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

NCT06109649 · tracked via the Priya Life Science UK tracker

Sponsor

Clinuvel, Inc.

Phase

Phase 3

Started

2023-10-11

Last updated

2025-07-08

Condition(s) studied

Vitiligo

Investigational drug(s) / intervention(s)

Afamelanotide and NB-UVB LightNB-UVB Light

Afamelanotide and NB-UVB Light: Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.

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.

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1 * Stable or active vitiligo * Aged 12 or more * Fitzpatrick skin types III-VI Exclusion Criteria: * Fitzpatrick skin types I-II * Extensive leukotrichia * Treatment with NB-UVB phototherapy in the last three months prior to study start * Allergy to afamelanotide or the polymer contained in the implant * Any other treatment for vitiligo within 30 days prior to the Screening Visit * History of melanoma or lentigo maligna * History of dysplastic nevus syndrome * Any malignant skin lesions * Presence of severe hepatic disease or hepatic impairment * Female who is pregnant or lactating * Female of child-bearing potential not using adequate contraceptive measures * Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures * Use of any prior and concomitant therapy which may interfere with the objective of the study * Extensive tattoos

Primary outcome measure(s)

Percentage of patients achieving T-VASI 50 on the body — From baseline to Day 140
Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).

Trial sites (30)

Facility	City	Region
CLINUVEL site	Birmingham	Alabama
CLINUVEL site	Fresno	California
CLINUVEL site	Los Angeles	California
CLINUVEL site	Palo Alto	California
CLINUVEL site	San Diego	California
CLINUVEL Site	Washington D.C.	District of Columbia
CLINUVEL site	Miami	Florida
CLINUVEL site	Miramar	Florida
CLINUVEL site	Alpharetta	Georgia
CLINUVEL site	Augusta	Georgia
CLINUVEL site	Chicago	Illinois
CLINUVEL site	Baton Rouge	Louisiana
CLINUVEL site	Detroit	Michigan
CLINUVEL site	Minneapolis	Minnesota
CLINUVEL site	Roseville	Minnesota
CLINUVEL Site	Lee's Summit	Missouri
CLINUVEL site	Rochester	New York
CLINUVEL site	Cleveland	Ohio
CLINUVEL site	Philadelphia	Pennsylvania
CLINUVEL Site	Charleston	South Carolina
CLINUVEL site	Thompson's Station	Tennessee
CLINUVEL Site	Cedar Park	Texas
CLINUVEL site	Dallas	Texas
CLINUVEL site	Tyler	Texas
CLINUVEL site	Charlottesville	Virginia
CLINUVEL site	La Réunion	France
CLINUVEL site	Nice	France
CLINUVEL site	Nairobi	Kenya
CLINUVEL site	London	United Kingdom
CLINUVEL site	Manchester	United Kingdom

Other trials for the same condition

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06109649 on ClinicalTrials.gov ↗ ← All trials in the UK