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

Phase 3Active Not RecruitingNCT06109649

Clinuvel, Inc.200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Vitiligo

Interventions

Afamelanotide and NB-UVB LightDRUG

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

NB-UVB LightPROCEDURE

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (30)

CLINUVEL site

Outcomes

Primary Outcomes

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).

Time frame: From baseline to Day 140

Secondary Outcomes

Time to onset of repigmentation of full body

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

Time to onset of repigmentation of face

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).

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

Percentage of patients achieving VASI 50 on the face

Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).

Time frame: From baseline to Day 140

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

Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).

Time frame: From Day 140 to 308

Percentage of patients maintaining VASI 50 on facial lesions

Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).

Time frame: From Day 140 to 308

Data from ClinicalTrials.gov

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