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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, where those on 27 mg or placebo will switch to one of the lower doses.
All participants will have a 4-week safety follow-up after treatment ends, with regular check-ups and blood tests throughout the study.
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 9 mg QD (Group A), D-2570 18 mg QD (Group B), D-2570 27 mg QD (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 D-2570 9 mg QD or 18 mg QD 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-2570 9 mg (experimental arm 1) | Experimental | Subjects in this arm will receive oral D-2570 9 mg once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 9 mg in the subsequent 24-week extension period. |
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| D-2570 18 mg (experimental arm 2) | Experimental | Subjects in this arm will receive oral D-2570 18 mg once daily (QD) for 24 weeks during the double-blind treatment period. Eligible subjects may continue the same dose of D-2570 18 mg in the subsequent 24-week extension period |
|
| D-2570 27 mg (experimental arm 3) | Experimental | Subjects in this arm will receive oral D-2570 27 mg once daily (QD) for 24 weeks during the double-blind treatment period. After 24 weeks, subjects will be re-randomized to either D-2570 9 mg or 18 mg once daily for the extension period. |
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| 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 9 mg or 18 mg once daily for the extension period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-2570 9mg | Drug | Oral D-2570 9 mg 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Proportion of subjects achieving F-VASI50/75/90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shilin Sha, project manager | Contact | 15601826678 | shilin.sha@inventisbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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All participants, care providers, investigators, and outcomes assessors are blinded to treatment assignment throughout the study
| D-2570 18mg | Drug | Oral D-2570 18 mg 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. |
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| Placebo | Drug | Oral placebo administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 9 mg or 18 mg in the extension period. |
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| D-2570 27mg | Drug | Oral D-2570 27 mg administered once daily for 24 weeks during the double-blind treatment period. Subjects will be re-randomized to D-2570 9 mg or 18 mg in the extension period. |
|
Percentage of subjects with ≥50%, ≥75%, or ≥90% reduction in F-VASI score from baseline. |
| 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. | 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. | 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). | 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). | 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). | 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. | 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. | Weeks 8, 16, 24, 32, 40, and 48 |
| Plasma concentrations of D-2570 | Through study completion (approximately Week 48) |
| Safety of D-2570(AEs) | Through study completion (approximately Week 48) |