Evaluating afamelanotide for patients with Xeroderma Pigmentosum
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)
PHASE2 · Clinuvel Pharmaceuticals Limited · NCT05159752
This study tests if a new drug called afamelanotide can help people with Xeroderma Pigmentosum type C heal their skin better after sun exposure and see if it protects them from UV damage.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Clinuvel Pharmaceuticals Limited (industry) |
| Locations | 1 site (Regensburg) |
| Trial ID | NCT05159752 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of afamelanotide in patients diagnosed with Xeroderma Pigmentosum type C (XP-C). It will investigate the drug's potential to enhance skin repair processes following UV-induced DNA damage and determine if it increases the threshold of UV light required to cause such damage. The study will involve patients aged 18 to 75 who have a confirmed genetic diagnosis of XP-C, and will monitor their responses to treatment with afamelanotide.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a molecular-genetically confirmed diagnosis of XP-C.
Not a fit: Patients with severe hepatic or renal impairment, or those with known allergies to afamelanotide, 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 XP-C, 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; * 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; * Female who is pregnant (confirmed by positive urine beta-Human chorionic gonadotropin pregnancy test) or lactating; * Females of child-bearing potential (pre-menopausal, not surgically sterile) not using highly effective contraceptive measures with a failure rate of less than 1% per year when used consistently and correctly (i.e. oral contraceptives, intrauterine device) or a life-style excluding pregnancy, for up to three months after the last implant administration; * Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using highly effective contraceptive measures, as described above; * Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit; * Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit.
Where this trial is running
Regensburg
- CLINUVEL investigative site — Regensburg, Germany (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.
Conditions: Xeroderma Pigmentosum