Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 9:15 PM
Study NCT ID:
NCT04322604
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2020-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535952', 'term': 'Eosinophilic enteropathy'}, {'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': 'Baseline up to Day 225', 'eventGroups': [{'id': 'EG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 41, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 31, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Coronavirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pharyngeal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Tissue Eosinophil Responders at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80.1', 'ciLowerLimit': '70.1', 'ciUpperLimit': '87.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 24', 'description': 'A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}, {'type': 'PRIMARY', 'title': 'Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3427', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '4.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Weeks 23 - 24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Change in Tissue Eosinophils From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.6', 'spread': '46.3', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '21.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.2', 'ciLowerLimit': '-48.1', 'ciUpperLimit': '-34.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)', 'unitOfMeasure': 'Cells/HPF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Subjects Achieving Mean Eosinophil Count ≤1 Cell/Hpf in 5 Highest Gastric Hpf and/or Mean Eosinophil Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.3', 'ciLowerLimit': '71.7', 'ciUpperLimit': '88.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 24', 'description': 'Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.5', 'ciLowerLimit': '25.4', 'ciUpperLimit': '52.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 23-24 and at Week 24, respectively', 'description': 'Treatment responders defined by \\>30% improvement in TSS at Weeks 23-24 and eosinophil count ≤4 cells/hpf in 5 gastric hpf and/or eosinophil count ≤15 cells/hpf in 3 duodenal hpf at Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Subjects Who Achieve ≥50% Reduction in TSS From Baseline to Weeks 23-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3549', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '21.6', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 23-24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '22.7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 23-24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Percent Change in Weekly TSS Over Time Using MMRM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-18.2', 'spread': '34.1', 'groupId': 'OG000'}, {'value': '-17.4', 'spread': '31.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-17.7', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '-21.2', 'spread': '32.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-29.8', 'spread': '37.2', 'groupId': 'OG000'}, {'value': '-28.3', 'spread': '37.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-29.8', 'spread': '40.4', 'groupId': 'OG000'}, {'value': '-31.3', 'spread': '33.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-34.6', 'spread': '39.7', 'groupId': 'OG000'}, {'value': '-36.3', 'spread': '39.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-33.1', 'spread': '39.9', 'groupId': 'OG000'}, {'value': '-36.2', 'spread': '37.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-36.3', 'spread': '40.2', 'groupId': 'OG000'}, {'value': '-38.7', 'spread': '36.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-33.1', 'spread': '40.8', 'groupId': 'OG000'}, {'value': '-38.8', 'spread': '38.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '-42.6', 'spread': '42.3', 'groupId': 'OG000'}, {'value': '-41.3', 'spread': '37.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-42.1', 'spread': '37.1', 'groupId': 'OG000'}, {'value': '-39.9', 'spread': '34.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '-41.7', 'spread': '39.8', 'groupId': 'OG000'}, {'value': '-41.4', 'spread': '37.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-39.4', 'spread': '39.9', 'groupId': 'OG000'}, {'value': '-38.5', 'spread': '37.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3812', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.0', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '16.0', 'groupDescription': 'Week 24 Percent Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.', 'unitOfMeasure': 'Percentage of Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '3 mg/kg of Lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.\n\nlirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '77'}, {'value': '41', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '78'}, {'value': '42', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Gastric Eosinophil Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.3', 'spread': '57.9', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '30.9', 'groupId': 'BG001'}, {'value': '44.3', 'spread': '46.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Eosinophil Count (cells/HPF) in gastric tissue', 'unitOfMeasure': 'Eosinophils/HPF', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Duodenal Eosinophil Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.4', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '17.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Eosinophil Count (cells/HPF) in duodenal tissue', 'unitOfMeasure': 'Eosinophils/HPF', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One subject did not have the duodenal biopsy samples'}, {'title': 'Baseline Patient Reported Outcome Total and Symptom Scores', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-02', 'size': 8347784, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-28T16:58', 'hasProtocol': True}, {'date': '2021-11-05', 'size': 2540079, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-28T16:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2020-03-24', 'resultsFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-13', 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Tissue Eosinophil Responders at Week 24', 'timeFrame': 'At Week 24', 'description': 'A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.'}, {'measure': 'Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24', 'timeFrame': 'Baseline to Weeks 23 - 24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Tissue Eosinophils From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)'}, {'measure': 'Subjects Achieving Mean Eosinophil Count ≤1 Cell/Hpf in 5 Highest Gastric Hpf and/or Mean Eosinophil Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24', 'timeFrame': 'At Week 24', 'description': 'Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)'}, {'measure': 'Number of Treatment Responders', 'timeFrame': 'Weeks 23-24 and at Week 24, respectively', 'description': 'Treatment responders defined by \\>30% improvement in TSS at Weeks 23-24 and eosinophil count ≤4 cells/hpf in 5 gastric hpf and/or eosinophil count ≤15 cells/hpf in 3 duodenal hpf at Week 24'}, {'measure': 'Subjects Who Achieve ≥50% Reduction in TSS From Baseline to Weeks 23-24', 'timeFrame': 'At Weeks 23-24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.'}, {'measure': 'Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24', 'timeFrame': 'At Weeks 23-24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.'}, {'measure': 'Percent Change in Weekly TSS Over Time Using MMRM', 'timeFrame': 'Baseline to Week 24', 'description': 'The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eosinophil', 'Eosinophilic', 'Eosinophilic gastrointestinal disorders', 'EGID', 'EG', 'EGE', 'Eosinophilic Gastritis', 'Eosinophilic Gastroenteritis', 'Eosinophilic Duodenitis'], 'conditions': ['Eosinophilic Gastritis', 'Eosinophilic Duodenitis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Provide written informed consent.\n2. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry.\n3. Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 5 hpf in the stomach and/or ≥30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD.\n4. Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.\n5. Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EG/EoD symptoms, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others.\n6. If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study.\n7. Willing and able to comply with all study procedures and visit schedule including follow-up visits.\n8. Female patients must be either post-menopausal for at least 1 year with FSH level \\>30 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or later menstrual period) at any time during study participation.\n\nKey Exclusion Criteria:\n\n1. Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit.\n2. Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit.\n3. Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.\n4. Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.\n5. Active Helicobacter pylori infection, unless treated and confirmed to be negative prior to randomization and symptoms remain consistent.\n6. History of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery.\n7. History of bleeding disorders and/or esophageal varices.\n8. Other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA).\n9. Confirmed diagnosis of Hypereosinophilic Syndrome (HES).\n10. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.\n11. Presence of an abnormal laboratory value considered to be clinically significant by the Investigator.\n12. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.\n13. History of malignancy, except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled (with the exception of breast cancer).\n14. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.\n15. Positive Ova and Parasite (O\\&P) test and/or seropositive for Strongyloides stercoralis.\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.\n17. Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved hepatitis, at screening.\n18. 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).\n19. Known history of alcohol, drug, or other substance abuse or dependence, considered by the Investigator to be ongoing and clinically significant.\n20. Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT04322604', 'acronym': 'ENIGMA 2', 'briefTitle': 'A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allakos Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)', 'orgStudyIdInfo': {'id': 'AK002-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3 mg/kg of lirentelimab (AK002)', 'description': 'Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.', 'interventionNames': ['Drug: lirentelimab (AK002)']}], 'interventions': [{'name': 'lirentelimab (AK002)', 'type': 'DRUG', 'description': 'Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.', 'armGroupLabels': ['3 mg/kg of 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', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '38801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Allakos Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85234', 'city': 'Gilbert', 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