Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 8:18 AM
Study NCT ID:
NCT03243058
Status:
WITHDRAWN
Last Update Posted:
2024-05-22
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose IL-2 in Established T1D - The "PROREG" Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The randomization will be performed by the Coordinating Center at the University of Miami. The participants will not be informed regarding the intervention assignment until the end of the study. The investigators and clinic personnel will also be masked as to study assignment. Laboratories performing assays for this protocol will be masked as to the identity and group assignment of biological materials to be studied.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'ILT-101 (aldesleukin; Interleukin-2, IL-2), 0.5 million IU (body surface area \\<2 m2) or 1 million IU (body surface area \\>2 m2), or placebo, will be given for 5 consecutive days (days 1-5), and then on day 15 and every 15 days thereafter, for one year; at the one-year endpoint, approximately half the subjects on ILT-101 will continue therapy and the other half will switch to placebo for 1 more year.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding withdrawal and COVID-19 environment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportions of regulatory T cells at (a) 1 year, (b) 2 years', 'timeFrame': '1 Year and 2 Years'}, {'measure': 'Changes in insulin requirements', 'timeFrame': '1 Year and 2 Years'}, {'measure': 'HbA1c level', 'timeFrame': '1 Year and 2 Years'}], 'primaryOutcomes': [{'measure': 'C-peptide response', 'timeFrame': '1 year primary outcome', 'description': 'Preservation of insulin secretion (measured as c-peptide nmol/L) based on stimulated area under the curve (AUC) during a 4-hour MMTT at 1 year'}], 'secondaryOutcomes': [{'measure': 'C-peptide response', 'timeFrame': '2 year secondary outcome', 'description': 'Preservation of insulin secretion (measured as c-peptide nmol/L) based on stimulated area under the curve (AUC) during a 4-hour MMTT at 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Type 1 Diabetes', 'Autoimmune', 'Diabetes, Autoimmune', 'Interleukin-2', 'Interleukin', 'IL-2'], 'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes', 'Diabetes, Autoimmune']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.', 'detailedDescription': 'Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.\n\nPatients will be treated with ILT-101 or placebo. ILT-101 will be given at doses of 0.5 million IU (body surface area \\<2 m2) or 1 million IU (body surface area \\>2 m2), via subcutaneous (s.c.) injections. Patients will receive a course of 5 daily injections (days 1-5. Starting on day 15, patients will receive an s.c. injection (same dose) every 15 days for 1 year. Thus, patients will receive 29 injections during the first year of treatment. At the end of the first year, approximately half of those randomized to ILT-101 will continue receiving treatment every 15 days, until the end of the second year (23 doses). The other half will stop therapy and will be switched to a placebo.\n\nA group of patients will be randomly assigned to a placebo for the duration of the study. Patients to be included in this study are those diagnosed with T1D who would have had T1D from 4 months to 1 year at the time of randomization, who have a current or past demonstration of autoimmunity (using autoantibodies), and maintain preserved β-cell function, defined as an MMTT stimulated C-peptide \\>0.2 nmol/L. This population is chosen because it will extend the scope of therapy beyond the immediate time following diagnosis when most previous studies of immunotherapy in T1D have been conducted. This trial can further impact the field if a therapeutic benefit is shown when the disease is more established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8-21 years of age\n* T1D, demonstrated by at least one islet autoantibody\n* T1D duration 4-12 months at the time of the first dose\n* Peak stimulated C-peptide \\>0.2 nmol/L during a 4-hour MMTT\n\nExclusion Criteria:\n\n* Treatment with oral anti-diabetic agents\n* Illnesses that would preclude use of low-dose IL-2'}, 'identificationModule': {'nctId': 'NCT03243058', 'briefTitle': 'Low-dose IL-2 in Established T1D - The "PROREG" Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'A Randomized, Double Blind, Phase I/II Trial of Low-Dose Interlekin-2 Immunotherapy in Established Type 1 Diabetes', 'orgStudyIdInfo': {'id': '20170301'}, 'secondaryIdInfos': [{'id': '20170301', 'type': 'OTHER', 'domain': 'University of Miami Central IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm', 'description': 'ILT-101 (Aldesleukin; IL-2), 0.5 million IU/m2 (up to a maximum of 1 million IU), or placebo, will be given for 5 consecutive days (days 1-5), and then on day 15 and every 15 days thereafter, for two years.', 'interventionNames': ['Biological: ILT-101 (Aldesleukin; IL-2)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment-Placebo Arm', 'description': 'Participants in this group will receive study drug ILT-101 for one year, and then placebo for the second year.', 'interventionNames': ['Biological: ILT-101 (Aldesleukin; IL-2)', 'Other: Treatment-Placebo Arm']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this group will receive a placebo injection for two years.', 'interventionNames': ['Other: Placebo Arm']}], 'interventions': [{'name': 'ILT-101 (Aldesleukin; IL-2)', 'type': 'BIOLOGICAL', 'otherNames': ['IL-2', 'Interleukin-2'], 'description': 'Administration of Low-Dose Interleukin-2 (ILT-101) for two years', 'armGroupLabels': ['Treatment Arm', 'Treatment-Placebo Arm']}, {'name': 'Treatment-Placebo Arm', 'type': 'OTHER', 'description': 'Administration of Low-Dose Interleukin-2 (ILT-101) for one year, and then placebo for the second year.', 'armGroupLabels': ['Treatment-Placebo Arm']}, {'name': 'Placebo Arm', 'type': 'OTHER', 'description': 'Participants in this group will receive a placebo injection for two years.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Diabetes Research Institute, University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Jay S Skyler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine'}, {'name': 'Alberto Pugliese, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine'}, {'name': 'David A Baidal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "A participant's privacy and confidentiality will be respected throughout the study. Each participant will be assigned a unique identification number and these numbers rather than names will be used to collect, store, and report participant information. Site personnel will not transmit documents containing personal health identifiers (PHI) to the study sponsor or their representatives."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jay S. Skyler', 'class': 'OTHER'}, 'collaborators': [{'name': 'Diabetes Research Institute Foundation', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Jay S. Skyler', 'investigatorAffiliation': 'University of Miami'}}}}