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

13. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

160

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201203
        • Rekrutierung
        • Huashan Hospital, Fudan University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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
Experimental: 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
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change and percentage change from baseline in F-VASI
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)
Safety of D-2570（AEs）
Zeitfenster: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

InventisBio Co., Ltd

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. Juni 2026

Primärer Abschluss (Geschätzt)

1. November 2027

Studienabschluss (Geschätzt)

1. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Mai 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D2570-206

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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