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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 11, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Vitiligo
Interventions
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.

Trial Locations (30)

00000

CLINUVEL site, Birmingham

CLINUVEL site, Fresno

CLINUVEL site, Los Angeles

CLINUVEL site, Palo Alto

CLINUVEL site, San Diego

CLINUVEL Site, Washington D.C.

CLINUVEL site, Miami

CLINUVEL site, Miramar

CLINUVEL site, Alpharetta

CLINUVEL site, Augusta

CLINUVEL site, Chicago

CLINUVEL site, Baton Rouge

CLINUVEL site, Detroit

CLINUVEL site, Minneapolis

CLINUVEL site, Roseville

CLINUVEL Site, Lee's Summit

CLINUVEL site, Rochester

CLINUVEL site, Cleveland

CLINUVEL site, Philadelphia

CLINUVEL Site, Charleston

CLINUVEL site, Thompson's Station

CLINUVEL Site, Cedar Park

CLINUVEL site, Dallas

CLINUVEL site, Tyler

CLINUVEL site, Charlottesville

Unknown

CLINUVEL site, La Réunion

CLINUVEL site, Nice

CLINUVEL site, Nairobi

CLINUVEL site, London

CLINUVEL site, Manchester

All Listed Sponsors
lead

Clinuvel, Inc.

INDUSTRY