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

Clinuvel

Status and phase

Active, not recruiting

Phase 3

Conditions

Vitiligo

Treatments

Procedure: NB-UVB Light

Drug: Afamelanotide and NB-UVB Light

Study type

Interventional

Funder types

Industry

Identifiers

NCT06109649

CUV105

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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