Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-03-09 @ 4:28 AM
Study NCT ID:
NCT03837093
Status:
COMPLETED
Last Update Posted:
2021-12-30
First Post:
2019-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of Tregs(in (expressed in % of CD4 and total)', 'timeFrame': 'from Day 1 to Day 5'}], 'secondaryOutcomes': [{'measure': 'AUC corresponding to the évolution of residual values of tregs/CD4+', 'timeFrame': 'Day 5 to Day 60'}, {'measure': 'numbers of different circulating immune populations', 'timeFrame': 'baseline to Day 60'}, {'measure': 'levels of serum cytokine(pg)', 'timeFrame': 'from baseline to Day 60'}, {'measure': 'levels of serum chemokine', 'timeFrame': 'from baseline to Day 60'}, {'measure': 'composition of the intestinal microbiota', 'timeFrame': 'from baseline to Day 60'}, {'measure': 'adverse events, anti IL-2 autoantibodies', 'timeFrame': 'from baseline to Day 60'}, {'measure': 'levels of serum anti-IL-2 autoantibodies', 'timeFrame': 'from baseline to Day 60'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low dose of IL-2', 'Healthy volunteers', 'Kinetic study'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.', 'detailedDescription': 'In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs) and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID).\n\nThe existence of an AID indicates a lack of Tregs. Our team has discovered that low-dose interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may improve AID. Exploiting this potential requires i) to better target the dose with the best benefit / risk ratio and also ii) to better understand the mechanism of action of this molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes, multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very thorough immunological follow-up is carried out in order to discover biomarkers of treatment efficacy. Exploitation of these results will benefit both the cross-analysis of the effects of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it possible to define the most effective dose of IL-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Without any chronic diseases diagnosed (including allergies);\n* Effective contraception\\> 2 weeks before the first administration of the experimental drug or its placebo and β-hCG negative at the verification of the selection criteria;\n* Affiliated to a social security system;\n* Free, informed and written consent, signed by the subject and the investigator, before any action required by the research.\n* Not taking any treatment\n\nExclusion Criteria:\n\n* Subject in a period of exclusion of participation in other biomedical research;\n* Participation in another research ≤ 1 month and during the study except for research Transimmunom (Non-interventional research involving the human person);\n* known antecedents of autoimmune diseases;\n* Hypersensitivity to any of the excipients of the investigational drug (mannitol, sodium laurilsulfate, monosodium phosphate dihydrate, disodium phosphate dihydrate);\n* Evolutionary infection requiring treatment;\n* Viral infection and benign infection less than 2 months old;\n* Venous capital not allowing blood samples;\n* Pregnant or lactating women;\n* Men and women of childbearing potential without effective contraception during the study;\n* Live attenuated virus vaccination in the month prior to inclusion or during the study;\n* Surgical intervention ≤ 2 months or planned during the study;\n* Psychiatric pathology or drug addiction that may impair ability to comply with protocol requirements or give informed consent;\n* Presence or history of cancer that has not been cured for less than 5 years, except in situ cervical cancer, or basocellular cancer;\n* Subject under a legal protection measure.'}, 'identificationModule': {'nctId': 'NCT03837093', 'acronym': 'HEALTHIL-2', 'briefTitle': 'Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Study of the Dose-response Relationship of Low-dose IL-2 to the Kinetics of Regulatory T-cell Response in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'APHP180274'}, 'secondaryIdInfos': [{'id': '2018-004123-37', 'type': 'EUDRACT_NUMBER'}, {'id': 'MEDAECNAT-2018-11-0048', 'type': 'OTHER', 'domain': 'ANSM'}, {'id': '2-17-33', 'type': 'OTHER', 'domain': 'CPP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose A', 'description': 'ILT-101', 'interventionNames': ['Drug: ILT101']}, {'type': 'EXPERIMENTAL', 'label': 'dose B', 'description': 'ILT-101', 'interventionNames': ['Drug: ILT101']}, {'type': 'EXPERIMENTAL', 'label': 'dose C', 'description': 'ILT-101', 'interventionNames': ['Drug: ILT101']}, {'type': 'EXPERIMENTAL', 'label': 'dose D', 'description': 'ILT-101', 'interventionNames': ['Drug: ILT101']}, {'type': 'EXPERIMENTAL', 'label': 'dose E', 'description': 'ILT-101', 'interventionNames': ['Drug: ILT101']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ILT101', 'type': 'DRUG', 'otherNames': ['low-dose IL-2'], 'description': 'Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks', 'armGroupLabels': ['dose A', 'dose B', 'dose C', 'dose D', 'dose E']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': "Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'David Klatzmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Investigation Center in Biotherapy et immunology Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris l'hopital 75013 Paris"}, {'name': 'Roberta Lorenzon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iltoo Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}