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

Clinuvel

Status and phase

Enrolling

Phase 2

Conditions

Vitiligo

Treatments

Drug: Afamelanotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05210582

CUV104

Details and patient eligibility

About

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.

Enrollment

6 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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