Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT06744920
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722911', 'term': 'remibrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2033-02-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score', 'timeFrame': 'Baseline to Month 6', 'description': "The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG.\n\nEach item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24)."}], 'secondaryOutcomes': [{'measure': 'Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score', 'timeFrame': 'Baseline to Month 6', 'description': 'The Quantitative Myasthenia Gravis (QMG) Score is a 13-item direct physician assessment scoring system that quantifies disease severity, based on impairments of body functions and structures. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity. The QMG score is composed of the following items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item) and respiratory (1 item).'}, {'measure': 'Proportion of participants with ≥ 5 points reduction from baseline to Month 6 of QMG total score without rescue medication and/or strongly confounding prohibited medication', 'timeFrame': 'Baseline to Month 6', 'description': 'The Quantitative Myasthenia Gravis (QMG) Score is a 13-item direct physician assessment scoring system that quantifies disease severity, based on impairments of body functions and structures. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity. The QMG score is composed of the following items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item) and respiratory (1 item).'}, {'measure': 'Proportion of participants with ≥ 3 points reduction from baseline to Month 6 of Myasthenia Gravis Activity of Daily Living (MG-ADL) scale total score without rescue medication and/or strongly confounding prohibited medication', 'timeFrame': 'Baseline to Month 6', 'description': "The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG.\n\nEach item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24)."}, {'measure': 'Proportion of participants achieving Minimal Symptom Expression (MSE) at Month 6, defined as MG-ADL score of 0 or 1 at Month 6 without rescue therapy and/or strongly confounding prohibited medication', 'timeFrame': 'Month 6', 'description': "The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG.\n\nEach item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24)."}, {'measure': 'Change from baseline to Month 6 in Myasthenia Gravis Composite score (MGC) total score', 'timeFrame': 'Baseline to Month 6', 'description': 'The MGC is a 10-item instrument that measures the symptoms and signs of MG based on physician examination and patient history. Items relate to ptosis, double vision, eye closure, talking, chewing, swallowing, breathing, neck flexion, shoulder abduction, and hip flexion. Each item is scored on an ordinal scale with 4 possible categories and weighted. The total score ranges from 0 to 50, where higher scores indicating more severe impairments.'}, {'measure': 'Change from baseline to Month 6 in revised Myasthenia Gravis Quality of Life Questionnaire (MG-QOL15r) survey score', 'timeFrame': 'Baseline to Month 6', 'description': 'The revised MG-QoL15 is a 15-item health related quality of life questionnaire completed by participants, designed to measure quality of life in gMG. Items on the MG-QoL15 relate to physical, social, and psychological components and are scored from 0 (not at all) to 2 (very much). The cumulative scores range from 0 to 30, with higher scores representing worse quality of life and dissatisfaction with MG-related dysfunction.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Baseline to Month 6', 'description': 'Incidence of adverse events including changes in clinical laboratory values, vital signs, electrocardiograms and suicidality results qualifying and reported as AEs.'}, {'measure': 'Proportion of time during which participants showed a reduction of ≥ 2 points in MG-ADL total score, that was maintained up to Month 6', 'timeFrame': 'Baseline to Month 6', 'description': "The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24)."}, {'measure': 'Proportion of early MG-ADL responders during treatment (early responders with first MG-ADL improvement from baseline of ≥ 2 points occurring by week 4）', 'timeFrame': 'Baseline to week 4', 'description': "The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24). Participants with a first MG-ADL improvement from baseline of ≥ 2 points occurring by week 4 are considered early responders."}, {'measure': 'Change from baseline to Month 6 in EuroQol-5 Dimensions-5 Level (EQ-5D-5L)', 'timeFrame': 'Baseline to Month 6', 'description': 'The EQ-5D-5L is a widely used questionnaire designed to assess health status in adults. The measure is divided into two distinct sections, the descriptive system and the EQ visual analogue scale (EQ VAS). The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Participants rate each of these items from 1 of the 5 levels: no problems, slight problems, moderate problems, severe problems, or unable to/extreme. A composite health state is then defined by combining the levels for each dimension into a 5-digit number. The second section includes the EQ visual analogue scale (EQ VAS) that measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the "best imaginable health state" and 0 represents the "worst imaginable health state." Respondents are asked to rate their current health by placing a mark along this continuum.'