Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 2:08 AM
Study NCT ID:
NCT05370235
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014983', 'term': 'Xeroderma Pigmentosum'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D010787', 'term': 'Photosensitivity Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534526', 'term': 'afamelanotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in minimal erythema dose (MED) in patients with XP-C.', 'timeFrame': 'From baseline to day 76.', 'description': 'MED is the lowest dose of UV light that causes reddening of the skin.'}, {'measure': 'Change in MED in patients with XP-V.', 'timeFrame': 'From baseline to day 76.', 'description': 'MED is the lowest dose of UV light that causes reddening of the skin.'}], 'secondaryOutcomes': [{'measure': 'Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-C.', 'timeFrame': 'From baseline to day 76.', 'description': 'Analysis of UV photoproducts from skin samples.'}, {'measure': 'Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-C.', 'timeFrame': 'From baseline to day 76.', 'description': 'Analysis of DNA repair mechanisms from skin samples.'}, {'measure': 'Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-V.', 'timeFrame': 'From baseline to day 76.', 'description': 'Analysis of UV photoproducts from skin samples.'}, {'measure': 'Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-V.', 'timeFrame': 'From baseline to day 76.', 'description': 'Analysis of DNA repair mechanisms from skin samples.'}, {'measure': 'Change in skin disease severity in patients with XP-C (A).', 'timeFrame': 'From baseline to day 76.', 'description': 'The higher the score, the more severe the disease.'}, {'measure': 'Change in skin disease severity in patients with XP-V (A)', 'timeFrame': 'From baseline to day 76.', 'description': 'The higher the score, the more severe the disease.'}, {'measure': 'Change in skin disease severity in patients with XP-C (B).', 'timeFrame': 'From baseline to day 76.', 'description': 'The higher the score, the more severe the disease.'}, {'measure': 'Change in skin disease severity in patients with XP-V (B).', 'timeFrame': 'From baseline to day 76.', 'description': 'The higher the score, the more severe the disease.'}, {'measure': 'Change in skin disease severity in patients with XP-C (C).', 'timeFrame': 'From baseline to day 76.', 'description': 'The higher the score, the more severe the disease.'}, {'measure': 'Change in skin disease severity in patients with XP-V (C).', 'timeFrame': 'From baseline to day 76.', 'description': 'The higher the score, the more severe the disease.'}, {'measure': 'Change in quality of life assessed by a disease specific tool (A) in patients with XP-C.', 'timeFrame': 'From baseline to day 76.', 'description': 'Higher scores represent worse health-related quality of life.'}, {'measure': 'Change in quality of life assessed by a disease specific tool (A) in patients with XP-V.', 'timeFrame': 'From baseline to day 76.', 'description': 'Higher scores represent worse health-related quality of life.'}, {'measure': 'Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-C.', 'timeFrame': 'From baseline to day 76.', 'description': 'Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.'}, {'measure': 'Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-V.', 'timeFrame': 'From baseline to day 76.', 'description': 'Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Xeroderma Pigmentosum']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;\n* Aged 18-75 years.\n\nExclusion Criteria:\n\n* Known allergy to afamelanotide or the polymer contained in the implant;\n* Presence of severe hepatic disease or hepatic impairment;\n* Renal impairment;\n* Any other medical condition which may interfere with the study protocol;\n* Existing melanoma;\n* Female who is pregnant or lactating;\n* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures;\n* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures;\n* Use of any other prior and concomitant therapy which may interfere with the objective of the study;\n* Participation in a clinical trial for an investigational agent.'}, 'identificationModule': {'nctId': 'NCT05370235', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinuvel Pharmaceuticals Limited'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CUV152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afamelanotide', 'interventionNames': ['Drug: Afamelanotide']}], 'interventions': [{'name': 'Afamelanotide', 'type': 'DRUG', 'description': 'Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.', 'armGroupLabels': ['Afamelanotide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clinuvel Investigational Site', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Head of Clinical Operations', 'role': 'CONTACT', 'email': 'mail@clinuvel.com', 'phone': '+441372860765'}], 'facility': 'CLINUVEL Investigational site'}, {'city': 'Clinuvel Investigational Site', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Head of Clinical Operations', 'role': 'CONTACT', 'email': 'mail@clinuvel.com', 'phone': '+441372860765'}], 'facility': 'CLINUVEL Investigational site'}], 'centralContacts': [{'name': 'Head of Clinical Operations', 'role': 'CONTACT', 'email': 'mail@clinuvel.com', 'phone': '+441372860765'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinuvel Europe Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}