A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face

An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the Face

The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Afamelanotide

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • CLINUVEL investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50%
• Stable face vitiligo with F-VASI of at least 0.1%
• Stable or slowly progressive vitiligo over a 3-month period
• Fitzpatrick skin types IV-VI
• Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming

Exclusion Criteria:

• Patients with segmental vitiligo
• Fitzpatrick skin types I-III
• Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming.
• Previous topical treatment for vitiligo
• Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant
• History of melanoma or lentigo maligna
• Any current skin disease that may interfere with the study evaluation
• Presence of severe hepatic disease or hepatic impairment
• Renal impairment
• History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation
• Female who is pregnant or lactating
• Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter
• Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above
• Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
• Use of any other prior and concomitant therapy which may interfere with the objective of the study
• Subjects assessed as not suitable for the study in the opinion of the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Afamelanotide	Drug: Afamelanotide; Patients will receive afamelanotide over a three-month period, with an additional three-month follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions	Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100)	From Baseline to Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in pigmentation on body surface area measured by the VASI scoring system	Percentage change in pigmentation on body surface area (excluding hands and feet) measured by VASI scoring system. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100)	From Baseline to Day 84
Percentage change in pigmentation on facial surface area measured by the VASI scoring system	A decreased VASI indicates a reduction in the faces' degree of depigmentation (possible range 1-100)	From Baseline to Day 168
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)	The higher the score, the more severe the disease	From Baseline to Day 168
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)	Higher the value means lower noticeability	From Baseline to Day 168
Change in Quality of life using a vitiligo specific tool (C)	Higher value means a lower quality of life	From Baseline to Day 168
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area	Proportion of participants achieving VASI25 on body surface area (excluding hands and feet). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100).	From Baseline to Day 84

Collaborators and Investigators

• Sponsor: Clinuvel, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (ACTUAL): January 27, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Dermatologic Agents; Afamelanotide
• Other Study ID Numbers: CUV104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No