CLINUVEL announces the start of global Phase 3 vitiligo clinical trial

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CLINUVEL jas announced that SCENESSE (afamelanotide) has been administered as a systemic treatment to the first vitiligo patient in a company-sponsored Phase 3 clinical trial, CUV105.

The company said that up to 200 adolescent and adult vitiligo patients with darker skin types (Fitpatrick Types IV-VI) will be enrolled in the study, comparing the use of SCENESSE in combination with narrowband UVB (NB-UVB) light therapy to NB-UVB as a monotherapy.

“Our clear goal is to bring the first systemic vitiligo therapy to market,” said CLINUVEL’s director of North American operations, Dr Linda Teng. “Physicians specialised in depigmentation disorders expect that afamelanotide will be an important tool in the treatment of severe vitiligo in patients with darker skin, since it is the only drug on the horizon which does not suppress the immmune system."

The study is evaluating whether SCENESSE in combination with NB-UVB provides faster, deeper, and longer-lasting repigmentation of the total body surface compared to NB-UVB alone (T-VASI50). A number of patient reported outcomes, including quality of life surveys, will provide data for secondary objectives.

All patients will receive NB-UVB twice weekly for the duration of twenty weeks, with half receiving SCENESSE every three weeks. Patients will be followed up for six months.

Vitiligo causes progressive loss of functional epidermal melanocytes (melanin producing skin cells), which lead to disfiguration and psychosocial distress.

“We possess data on the efficacy of the drug-UVB combination from 58 patients who participated in the CUV102 trial, now we look forward to evaluating the effects of the drug in a larger randomised study, since vitiligo patients deserve a systemic solution,” said Dr Teng.