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

NCT ID: NCT05210582

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-08-31

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.

Conditions

Vitiligo

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afamelanotide

Group Type: EXPERIMENTAL

Afamelanotide

Intervention Type: DRUG

Patients will receive afamelanotide over a three-month period, with an additional three-month follow up.

Interventions

Afamelanotide

Patients will receive afamelanotide over a three-month period, with an additional three-month follow up.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinuvel, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CLINUVEL Investigational site

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Head of Clinical Operations

Role: CONTACT

mail@clinuvel.com

+441372860765

Other Identifiers

CUV104

Identifier Type: -

Identifier Source: org_study_id