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

Launched by CLINUVEL EUROPE LIMITED · May 6, 2022

Keywords

ClinConnect Summary

The CUV152 study is a clinical trial looking at a new treatment called afamelanotide for people with Xeroderma Pigmentosum types C (XP-C) and V (XP-V), conditions that increase sensitivity to sunlight and can lead to skin damage. The trial aims to determine if afamelanotide is safe and if it can help the skin repair itself after being damaged by ultraviolet (UV) light. Researchers will see if this treatment can increase the amount of UV light a person's skin can tolerate before damage occurs, and how well the skin heals after treatment.

To participate in this study, you need to be between 18 and 75 years old and have a confirmed diagnosis of XP-C or XP-V. However, some individuals may not be able to join, such as those with severe liver or kidney problems, allergies to afamelanotide, or certain other health conditions. If you decide to take part, you'll receive the treatment and be monitored to understand how well it works and how safe it is. This study is currently recruiting participants, and it offers a chance to contribute to important research that could help others with similar conditions.

Gender

ALL

Eligibility 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.