Phase II AK Study in Organ Transplant Patients - Full Text View

Sponsor:	Clinuvel Pharmaceuticals Limited
Information provided by:	Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier:	NCT00829192

Purpose

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.

Condition	Intervention	Phase
Actinic Keratoses Carcinoma, Squamous Cell Organ Transplant Recipients	Drug: Afamelanotide (CUV1647) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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.

Further study details as provided by Clinuvel Pharmaceuticals Limited:

Primary Outcome 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 Outcome 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 ]

Estimated Enrollment:	200
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829192

Locations

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

Sponsors and Collaborators

Clinuvel Pharmaceuticals Limited

Investigators

Principal Investigator:

Günther Hofbauer, M.D.

Universitätsspital, Zürich

More Information

No publications provided

Responsible Party:	Dr Dennis Wright, Clinuvel Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00829192 History of Changes
Other Study ID Numbers:	CUV011
Study First Received:	January 23, 2009
Last Updated:	December 3, 2010
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Clinuvel Pharmaceuticals Limited:

Actinic keratoses (AK)
Squamous cell carcinomas (SCC)
CUV1647
Afamelanotide

Clinuvel
Photoprotection
Organ transplant

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Keratosis
Keratosis, Actinic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

Skin Diseases
Precancerous Conditions
Alpha-MSH
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012