Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT07138833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate at Week 48', 'timeFrame': '48 weeks', 'description': 'The primary efficacy endpoint is the annualized relapse rate (ARR), calculated as total relapses divided by total patient-years of observation, measured at Week 48'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsing Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy and safety\\] in \\[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).\n\nThe main questions it aims to answer are:\n\n\\[Question 1\\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\n\\[Question 2\\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\nParticipants will:\n\nEligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.\n\nThe annualized relapse rate (ARR) at Week 48 will be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)\n* At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening\n* Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening\n\nExclusion Criteria:\n\n* History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological \\[excluding multiple sclerosis\\]) that, in the investigator\'s assessment, pose a significant risk to the subject or could confound study results.\n* Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.\n* History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a "Yes" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring \\>5 years prior to screening require investigator assessment of eligibility.'}, 'identificationModule': {'nctId': 'NCT07138833', 'briefTitle': 'A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical (Hainan) Co., Ltd.'}, 'officialTitle': 'A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)', 'orgStudyIdInfo': {'id': 'QLG1031-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dimethyl Fumarate Group', 'interventionNames': ['Drug: Dimethyl Fumarate Enteric-coated Capsules']}], 'interventions': [{'name': 'Dimethyl Fumarate Enteric-coated Capsules', 'type': 'DRUG', 'description': 'Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks', 'armGroupLabels': ['Dimethyl Fumarate Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Junwei Hao, doctor', 'role': 'CONTACT', 'email': 'haojunwei@vip.163.com', 'phone': '010-83198082'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical (Hainan) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}