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Study of D-2570 in Subjects With Non-Segmental Vitiligo

ConditionsVitiligoNon-Segmental Vitiligo (NSV)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInventisBio Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

- 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • D-2570 Dose 1

    Drug

    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

  • D-2570 Dose 2

    Drug

    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.

  • Placebo

    Drug

    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.

  • D-2570 Dose 3

    Drug

    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.

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: D-2570 Dose 1 (experimental arm 1)Experimental treatment 1 intervention
Group B: D-2570 Dose 2 (experimental arm 2)Experimental treatment 1 intervention
Group C: D-2570 Dose 3 (experimental arm 3)Experimental treatment 1 intervention
Group D: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
week24

Secondary outcomes

1

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.

Time frame
Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
2

Proportion of subjects achieving F-VASI50/75/90

Percentage of subjects with ≥50%, ≥75%, or ≥90% reduction in F-VASI score from baseline.

Time frame
Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
3

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.

Time frame
Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48
4

Proportion of subjects achieving T-VASI50/75/90

Percentage of subjects with ≥50%, ≥75%, or ≥90% reduction in T-VASI score from baseline.

Time frame
Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InventisBio Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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