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.

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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Squamous Cell; Actinic Keratoses; Organ Transplant Recipients
• Intervention / Treatment: Drug: Afamelanotide (CUV1647); Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • The Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Melbourne, Victoria, Australia
      • The Royal Melbourne Hospital
• Belgium
  • Brussels, Belgium
    • Hospital Erasme
  • Gent, Belgium
    • Gent University Hospital
• France
  • Besancon, France
    • University Hospital
• Germany
  • Berlin, Germany
    • Charité Univeritätsklinikum
  • Kiel, Germany
    • Kiel University Hospital
• Italy
  • Bergamo, Italy
    • Ospedali Riuniti di Bergamo
  • Padua, Italy
    • University of Padua
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital
• Switzerland
  • Zürich, Switzerland
    • Universitätsspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Clinuvel Pharmaceuticals Limited
• Investigators: Principal Investigator: Günther Hofbauer, M.D., Universitätsspital Zürich

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: January 23, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2010
• Last Update Submitted That Met QC Criteria: December 3, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Organ transplant; Photoprotection; Afamelanotide; Actinic keratoses (AK); Squamous cell carcinomas (SCC); CUV1647; Clinuvel
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Precancerous Conditions; Neoplasms, Squamous Cell; Keratosis, Actinic; Keratosis; Carcinoma, Squamous Cell; Dermatologic Agents; Afamelanotide
• Other Study ID Numbers: CUV011