NCT06109649

A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Vitiligo

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Clinuvel, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Afamelanotide and NB-UVB Light	Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.
PROCEDURE	NB-UVB Light	Patients will receive NB-UVB light twice per week for 20 weeks. Upon study completion, NB-UVB Light Arm participants will have the opportunity to enroll in an open-label extension phase of the study. In this extension phase, participants will undergo the same evaluations and assessments as the ones performed in the main part of the study under Afamelanotide and NB-UVB Light Arm.

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2023-10-31
• Last updated: 2025-07-08

Locations

30 sites across 4 countries: United States, France, Kenya, United Kingdom

Regulatory

• FDA-regulated drug study