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

• Sponsor: Clinuvel, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06109649
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.7
• Patients Per Site Per Month: 10.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Drug: Afamelanotide and NB-UVB Light; Procedure: NB-UVB Light	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 11, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Afamelanotide and NB-UVB Light	Drug: Afamelanotide and NB-UVB Light; Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.
Other: NB-UVB Light	Procedure: NB-UVB Light; Patients will receive NB-UVB light twice per week for 20 weeks.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

6. 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).

7. 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).

8. 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).

9. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinuvel investigational site	Los Angeles	California	United States	90001

Sponsors and Collaborators

• Clinuvel, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinuvel, Inc.
• ClinicalTrials.gov Identifier: NCT06109649
• Other Study ID Numbers: CUV105
• First Posted: Oct 31, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vitiligo; Afamelanotide

Study Results

No Results Posted as of Oct 31, 2023