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.