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 immunce compromised, organ transplant patients. - Phase II AK Study

• Register: EUCTR
• Last refreshed on: 18 September 2012
• Main ID: EUCTR2007-007015-89-IT
• Date of registration: 07/04/2010
• Prospective Registration: No
• Primary sponsor: CLINUVEL PHARMACUETICALS LTD
• 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 immunce 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 immunce compromised, organ transplant patients. - Phase II AK Study
• Date of first enrolment: 11/09/2008
• Target sample size: 200
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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: Placebo: Other:

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 SCC. Aged 18-75 years. Written informed consent to the performance of all 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:
Allergy to CUV1647 or the polymer contained in the implant. History of melanoma. Current pigmentation disorders such as melasma. Diagnosed with HIV/AIDS or Hepatitis B or C. Pregnancy. Use of regular medication or any factors 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

Intervention(s)

Product Name: afamelanotide
Pharmaceutical Form: Implant
CAS Number: 75921-69-6
Current Sponsor code: CUV1647
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16-
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 aktinic keratoses (AKs) on the head, back of hands and forearms during a 24 months test period.

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

Primary end point(s): Number of clinical AK lesions on the head, forearms and back of the hands.

Secondary ID(s)

2007-007015-89-SE

CUV011