Evaluating afamelanotide for 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)
This study is testing if a new drug called afamelanotide can help people with Xeroderma Pigmentosum types C and V heal their skin better and protect it from UV damage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Clinuvel Pharmaceuticals Limited Industry-sponsored |
| Locations | 2 sites (Clinuvel Investigational Site and 1 other locations) |
| Trial ID | NCT05370235 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of afamelanotide in patients diagnosed with Xeroderma Pigmentosum types C and V. It will investigate the drug's ability to enhance skin repair and increase the threshold of UV light required to cause DNA damage. Participants will be monitored for their response to treatment, focusing on the reparative processes following UV-induced skin damage. The study will include patients aged 18 to 75 with a confirmed genetic diagnosis of the condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a genetically confirmed diagnosis of Xeroderma Pigmentosum types C or V.
Not a fit: Patients with severe hepatic or renal impairment, existing melanoma, or those who are pregnant or not using adequate contraception may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve skin protection and repair for patients with Xeroderma Pigmentosum.
How similar studies have performed: While this approach is novel for Xeroderma Pigmentosum, similar studies evaluating afamelanotide for other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clinuvel Investigational Site and 1 other locations
- CLINUVEL Investigational site — Clinuvel Investigational Site, Belgium (Recruiting)
- CLINUVEL Investigational site — Clinuvel Investigational Site, Spain (Recruiting)
Study contacts
- Study coordinator: Head of Clinical Operations
- Email: mail@clinuvel.com
- Phone: +441372860765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.