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

Vitiligo Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109649
• Other study ID #: CUV105
• Status: Recruiting
• Phase: Phase 3
• Start date: October 11, 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Clinuvel Pharmaceuticals Limited
• Contact: Head of Clinical Operations
• Phone: +441372860765
• Email: clinicaltrials[@]clinuvel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Afamelanotide and NB-UVB Light
Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.

Procedure:
• NB-UVB Light
Patients will receive NB-UVB light twice per week for 20 weeks.

Locations

Country	Name	City	State
United Kingdom	CLINUVEL site	Manchester
United States	CLINUVEL site	Baton Rouge	Louisiana
United States	CLINUVEL Site	Cedar Park	Texas
United States	CLINUVEL Site	Charleston	South Carolina
United States	CLINUVEL site	Charlottesville	Virginia
United States	CLINUVEL site	Detroit	Michigan
United States	CLINUVEL Site	Lee's Summit	Missouri
United States	CLINUVEL site	Los Angeles	California
United States	CLINUVEL site	Miami	Florida
United States	CLINUVEL site	Miramar	Florida
United States	CLINUVEL site	Roseville	Minnesota
United States	CLINUVEL site	Thompson's Station	Tennessee
United States	CLINUVEL site	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Clinuvel, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving VASI50 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).	From baseline to Day 140
Secondary	Time to onset of repigmentation of full body	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).	From day 0 to day 140
Secondary	Time to onset of repigmentation of face	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).	From day 0 to day 140
Secondary	Percentage of patients achieving VASI50 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).	From baseline to Day 140
Secondary	Percentage of patients maintaining VASI50 on body surface area	Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).	From Day 140 to 308
Secondary	Percentage of patients maintaining VASI50 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).	From Day 140 to 308
Secondary	Percentage of patients achieving VASI25/75/90 on the body	Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).	From baseline to Day 140
Secondary	Percentage of patients achieving VASI25/75/90 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).	From baseline to Day 140
Secondary	Percentage change in pigmentation on body surface area measured by the VASI scoring system	Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).	From baseline to Day 308
Secondary	Percentage change in pigmentation on facial surface area measured by the VASI scoring system	Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).	From baseline to Day 308