Phase II AK Study in Organ Transplant Patients

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Actinic Keratoses, Carcinoma, Squamous Cell, Organ Transplant Recipients

Intervention / Treatment
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* Drug: Afamelanotide (CUV1647)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months | Drug: Afamelanotide (CUV1647)<br>* 16 mg subcutaneous implant administered every 60 days<br>|
| Placebo Comparator: 2<br>Placebo implant administered subcutaneously every 60 days for 24 months | Drug: Placebo<br>* Placebo subcutaneous implant administered every 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC) |  | 24 months | 
| To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group |  | 24 months | 
| To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic keratoses (AK), Squamous cell carcinomas (SCC), CUV1647, Afamelanotide, Clinuvel, Photoprotection, Organ transplant