Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Precancerous Conditions

Neoplasms, Squamous Cell

Dermatologic Agents

All Drugs and Chemicals

Afamelanotide

Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months

Placebo implant administered subcutaneously every 60 days for 24 months

16 mg subcutaneous implant administered every 60 days

Afamelanotide (CUV1647)

Placebo subcutaneous implant administered every 60 days

Placebo

Günther Hofbauer, M.D.

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.

Phase II AK Study in Organ Transplant Patients

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.

Clinuvel Pharmaceuticals Limited

Dr Dennis Wright

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Xeroderma Pigmentosum

Ichthyosis

Congenital Abnormalities

Skin Abnormalities

Infant, Newborn, Diseases

Skin Diseases, Genetic

Genetic Diseases, Inborn

Photosensitivity Disorders

Pigmentation Disorders

DNA Repair-Deficiency Disorders

Metabolic Diseases

Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.

Head of Clinical Operations

The CUV156 study will evaluate the safety of afamelanotide in XP-C patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.

A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)

A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)

MED is the lowest dose of UV light that causes reddening of the skin.

Analysis of UV photoproducts and DNA repair mechanisms.

The higher the score, the more severe the disease.

Non-invasive quantitative skin reflectance measurement.

Higher scores represent worse health-related quality of life.

Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.

Clinuvel Europe Limited

The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.

A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (XPC and XPV)

Analysis of UV photoproducts from skin samples.

Analysis of DNA repair mechanisms from skin samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II AK Study in Organ Transplant Patients	NCT00829192	Actinic Keratos... Carcinoma, Squa... Organ Transplan...	Afamelanotide (... Placebo	18 Years - 75 Years	Clinuvel Pharmaceuticals Limited
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)	NCT05159752	Xeroderma Pigme...	Afamelanotide	18 Years - 75 Years	Clinuvel Pharmaceuticals Limited
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V	NCT05370235	Xeroderma Pigme...	Afamelanotide	18 Years - 75 Years	Clinuvel Pharmaceuticals Limited
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V	NCT05370235	Xeroderma Pigme...	Afamelanotide	18 Years - 75 Years	Clinuvel Pharmaceuticals Limited

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