}, {'measure': 'Proportion of participants achieving a reduction from baseline of ≥ 3 points in MGC total score at Month 6', 'timeFrame': 'Baseline to Month 6', 'description': 'The MGC is a 10-item instrument that measures the symptoms and signs of MG based on physician examination and patient history. Items relate to ptosis, double vision, eye closure, talking, chewing, swallowing, breathing, neck flexion, shoulder abduction, and hip flexion. Each item is scored on an ordinal scale with 4 possible categories and weighted. The total score ranges from 0 to 50, where higher scores indicating more severe impairments.'}, {'measure': 'Change from baseline in MG-ADL total score', 'timeFrame': 'Baseline to Month 66', 'description': "The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24)."}, {'measure': 'Proportion of participants achieving a reduction from core part in oral corticosteroids (OCS) dose till the end of extension part', 'timeFrame': 'Baseline to month 66', 'description': 'Participants receiving oral corticosteroids are required to be on a stable dose for at least 4 weeks prior to baseline. The dose can be reduced or discontinued during the open label extension period at investigator discretion. Oral corticosteroids use will be recorded.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Month 7 to month 66', 'description': 'Incidence of adverse events including changes in clinical laboratory values, vital signs, electrocardiograms and suicidality results qualifying and reported as AEs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'gMG', 'Generalized Myasthenia Gravis', 'LOU064', 'Remibrutinib', 'placebo-controlled', 'double-blind', 'phase III'], 'conditions': ['Generalized Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.', 'detailedDescription': 'This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo.\n\nThe study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with gMG (age 18-75 years)\n* Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the duration of the study, as judged by the Investigator\n* Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening\n* Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms\n* Participants who have been on a stable dose of standard-of-care treatment as specified in the protocol\n* Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline\n\nExclusion Criteria:\n\n* Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06744920', 'acronym': 'RELIEVE', 'briefTitle': 'A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase', 'orgStudyIdInfo': {'id': 'CLOU064O12301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remibrutinib arm', 'description': 'Core Part: Remibrutinib tablet taken orally\n\n\\[Extension Part: Open-label remibrutinib tablet taken orally\\]', 'interventionNames': ['Drug: Remibrutinib (Blinded)', 'Drug: Remibrutinib (Open Label)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Core Part: Placebo tablet taken orally\n\n\\[Extension Part: Open-label remibrutinib tablet taken orally\\]', 'interventionNames': ['Other: Placebo', 'Drug: Remibrutinib (Open Label)']}], 'interventions': [{'name': 'Remibrutinib (Blinded)', 'type': 'DRUG', 'otherNames': ['LOU64'], 'description': 'Remibrutinib (Blinded) active treatment', 'armGroupLabels': ['Remibrutinib arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo arm']}, {'name': 'Remibrutinib (Open Label)', 'type': 'DRUG', 'otherNames': ['LOU064'], 'description': 'Remibrutinib (Open Label) active treatment', 'armGroupLabels': ['Placebo arm', 'Remibrutinib arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucia Rodriguez', 'role': 'CONTACT', 'email': 'nrsresearch@nrcaz.com'}, {'name': 'Kumaraswamy Sivakumar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neuromuscular Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristy Osgood', 'role': 'CONTACT', 'email': 'kosgood@honorhealth.com', 'phone': '480-323-3990'}, {'name': 'Anne Hatch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Honor Health Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexandra Vasquez', 'role': 'CONTACT', 'email': 'avasquez@fullertonneuro.net', 'phone': '714-738-0800'}, {'name': 'Jack H Florin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fullerton Neuro and Headache Ctr', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nasrin Ahmed', 'role': 'CONTACT', 'email': 'nasrin.ahmed@med.usc.edu', 'phone': '323-865-3900'}, {'name': 'Said R Beydoun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karina Bjazevic', 'role': 'CONTACT', 'email': 'kbjazevi@hs.uci.edu', 'phone': '714-456-2332'}, {'name': 'Ali Habib', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univ Cali Irvine ALS Neuromuscular', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabrielle Demaria', 'role': 'CONTACT', 'email': 'Gabrielle@sfmresearch.com', 'phone': '561-939-0300'}, {'name': 'Marc Feinberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SFM Clinical Research LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33033', 'city': 'Homestead', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daydene Ordaz', 'role': 'CONTACT', 'email': 'dordaz@associatesinresearch.com', 'phone': '305-246-0873'}, {'name': 'Christopher Jimenez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Homestead Assoc In Research Inc', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel Pierre Louis', 'role': 'CONTACT', 'email': 'samuel.pierrelouis@adventhealth.com', 'phone': '+1 407 303 6729'}, {'name': 'Anita Fletcher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AdventHealth', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tanya Palafox', 'role': 'CONTACT', 'email': 