Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT03358693
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2017-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Signatures in Inflammatory Skin Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}, {'id': 'C000596027', 'term': 'baricitinib'}, {'id': 'C000634427', 'term': 'abrocitinib'}, {'id': 'C000613732', 'term': 'upadacitinib'}, {'id': 'C574065', 'term': 'tralokinumab'}, {'id': 'C561806', 'term': 'lebrikizumab'}, {'id': 'C000612881', 'term': 'nemolizumab'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, swabs, tape strips, skin biopsies (only adults)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2017-11-04', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of molecular profiles over time', 'timeFrame': 'Baseline and week 2, week 4, week 12, week 52', 'description': 'Changes of immune cell composition, transcriptome, proteome and microbiome signatures'}, {'measure': 'Changes of molecular profiles associated with disease severity/remission', 'timeFrame': 'Baseline and week 2, week 4, week 12, week 52', 'description': 'Changes of immune cell composition, transcriptome, proteome and microbiome signatures'}, {'measure': 'Changes of molecular profiles associated with treatment', 'timeFrame': 'Baseline and week 2, week 4, week 12, week 52', 'description': 'Changes of immune cell composition, transcriptome, proteome and microbiome signatures'}, {'measure': 'Changes of molecular profiles associated with treatment response', 'timeFrame': 'Baseline and week 2, week 4, week 12, week 52', 'description': 'Changes of immune cell composition, transcriptome, proteome and microbiome signatures'}], 'secondaryOutcomes': [{'measure': 'Change in Eczema Area and Severity Index (EASI) score', 'timeFrame': 'Baseline and week 1, week 2, week 12, week 52', 'description': 'Clinical severity score'}, {'measure': 'Change in Score of Atopic Dermatitis (SCORAD)', 'timeFrame': 'Baseline and week 1, week 2, week 12, week 52', 'description': 'Clinical severity score'}, {'measure': 'Change in Psoriasis Area and Severity Index (PASI)', 'timeFrame': 'Baseline and week 1, week 2, week 12, week 52', 'description': 'Clinical severity score'}, {'measure': 'Change in Hidradenitis Suppurativa Severity Score (IHS4)', 'timeFrame': 'Baseline and week 1, week 2, week 12, week 52', 'description': 'Clinical severity score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis', 'Psoriasis']}, 'descriptionModule': {'briefSummary': 'This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and disease control by integrating and modelling data across multiple cellular levels and time following specific blockade of single pathophysiological factors through use of licensed biologics during routine care as systems biology challenge. To this end, ultra-deep phenotyping and prospective molecular characterization in short time-intervals and different disease equilibrium states will be carried out in targeted small sets of patients. The different layers and types of clinical and molecular information will then be integrated (integrative personal omics profiling iPOP) for generating insights into disease pathways and for extraction of molecular signatures that correspond to clinical severity scores. It will provide a good starting point for planning future trials aimed at identifying biological patterns useful for guiding targeted treatment.', 'detailedDescription': 'This is an exploratory study with the aim to identify molecular profiles and signatures in skin and blood that correlate with inflammatory skin disease, disease activity and disease progression, and that are associated with possible disease subtypes/endotypes. Primary target variables are differentially expressed genes (alone or in combination), secondary target variables are genetic, immunological and microbiological signatures. Influencing variables of interest include age of manifestation, disease duration, disease activity/severity, disease progression, comorbidities and therapy/treatment. Obtained biomaterial will be used for molecular profiling including DNA/RNA sequencing, ELISA, mass spectrometry, flow cytometry to identify markers and/or signatures that can correlate with individual disease courses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic inflammatory skin disease who receive systemic therapy from their treating dermatologist during routine care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent and comply with the protocol\n* Dermatologist-diagnosed chronic inflammatory skin disease\n* Subject receives systemic therapy within routine care (in-label use of biologics)\n\nExclusion Criteria:\n\n* Subject is unable to provide written informed consent or comply with the protocol.\n* Having used immunosuppressive/immunomodulating therapy or phototherapy within 4 weeks before the baseline visit.\n* Treatment of selected skin areas to be examined with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit.'