Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-30 @ 6:10 PM
Study NCT ID:
NCT05528861
Status:
TERMINATED
Last Update Posted:
2024-09-27
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}], 'ancestors': [{'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'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': 'C000654568', 'term': 'AK002'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@allakos.com', 'phone': '650-597-5002', 'title': 'Medical Information', 'organization': 'Allakos'}, 'certainAgreement': {'otherDetails': 'Clinical Trial Agreement contains a limit on publication of results following completion of the trial. PIs are not allowed to publish results until a joint publication for the multicenter study or a set period of time. After that time, PIs may only publish results from their portion of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, up to 34 weeks (open-label extension period)', 'eventGroups': [{'id': 'EG000', 'title': 'AK002 SC 300 mg (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 26, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks in the main study.\n\nPlacebo: Placebo', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 18, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'AK002 Continuing (OLE)', 'description': 'Subjects in this arm received AK002 in the main study and continued to receive up to 6 doses of 300 mg AK002 SC in the open-label extension (OLE) period.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 22, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo Rollover (OLE)', 'description': 'Subjects in this arm received placebo in the main study and rolled over to receive up to 6 doses of 300 mg AK002 SC in the open-label extension (OLE) period.\n\nPlacebo: Placebo\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 19, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Injection related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Chronic spontaneous urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Epiglottitis obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AK002 SC 300 mg (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8'}, {'id': 'OG001', 'title': 'Placebo (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks in the main study.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8174', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '4.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (\\>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AK002 SC 300 mg (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8'}, {'id': 'OG001', 'title': 'Placebo (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks in the main study.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '2.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The severity of hives will be recorded by all subjects once daily on a scale of 0 (none) to 3 (\\> 50 hives). A weekly HSS score (HSS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AK002 SC 300 mg (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8'}, {'id': 'OG001', 'title': 'Placebo (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks in the main study.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '2.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The severity of itching will be recorded by all subjects once daily on a scale of 0 (none) to 3 (severe). A weekly ISS score (ISS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AK002 SC 300 mg (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8'}, {'id': 'OG001', 'title': 'Placebo (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks in the main study.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.25', 'ciLowerLimit': '-11.40', 'ciUpperLimit': '23.78', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The possible range of the UAS7 is 0-42.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety and Tolerability of up to 6 Doses of Open-label AK002 in Subjects With Chronic Spontaneous Urticaria in the Open-label Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AK002 Continuing (OLE)', 'description': 'Subjects in this arm received AK002 in the main study and continued to receive up to 6 doses of 300 mg AK002 SC in the open-label extension (OLE) period.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8'}, {'id': 'OG001', 'title': 'Placebo Rollover (OLE)', 'description': 'Subjects in this arm received placebo in the main study and rolled over to receive up to 6 doses of 300 mg AK002 SC in the open-label extension (OLE) period.\n\nPlacebo: Placebo AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8'}], 'classes': [{'title': 'Subjects with ≥1 adverse events', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with ≥1 treatment-related adverse events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with an adverse event leading to study drug discontinuation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with ≥1 serious adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with ≥1 treatment-related serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, up to 34 weeks (open-label extension period)', 'description': 'Adverse events were assessed throughout the open-label extension period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE)', 'description': 'For the main study period, subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously (SC) every 2 weeks.\n\nFor the open-label extension (OLE) period, subjects who completed the main study and met eligibility criteria had the option to receive up to 6 doses of AK002 SC.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8'}, {'id': 'FG001', 'title': 'Placebo (Main Study) - Placebo Rollover (OLE)', 'description': 'For the main study period, subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks.\n\nFor the open-label extension (OLE) period, subjects who completed the main study and met eligibility criteria had the option to rollover and receive up to 6 doses of 300 mg AK002 SC.\n\nPlacebo: Placebo\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Open-Label Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}], 'recruitmentDetails': '127 subjects who were enrolled in the main study received up to 6 doses of AK002 or placebo. 117 subjects from the main study continued into the open-label extension (OLE) period and received up to 6 doses of AK002.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AK002 SC 300 mg (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.\n\nAK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8'}, {'id': 'BG001', 'title': 'Placebo (Main Study)', 'description': 'Subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks in the main study.\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '77'}, {'value': '43', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '76'}, {'value': '41', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weekly Urticaria Assessment Score (UAS7)', 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '31.9', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (\\>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weekly Hive Severity Score (HSS7)', 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '15.8', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '15.3', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The severity of hives will be recorded on a scale of 0 (none) to 3 (\\> 50 hives). A weekly Hives Severity score (HSS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weekly Itch Severity Score (ISS7)', 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '16.1', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '16.1', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The severity of itching will be recorded on a scale of 0 (none) to 3 (severe). A weekly Itch Severity Score (ISS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline analysis is reported on the safety population of the main study period. Baseline information of OLE subjects is not reported since it is already captured as part of the main study population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-22', 'size': 4582954, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-08T19:31', 'hasProtocol': True}, {'date': '2023-11-03', 'size': 1411100, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-08T19:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'whyStopped': 'No longer pursuing development', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2022-09-01', 'resultsFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-24', 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety and Tolerability of up to 6 Doses of Open-label AK002 in Subjects With Chronic Spontaneous Urticaria in the Open-label Extension Period', 'timeFrame': 'Through study completion, up to 34 weeks (open-label extension period)', 'description': 'Adverse events were assessed throughout the open-label extension period.'