'tanya.nso@outlook.com', 'phone': '941-400-4578'}, {'name': 'Daniel H Jacobs', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurological Services of Orlando PA', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '20817-1807', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arkady Barber', 'role': 'CONTACT', 'email': 'barbera@epilepsydc.com'}, {'name': 'Jonathan Ross', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mid Atlantic Epilepsy and Sleep Ctr', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aubrey Alexander', 'role': 'CONTACT', 'email': 'alexaub@msu.edu'}, {'name': 'Amit Sachdev', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Michigan State University-Department of Neurology', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Mattle', 'role': 'CONTACT', 'email': 'amattle@dentinstitute.com', 'phone': '716-887-4799'}, {'name': 'Bennett Myers', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dent Neurological Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaiya Payne', 'role': 'CONTACT', 'email': 'payne2ka@ucmail.uc.edu', 'phone': '513-475-8730'}, {'name': 'Hani Kushlaf', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univ of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Delrose Vernon', 'role': 'CONTACT', 'email': 'davernon@houstonmethodist.org', 'phone': '713-441-9484'}, {'name': 'Ericka Greene', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaycie Opiyo', 'role': 'CONTACT', 'email': 'tkaycie@uw.edu', 'phone': '206-685-1048'}, {'name': 'Barbara Jane Distad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of WA Division of Cardio', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53228-1321', 'city': 'Greenfield', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Barraza', 'role': 'CONTACT', 'email': 'Emily.barraza@cndmilwaukee.com'}, {'name': 'Bhupendra Khatri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Neurological Disorders G', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '4215', 'city': 'Southport', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '510030', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '50030', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '214023', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '06001', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '4600', 'city': 'Kutaisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.26791, 'lon': 42.69459}}, {'zip': '575002', 'city': 'Mangalore', 'state': 'Karnataka', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '422005', 'city': 'Nashik', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '141001', 'city': 'Ludhiana', 'state': 'Punjab', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '632 004', 'city': 'Vellore', 'state': 'Tamil Nadu', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '608543', 'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '630005', 'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '663 8501', 'city': 'Nishinomiya', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'zip': '025-0082', 'city': 'Hanamaki', 'state': 'Iwate', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.38333, 'lon': 141.11667}}, {'zip': '983 8520', 'city': 'Sendai', 'state': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '565 0871', 'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '355-0005', 'city': 'Higashi-Matsuyama', 'state': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.03333, 'lon': 139.41667}}, {'zip': '343-8555', 'city': 'Koshigaya', 'state': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'zip': '160-0023', 'city': 'Shinjuku Ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '260 8677', 'city': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '960 1295', 'city': 'Fukushima', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '7348551', 'city': 'Hiroshima', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '20-064', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '20-080', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '31-505', 'city': 'Krakow', 'state': 'POL', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '85-796', 'city': 'Bydgoszcz', 'state': 'Woj Kujawsko Pomorskie', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '85-065', 'city': 'Bydgoszcz', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '40-689', 'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '20-410', 'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '61-731', 'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '60-185', 'city': 'Skorzewo', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.16909, 'lon': 17.97006}}, {'zip': '01-684', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02 106', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '500283', 'city': 'Brasov', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '040215', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '550245', 'city': 'Sibiu', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '49241', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134 727', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '25198', 'city': 'Lleida', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28034', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '83301', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '70403', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '111045', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '33305', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], '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. This 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'}}}}