Overview

This trial is active, not recruiting.

Conditions actinic keratoses, carcinoma, squamous cell, organ transplant recipients
Treatments afamelanotide (cuv1647), placebo
Phase phase 2
Sponsor Clinuvel Pharmaceuticals Limited
Start date November 2007
End date July 2012
Trial size 200 participants
Trial identifier NCT00829192, CUV011

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
afamelanotide (cuv1647)
16 mg subcutaneous implant administered every 60 days
(Placebo Comparator)
Placebo implant administered subcutaneously every 60 days for 24 months
placebo
Placebo subcutaneous implant administered every 60 days

Primary Outcomes

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
time frame: 24 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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.
Principal investigator Günther Hofbauer, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Clinuvel Pharmaceuticals Limited.