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

NCTNCT06109649Other idCUV105

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Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 200 participants (estimated)
Sponsor: Clinuvel, Inc. · Industry
Design: Randomized · Open label (no masking)
Countries: 4 countries
United States, France, Kenya, United Kingdom
Start: 11 Oct 2023
Primary completion: Dec 2025 (estimated)
Completion: Jun 2026 (estimated)
First posted: 31 Oct 2023
Last update posted: 8 Jul 2025
Conditions: Vitiligo

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024202520262027

Ph 3
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
11 Oct 2023 to est. Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Afamelanotide and NB-UVB LightDrug
NB-UVB LightProcedure

Arms2

Experimental
Afamelanotide and NB-UVB Light
Other
NB-UVB Light

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of patients achieving T-VASI 50 on the body
Time frame · From baseline to Day 140
Registry description
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(9)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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