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

• Sponsor: Clinuvel, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05210582
• Collaborator: (none)
• Enrollment: 6
• Arm: 1
• Anticipated Duration (Months): 11

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Drug: Afamelanotide	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of participants achieving VASI25 on facial lesions [From Baseline to Day 84]

   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

1. Proportion of participants achieving VASI25 on body surface area [From Baseline to Day 84]

   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).

2. Percentage change in pigmentation on body surface area measured by the VASI scoring system [From Baseline to Day 84]

   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)

3. Percentage change in pigmentation on facial surface area measured by the VASI scoring system [From Baseline to Day 168]

   A decreased VASI indicates a reduction in the faces' degree of depigmentation (possible range 1-100)

4. Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A) [From Baseline to Day 168]

   The higher the score, the more severe the disease

5. Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B) [From Baseline to Day 168]

   Higher the value means lower noticeability

6. Change in Quality of life using a vitiligo specific tool (C) [From Baseline to Day 168]

   Higher value means a lower quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female patients with a confirmed diagnosis of vitiligo on the face and with Total-VASI > 10 and Facial-VASI of at least 0.25

• Face vitiligo which is stable and has an onset of less than two years ago

• Stable or slowly progressive vitiligo over a 3-month period

• Fitzpatrick skin types IV-VI

• Previous treatment with Narrow-band Ultraviolet B (NB-UVB) light three times per week during the last four weeks prior to baseline

• Aged 18-75

Exclusion Criteria:

• Patients with segmental vitiligo

• Patients with lip-tip (acrofacial) variant of vitiligo

• Fitzpatrick skin types I-III

• Patient not responsive to previous NB-UVB light treatment

• 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

Contacts and Locations

Locations

No locations specified.

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: NCT05210582
• Other Study ID Numbers: CUV104
• First Posted: Jan 27, 2022
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• 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 May 31, 2022