Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Clinuvel, Inc.
Conditions:
Vitiligo
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06109649
Start Date
October 11 2023
End Date
June 1 2026
Last Update
July 8 2025
Active Locations (30)
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1
CLINUVEL site
Birmingham, Alabama, United States, 00000
2
CLINUVEL site
Fresno, California, United States, 00000
3
CLINUVEL site
Los Angeles, California, United States, 00000
4
CLINUVEL site
Palo Alto, California, United States, 00000