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

13 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

160

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 201203
        • Reclutamento
        • Huashan Hospital, Fudan University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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
Sperimentale: 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
Droga: 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.
Sperimentale: 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.
Droga: 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.
Comparatore placebo: 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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI)
Lasso di tempo: week24
Change rate of facial vitiligo area, measured by F-VASI score, relative to baseline
week24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change and percentage change from baseline in F-VASI
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)
Safety of D-2570（AEs）
Lasso di tempo: Through study completion (approximately Week 48)
Through study completion (approximately Week 48)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

InventisBio Co., Ltd

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 giugno 2026

Completamento primario (Stimato)

1 novembre 2027

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

28 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D2570-206

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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