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Trial · Interventional

RecruitingPhase 2Registry data

Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo

Short name MTII-VIT

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
60 participants (estimated)
Sponsor
Hudson Biotech · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
2 Feb 2026
Primary completion
14 Feb 2027 (estimated)
Completion
17 Feb 2028 (estimated)
First posted
27 Feb 2026
Last update posted
27 Feb 2026
Conditions
NonSegmental Vitiligo · Nonsegmental Vitiligo (Stable)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 2

    MTII-VIT

    NCT07437560

    2 Feb 2026 to est. 17 Feb 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This example interventional study record describes a randomized Phase 2 clinical trial evaluating investigational Melanotan II (MT-II) as an adjunct to standard NB-UVB phototherapy for repigmentation in adults with stable nonsegmental vitiligo.

Interventions

  • Melanotan II (MT-II)Drug
  • PlaceboDrug
  • Narrowband UV-B (NB-UVB) phototherapyProcedure

Arms2

  • Experimental

    Melanotan II + NB-UVB phototherapy

  • Placebo comparator

    Placebo + NB-UVB phototherapy

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in Vitiligo Area Scoring Index (VASI) total score

    Time frame · 24 Weeks

Secondary outcomes(1)
  1. Proportion of participants achieving

    Time frame · 24 Weeks

    Registry description

    50% improvement in VASI (VASI50). 2) Time to first clinically detectable repigmentation in target lesions (standardized photography). 3) Change from baseline in objective pigmentation (melanin index) in predefined target lesions (colorimetry). 4) Change from baseline in Dermatology Life Quality Index (DLQI). 5) Incidence and severity of adverse events (AEs) and clinically significant dermatologic changes

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adults aged 18-65 years able to provide informed consent. * Clinical diagnosis of nonsegmental vitiligo with stable disease (no new lesions and no lesion expansion) for \>=6 months prior to screening. * Total body surface area involvement between 3% and 20% (inclusive), with at least two measurable target lesions suitable for standardized photography and colorimetry. * Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study. * For participants of childbearing potential: agreement to use effective contraception during the study and for a protocol-specified period after the last dose. Exclusion Criteria: * Segmental vitiligo as the predominant type, or rapidly progressive disease within the past 6 months. * Use of systemic immunosuppressive therapy, systemic corticosteroids, or JAK inhibitors within 8 weeks prior to screening (time windows may vary by drug/class). * Use of topical calcineurin inhibitors or topical corticosteroids on target lesions within 2 weeks prior to baseline. * Prior treatment with afamelanotide or melanotan (including Melanotan II) within 6 months prior to baseline. * History of melanoma, dysplastic nevus syndrome, or other high-risk skin cancer history requiring close surveillance, as judged by the investigator. * Clinically significant uncontrolled hypertension, cardiovascular disease, or any condition that, in the investigator's judgment, increases risk with melanocortin agonist exposure. * Pregnant or breastfeeding. * Known hypersensitivity to study product components. * Participation in another interventional clinical trial within 30 days prior to screening.

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