Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06479018
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010391', 'term': 'Pemphigoid, Bullous'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood', 'timeFrame': 'Day 1', 'description': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry'}, {'measure': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood', 'timeFrame': 'Day 30', 'description': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry'}, {'measure': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood', 'timeFrame': 'Day 60', 'description': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry'}, {'measure': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood', 'timeFrame': 'Day 90', 'description': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry'}, {'measure': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood', 'timeFrame': 'Day 150', 'description': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry'}, {'measure': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood', 'timeFrame': 'Day 270', 'description': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry'}, {'measure': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood', 'timeFrame': 'Day 365', 'description': 'Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry'}, {'measure': 'Identification of IL-17RB-expressing cells at the lesional site', 'timeFrame': 'Day 1', 'description': 'Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry'}, {'measure': 'Identification of IL-17RB-expressing cells at the lesional site', 'timeFrame': 'Day 60', 'description': 'Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry'}], 'secondaryOutcomes': [{'measure': 'Measurement of IL-17B concentrations in sera', 'timeFrame': 'Day 1', 'description': 'Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique'}, {'measure': 'Measurement of IL-17B concentrations in sera', 'timeFrame': 'Day 30', 'description': 'Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique'}, {'measure': 'Measurement of IL-17B concentrations in sera', 'timeFrame': 'Day 60', 'description': 'Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique'}, {'measure': 'Measurement of IL-17B concentrations in sera', 'timeFrame': 'Day 90', 'description': 'Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique'}, {'measure': 'Measurement of IL-17B concentrations in sera', 'timeFrame': 'Day 150', 'description': 'Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique'}, {'measure': 'Measurement of IL-17B concentrations in sera', 'timeFrame': 'Day 270', 'description': 'Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique'}, {'measure': 'Measurement of IL-17B concentrations in sera', 'timeFrame': 'Day 365', 'description': 'Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bullous pemphigoid', 'IL-17 family', 'inflammatory response'], 'conditions': ['Bullous Pemphigoid']}, 'descriptionModule': {'briefSummary': 'Bullous pemphigoid (BP) is the most frequent autoimmune skin disease and mainly affects elderly individuals. BP classically manifests with tense blisters over urticarial plaques on the trunk and extremities accompanied by intense itches. However, BP is characterized by a large spectrum of clinical presentations allowing to distinguish between typical (with blisters) and atypical forms (non bullous, mucosal damage).\n\nHigh potency topical steroids and systemic steroids are the current first line intention treatments. While very efficient, these therapies are non-targeted and cause numerous side-effects, especially in these elderly patients that are the most affected. Furthermore, around 30% of BP patients will relapse during the first year of treatment when corticotherapy is decreased or stopped.\n\nThe investigators and others have highlighted the presence of Il-17 family belonging-inflammatory cytokines in BP patients. Their functions in the amplification of the inflammatory response and in the mechanisms of relapse have to be precisely determined in order to develop innovative therapeutic approaches and to move forwards precision medicine.', 'detailedDescription': 'This is a pathophysiological study with prospective and monocentric inclusion.\n\n90 patients with bullous phemphigoid will be recruited from the department of dermatology at the Reims University Hospital.\n\nThe main objectives of this study are to identify the cellular and molecular actors of the IL-17B/IL-17RB axis at diagnosis in patients with bullous pemphigoid and to determine their functions in the pathophysiological mechanisms associated with BP at systemic and in situ levels.\n\nThe secondary aims of this research are:\n\n1. To confirm IL-17B concentrations in sera at diagnosis as predictive biomarker of BP outcome under local corticotherapy\n2. To study the expression kinetics of IL-17B and its receptor IL-17RB in BP patients under treatment\n3. To study the implication of IL-17B/IL-17RB axis in BP relapse\n4. To establish inflammatory cell composition profile in skin and blood issued from clinical variants of BP as well as from BP patients during the first year of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with Bullous Pemphigoid (BP) using the following criteria: clinical features typical of BP with presence of at least three out of four well-established criteria by Vaillant et al.47; subepidermal blister on skin biopsy; and deposits of IgG and/or C3 in a linear pattern along the epidermal basement membrane zone by direct IF.\n* patient agreed to participate to the study\n* patient affiliated to the French Healthcare System\n\nExclusion Criteria:\n\n* patient that does not have the ability to give its written informed consent before inclusion in the study\n* patient with a pemphigoid gestationis\n* patient with a relapse of Bullous Pemphigoid\n* patient with Bullous Pemphigoid that already received local superpotent corticotherapy during the last 14 days before inclusion or systemic corticoid treatment during the last 28 days before inclusion\n* anemic patient (hemoglobin \\< 10 g/dL)'}, 'identificationModule': {'nctId': 'NCT06479018', 'acronym': 'BP-IL17RB', 'briefTitle': 'Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Identification and Functional Characterization of the Cellular and Molecular Actors of the IL-17B/IL-17RB Axis in Bullous Pemphigoid', 'orgStudyIdInfo': {'id': 'PO21096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Bullous Pemphigoid', 'interventionNames': ['Biological: Blood sampling', 'Biological: Liquid bubble sampling', 'Procedure: Cutaneous biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Control subjects', 'interventionNames': ['Biological: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Venous blood sampling will be carried out for each patient included in the study.', 'armGroupLabels': ['Control subjects', 'Patients with Bullous Pemphigoid']}, {'name': 'Liquid bubble sampling', 'type': 'BIOLOGICAL', 'description': 'Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study.', 'armGroupLabels': ['Patients with Bullous Pemphigoid']}, {'name': 'Cutaneous biopsy', 'type': 'PROCEDURE', 'description': 'At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study.', 'armGroupLabels': ['Patients with Bullous Pemphigoid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien JOLLY, Pr.', 'role': 'CONTACT', 'email': 'djolly@chu-reims.fr', 'phone': '326788472', 'phoneExt': '33'}], 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Manuelle VIGUIER, Pr.', 'role': 'CONTACT', 'email': 'mviguier@chu-reims.fr', 'phone': '03.10.73.66.76'}, {'name': 'Sébastien LE JAN, Dr.', 'role': 'CONTACT', 'email': 'sebastien.le-jan@univ-reims.fr', 'phone': '03.26.91.35.24'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}