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 3

Recruiting

• Conditions: Vitiligo
• Interventions: Drug: Afamelanotide and NB-UVB Light; Procedure: NB-UVB Light

• Registration Number: NCT06109649
• Lead Sponsor: Clinuvel, Inc.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2023-10-11
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥0.3 of the body and F-VASI≥0.3
• Stable or active vitiligo
• Aged 12 or more
• Fitzpatrick skin types IV-VI

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Exclusion Criteria

• Fitzpatrick skin types I-III
• 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 four weeks 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afamelanotide and NB-UVB Light	Afamelanotide and NB-UVB Light	-
NB-UVB Light	NB-UVB Light	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving VASI50 on the body	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 Outcome Measures

Name	Time	Method
Percentage of patients achieving VASI50 on the face	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).
Time to onset of repigmentation of full body	From day 0 to day 140	Measured using Total (T)-VASI25. 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	From day 0 to day 140	Measured using Face (F)-VASI25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100).
Percentage of patients maintaining VASI50 on body surface area	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).
Percentage of patients achieving VASI25/75/90 on the body	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).
Percentage of patients achieving VASI25/75/90 on the face	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).
Percentage change in pigmentation on body surface area measured by the VASI scoring system	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).
Percentage of patients maintaining VASI50 on facial lesions	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).
Percentage change in pigmentation on facial surface area measured by the VASI scoring system	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).

Trial Locations

Locations (2)

CLINUVEL site; 🇬🇧 Manchester, United Kingdom

CLINUVEL Site; 🇺🇸 Cedar Park, Texas, United States