Clinuvel recruiting for phase II vitiligo trial
Clinuvel Pharmaceuticals (ASX:CUV) has commenced recruitment for a phase II trial of Scenesse in vitiligo, after securing all the required approvals.
The seven-month, double-blind, placebo-controlled trial will be conducted at Singapore’s National Skin Centre. The company aims to enrol 60 patients.
The trial will evaluate Scenesse as a combination treatment with narrowband ultraviolet B (NB-UVB) therapy for vitiligo. Patients will be randomised to receive either Scenesse or placebo implants every 28 days. Both cohorts will be administered NB-UVB twice weekly.
Patients will be assessed for treatment efficacy using measures including time to onset of repigmentation, quality-of-life questionnaires and their scores on the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF) assessments.
Scenesse, or afamelanotide, activates eumelanin production in the skin. It is designed to be administered subdermally as a dissolvable implant.
Clinuvel hopes to confirm the results of a phase IIa open label trial, which indicate that four doses of Scenesse in combination with NB-UVB provided greater and faster repigmentation compared to NB-UVB alone.
The company is also trialling Scenesse in the rare genetic disorders erythropoietic protoporphyria (severe phototoxicity of the skin) and Hailey-Hailey Disease (HHD).
Clinuvel (ASX:CUV) shares were trading unchanged at $1.60 as of around 2 pm on Tuesday
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