Phase II AK Study in Organ Transplant Patients

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2012

Interventions

  • Drug: Afamelanotide (CUV1647)
    • 16 mg subcutaneous implant administered every 60 days
  • Drug: Placebo
    • Placebo subcutaneous implant administered every 60 days

Arms, Groups and Cohorts

  • Experimental: 1
    • Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
  • Placebo Comparator: 2
    • Placebo implant administered subcutaneously every 60 days for 24 months

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clinuvel Pharmaceuticals Limited
  • Provider of Information About this Clinical Study
    • Dr Dennis Wright, Clinuvel Pharmaceuticals
  • Overall Official(s)
    • Günther Hofbauer, M.D., Principal Investigator, Universitätsspital Zürich

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