Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
Study NCT ID:
NCT06136403
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2023-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016110', 'term': 'Epidermolysis Bullosa Simplex'}, {'id': 'D007057', 'term': 'Ichthyosis'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}], 'ancestors': [{'id': 'D004820', 'term': 'Epidermolysis Bullosa'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007642', 'term': 'Keratosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'challenge dechalenge rechalenge design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of deucravacitinib', 'timeFrame': 'week 44', 'description': 'number of new blister conting every day'}], 'secondaryOutcomes': [{'measure': 'Safety of deucravacitinib treatment', 'timeFrame': 'week 44', 'description': 'record of adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deucravacitinib'], 'conditions': ['Epidermolysis Bullosa Simplex', 'Ichthyosis', 'Genodermatosis', 'Inflammatory Congenital Ichthyoses']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about deucravacitinib treatment in adults with inflammatory epidermal genodermatoses . The main question it aims to answer are: describe efficacity and safety of this treatment.\n\nParticipants will take treatments and have to use bullets during the study period.', 'detailedDescription': 'The patient will have 8 visits After Confirmation of inclusion criteria and no exclusion criteria, the study will be explain to the patient after signing the inform consent and be included in the study Treatment Period (Period 1); challenge period This period will be the first treatment period that will occur from 16 weeks. During this period the patient will see the doctor at the hospital, he will perform the study procedures The second period : dechallenge (period 2): All patients stop their treatment for 12 weeks.\n\nThe second treatment period - rechallenge (period 3) the patient will take the treatment for a second 16 weeks period At week 44 - End of study\n\nAt each visit:\n\nThe investigator at each visit compliance to the treatment and adverse events, Measure vital signs and perform clinical examination.\n\nThe patient will assess the different questionnaires, for the study and have blood sample'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has congenital skin fragility with skin and/or mucosal blisters, a clinical phenotype of EBS-sev and a laboratory confirmed diagnosis of EBS by KRT5 and/or 14 mutation (autosomal only) OR a clinical phenotype of inflammatory ichthyosis (IC) including keratinopathic ichthyosis due to KRT1/10 mutation, ECI with identified genetic mutations (TGM5, NIPAL4, ABCA12, etc…).\n* Subject has at least a mean daily number of 4 new blisters (EBS-sev) OR an ISS \\> 50/128.\n\n * Subject agrees not to use any topical therapies other than the investigator approved.\n\nExclusion Criteria:\n\n* Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.\n* Infectious/Immune-related Exclusions\n* Medical History and Concurrent Diseases'}, 'identificationModule': {'nctId': 'NCT06136403', 'acronym': 'GENEPID', 'briefTitle': 'A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses', 'orgStudyIdInfo': {'id': '22-PP-20'}, 'secondaryIdInfos': [{'id': '2022-502879-32-00', 'type': 'OTHER', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'deucravacitinib treatment', 'description': 'challenge-dechallenge -rechallenge design', 'interventionNames': ['Drug: deucravacitinib']}], 'interventions': [{'name': 'deucravacitinib', 'type': 'DRUG', 'description': 'treatment by deucravacitinib in two phases of challenge', 'armGroupLabels': ['deucravacitinib treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06003', 'city': 'Nice', 'state': 'CHU de NICE', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0492034702'}, {'name': 'Christine CHIAVERINI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle BOURRAT, Doctor', 'role': 'CONTACT', 'email': 'marioncauseret@yahoo.fr', 'phone': '01 42 49 45 41'}, {'name': 'Emmanuelle BOURRAT, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'christine chiaverini', 'role': 'CONTACT', 'email': 'chiaverini.c@chu-nice.fr', 'phone': '04.92.03.47.02'}], 'overallOfficials': [{'name': 'Christine Chiaverini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}