A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of CUV1647 for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients - Phase II AK Study

• Register: EUCTR
• Last refreshed on: 18 September 2012
• Main ID: EUCTR2007-007015-89-SE
• Date of registration: 24/06/2008
• Prospective Registration: Yes
• Primary sponsor: Clinuvel Pharmaceuticals Limited
• Public title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of CUV1647 for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients - Phase II AK Study
• Scientific title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of CUV1647 for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients - Phase II AK Study
• Date of first enrolment: 07/11/2008
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007015-89
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, France, Germany, Italy, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
- Male and female organ transplant recipients with stable transplant function who received their transplant at least 2 years prior to study entry.
- Organ transplant patients who have had at least one biopsy-positive squamous cell carcinoma.
- Aged 18-75 years.
- Written informed consent prior to the performance of any study-specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Any allergy to 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 1 year).
- Clinically significant organ dysfunction, history of medical disorders or other factors (e.g. non-compliance history, allergic to local anaesthetics, faints when given injections or giving blood) which in the opinion of the investigator will interfere with the interpretation of the study outcome measures.
- Major medical or psychiatric illness.
- Pregnancy as confirmed by positive serum ß-HCG pregnancy test prior to baseline or lactating mothers.
- Females of child bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).
-Participation in a clinical trial of an investigational agent within 30 days prior to the screening visit.
- use of regular medications or any other factor that may affect skin pigmentation.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pre-cancerous skin lesions
MedDRA version: 9.1 Level: LLT Classification code 10000614 Term: Actinic keratosis
MedDRA version: 9.1 Level: LLT Classification code 10004146 Term: Basal cell carcinoma
MedDRA version: 9.1 Level: LLT Classification code 10041823 Term: Squamous cell carcinoma

Intervention(s)

Product Name: CUV1647 implant
Product Code: CUV1647
Pharmaceutical Form: Implant
INN or Proposed INN: Afamelanotide
CAS Number: 75921-69-6
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: - To determine the effect of CUV1647 administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands during a 24 month test period.

Primary end point(s): Primary efficacy endpoint:
-Number of AK lesions will be systematically mapped, counted and photographed.

Primary safety endpoint:
- Incidence of any toxicities as judged from Adverse Events.

Secondary Objective: - To determine and compare the proportion of patients in each group that develops one or more SCC during a 24 month test period.
- To examine the effect of ongoing sun exposure on lesion formation and progression in this patient group.
- To evaluate the safety and tolerability of multiple slow release subcutaneous implants of CUV1647.

Secondary ID(s)

CUV011