Recruiting
Phase 2

Afamelanotide

Sponsor:

Clinuvel, Inc.

Code:

NCT05210582

Conditions

Vitiligo

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Afamelanotide

Study Details

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 ID

NCT05210582

Start date

Oct 11, 2022

Status verified date

Feb, 2023

Completion date

Aug, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afamelanotide

Interventions

Afamelanotide

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

Primary outcome measure

  • Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions [ Time Frame: From Baseline to Day 84 ]

Central Contacts and Locations

Central contacts

Head of Clinical Operations

+441372860765mail@clinuvel.com

Locations

CLINUVEL Investigational site

Recruiting

Detroit, Michigan, United States, 48202

More Information

Sponsor

Clinuvel, Inc.

Last update posted

Feb 9, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clinuvel, Inc. on 2023-02-09.