search
Back to results

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

Primary Purpose

Vitiligo

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Afamelanotide
Sponsored by
Clinuvel, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.3-50
  • Stable face vitiligo with F-VASI of at least 0.25
  • Stable or slowly progressive vitiligo over a 3-month period
  • Fitzpatrick skin types IV-VI
  • Treatment with 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
  • Patients with lip-tip (acrofacial) variant of 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

Sites / Locations

  • CLINUVEL Investigational siteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Afamelanotide

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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)
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)
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
The higher the score, the more severe the disease
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
Higher the value means lower noticeability
Change in Quality of life using a vitiligo specific tool (C)
Higher value means a lower quality of life

Full Information

First Posted
January 11, 2022
Last Updated
February 7, 2023
Sponsor
Clinuvel, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05210582
Brief Title
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinuvel, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Afamelanotide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Afamelanotide
Intervention Description
Patients will receive afamelanotide over a three-month period, with an additional three-month follow up.
Primary Outcome Measure Information:
Title
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
Description
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)
Time Frame
From Baseline to Day 84
Secondary Outcome Measure Information:
Title
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area
Description
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).
Time Frame
From Baseline to Day 84
Title
Percentage change in pigmentation on body surface area measured by the VASI scoring system
Description
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)
Time Frame
From Baseline to Day 84
Title
Percentage change in pigmentation on facial surface area measured by the VASI scoring system
Description
A decreased VASI indicates a reduction in the faces' degree of depigmentation (possible range 1-100)
Time Frame
From Baseline to Day 168
Title
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
Description
The higher the score, the more severe the disease
Time Frame
From Baseline to Day 168
Title
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
Description
Higher the value means lower noticeability
Time Frame
From Baseline to Day 168
Title
Change in Quality of life using a vitiligo specific tool (C)
Description
Higher value means a lower quality of life
Time Frame
From Baseline to Day 168

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Head of Clinical Operations
Phone
+441372860765
Email
mail@clinuvel.com
Facility Information:
Facility Name
CLINUVEL Investigational site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs