Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02620332
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2015-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2015-09-24', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of MultiPepT1De safety profile', 'timeFrame': 'Every 28 days for 147 days', 'description': 'Safety assessed through measurement and comparison of any reactions or hypersensitivity to MultipepT1De injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests'}], 'secondaryOutcomes': [{'measure': 'Assessment of residual beta cell function and markers of metabolic control', 'timeFrame': '24 weeks versus baseline', 'description': 'Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and amplitude of glucose excursions from baseline and between groups'}, {'measure': 'Assessment of T lymphocyte immune response to islet cell antigens', 'timeFrame': '24 weeks versus 12 weeks', 'description': 'Comparison of changes in antigen specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '35073398', 'type': 'DERIVED', 'citation': 'Liu YF, Powrie J, Arif S, Yang JHM, Williams E, Khatri L, Joshi M, Lhuillier L, Fountoulakis N, Smith E, Beam C, Lorenc A, Peakman M, Tree T. Immune and Metabolic Effects of Antigen-Specific Immunotherapy Using Multiple beta-Cell Peptides in Type 1 Diabetes. Diabetes. 2022 Apr 1;71(4):722-732. doi: 10.2337/db21-0728.'}]}, 'descriptionModule': {'briefSummary': 'Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the pancreas are destroyed such that the patient is reliant on injection of insulin to adequately control blood glucose levels for the remainder of his/her life. The autoimmune process targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is a mixture of peptides from islet auto antigens. The mixture has been designed to induce or restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to protect beta-cells', 'detailedDescription': 'Recent onset type 1 diabetes patients will be randomized into 4 groups of 6 subjects and each group will receive 6 injections of either placebo, low, medium or high dose of IMP; each injection is intradermal and spaced 1 month apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Type 1 diabetes\n* Age 18-45 years\n* Maximum of 4 years from diagnosis\n* Evidence of ≥1 autoantibody against β-cell autoantigens\n* Possession of the HLA-DR4 (DRB1\\*0401) genotype\n* Residual β-cell function (peak C-peptide \\>200)\n\nExclusion Criteria:\n\n* Females who are pregnant, breast-feeding or not using adequate forms of contraception.\n* Use of β-cell stimulants, immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization, any monoclonal antibody therapy given for any indication and any antigen-specific'}, 'identificationModule': {'nctId': 'NCT02620332', 'acronym': 'MultiPepT1De', 'briefTitle': 'Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)', 'orgStudyIdInfo': {'id': 'MultiPep001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo injection', 'description': 'Water for injection', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MultiPepT1De injection low dose', 'description': 'Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)', 'interventionNames': ['Drug: MultiPepT1De injection']}, {'type': 'EXPERIMENTAL', 'label': 'MultiPepT1De injection medium dose', 'description': 'Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)', 'interventionNames': ['Drug: MultiPepT1De injection']}, {'type': 'EXPERIMENTAL', 'label': 'MultiPepT1De injection high dose', 'description': 'Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)', 'interventionNames': ['Drug: MultiPepT1De injection']}], 'interventions': [{'name': 'MultiPepT1De injection', 'type': 'DRUG', 'otherNames': ['Multipeptide injection'], 'description': 'A mix of peptides', 'armGroupLabels': ['MultiPepT1De injection high dose', 'MultiPepT1De injection low dose', 'MultiPepT1De injection medium dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Water for injection', 'armGroupLabels': ['Placebo injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jake Powrie, MD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}, {'name': 'Mark Peakman, MBBS PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}