}, 'identificationModule': {'nctId': 'NCT03358693', 'acronym': 'MSID', 'briefTitle': 'Molecular Signatures in Inflammatory Skin Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders', 'orgStudyIdInfo': {'id': 'A100/12'}, 'secondaryIdInfos': [{'id': 'A100/12_A', 'type': 'OTHER', 'domain': 'Ethics Committee Medical Faculty Kiel, Amendment 11MAR2017'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors', 'description': 'Pso\\_Tumor Necrosis Factor (TNF) Inhibitors', 'interventionNames': ['Drug: Anti-TNF']}, {'label': 'Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors', 'description': 'Interleukin (IL)-12/23 Inhibitors', 'interventionNames': ['Drug: Anti-IL12/23']}, {'label': 'Psoriasis patients receiving Interleukin (IL)-17 Inhibitors', 'description': 'Pso\\_Interleukin (IL)-17 Inhibitors', 'interventionNames': ['Drug: Anti-IL17']}, {'label': 'Atopic dermatitis patients receiving dupilumab', 'description': 'Dupilumab', 'interventionNames': ['Drug: Dupilumab']}, {'label': 'Atopic dermatitis patients receiving lebrikizumab', 'description': 'Brodalumab', 'interventionNames': ['Drug: Lebrikizumab']}, {'label': 'Atopic dermatitis patients receiving tralokinumab', 'description': 'Tralokinumab', 'interventionNames': ['Drug: Tralokinumab']}, {'label': 'Atopic dermatitis patients receiving baricitinib', 'description': 'Baricitinib', 'interventionNames': ['Drug: Baricitinib']}, {'label': 'Atopic dermatitis patients receiving abrocitinib', 'description': 'Abrocitinib', 'interventionNames': ['Drug: Abrocitinib']}, {'label': 'Atopic dermatitis patients receiving upadacitinib', 'description': 'Upadacitinib', 'interventionNames': ['Drug: Upadacitinib']}, {'label': 'Psoriasis patients receiving Interleukin (IL)-23 Inhibitors', 'description': 'Interleukin (IL)-23 Inhibitors', 'interventionNames': ['Drug: Anti-IL23']}, {'label': 'Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors', 'description': 'Interleukin (IL)-31 Inhibitors', 'interventionNames': ['Drug: Nemolizumab']}, {'label': 'Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors', 'description': 'HS\\_Interleukin (IL)-17 Inhibitors', 'interventionNames': ['Drug: Anti-IL17']}, {'label': 'Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors', 'description': 'HS\\_Tumor Necrosis Factor (TNF) Inhibitors', 'interventionNames': ['Drug: Anti-TNF']}], 'interventions': [{'name': 'Anti-TNF', 'type': 'DRUG', 'description': 'Subject receives anti-TNF antibodies open-label as per guidelines', 'armGroupLabels': ['Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors', 'Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors']}, {'name': 'Anti-IL12/23', 'type': 'DRUG', 'description': 'Subject receives anti-IL12/23 antibodies open-label as per guidelines', 'armGroupLabels': ['Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors']}, {'name': 'Anti-IL17', 'type': 'DRUG', 'description': 'Subject receives anti-IL17 antibodies open-label as per guidelines', 'armGroupLabels': ['Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors', 'Psoriasis patients receiving Interleukin (IL)-17 Inhibitors']}, {'name': 'Dupilumab', 'type': 'DRUG', 'description': 'Subject receives Dupilumab open-label as per guidelines', 'armGroupLabels': ['Atopic dermatitis patients receiving dupilumab']}, {'name': 'Anti-IL23', 'type': 'DRUG', 'description': 'Subject receives anti-IL23 antibodies open-label as per guidelines', 'armGroupLabels': ['Psoriasis patients receiving Interleukin (IL)-23 Inhibitors']}, {'name': 'Baricitinib', 'type': 'DRUG', 'description': 'Subject receives Baricitinib open-label as per guidelines', 'armGroupLabels': ['Atopic dermatitis patients receiving baricitinib']}, {'name': 'Abrocitinib', 'type': 'DRUG', 'description': 'Subject receives Abrocitinib open-label as per guidelines', 'armGroupLabels': ['Atopic dermatitis patients receiving abrocitinib']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'description': 'Subject receives Upadacitinib open-label as per guidelines', 'armGroupLabels': ['Atopic dermatitis patients receiving upadacitinib']}, {'name': 'Tralokinumab', 'type': 'DRUG', 'description': 'Subject receives Tralokinumab open-label as per guidelines', 'armGroupLabels': ['Atopic dermatitis patients receiving tralokinumab']}, {'name': 'Lebrikizumab', 'type': 'DRUG', 'description': 'Subject receives Lebrikizumab open-label as per guidelines', 'armGroupLabels': ['Atopic dermatitis patients receiving lebrikizumab']}, {'name': 'Nemolizumab', 'type': 'DRUG', 'description': 'Subject receives Nemolizumab open-label as per guidelines', 'armGroupLabels': ['Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan Weidinger, MD', 'role': 'CONTACT'}, {'name': 'Sascha Gerdes, MD', 'role': 'CONTACT'}], 'facility': 'Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'centralContacts': [{'name': 'Stephan Weidinger, MD', 'role': 'CONTACT', 'email': 'sweidinger@dermatology.uni-kiel.de', 'phone': '004943150021101'}, {'name': 'Sascha Gerdes, MD', 'role': 'CONTACT', 'email': 'sgerdes@dermatology.uni-kiel.de', 'phone': '004943150021101'}], 'overallOfficials': [{'name': 'Stephan Weidinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Stephan Weidinger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head, Inflammatory Skin Disease Center', 'investigatorFullName': 'Prof. Dr. Stephan Weidinger', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}