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 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CUV105
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 30

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving T-VASI 50 on the body

  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 Outcomes (9)

• Time to onset of repigmentation of full body

  From baseline to first documented occurrence of TVASI25, assessed up to Day 140

• Time to onset of repigmentation of face

  From baseline to first documented occurrence of FVASI25, assessed up to Day 140

• Percentage of patients achieving VASI 50 on the face

  From baseline to Day 140

• Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet

  From Day 140 to 308

• Percentage of patients maintaining VASI 50 on facial lesions

  From Day 140 to 308

Study Arms (2)

Afamelanotide and NB-UVB Light

EXPERIMENTAL

Drug: Afamelanotide and NB-UVB Light

NB-UVB Light

OTHER

Procedure: NB-UVB Light

Interventions

Afamelanotide and NB-UVB Light DRUG

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

Afamelanotide and NB-UVB Light

NB-UVB Light PROCEDURE

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.

NB-UVB Light

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinuvel, Inc.: lead

Study Sites (30)

CLINUVEL site

Birmingham, Alabama, 00000, United States

Location

CLINUVEL site

Fresno, California, 00000, United States

Location

CLINUVEL site

Los Angeles, California, 00000, United States

Location

CLINUVEL site

Palo Alto, California, 00000, United States

Location

CLINUVEL site

San Diego, California, 00000, United States

Location

CLINUVEL Site

Washington D.C., District of Columbia, 00000, United States

Location

CLINUVEL site

Miami, Florida, 00000, United States

Location

CLINUVEL site

Miramar, Florida, 00000, United States

Location

CLINUVEL site

Alpharetta, Georgia, 00000, United States

Location

CLINUVEL site

Augusta, Georgia, 00000, United States

Location

CLINUVEL site

Chicago, Illinois, 00000, United States

Location

CLINUVEL site

Baton Rouge, Louisiana, 00000, United States

Location

CLINUVEL site

Detroit, Michigan, 00000, United States

Location

CLINUVEL site

Minneapolis, Minnesota, 00000, United States

Location

CLINUVEL site

Roseville, Minnesota, 00000, United States

Location

CLINUVEL Site

Lee's Summit, Missouri, 00000, United States

Location

CLINUVEL site

Rochester, New York, 00000, United States

Location

CLINUVEL site

Cleveland, Ohio, 00000, United States

Location

CLINUVEL site

Philadelphia, Pennsylvania, 00000, United States

Location

CLINUVEL Site

Charleston, South Carolina, 00000, United States

Location

CLINUVEL site

Thompson's Station, Tennessee, 00000, United States

Location

CLINUVEL Site

Cedar Park, Texas, 00000, United States

Location

CLINUVEL site

Dallas, Texas, 00000, United States

Location

CLINUVEL site

Tyler, Texas, 00000, United States

Location

CLINUVEL site

Charlottesville, Virginia, 00000, United States

Location

CLINUVEL site

La Réunion, France

Location

CLINUVEL site

Nice, France

Location

CLINUVEL site

Nairobi, Kenya

Location

CLINUVEL site

London, United Kingdom

Location

CLINUVEL site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Vitiligo

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 31, 2023
• Study Start: October 11, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-02

Locations

FR (2); US (25); KE (1); GB (2)