CLINUVEL Hits 200-Patient Mark in Pivotal Vitiligo Trial, Eyes 2026 Data
CLINUVEL Pharmaceuticals has completed recruitment for its Phase III trial of SCENESSE® in vitiligo patients with darker skin types, setting the stage for first results in late 2026. Early clinical observations suggest promising repigmentation outcomes.
- Full recruitment of 200 vitiligo patients achieved in Phase III CUV105 trial
- Trial spans 37 sites across North America, Africa, and Europe
- Treatment combines SCENESSE® with NB-UVB phototherapy or NB-UVB alone
- First clinical case studies show encouraging repigmentation and tolerability
- Regulatory discussions underway; second large trial (CUV107) planned
A Milestone in Vitiligo Treatment Development
CLINUVEL Pharmaceuticals has announced the successful recruitment of 200 patients for its pivotal Phase III trial, CUV105, evaluating SCENESSE® (afamelanotide 16mg) as a systemic treatment for vitiligo. This milestone marks a critical step forward for a condition that affects 1-2% of the global population, particularly impacting individuals with darker skin types who often face more severe psychosocial consequences.
The randomized, multi-center trial spans 37 sites across North America, Africa, and Europe, with the majority of patients enrolled in the United States. Participants receive either SCENESSE® implants every three weeks combined with narrowband ultraviolet B (NB-UVB) phototherapy twice weekly, or NB-UVB phototherapy alone, over a 20-week treatment period followed by six months of follow-up.
Encouraging Early Clinical Observations
Preliminary clinical observations presented at major dermatology congresses have been positive. Case studies reveal notable repigmentation of vitiliginous lesions in patients with skin types IV and V, some with longstanding disease histories. Patients reported satisfaction with treatment outcomes and good tolerability of SCENESSE® alongside NB-UVB therapy.
The trial’s primary endpoint focuses on achieving at least 50% repigmentation across total body surface area, measured by the Vitiligo Area Scoring Index (VASI). Secondary endpoints include repigmentation in visible areas such as the face and neck, as well as patient-reported outcomes assessing quality of life improvements.
Strategic Positioning Ahead of Market Entry
CLINUVEL’s Director of Global Clinical Affairs, Dr Emilie Rodenburger, highlighted the strategic importance of this recruitment milestone, noting the establishment of a North American distribution network among dermatologists in preparation for potential market entry. The company is actively engaging with regulatory authorities across multiple regions and is planning a second large-scale trial, CUV107, to further evaluate SCENESSE®’s efficacy in vitiligo.
Currently, treatment options for vitiligo are limited, especially for patients with darker skin tones. SCENESSE® offers a novel systemic, non-immunosuppressive approach that could fill a significant unmet need in this patient population.
Looking Ahead
The final patient screening is expected to conclude in May 2025, with topline data anticipated in the second half of 2026. Investors and clinicians alike will be watching closely to see if these promising early signals translate into robust clinical efficacy and regulatory approvals that could reshape vitiligo management.
Bottom Line?
With recruitment complete, CLINUVEL now pivots to data readouts that could unlock a new systemic therapy for vitiligo.
Questions in the middle?
- Will SCENESSE® demonstrate statistically significant repigmentation in the full trial cohort?
- How will regulatory agencies across different regions respond to the Phase III data?
- What is the potential market uptake given the current limited treatment options for darker-skinned vitiligo patients?
