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
Conditions
Interventions
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 administ
Sponsors
Clinuvel Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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. | — |
Countries
Belgium, France, Germany, Italy, Sweden
Outcome results
None listed