Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05777902
Status:
TERMINATED
Last Update Posted:
2025-01-15
First Post:
2023-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': "Sponsor's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.', 'timeFrame': '12 months', 'description': 'To evaluate the innate immune mediated inflammation in MS patients and to correlate it with the cognitive reserve and with serum NFL levels before and afterOzanimod treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration.\n\nPatients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.', 'detailedDescription': 'This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration.\n\nPatients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.\n\nThe primary objective of the study is to use this multidimensional integrated approach to verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.\n\nThe endpoint that relate to this objective is to evaluate the innate immune mediated inflammation in MS patients and to correlate it with the cognitive reserve and with serum NFL levels before and after Ozanimod treatment.\n\nPatients must meet all the following inclusion criteria to be eligible for enrolment into the study:\n\n1. Diagnosis of MS accordingly to 2017 revised McDonald criteria;\n2. Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.);\n3. Age between 18 and 45 years;\n4. EDSS score from 0 to 4;\n5. Signature and date of written ICF prior to entering the study;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Diagnosis of MS accordingly to 2017 revised McDonald criteria; 2) Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.); 3) Age between 18 and 45 years; 4) EDSS score from 0 to 4; 5) Signature and date of written ICF prior to entering the study;\n\nExclusion Criteria:\n\n* The presence of any of the following will exclude a patient from study enrolment:\n\n 1. Ongoing immunomodulatory or immunosuppressive treatment;\n 2. Other autoimmune comorbidities (i.e. antiphospolipid syndrome);\n 3. Treatment with steroids in the last 30 days before enrollment;\n 4. Acute inflammatory status not MS related (i.e. bacterial or viral infections) in the previous 30 days;\n 5. Patients unable to read and understand the documents of the study.\n 6. Participation in any interventional clinical trials or compassionate use programs\n 7. Contraindications and "not-recommendations" reported in SmP'}, 'identificationModule': {'nctId': 'NCT05777902', 'acronym': 'OMNIAOMS', 'briefTitle': 'Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.', 'organization': {'class': 'OTHER', 'fullName': 'I.R.C.C.S. Fondazione Santa Lucia'}, 'officialTitle': 'Multidimensional Integrated Assessment of Neurological and Immunological Patterns to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.', 'orgStudyIdInfo': {'id': 'EUDRACT 2021-005860-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient', 'interventionNames': ['Drug: Ozanimod Oral Capsule']}], 'interventions': [{'name': 'Ozanimod Oral Capsule', 'type': 'DRUG', 'otherNames': ['Zeposia'], 'description': "We propose to integrate measurements obtained using multiple tools. Patients will undergo MRI and hdEEG procedures, and blood samples will be obtained for the immunological and biochemical studies on the same day. The study of the immune system's status will include an extensive immunophenotypic analysis, a functional characterization following ex vivo stimulation of innate immune cells, and the measurement of soluble products in the serum, such as cytokines. Cellular traits of interest include the absolute numbers and relative proportions of specific cell subsets, transcriptional states, secretory functions, proliferative capacity or cytolytic potential. Specifically, the following antibody combination will constitute the core of the immunophenotypic analysis: HLADR CD11c, CD38, CD14, CD123, lineage (CD3, CD56, CD19).", 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00179', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'IRCCS Fondazione Santa Lucia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.R.C.C.S. Fondazione Santa Lucia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}