Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-26 @ 9:45 AM
Study NCT ID:
NCT07225504
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722911', 'term': 'remibrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind on Core part and Open label on Extension part'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1275}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05170724', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2034-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-11-04', 'studyFirstSubmitQcDate': '2025-11-04', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).\n\n6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.'}], 'secondaryOutcomes': [{'measure': 'Time to 3-month confirmed disability progression (3mCDP) on EDSS', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).\n\n3mCDP is defined as an increase from baseline in EDSS sustained for at least 3 months.'}, {'measure': 'Time to 6-month confirmed disability improvement (6mCDI) on EDSS', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)).\n\nA 6mCDI is defined as a decrease from baseline in EDSS sustained for at least 6 months.'}, {'measure': 'Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'The T25FW is an ambulation measurement assessing speed of walking: a timed (in seconds) walk of 25 feet (7.62 meters). Longer time indicates poorer lower limb function.\n\n3-month worsening by at least 20% in T25FW is defined as an increase from baseline in T25FW of at least 20% sustained for at least 3 months.'}, {'measure': 'Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'The 9-HPT is an objective quantitative test of neurological function. It is measured to assess both right and left arm scores, the metric is the time, in seconds, required to insert and remove 9 pegs. Longer time indicates poorer upper limb function.\n\nA 3-month worsening by at least 20% in 9-HPT is defined as an increase from baseline in 9-HPT of at least 20% sustained for at least 3 months'}, {'measure': 'Annualized rate of new or enlarging T2 lesions', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'Number of new or enlarging T2 lesions per year based on MRI'}, {'measure': 'Annualized rate of brain atrophy', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'Percentage change in brain volume relative to baseline per year based on MRI assessments'}, {'measure': 'Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'The SDMT is a sensitive and specific test to assess information processing speed which is typically affected in cognitively impaired MS participants, The test scoring is calculated based on the number of correct answers in 90 seconds.\n\nA 6-month worsening by at least 4 points in SDMT is defined as an increase from baseline in SDMT of at least 4 points sustained for at least 6 months.'}, {'measure': 'Number of participants with Adverse events and Serious adverse events (SAE)', 'timeFrame': 'From baseline up to approximately 5 years', 'description': 'Incidence of adverse events including changes in laboratory data, vital signs, electrocardiogram (ECG) and Columbia Suicide Severity Rating Scale (C-SSRS) qualifying and reported as AEs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MS', 'Multiple sclerosis', 'secondary progressive multiple sclerosis', 'SPMS', 'remibrutinib', 'LOU064', 'adult', 'Expanded Disability Status Scale', 'EDSS', 'McDonald diagnostic criteria'], 'conditions': ['Secondary Progressive Multiple Sclerosis (SPMS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)', 'detailedDescription': 'This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo.\n\nThe study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to any assessment performed.\n* Male or female participants aged 18-65 (inclusive) at Screening.\n* Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening.\n* Absence of documented clinical relapses in the 24 months before Screening and randomization.\n* EDSS score of 3.0 to 6.0 (inclusive) at Screening.\n* Documented evidence of disability progression in the 12 months before Screening.\n\nExclusion Criteria:\n\n* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).\n* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).\n* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.\n* Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \\< 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.\n* Significant bleeding risk or coagulation disorders, at Screening.\n* Use of exclusionary medication prior to Screening/randomization as listed in the protocol.\n\nOther protocol-defined inclusion/exclusion critria may apply"}, 'identificationModule': {'nctId': 'NCT07225504', 'acronym': 'REMASTER', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CLOU064P12301'}, 'secondaryIdInfos': [{'id': '2025-521546-23', 'type': 'OTHER', 'domain': 'EU Trial (CTIS) Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remibrutinib (LOU064)', 'description': 'Core Part: Remibrutinib film-coated tablet taken orally\n\n\\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\\]', 'interventionNames': ['Drug: Remibrutinib (blinded)', 'Drug: Remibrutinib (Open label)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Core Part: Matching placebo film-coated tablet taken orally\n\n\\[Extension Part: Open-label remibrutinib film-coated tablet taken orally\\]', 'interventionNames': ['Drug: Placebo', 'Drug: Remibrutinib (Open label)']}], 'interventions': [{'name': 'Remibrutinib (blinded)', 'type': 'DRUG', 'otherNames': ['LOU064'], 'description': 'Remibrutinib (Blinded) active treatment, oral tablet', 'armGroupLabels': ['Remibrutinib (LOU064)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo (binded), oral tablet', 'armGroupLabels': ['Placebo']}, {'name': 'Remibrutinib (Open label)', 'type': 'DRUG', 'otherNames': ['LOU064'], 'description': 'Remibrutinib (Open Label), oral tablet', 'armGroupLabels': ['Placebo', 'Remibrutinib (LOU064)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Virginia Weinacker', 'role': 'CONTACT', 'email': 'gweinacker@alaneuro.com', 'phone': '+1 205 803 2210'}, {'name': 'Emily Sherill Riser', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alabama Neurology Associates PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85037', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brandon McCravey', 'role': 'CONTACT', 'email': 'bmccravey@prcresearcheducation.com'}, {'name': 'Barry Hendin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ Integrated Neuro and Spine', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32714', 'city': 'Altamonte Springs', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adiana Perez', 'role': 'CONTACT', 'email': 'adiresearchcfl@gmail.com', 'phone': '407-790-4990'}, {'name': 'Alicia V Cabrera', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurology of Central FL Res Ctr', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charlene Carlo', 'role': 'CONTACT', 'email': 'Charlene.carlo@orlandohealth.com', 'phone': '321-841-3686'}, {'name': 'Amparo Gutierrez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orlando Health Clinical Trials', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Schutz', 'role': 'CONTACT', 'email': 'hschutz@naobresearch.com', 'phone': '386-676-6340'}, {'name': 'James Scott', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurology Associates of Ormond Beach', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ye Liu', 'role': 'CONTACT', 'email': 'yliu@neuroclinic.org', 'phone': '901-866-9252'}, {'name': 'Lee Stein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurology Clinic PC', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': 'G6W 0M5', 'city': 'Lévis', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '7661041', 'city': 'Rehovot', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '6423906', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '7030000', 'city': 'Ẕerifin', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '1-888-669-6682'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'phone': '+41613241111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}