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

13. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

160

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201203
        • Rekruttering
        • Huashan Hospital, Fudan University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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
Eksperimentell: 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
Legemiddel: 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.
Eksperimentell: 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.
Legemiddel: 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 komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change and percentage change from baseline in F-VASI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)
Safety of D-2570（AEs）
Tidsramme: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

InventisBio Co., Ltd

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. juni 2026

Primær fullføring (Antatt)

1. november 2027

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

28. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D2570-206

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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