Phase II AK Study in Organ Transplant Patients

Sponsor

Clinuvel Pharmaceuticals Limited (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00829192

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

16.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses Carcinoma, Squamous Cell Organ Transplant Recipients	Drug: Afamelanotide (CUV1647) Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Study Start Date :

Nov 1, 2007

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

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

Outcome Measures

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 [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) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Princess Alexandra Hospital	Brisbane	Queensland	Australia	4102
2	The Queen Elizabeth Hospital	Adelaide	South Australia	Australia	5011
3	The Royal Melbourne Hospital	Melbourne	Victoria	Australia
4	Hospital Erasme	Brussels		Belgium
5	Gent University Hospital	Gent		Belgium
6	University Hospital	Besancon		France
7	Charité Univeritätsklinikum	Berlin		Germany
8	Kiel University Hospital	Kiel		Germany
9	Ospedali Riuniti di Bergamo	Bergamo		Italy
10	University of Padua	Padua		Italy
11	Karolinska University Hospital	Stockholm		Sweden
12	Universitätsspital Zürich	Zürich		Switzerland