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

Status unconfirmed · Phase 2

Conditions studied: Vitiligo

In brief

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.

Key facts

Study ID

NCT05210582

Run by

Clinuvel, Inc.

People needed

6

Starts

2022-10-11

Expected to finish

2023-08-01

Last updated by the study team

2023-02-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Subjects assessed as not suitable for the study in the opinion of the Investigator

Where it is running

• CLINUVEL Investigational site — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.