CUV105: Phase III Clinical Trial in Vitiligo

Vitiligo is the most common depigmentation disorder characterised by chronic and progressive (worsening) ability for cells in the skin (melanocytes) to produce skin pigment. Vitiligo can affect any area of skin, but it commonly happens on the face, neck and hands, and in skin creases. There is no cure or any effective method of stopping the spread of vitiligo yet.

Afamelanotide works similarly to the natural hormone (α-MSH), causing skin cells to stimulate production of the pigment and the protective substance called melanin. It increases skin pigmentation faster and more effectively than the natural hormone, providing protection against light and sun, which is also known as photoprotection. Afamelanotide is not approved to treat vitiligo.

CLINUVEL has completed three clinical trials with afamelanotide, to look at its safety in patients with vitiligo, with no serious safety concerns identified. This led to the design of a new, bigger phase III study which has been just open to recruitment.

The purpose of this study is to evaluate if afamelanotide combined with Narrow-Band Ultraviolet B (NB-UVB) can improve repigmentation and for how long the pigmentation is maintained after the treatment is complete. Additionally, the study will investigate the safety of afamelanotide in combination with NB-UVB Light in patients with vitiligo.

This study will last approximately 12 months, with up to one (1) month screening period, five (5) months of treatment and up to six (6) months of follow up. Up to 200 patients with vitiligo from different countries will be enrolled to this study and randomly allocated (using computer program) to one of the two study groups:

1. Narrowband ultraviolet B (NB-UVB) in combination with afamelanotide
2. NB-UVB alone