Phase II AK Study in Organ Transplant Patients

Phase 2

• Conditions: Actinic Keratoses; Carcinoma, Squamous Cell; Organ Transplant Recipients
• Interventions: Drug: Afamelanotide (CUV1647); Drug: Placebo

• Registration Number: NCT00829192
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-06
• Primary Completion: 2012-07
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Afamelanotide (CUV1647)	Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
2	Placebo	Placebo implant administered subcutaneously every 60 days for 24 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (12)

The Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Hospital Erasme; 🇧🇪 Brussels, Belgium

Gent University Hospital; 🇧🇪 Gent, Belgium

The Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

University Hospital; 🇫🇷 Besancon, France

University of Padua; 🇮🇹 Padua, Italy

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Kiel University Hospital; 🇩🇪 Kiel, Germany

Charité Univeritätsklinikum; 🇩🇪 Berlin, Germany

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland

The Queen Elizabeth Hospital; 🇦🇺 Adelaide, South Australia, Australia