Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
Study NCT ID:
NCT06745557
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intra-patient randomisation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of safety and tolerability using the National Cancer Institute-CTCAE v5.0 throughout the study: - Assessment of the incidence of treatment-emergent adverse events (TEAEs), total AEs, and serious adverse events (SAEs)', 'timeFrame': '24 months', 'description': 'Assessment of safety and tolerability using the National Cancer Institute-CTCAE v5.0 throughout the study:\n\n\\- Assessment of the incidence of treatment-emergent adverse events (TEAEs), total AEs, and serious adverse events (SAEs)'}], 'primaryOutcomes': [{'measure': 'A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)', 'timeFrame': '6 months post grafting', 'description': 'A composite endpoint whereby success is defined by meeting both of the following criteria:\n\n* Wound closure\n* Scar quality (POSAS v2.0)'}], 'secondaryOutcomes': [{'measure': 'Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting', 'timeFrame': '4 weeks', 'description': 'Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting'}, {'measure': 'Assessment of scar contracture', 'timeFrame': '6 months post grafting', 'description': 'Assessment of scar contracture'}, {'measure': 'Epithelialisation percentage at 3 months and 6 months post-grafting', 'timeFrame': '3 months and 6 months post-grafting', 'description': 'Epithelialisation percentage at 3 months and 6 months post-grafting'}, {'measure': 'Graft take at 14 and 21 days post-grafting', 'timeFrame': '14 and 21 days post-grafting', 'description': 'Graft take at 14 and 21 days post-grafting'}, {'measure': 'Assessment of the donor sites', 'timeFrame': '4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting', 'description': 'Assessment of the donor sites'}, {'measure': 'Assessment of the grafted burn wounds areas', 'timeFrame': '4 and 10 weeks and 3, 6, 12, and 24 months post-grafting', 'description': 'Assessment of the grafted burn wounds areas'}, {'measure': 'Assessment of scar contracture', 'timeFrame': '12 and 24 months post-grafting', 'description': 'Assessment of scar contracture'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burns', 'Skin', 'Scars', 'Wound healing', 'Dermis', 'Epidermis', 'Thermal burns'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated\n* Patients of either sex aged ≥12 years\n* Signed informed consent from the patient and/or legally authorised representative\n\nExclusion Criteria:\n\n* Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck)\n* Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies\n* Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen \\[HbsAg\\] or immunoglobulin M total hepatitis B core antibody \\[anti-HBc\\]), active hepatitis C infection (hepatitis C virus \\[HCV\\] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion\n* Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) ≥53 mmol/mol and/or systemic skin and connective tissue diseases\n* Patients with pre-existing coagulation disorders as defined by international normalised ratio (INR) outside its normal value, a prothrombin time (PT) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission\n* Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine)\n* Previous treatment with denovoSkin™\n* Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and \\<30 days for all other IMPs\n* Patients unwilling or unable to comply with procedures required in this clinical study protocol\n* Pregnant or lactating women\n* Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate \\<1% per year) throughout the study and/or unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (β-hCG) test is required on the day of grafting\n* Patient is the Investigator, one of his/her family members, employees, and other dependent persons"}, 'identificationModule': {'nctId': 'NCT06745557', 'briefTitle': 'Phase III Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'CUTISS AG'}, 'officialTitle': 'A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of DenovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients with Deep Partial and Full-thickness Burns', 'orgStudyIdInfo': {'id': 'dS-BA-PIII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Option 1', 'description': 'Location A is the experimental area and Location B is the control area', 'interventionNames': ['Biological: denovoSkin(TM)', 'Other: STSG']}, {'type': 'OTHER', 'label': 'Option 2', 'description': 'Location A is the control area and Location B is the experimental area', 'interventionNames': ['Biological: denovoSkin(TM)', 'Other: STSG']}], 'interventions': [{'name': 'denovoSkin(TM)', 'type': 'BIOLOGICAL', 'otherNames': ['EHSG-KF'], 'description': 'Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area', 'armGroupLabels': ['Option 1', 'Option 2']}, {'name': 'STSG', 'type': 'OTHER', 'otherNames': ['split-thickness skin graft'], 'description': 'Transplantation of autologous split-thickness skin to the control area', 'armGroupLabels': ['Option 1', 'Option 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1942', 'city': 'Beverwijk', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Prof. E. Middelkoop', 'role': 'CONTACT', 'email': 'emiddelkoop@burns.nl', 'phone': '+31 251 265 555'}], 'facility': 'Rode Kruis Ziekenhuis', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}], 'centralContacts': [{'name': 'Daniela Marino', 'role': 'CONTACT', 'email': 'clinicaltrials@cutiss.swiss', 'phone': '+41 44 244 36 60'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CUTISS AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'RCTs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}