Overview

A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
Summary
The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clinuvel Europe Limited
Treatments:
Afamelanotide
Criteria
Inclusion Criteria:

- Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or
XP-V;

- Aged 18-75 years.

Exclusion Criteria:

- Known allergy to afamelanotide or the polymer contained in the implant;

- Presence of severe hepatic disease or hepatic impairment;

- Renal impairment;

- Any other medical condition which may interfere with the study protocol;

- Existing melanoma;

- Female who is pregnant or lactating;

- Females of child-bearing potential (pre-menopausal, not surgically sterile) 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 other prior and concomitant therapy which may interfere with the objective
of the study;

- Participation in a clinical trial for an investigational agent.