Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-06 @ 3:11 AM
Study NCT ID:
NCT02173392
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Sponsor:
Organization:
Raw JSON
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Pre-filled Syringes \\[1.0mL + 0.5mL, treatment A Days 29-56)\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases', 'otherNumAtRisk': 141, 'otherNumAffected': 41, 'seriousNumAtRisk': 141, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '(Treatment B Days 1-28 + Treatment A Days 29-56)', 'description': '210 mg SC Brodalumab (2 Pre-filled Syringes \\[1.0mL + 0.5mL, Treatment B Days 1-28\\])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases', 'otherNumAtRisk': 131, 'otherNumAffected': 39, 'seriousNumAtRisk': 131, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe)', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}, {'id': 'OG001', 'title': 'Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '7.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection', 'unitOfMeasure': 'milligrams per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two'}, {'type': 'PRIMARY', 'title': 'Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brodalumab (Single 1.5mL Pre-filled Syringe)', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}, {'id': 'OG001', 'title': 'Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '69', 'groupId': 'OG000'}, {'value': '149', 'spread': '81.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection', 'unitOfMeasure': '(day*mg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed'}, {'type': 'SECONDARY', 'title': 'Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brodalumab (Single 1.5mL Pre-filled Syringe)', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}, {'id': 'OG001', 'title': 'Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL])', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'Presence of binding or neutralizing anti-brodalumab antibodies', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '(Treatment A Day 1-28 + Treatment B Day 29-56)', 'description': '210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes \\[1.0mL + 0.5mL, treatment A Days 29-56)\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}, {'id': 'FG001', 'title': '(Treatment B Days 1-28 + Treatment A Days 29-56)', 'description': '210 mg SC Brodalumab (2 Pre-filled Syringes \\[1.0mL + 0.5mL, Treatment B Days 1-28\\])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '(Treatment A Day 1-28 + Treatment B Day 29-56)', 'description': '210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes \\[1.0mL + 0.5mL, treatment A Days 29-56)\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}, {'id': 'BG001', 'title': '(Treatment B Days 1-28 + Treatment 8 Days 29-56)', 'description': '210 mg SC Brodalumab (2 Pre-filled Syringes \\[1.0mL + 0.5mL, Treatment B Days 1-28\\])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)\n\nBrodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '40.8', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2014-06-13', 'resultsFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-06', 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.', 'timeFrame': '60 days', 'description': 'Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection'}, {'measure': 'Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab', 'timeFrame': '60 days', 'description': 'Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': '60 days', 'description': 'Presence of binding or neutralizing anti-brodalumab antibodies'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab', 'detailedDescription': 'A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females must be of non-reproductive potential\n\nExclusion Criteria:\n\n* no history or evidence of clinically significant disorder that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.'}, 'identificationModule': {'nctId': 'NCT02173392', 'briefTitle': 'A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Bioequivalence Study Comparing a Single Subcutaneous Injection With a 1.5 mL Prefilled Syringe Versus 2 Subcutaneous Injections of 1 mL and 0.5 mL Prefilled Syringes of Brodalumab 140 mg/mL to Healthy Subjects', 'orgStudyIdInfo': {'id': '20130307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brodalumab (single 1.5mL pre-filled syringe)', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection', 'interventionNames': ['Drug: Brodalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Brodalumab (2 pre-filled syringes [1.0mL + 0.5mL])', 'description': 'A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections', 'interventionNames': ['Drug: Brodalumab']}], 'interventions': [{'name': 'Brodalumab', 'type': 'DRUG', 'description': 'Brodalumab is a large molecule for the treatment of inflammatory diseases', 'armGroupLabels': ['Brodalumab (2 pre-filled syringes [1.0mL + 0.5mL])', 'Brodalumab (single 1.5mL pre-filled syringe)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}