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A Two-Arm, Randomized, Double-Blind, Phase IIb Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source With Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo AND A Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo

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Trial Profile

A Two-Arm, Randomized, Double-Blind, Phase IIb Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source With Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo AND A Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 May 2021

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At a glance

  • Drugs Afamelanotide (Primary)
  • Indications Vitiligo
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Clinuvel Pharmaceuticals

    • Most Recent Events

    • 19 Dec 2018 Results of pooled analysis of all patients who received SCENESSE plus NB-UVB (n=18; randomized and open label parts) presented in a Clinuvel Pharmaceuticals media release.
    • 19 Dec 2018 According to a Clinuvel Pharmaceuticals media release, recruitment of patients of Asian origin who would accept temporary pandermal skin darkening during treatment was slow and the study design was modified from a randomised controlled (SCENESSE plus NB-UVB versus placebo plus NB-UVB) to an open label study (SCENESSE plus NB-UVB).
    • 19 Dec 2018 Status changed from active, no longer recruiting to completed, according to a Clinuvel Pharmaceuticals media release.

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