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Recruiting Phase 2 NCT07437560

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

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Trial Parameters

Condition NonSegmental Vitiligo
Sponsor Hudson Biotech
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2026-02-02
Completion 2027-02-14
Interventions
Melanotan II (MT-II)PlaceboNarrowband UV-B (NB-UVB) phototherapy

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Brief Summary

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.

Eligibility Criteria

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

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