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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinuvel, Inc.
• Treatments: Afamelanotide

Criteria

Inclusion Criteria:

• Male and female patients with a confirmed diagnosis of vitiligo on the face and with Total-VASI > 10 and Facial-VASI of at least 0.25

• Face vitiligo which is stable and has an onset of less than two years ago

• Stable or slowly progressive vitiligo over a 3-month period

• Fitzpatrick skin types IV-VI

• Previous treatment with Narrow-band Ultraviolet B (NB-UVB) light three times per week during the last four weeks prior to baseline

• Aged 18-75

Exclusion Criteria:

• Patients with segmental vitiligo

• Patients with lip-tip (acrofacial) variant of vitiligo

• Fitzpatrick skin types I-III

• Patient not responsive to previous NB-UVB light treatment

• 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