}], 'primaryOutcomes': [{'measure': 'Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (\\>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'The severity of hives will be recorded by all subjects once daily on a scale of 0 (none) to 3 (\\> 50 hives). A weekly HSS score (HSS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.'}, {'measure': 'Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'The severity of itching will be recorded by all subjects once daily on a scale of 0 (none) to 3 (severe). A weekly ISS score (ISS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.'}, {'measure': 'Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12', 'timeFrame': 'At Week 12', 'description': 'The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The possible range of the UAS7 is 0-42.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Spontaneous Urticaria', 'Chronic Urticaria', 'Urticaria', 'Chronic Idiopathic Urticaria', 'Chronic Autoimmune Urticaria', 'Idiopathic Chronic Urticaria', 'Autoimmune Urticaria'], 'conditions': ['Chronic Spontaneous Urticaria']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 6 doses of subcutaneous lirentelimab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.\n2. Male and female subjects ≥18 years of age at the time of screening.\n3. CSU diagnosis for ≥6 months.\n4. Diagnosis of moderate-severe CSU refractory to H1-antihistamine (H1-AH) at a minimum of the licensed dose at the licensed frequency at the time of randomization as defined by the following: presence of hives and itch for ≥6 consecutive weeks prior to Screening Visit 1; UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥8 during the 7 days prior to randomization.\n5. Subjects that are omalizumab-naïve or omalizumab-exposed.\n6. Subjects must be on stable dose of H1-AH, between 1x and 4x of the licensed dose and at the licensed frequency, for treatment of CSU for at least 1 week prior to screening and willing to remain on a stable dose throughout the study.\n7. Able and compliant with completing a daily symptom eDiary for the duration of the study and adherent to the study visit schedules.\n\nKey Exclusion Criteria:\n\n1. History of hypersensitivity to the study drugs or their excipients or to drugs of similar chemical classes (i.e., murine, chimeric or human antibodies).\n2. Current use of biologics for any indication.\n3. Demonstrated lack of primary response to treatment with a biologic therapy (e.g., omalizumab) for the treatment of CSU.\n4. Use of any of the following treatments within 4 weeks prior to the baseline visit or any condition that in the opinion of the Investigator is likely to require such treatment(s) during the first 4 weeks of study treatment: (i) immunosuppressive or immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), TNF inhibitors (e.g., infliximab, adalimumab), and eosinophil-depleting drugs (e.g., benralizumab, pramipexole); (ii) routine (daily or every other day during 5 or more consecutive days) doses of systemic hydroxychloroquine; (iii) intravenous immunoglobulin (IVIG); (iv) plasmapheresis.\n5. Use of oral Janus kinase (JAK) inhibitors within 8 weeks of the baseline visit.\n6. Use of any of the following treatments within 3 weeks prior to the baseline visit: (i) H2 antihistamines (H2-AH); (ii) routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids; (iii) regular (daily or every other day) doxepin (oral); (iv) leukotriene receptor antagonists (LTRA) (e.g., montelukast, zafirlukast).\n7. H1-AH use at greater than approved doses or greater than local CSU guideline recommended doses after Screening Visit 1.\n8. Previous treatment with biologics: (i) any cell-depleting agents including but not limited to rituximab within 6 months prior to the baseline visit or until lymphocyte count returns to normal, whichever is longer; (ii) other biologics, including investigational biologics (e.g., dupilumab, omalizumab, benralizumab, etc) within 5 half-lives if known or 8 weeks prior to the baseline visit, whichever is longer.\n9. Planned or anticipated use of any prohibited medication.\n10. Subjects having causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria.\n11. Subjects with known or suspected urticarial vasculitis.\n12. Subjects with known or suspected hereditary angioedema.\n13. Any other skin disease associated with chronic itch, including atopic dermatitis, that in the Investigator's opinion might influence study outcome and subject's interpretation of symptoms caused by CSU.\n14. A helminth parasitic infection diagnosed within 6 months prior to the date that informed consent is obtained and has not been treated with or has failed to respond to standard-of-care therapy.\n15. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products).\n16. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. This exclusion criterion does not apply to all types and formulations of vaccines (including live attenuated vaccines) currently authorized/approved by FDA or other regulatory authority for the prevention of COVID-19, which may be administered before, during, or after the study. The vaccine should not be administered within 3 days before and within 3 days after the administration of lirentelimab so that any side effects caused by either of the 2 medications can more easily be determined."}, 'identificationModule': {'nctId': 'NCT05528861', 'acronym': 'MAVERICK', 'briefTitle': 'A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allakos Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria', 'orgStudyIdInfo': {'id': 'AK002-027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive lirentelimab (AK002) administered subcutaneously.', 'interventionNames': ['Drug: Lirentelimab (AK002)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lirentelimab (AK002)', 'type': 'DRUG', 'otherNames': ['AK002'], 'description': 'Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8', 'armGroupLabels': ['Lirentelimab (AK002)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-024', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-068', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85021', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-014', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-023', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-058', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-026', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-009', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-011', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-021', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-031', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-006', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-036', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-062', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-041', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-067', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-005', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-018', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-045', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-045', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '60305', 'city': 'River Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-057', 'geoPoint': {'lat': 41.89781, 'lon': -87.81395}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-074', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-047', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-051', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-019', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-012', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '21162', 'city': 'White Marsh', 'state': 'Maryland', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-063', 'geoPoint': {'lat': 39.38372, 'lon': -76.43218}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-016', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-034', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-032', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48346', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-070', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '56529', 'city': 'Dilworth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-073', 'geoPoint': {'lat': 46.87663, 'lon': -96.70341}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-052', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-008', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Allakos Investigational Site 227-059', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '11203', 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