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Study of D-2570 in Subjects With Non-Segmental Vitiligo (D2570-206)

13 juli 2026 bijgewerkt door: InventisBio Co., Ltd

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

160

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201203

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • - 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.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: D-2570 Dose 1 (experimental arm 1)
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.
Geneesmiddel: D-2570 Dose 1
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
Experimenteel: D-2570 Dose 2 (experimental arm 2)
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
Geneesmiddel: D-2570 Dose 2
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.
Experimenteel: D-2570 Dose 3 (experimental arm 3)
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.
Geneesmiddel: D-2570 Dose 3
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.
Placebo-vergelijker: placebo
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.
Geneesmiddel: Placebo
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI)
Tijdsspanne: week24
Change rate of facial vitiligo area, measured by F-VASI score, relative to baseline
week24

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change and percentage change from baseline in F-VASI
Tijdsspanne: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 8, 16, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 8, 16, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 8, 16, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 8, 16, 24, 32, 40, and 48
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
Tijdsspanne: Weeks 8, 16, 24, 32, 40, and 48
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
Tijdsspanne: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)
Safety of D-2570（AEs）
Tijdsspanne: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

InventisBio Co., Ltd

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 juni 2026

Primaire voltooiing (Geschat)

1 november 2027

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

28 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

13 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D2570-206

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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