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NCT Number: NCT06109649

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CLINUVEL site, La Réunion, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afamelanotide and NB-UVB Light

Drug

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

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

Sponsors and collaborators

Lead sponsor

Clinuvel, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 31, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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