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

July 2, 2025 updated by: Clinuvel, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Réunion, France
        • CLINUVEL Site
      • Nice, France
        • CLINUVEL Site
  • Kenya
      • Nairobi, Kenya
        • CLINUVEL Site
  • United Kingdom
      • London, United Kingdom
        • CLINUVEL Site
      • Manchester, United Kingdom
        • CLINUVEL Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 00000
        • CLINUVEL Site
    • California
      • Fresno, California, United States, 00000
        • CLINUVEL Site
      • Los Angeles, California, United States, 00000
        • CLINUVEL Site
      • Palo Alto, California, United States, 00000
        • CLINUVEL Site
      • San Diego, California, United States, 00000
        • CLINUVEL Site
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 00000
        • CLINUVEL Site
    • Florida
      • Miami, Florida, United States, 00000
        • CLINUVEL Site
      • Miramar, Florida, United States, 00000
        • CLINUVEL Site
    • Georgia
      • Alpharetta, Georgia, United States, 00000
        • CLINUVEL Site
      • Augusta, Georgia, United States, 00000
        • CLINUVEL Site
    • Illinois
      • Chicago, Illinois, United States, 00000
        • CLINUVEL Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 00000
        • CLINUVEL Site
    • Michigan
      • Detroit, Michigan, United States, 00000
        • CLINUVEL Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 00000
        • CLINUVEL Site
      • Roseville, Minnesota, United States, 00000
        • CLINUVEL Site
    • Missouri
      • Lee's Summit, Missouri, United States, 00000
        • CLINUVEL Site
    • New York
      • Rochester, New York, United States, 00000
        • CLINUVEL Site
    • Ohio
      • Cleveland, Ohio, United States, 00000
        • CLINUVEL Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 00000
        • CLINUVEL Site
    • South Carolina
      • Charleston, South Carolina, United States, 00000
        • CLINUVEL Site
    • Tennessee
      • Thompson's Station, Tennessee, United States, 00000
        • CLINUVEL Site
    • Texas
      • Cedar Park, Texas, United States, 00000
        • CLINUVEL Site
      • Dallas, Texas, United States, 00000
        • CLINUVEL Site
      • Tyler, Texas, United States, 00000
        • CLINUVEL Site
    • Virginia
      • Charlottesville, Virginia, United States, 00000
        • CLINUVEL Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afamelanotide and NB-UVB Light
Drug: Afamelanotide and NB-UVB Light
Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.
Other: NB-UVB Light
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients achieving T-VASI 50 on the body
Time Frame: 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).
From baseline to Day 140

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in pigmentation on body surface area measured by the VASI scoring system
Time Frame: From baseline to Day 308
Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
From baseline to Day 308
Percentage change in pigmentation on facial surface area measured by the VASI scoring system
Time Frame: From baseline to Day 308
Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
From baseline to Day 308
Time to onset of repigmentation of full body
Time Frame: From baseline to first documented occurrence of TVASI25, assessed up to Day 140
Measured using T-VASI 25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100)
From baseline to first documented occurrence of TVASI25, assessed up to Day 140
Time to onset of repigmentation of face
Time Frame: From baseline to first documented occurrence of FVASI25, assessed up to Day 140
Measured using F-VASI 25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100).
From baseline to first documented occurrence of FVASI25, assessed up to Day 140
Percentage of patients achieving VASI 50 on the face
Time Frame: From baseline to Day 140
Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
From baseline to Day 140
Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet
Time Frame: From Day 140 to 308
Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
From Day 140 to 308
Percentage of patients maintaining VASI 50 on facial lesions
Time Frame: From Day 140 to 308
Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
From Day 140 to 308
Percentage of patients achieving VASI 25/75/90 on the body
Time Frame: From baseline to Day 140
Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
From baseline to Day 140
Percentage of patients achieving VASI 25/75/90 on the face
Time Frame: From baseline to Day 140
Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
From baseline to Day 140

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinuvel, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUV105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitiligo

Clinical Trials on Afamelanotide and NB-UVB Light

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe