NCT05370235

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

A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (XPC and XPV)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Clinuvel Europe Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Xeroderma Pigmentosum

Interventions

Type	Name	Description
DRUG	Afamelanotide	Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.

Timeline

• Start date: 2022-03-28
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2022-05-11
• Last updated: 2023-09-21

Locations

2 sites across 2 countries: Belgium, Spain

Regulatory

• FDA-regulated drug study