Clinuvel Pharmaceuticals completed enrollment of over 200 patients in its Phase III trial (CUV105) for SCENESSE® (afamelanotide 16mg) as a repigmentation therapy for vitiligo. The trial focuses on adolescents and adults with darker skin types (Fitzpatrick III-VI), spanning 37 sites in North America, Africa, and Europe. The study aims to determine the efficacy of afamelanotide combined with narrowband ultraviolet B (NB-UVB) phototherapy compared to NB-UVB therapy alone.
This trial is important because it addresses a significant unmet need for effective vitiligo treatments, particularly for individuals with darker skin tones who are often disproportionately affected by the psychosocial impact of the condition. Currently, treatment options are limited, especially for those with widespread vitiligo. A successful outcome for CUV105 could significantly improve the quality of life for these patients and expand the available therapeutic landscape.
CUV105 is a randomized, multi-center trial. Patients receive either afamelanotide every three weeks alongside NB-UVB therapy twice a week or NB-UVB monotherapy twice a week for 20 weeks, followed by a six-month observation period. The primary endpoint is at least 50% repigmentation across the total body surface area (T-VASI50). Secondary endpoints include facial repigmentation and the maintenance of repigmentation after treatment. Early clinical observations have shown promising repigmentation in some patients, and five case studies have been presented at dermatology conferences.
The completion of enrollment is a critical step toward potential regulatory discussions in Europe, Africa, and North America. Positive results from this trial could pave the way for a second large-scale trial (CUV107) and ultimately lead to the approval and commercialization of SCENESSE® for vitiligo, offering a new systemic treatment option for this prevalent skin condition. This development also allows Clinuvel to establish relationships with dermatologists, anticipating future market entry and distribution of the drug.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
