Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-30 @ 1:35 PM
Study NCT ID:
NCT03469934
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2018-02-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011657', 'term': 'Pulmonary Eosinophilia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@anaptysbio.com', 'phone': '858-362-6295', 'title': 'Clinical Project Leader', 'organization': 'AnaptysBio, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to Day 127', 'description': 'Participants from the Safety Analysis Set were analyzed.', 'eventGroups': [{'id': 'EG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Peripheral Eosinophil Count at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.199', 'groupId': 'OG000', 'lowerLimit': '-0.351', 'upperLimit': '-0.046'}, {'value': '-0.141', 'groupId': 'OG001', 'lowerLimit': '-0.280', 'upperLimit': '-0.002'}]}]}], 'analyses': [{'pValue': '0.5703', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.058', 'ciLowerLimit': '-0.265', 'ciUpperLimit': '0.150', 'groupDescription': 'Mixed-model repeated measures (MMRM) analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.', 'statisticalMethod': 'Mixed-model repeated measures', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 22', 'unitOfMeasure': '10^9 cells/Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PD analysis set with available data were evaluated.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to Day 127', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.\n\nAn AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events.\n\nTreatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the safety analysis set were evaluated.'}, {'type': 'PRIMARY', 'title': 'Number of Asthma Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to Day 127', 'description': 'Asthma exacerbation was defined as follows:\n\n1. Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.\n\n OR\n2. An emergency room/urgent care visit (defined as evaluation and treatment for \\<24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above).\n\n OR\n3. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).', 'unitOfMeasure': 'asthma exacerbations', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received etokimab or placebo and had at least one post-baseline blood eosinophils count assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Positive Anti-drug Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 36', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 106', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'End of Study (up to Day 127)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the safety analysis set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peripheral Eosinophil Count at Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.194', 'groupId': 'OG000', 'lowerLimit': '-0.330', 'upperLimit': '-0.058'}, {'value': '-0.144', 'groupId': 'OG001', 'lowerLimit': '-0.275', 'upperLimit': '-0.014'}]}]}], 'analyses': [{'pValue': '0.5901', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.050', 'ciLowerLimit': '-0.239', 'ciUpperLimit': '0.139', 'groupDescription': 'MMRM analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.', 'statisticalMethod': 'Mixed-model repeated measures', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 127', 'unitOfMeasure': '10^9 cells/Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PD analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.51'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.42'}]}]}], 'analyses': [{'pValue': '0.5960', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.164', 'groupDescription': 'Change from baseline for FEV1 was compared between etokimab and placebo using an analysis of covariance (ANCOVA) with treatment as fixed effect and baseline result as covariate and participant as a random effect', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 127', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'groupId': 'OG000', 'lowerLimit': '-11.59', 'upperLimit': '15.78'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-14.12', 'upperLimit': '13.25'}]}]}], 'analyses': [{'pValue': '0.7993', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.53', 'ciLowerLimit': '-17.90', 'ciUpperLimit': '22.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.823', 'groupDescription': 'Change from baseline for FeNO was compared between etokimab and placebo using an ANCOVA with treatment as fixed effect and baseline result as covariate and participant as a random effect', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 127', 'description': 'Measurement of FeNO was performed in accordance with the guidelines published by American Thoracic Society/European Respiratory Society (ATS/ERS).', 'unitOfMeasure': 'parts per billion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Whole Blood Ex-vivo Induced Interferon Gamma (IFN-γ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '702.215', 'spread': '581.947', 'groupId': 'OG000'}, {'value': '2490.575', 'spread': '3577.893', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-377.747', 'spread': '359.751', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The mean and standard deviation were not determined as the values were below the lower limit of quantification (LLOQ).', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The mean and standard deviation were not determined as the values were below the lower limit of quantification (LLOQ).', 'groupId': 'OG000'}, {'value': '5035.623', 'spread': '5790.397', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The mean and standard deviation were not determined as the values were below the lower limit of quantification (LLOQ).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The mean and standard deviation were not determined as the values were below the lower limit of quantification (LLOQ).', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 106', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The mean and standard deviation were not determined as the values were below the lower limit of quantification (LLOQ).', 'groupId': 'OG000'}]}]}, {'title': 'Change at end of study (up to Day 127)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '401.108', 'spread': '1002.500', 'groupId': 'OG000'}, {'value': '2635.555', 'spread': '4491.890', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 36, Day 85, Day 106, and End of Study (up to Day 127)', 'description': 'Blood samples for ex vivo induced IFN-γ assessment were collected in a sodium heparin tube. The measurement of ex vivo induced IFN-γ was performed using validated assay method.', 'unitOfMeasure': 'nanograms per liter (ng/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PD analysis set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.84', 'spread': '20.