CUV recruits 200 patients in Phase III vitiligo trial CUV105

• Recruitment target of 200 vitiligo patients (Fitzpatrick skin type III-VI) in CUV105 study achieved
• Randomised trial, 20-week treatment protocol plus 6-month follow up
• Study sites in North America, Africa and Europe

Clinuvel Pharmaceuticals has met its recruitment target of 200 vitiligo patients (Fitzpatrick skin type III-VI) for its phase III trial (CUV105) of SCENESSE (afamelanotide 16mg). The randomised trial has study sites across North America, Africa and Europe, with the majority of patients (57%) enrolled in the United States. Patients receive treatment with either SCENESSE every three weeks alongside adjuvant narrowband ultraviolet B (NB-UVB) phototherapy administered twice weekly, or NB-UVB monotherapy twice weekly, for 20 weeks. All patients are then followed up for six months. The primary endpoint is to achieve a minimum of 50% repigmentation across the total body surface area (T-VASI50). Secondary endpoints include evaluations of repigmentation on the face, neck and head, as well as patient-reported outcomes. Clinical observations from the trial have been presented at medical congresses, demonstrating repigmentation of vitiliginous lesions in patients with skin types IV and V. The first results from the CUV105 study are expected in the second half of 2026.

Clinuvel plans to continue regulatory discussions in Europe, Africa and North America, in anticipation of CUV107, a second large trial evaluating the treatment effects of SCENESSE in vitiligo.