQoL score
Change in Vitiligo-Specific Quality of Life (VitiQoL) score relative to baseline.
Measured: Weeks 8, 16, 24, 32, 40, and 48
Plasma concentrations of D-2570
Measured: Through study completion (approximately Week 48)
Safety of D-2570（AEs）
Measured: Through study completion (approximately Week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start11 Jun 2026
- Primary completionNov 2027 (estimated)
- Study completionMay 2028 (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 InventisBio Co., LtdThe 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625891
- Sponsor's protocol ID
- D2570-206
- Acronym
- D2570-206
- Status last verified
- Jul 2026
- First submitted
- 28 May 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Parallel-group, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of D-2570 in Subjects With Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07625891
- Acronym / sponsor ID
- D2570-206 / D2570-206
- Conditions
- Vitiligo, Non-Segmental Vitiligo (NSV)
- Keywords
- Non-segmental Vitiligo, D-2570, Phase 2 Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 4 Jun 2026 (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.
This study tests D-2570, an investigational drug, in people with non-segmental vitiligo to check its safety and effect on skin discoloration.
Eligible participants will take D-2570, or a placebo, once daily for 24 weeks in a double-blind setting. Most will then continue into a 24-week extension phase All participants will have a 4-week safety follow-up after treatment ends, with regular check-ups and blood tests throughout the study.
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of D-2570 in subjects with non-segmental vitiligo. The study consists of three periods: a screening period (up to 4 weeks), a 24-week double-blind treatment period, and a 24-week extension treatment period, followed by a 4-week safety follow-up period.
During the screening period, written informed consent will be obtained from each subject, and eligibility will be assessed based on predefined inclusion and exclusion criteria. Subjects who meet all eligibility criteria will be stratified according to baseline vitiligo severity (T-VASI <15 or ≥15) and disease activity (active or stable), then randomized in a 1:1:1:1 ratio to one of four treatment groups: D-2570 Group A, D-2570 Group B, D-2570 Group C, or placebo.
During the 24-week double-blind treatment period, subjects will receive once-daily oral study medication. Subjects in Groups A and B will continue the same dose in the subsequent 24-week extension period. Subjects in Group C and the placebo group will be re-randomized in a 1:1 ratio to either Group A or Group B for the extension period, maintaining the blind.
All subjects will attend study visits at protocol-specified time points, including assessments of efficacy (including T-VASI), safety (including adverse events, clinical laboratory tests, vital signs, and physical examinations), and pharmacokinetic evaluations via blood sampling. The study will conclude with an end-of-study (EOS) visit at Week 52, 4 weeks after the last dose of study medication, to collect final safety data. All subjects, investigators, and study site personnel will remain blinded to treatment assignments throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D-2570 Dose 1 (experimental arm 1) | Experimental | Drug: D-2570 Dose 1Subjects in this arm will receive oral D-2570 Dose 1 once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 Dose 1 in the subsequent 24-week extension period. |
| D-2570 Dose 2 (experimental arm 2) | Experimental | Drug: D-2570 Dose 2Subjects in this arm will receive oral D-2570 Dose 2 once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 Dose 2 in the subsequent 24-week extension period |
| D-2570 Dose 3 (experimental arm 3) | Experimental | Drug: D-2570 Dose 3Subjects in this arm will receive oral D-2570 Dose 3 once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 Dose 1 or Dose 2 once daily for the extension period. |
| placebo | Placebo comparator | Drug: PlaceboSubjects in this arm will receive matching placebo once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 Dose 1 or Dose 2 once daily for the extension period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily signs informed consent and complies with study procedures.
- Age 18-65 years, male or female.
- Clinical diagnosis of non-segmental vitiligo at screening.
- F-VASI ≥0.25 and T-VASI ≥5 at screening and baseline, with either active or stable vitiligo.
- Women of childbearing potential have negative pregnancy tests at screening and baseline. All eligible subjects agree to effective contraception from consent through 30 days after last study drug dose.
Key exclusion criteria (15 listed)
- - Segmental, mixed vitiligo or other concurrent pigmentary/active skin disorders interfering with study assessment.
- Over 33% facial or total vitiligo lesions with leukotrichia.
- Pregnant or breastfeeding females.
- Active, latent or inadequately treated tuberculosis infection.
- Positive HIV, active HBV/HCV infection, or untreated syphilis.
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 |
|---|---|---|
| D-2570 Dose 1Oral D-2570 Dose 1 administered once daily for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose in the 24-week extension period | Drug | D-2570 Dose 1 (experimental arm 1) |
| D-2570 Dose 2Oral D-2570 Dose 2 administered once daily for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose in the 24-week extension period. | Drug | D-2570 Dose 2 (experimental arm 2) |
| PlaceboOral placebo administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 Dose 1 or Dose 2 in the extension period. | Drug | placebo |
| D-2570 Dose 3Oral D-2570 Dose 3 administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 Dose 1 or Dose 2 in the extension period. | Drug | D-2570 Dose 3 (experimental arm 3) |
Primary outcome
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI)
Time frame: week24
Change rate of facial vitiligo area, measured by F-VASI score, relative to baseline
11 secondary outcomes
Change and percentage change from baseline in F-VASI
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects achieving F-VASI50/75/90
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Change and percentage change from baseline in T-VASI
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects achieving T-VASI50/75/90
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
Proportion of subjects with F-PhGVA score 0 or 1
Time frame: Weeks 8, 16, 24, 32, 40, and 48
Proportion of subjects with T-PhGVA score 0 or 1
Time frame: Weeks 8, 16, 24, 32, 40, and 48
Proportion of subjects with VNS score 4 or 5
Time frame: Weeks 8, 16, 24, 32, 40, and 48
Change from baseline in DLQI score
Time frame: Weeks 8, 16, 24, 32, 40, and 48
Change from baseline in VitiQoL score
Time frame: Weeks 8, 16, 24, 32, 40, and 48
Plasma concentrations of D-2570
Time frame: Through study completion (approximately Week 48)
Safety of D-2570（AEs）
Time frame: Through study completion (approximately Week 48)
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 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 D-2570 Dose 1, D-2570 Dose 2 and D-2570 Dose 3 in people with Vitiligo and Non-Segmental Vitiligo (NSV), run by InventisBio 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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 15 Jul 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?
Contact shilin Sha (15601826678, shilin.sha@inventisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) (time frame: week24). 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 Jul 2026.