Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT03515304
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2018-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evolocumab in Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
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'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent non-ST elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient myocardial ischemia prompting hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for planned vascular surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemic attack, slurred speech', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change 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(ml) by echocardiography', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Ejection Fraction as Assessed by Echocardiography', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Evaluation of ejection fraction (%) by echocardiography', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in PCSK9 serum levels', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Soluble Lectin-like Oxidized Low-density Lipoprotein Receptor-1 (LOX-1)', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in plasma soluble lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) (pg/ml)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evolocumab', 'description': '420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.\n\nEvolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.\n\nPlacebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.134705882', 'spread': '8.448074995', 'groupId': 'OG000'}, {'value': '3.708333333', 'spread': '10.05850912', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2497', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to day 30', 'description': 'Target artery to background ratio endpoint (standardized uptake value) for left carotid artery', 'unitOfMeasure': 'SUV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with PET data collected and adequate image quality for analysis'}, {'type': 'SECONDARY', 'title': 'Change in New York Heart Association (NYHA) Class', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Assess NYHA class I-IV', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in hs-CRP serum levels (mg/L)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Tumor Necrosis Factor (TNF)-Alpha Serum Levels', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in TNF-alpha serum levels (pg/mL)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Levels of Interleukin 1', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in serum levels of Interleukin 1 (pg/mL)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Serum Levels of Interleukin 6', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change in baseline in serum levels of Interleukin 6 (pg/mL)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Serum Levels of Interleukin 10', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change in baseline in serum levels of Interleukin 10 (pg/mL)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Canadian Angina Class', 'timeFrame': 'Baseline, 30 days, 6 months', 'description': 'Assess Canadian Angina Classification, I-IV', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Evolocumab', 'description': '420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.\n\nEvolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.\n\nPlacebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'placebo group'}, {'id': 'BG001', 'title': 'Evolocumab', 'description': 'evolocumab group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '60.1', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-05', 'size': 367542, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-04T16:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Persons performing the PET imaging, laboratory technicians are all masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, placebo controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2018-04-10', 'resultsFirstSubmitDate': '2025-10-24', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-12', 'studyFirstPostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in LDL-Cholesterol', 'timeFrame': 'Baseline to 30 days'}, {'measure': 'Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans', 'timeFrame': 'Baseline to 30 days', 'description': 'PET Imaging for Inflammation: Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium.'}], 'secondaryOutcomes': [{'measure': 'Change in Left Ventricular Volume as Assessed by Echocardiography', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Evaluation of left ventricular volume (ml) by echocardiography'}, {'measure': 'Change in Ejection Fraction as Assessed by Echocardiography', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Evaluation of ejection fraction (%) by echocardiography'}, {'measure': 'Change in Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in PCSK9 serum levels'}, {'measure': 'Change in Plasma Soluble Lectin-like Oxidized Low-density Lipoprotein Receptor-1 (LOX-1)', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in plasma soluble lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) (pg/ml)'}, {'measure': 'PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)', 'timeFrame': 'Baseline to day 30', 'description': 'Target artery to background ratio endpoint (standardized uptake value) for left carotid artery'}, {'measure': 'Change in New York Heart Association (NYHA) Class', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Assess NYHA class I-IV'}, {'measure': 'Change in High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in hs-CRP serum levels (mg/L)'}, {'measure': 'Change in Tumor Necrosis Factor (TNF)-Alpha Serum Levels', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in TNF-alpha serum levels (pg/mL)'}, {'measure': 'Change in Plasma Levels of Interleukin 1', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change from baseline in serum levels of Interleukin 1 (pg/mL)'}, {'measure': 'Change in Serum Levels of Interleukin 6', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change in baseline in serum levels of Interleukin 6 (pg/mL)'}, {'measure': 'Change in Serum Levels of Interleukin 10', 'timeFrame': 'Baseline, day 30 and 6 months', 'description': 'Change in baseline in serum levels of Interleukin 10 (pg/mL)'}, {'measure': 'Change in Canadian Angina Class', 'timeFrame': 'Baseline, 30 days, 6 months', 'description': 'Assess Canadian Angina Classification, I-IV'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '35314069', 'type': 'DERIVED', 'citation': 'Vavuranakis MA, Jones SR, Ziogos E, Blaha MJ, Williams MS, Foran P, Schindler TH, Lai S, Schulman SP, Gerstenblith G, Leucker TM. The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition. Am J Cardiol. 2022 May 15;171:1-6. doi: 10.1016/j.amjcard.2022.01.058. Epub 2022 Mar 21.'}]}, 'descriptionModule': {'briefSummary': "Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.", 'detailedDescription': 'In a placebo-controlled, randomized double blind trial, the addition of evolocumab to standard care in NSTEMI patients (1) decreases LDL-C during hospitalization and at 30 days, (2) decreases vascular/plaque and myocardial inflammation as assessed by Positron Emission Tomography (PET) scanning at 30 days, and improves (3) serum markers of endothelial function at hospital discharge and at 30 days, and (4) echocardiographic assessment of left ventricular function at 30 days and six months.\n\nThis is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population. It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation, all of which may significantly impact important clinical outcomes in this high risk patient cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non ST segment elevation myocardial infarction\n* Troponin I \\>/ 5.0 ng/dL\n* Permission of attending physician\n\nExclusion Criteria:\n\n* ST elevation myocardial infarction\n* Patients requiring invasive hemodynamic support\n* Scheduled for cardiac surgery\n* Current or prior treatment with a PCSK9 antibody\n* Current participation in an intervention clinical trial\n* Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening\n* Contraindication to statin therapy\n* Subject likely not able to complete protocol related visits or procedures\n* Latex allergy\n* History of hypersensitivity to any monoclonal antibody'}, 'identificationModule': {'nctId': 'NCT03515304', 'acronym': 'EVACS', 'briefTitle': 'Evolocumab in Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study', 'orgStudyIdInfo': {'id': 'IRB00156313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evolocumab', 'description': '420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.', 'interventionNames': ['Drug: Evolocumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Evolocumab', 'type': 'DRUG', 'otherNames': ['Repatha'], 'description': '420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.', 'armGroupLabels': ['Evolocumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21136', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Steven Paul Schulman', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Thorsten M Leucker, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}