Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Xeroderma Pigmentosum | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afamelanotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Afamelanotide
- interventionNames
- Drug: Afamelanotide
Primary outcomes (2)
- measure
- Change in minimal erythema dose (MED) in patients with XP-C.
- timeFrame
- From baseline to day 76.
- description
- MED is the lowest dose of UV light that causes reddening of the skin.
- measure
- Change in MED in patients with XP-V.
- timeFrame
- From baseline to day 76.
- description
- MED is the lowest dose of UV light that causes reddening of the skin.
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available