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

NCT05210582 | Unknown Phase 2 FDA Drug

• 1 other identifier: CUV104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area

  From Baseline to Day 84

• Percentage change in pigmentation on body surface area measured by the VASI scoring system

  From Baseline to Day 84

• Percentage change in pigmentation on facial surface area measured by the VASI scoring system

  From Baseline to Day 168

• Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)

  From Baseline to Day 168

• Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)

  From Baseline to Day 168

Study Arms (1)

Afamelanotide

EXPERIMENTAL

Drug: Afamelanotide

Interventions

Afamelanotide DRUG

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

Afamelanotide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinuvel, Inc.: lead

Study Sites (1)

CLINUVEL Investigational site

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Head of Clinical Operations

CONTACT

+441372860765; mail@clinuvel.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 27, 2022
• Study Start: October 11, 2022
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

US (1)