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

Last updated: February 28, 2025
Sponsor: Clinuvel, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Vitiligo

Treatment

Afamelanotide and NB-UVB Light

NB-UVB Light

Clinical Study ID

NCT06109649
CUV105
  • Ages > 12
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients with a confirmed diagnosis of generalized vitiligo withVASI≥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

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 usingadequate contraceptive measures

  • Use of any prior and concomitant therapy which may interfere with the objective ofthe study

  • Extensive tattoos

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Afamelanotide and NB-UVB Light
Phase: 3
Study Start date:
October 11, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • CLINUVEL site

    La Réunion,
    France

    Active - Recruiting

  • CLINUVEL site

    Nice,
    France

    Active - Recruiting

  • CLINUVEL site

    Nairobi,
    Kenya

    Active - Recruiting

  • CLINUVEL site

    London,
    United Kingdom

    Active - Recruiting

  • CLINUVEL site

    Manchester,
    United Kingdom

    Active - Recruiting

  • CLINUVEL site

    Birmingham, Alabama 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Fresno, California 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Los Angeles, California 00000
    United States

    Active - Recruiting

  • Clinuvel investigational site

    Los Angeles, California 90001
    United States

    Active - Recruiting

  • CLINUVEL site

    Palo Alto, California 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    San Diego, California 00000
    United States

    Active - Recruiting

  • CLINUVEL Site

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

    Active - Recruiting

  • CLINUVEL site

    Miami, Florida 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Miramar, Florida 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Alpharetta, Georgia 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Augusta, Georgia 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Chicago, Illinois 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Baton Rouge, Louisiana 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Detroit, Michigan 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Minneapolis, Minnesota 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Roseville, Minnesota 00000
    United States

    Active - Recruiting

  • CLINUVEL Site

    Lee's Summit, Missouri 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Rochester, New York 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Cleveland, Ohio 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Philadelphia, Pennsylvania 00000
    United States

    Active - Recruiting

  • CLINUVEL Site

    Charleston, South Carolina 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Thompson's Station, Tennessee 00000
    United States

    Active - Recruiting

  • CLINUVEL Site

    Cedar Park, Texas 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Dallas, Texas 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Tyler, Texas 00000
    United States

    Active - Recruiting

  • CLINUVEL site

    Charlottesville, Virginia 00000
    United States

    Active - Recruiting

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