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 (XP)
Who is this study for? Patients with Xeroderma Pigmentosum
What treatments are being studied? Afamelanotide
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The CUV156 study will evaluate the safety of afamelanotide in XP-C 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female patient with a molecular-genetically confirmed diagnosis of XP-C;
• Aged 18-75 years.
Locations
Other Locations
Germany
CLINUVEL investigative site
RECRUITING
Regensburg
Contact Information
Primary
Head of Clinical Operations
mail@clinuvel.com
+441372860765
Time Frame
Start Date: 2021-10-19
Completion Date: 2024-10
Participants
Target number of participants: 6
Treatments
Experimental: Afamelanotide
Related Therapeutic Areas
Sponsors
Leads: Clinuvel Europe Limited