Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-03 @ 5:20 AM
Study NCT ID:
NCT03272269
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind, placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-09-01', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of T lymphocyte immune response to IMCY-0098', 'timeFrame': 'up to 24 weeks', 'description': 'Comparison of changes in IMCY-0098 specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.'}], 'primaryOutcomes': [{'measure': 'Incidence of all adverse events reported for subjects', 'timeFrame': 'up to 24 weeks', 'description': 'Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 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': 'up to 24 weeks', 'description': 'Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and glucose levels and excursions from baseline and between groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus type 1', 'Autoimmune disease', 'Immunotherapy', 'Diabetes treatment', 'Residual beta cell function', 'Adult patients'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23056200', 'type': 'BACKGROUND', 'citation': 'Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.'}, {'pmid': '26388872', 'type': 'BACKGROUND', 'citation': 'Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015.'}, {'pmid': '26973647', 'type': 'BACKGROUND', 'citation': 'Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016.'}, {'pmid': '38902652', 'type': 'DERIVED', 'citation': 'Van Rampelbergh J, Achenbach P, Leslie RD, Kindermans M, Parmentier F, Carlier V, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes: an exploratory analysis of immune biomarkers. BMC Med. 2024 Jun 21;22(1):259. doi: 10.1186/s12916-024-03476-y.'}, {'pmid': '37226224', 'type': 'DERIVED', 'citation': 'Van Rampelbergh J, Achenbach P, Leslie RD, Ali MA, Dayan C, Keymeulen B, Owen KR, Kindermans M, Parmentier F, Carlier V, Ahangarani RR, Gebruers E, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes. BMC Med. 2023 May 24;21(1):190. doi: 10.1186/s12916-023-02900-z.'}], 'seeAlsoLinks': [{'url': 'http://www.bdronline.be/index.php?n=169&id=267&sid=267&taal=F&mnav=2', 'label': 'Registre belge du diabète'}, {'url': 'http://www.bdronline.be/index.php?n=164&id=265&sid=265&taal=N&mnav=2', 'label': 'Belgisch diabetes register'}, {'url': 'http://www.address2.org/t1d-studies/', 'label': 'Research study for people with Type 1 Diabetes: EXALT'}]}, 'descriptionModule': {'briefSummary': 'This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female 18 to 30 years of age\n2. Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months\n3. Insulin requirement, as determined by the investigator\n4. Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)\n5. Fasting C-peptide at screening \\>0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.\n6. HLADR3-positive and/or HLADR4-positive\n7. Willingness to undergo the insulin treatment prescribed by the physician\n8. Body mass index (BMI) between 17-28 kg/m2 at screening\n9. Fully informed written consent obtained\n10. Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.\n11. Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.\n\nExclusion Criteria:\n\n1. Ongoing or planned pregnancy during the whole duration of the study or lactation\n2. Presence of significant medical conditions in particular chronic liver condition, chronic hematological disease, renal dysfunction of grade 2 or more according to the World Health Organization (WHO) Toxicity Scale .\n3. Has any current signs or symptoms of infection at entry or within 2 weeks of entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product\n4. Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (i.e. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin \\[BCG\\] vaccine, oral typhoid vaccine)\n5. History of, or current malignancy (except excised basal cell skin cancer)\n6. Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study\n7. Primary or secondary immune deficiency disorders\n8. Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n9. Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale\n10. Anti-diabetic treatments other than insulin in the week prior to first study drug administration\n11. Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.\n12. Treatment with immunotherapy within the past 3 months\n13. Treatment with an investigational drug within the past 3 months\n14. Patients with a known hypersensitivity to any component of the drug product should be excluded from the study\n15. Patients under treatment with statins at the time of screening."}, 'identificationModule': {'nctId': 'NCT03272269', 'briefTitle': 'Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imcyse SA'}, 'officialTitle': "A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes", 'orgStudyIdInfo': {'id': 'IMCY-T1D-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1, low dose', 'description': '4 SC injections of IMCY-0098 or Placebo', 'interventionNames': ['Drug: IMCY-0098', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, medium dose', 'description': '4 SC injections of IMCY-0098 or Placebo', 'interventionNames': ['Drug: IMCY-0098', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, high dose', 'description': '4 SC injections of IMCY-0098 or Placebo', 'interventionNames': ['Drug: IMCY-0098', 'Other: Placebo']}], 'interventions': [{'name': 'IMCY-0098', 'type': 'DRUG', 'otherNames': ['Imotope'], 'description': 'Small synthetic peptide for SC admin. Solvent: alum hydroxide', 'armGroupLabels': ['Cohort 1, low dose', 'Cohort 2, medium dose', 'Cohort 3, high dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Solvent: alum hydroxide', 'armGroupLabels': ['Cohort 1, low dose', 'Cohort 2, medium dose', 'Cohort 3, high dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg and Frederiksberg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes, Hôpital Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'GWT-TUD GmbH', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'Klaipeda University Hospital', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'University Hospital Santaros Klinikos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Clinical Trial Center, CTC', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'ProbarE Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Cardiff University', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter NHS Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St. Thomas NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. Bartholomew's Hospital (Barts Health NHS Trust)", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Pierre Vandepapelière, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Imcyse SA'}, {'name': 'Christian Boitard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Cochin, Paris, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imcyse SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}