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

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Vitiligo

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.

Inclusion Criteria:

• Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1
• Stable or active vitiligo
• Aged 12 or more
• Fitzpatrick skin types III-VI

Exclusion Criteria:

• Fitzpatrick skin types I-II
• 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 30 days 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
• Extensive tattoos