Clinuvel’s phase II vitiligo study commences in Singapore

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Clinuvel Pharmaceuticals Limited announced a Phase II study of its drug SCENESSE® (afamelanotide 16mg implant) in Singapore (CUV103) had received the necessary approvals and commenced recruitment. Sixty adults with vitiligo will be recruited to the seven month, double‐blind, placebo controlled study at the National Skin Centre, the leading dermatology hospital in Singapore. The CUV103 study will evaluate SCENESSE® as a combination treatment with narrow band ultraviolet B (NB‐UVB) phototherapy. Patients will be randomised into two treatment arms to receive either SCENESSE® or placebo implants every 28 days and will all be administered NB‐UVB twice weekly. Assessment of treatment efficacy will include the use of validated VASI and VETF scores for vitiligo repigmentation, time to onset of repigmentation, standardised digital photography, quality of life questionnaires, and investigator and patient statements. A three month follow‐up period will assess the maintenance (stability) of pigmentation achieved. The CUV103 study aims to confirm results from an earlier, open label Phase IIa study of SCENESSE® in vitiligo (CUV102) – conducted in the US – which showed that the combination of SCENESSE® and NB‐UVB light therapy provided greater and faster repigmentation in vitiligo patients compared to NB‐UVB light monotherapy.

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