Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-07 @ 7:20 AM
Study NCT ID:
NCT02398461
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2015-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2015-03-13', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs)', 'timeFrame': 'Up to 180 days', 'description': 'Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).'}], 'secondaryOutcomes': [{'measure': 'Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22', 'timeFrame': 'Pre-dose (day 1), specified time points up to 48 hours post treatment'}, {'measure': 'Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22', 'timeFrame': 'Pre-dose (day 1), specified time points up to 48 hours post treatment'}, {'measure': 'Half-life (T1/2) of single ascending doses of rHIgM22', 'timeFrame': 'Pre-dose (day 1), specified time points up to 48 hours post treatment'}, {'measure': 'Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22', 'timeFrame': 'Pre-dose (day 1), specified time points up to 48 hours post treatment'}, {'measure': 'Immunogenicity profile of single ascending doses of rHIgM22', 'timeFrame': 'Specified time points up to 180 days post treatment', 'description': 'Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.'}, {'measure': 'The Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Screening, specified time points up to 180 days post treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Acute Relapsing']}, 'referencesModule': {'references': [{'pmid': '35496758', 'type': 'DERIVED', 'citation': 'Greenberg BM, Bowen JD, Alvarez E, Rodriguez M, Caggiano AO, Warrington AE, Zhao P, Eisen A. A double-blind, placebo-controlled, single-ascending-dose intravenous infusion study of rHIgM22 in subjects with multiple sclerosis immediately following a relapse. Mult Scler J Exp Transl Clin. 2022 Apr 26;8(2):20552173221091475. doi: 10.1177/20552173221091475. eCollection 2022 Apr-Jun.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females (18-70 years of age; \\< 104 kg)\n* Capable of giving informed consent\n* Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria\n* Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator\n* Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.\n\nExclusion Criteria:\n\n* Certain specified co-morbidities (including pregnancy)\n* Taking certain proscribed medications\n* A medical regimen that has changed in the month prior to screening\n* Inability to undergo requisite MRI evaluations\n* Drug or alcohol abuse\n* Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT02398461', 'briefTitle': 'An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acorda Therapeutics'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse', 'orgStudyIdInfo': {'id': 'IM22-MS-1033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rHIgM22', 'description': 'Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).', 'interventionNames': ['Drug: rHIgM22']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'rHIgM22', 'type': 'DRUG', 'otherNames': ['M22'], 'description': 'Administered via IV infusion', 'armGroupLabels': ['rHIgM22']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Acorda Site #12', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Acorda Site #3', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Acorda Site #7', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Acorda Site #11', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Acorda Site #16', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acorda Site #22', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Acorda Site #14', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Acorda Site #19', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Acorda Site #10', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '75390-8508', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Acorda Site #18', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Acorda Site #2', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Acorda Site #6', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acorda Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PRA Health Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}