Clinical trial · Interventional
Phase II AK Study in Organ Transplant Patients
A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.
- 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 purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period. The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Organ Transplant Recipients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afamelanotide (CUV1647) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
- interventionNames
- Drug: Afamelanotide (CUV1647)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo implant administered subcutaneously every 60 days for 24 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry * Organ transplant patients who have had at least one biopsy-positive SCC * Aged 18 - 75 years * Written informed consent to the performance of all study-specific procedures Exclusion Criteria: * Allergy to afamelanotide (CUV1647) or the polymer contained in the implant * History of melanoma * Current pigmentary disorders such as melasma * Diagnosed with HIV/AIDS, or hepatitis B or C * Current history of drug or alcohol abuse (in the last 12 months) * Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures * Major medical or psychiatric illness * Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers * Females of child bearing potential not using adequate contraceptive measures * Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit * Use of regular medications or any other factors that may affect skin pigmentation Discontinuation Criteria: * Initiation of treatment with systemic retinoids * Change of class of systemic immunosuppressant treatment
References
Publications (0)
Data not yet available