A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥0.3 of the body and F-VASI≥0.3

• Stable or active vitiligo

• Aged 12 or more

• Fitzpatrick skin types IV-VI

Exclusion Criteria:

• Fitzpatrick skin types I-III

• Extensive leukotrichia

• Treatment with NB-UVB phototherapy in the last three months prior to study start

• Allergy to afamelanotide or the polymer contained in the implant

• Any other treatment for vitiligo within four weeks prior to the Screening Visit

• History of melanoma or lentigo maligna

• History of dysplastic nevus syndrome

• Any malignant skin lesions

• Presence of severe hepatic disease or hepatic impairment

• Female who is pregnant or lactating

• Female of child-bearing potential not using adequate contraceptive measures

• Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures

• Use of any prior and concomitant therapy which may interfere with the objective of the study