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, end of infusion (EOI), EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Cmax was obtained directly from the observed concentration versus time data.', 'unitOfMeasure': 'micrograms per milliliter (µg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set included all participants who received etokimab and have at least one post-dose serum concentration data value available for etokimab without any events or protocol deviation deemed to affect PK assessments.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Concentration (Tmax) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.020', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '4.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Tmax was obtained directly from the observed concentration versus time data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve in Serum From Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14400', 'spread': '4698', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'AUC0-inf was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant.', 'unitOfMeasure': 'hours*µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13590', 'spread': '4117', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'AUC0-last was calculated by linear up/log down trapezoidal summation.', 'unitOfMeasure': 'hours*µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance (CL) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02278', 'spread': '0.006896', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'CL was calculated as dose/ AUC0-inf.', 'unitOfMeasure': 'L/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Rate Constant (λz) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002174', 'spread': '0.0006052', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'λz was determined by linear regression of the terminal points of the log-linear concentration-time curve.', 'unitOfMeasure': '1/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Half-life (t1/2) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '343.3', 'spread': '102.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Apparent terminal half-life was determined as (natural logarithm of 2 \\[ln2\\] divided by λz).', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution During Terminal Phase (Vz) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.55', 'spread': '1.701', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Vz was estimated by dividing the systemic clearance by λz.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State Following Intravenous Dosing (Vss) of Etokimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.485', 'spread': '1.378', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Volume of distribution at steady state following intravenous dosing was calculated as \\[(\\[AUMClast + (\\[tlast\\*Clast\\]/λz) + Clast/λz\\^2\\]/ AUC(0-inf)) - TI/ 2\\]\\*CL, Clast is last observed (quantifiable) plasma concentration, where AUMClast is the area under the moment curve from the time of dosing to Clast, tlast is the time of Clast, and TI is infusion duration.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK analysis set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 milligrams (mg) etokimab administered on Day 1 by intravenous (IV) infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Pharmacodynamic (PD) Analysis Set', 'comment': 'All participants who received etokimab or placebo and provided at least one evaluable post-dose PD measurement without any events or protocol deviation deemed to affect PD assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 6 centers in the United Kingdom (UK) and United States of America (USA).', 'preAssignmentDetails': 'Eligible participants were randomized in a 1:1 ratio to receive a single dose of either etokimab or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etokimab', 'description': 'Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '14.72', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '14.70', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '14.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Eosinophil Count', 'classes': [{'categories': [{'measurements': [{'value': '0.545', 'spread': '0.379', 'groupId': 'BG000'}, {'value': '0.705', 'spread': '0.362', 'groupId': 'BG001'}, {'value': '0.628', 'spread': '0.3715', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^9 cells/Liters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety analysis set included all participants who received etokimab or placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-16', 'size': 1150085, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-29T08:55', 'hasProtocol': True}, {'date': '2018-12-18', 'size': 4350301, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-29T08:59', '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': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2018-02-28', 'resultsFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-25', 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Peripheral Eosinophil Count at Day 22', 'timeFrame': 'Baseline, Day 22'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'From first dose to Day 127', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.\n\nAn AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events.\n\nTreatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion.'}, {'measure': 'Number of Asthma Exacerbations', 'timeFrame': 'From first dose to Day 127', 'description': 'Asthma exacerbation was defined as follows:\n\n1. Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.\n\n OR\n2. An emergency room/urgent care visit (defined as evaluation and treatment for \\<24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above).\n\n OR\n3. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).'}, {'measure': 'Number of Participants With Positive Anti-drug Antibody', 'timeFrame': 'Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Peripheral Eosinophil Count at Day 127', 'timeFrame': 'Baseline, Day 127'}, {'measure': 'Change From Baseline in Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Day 127', 'timeFrame': 'Baseline, Day 127', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.'}, {'measure': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Day 127', 'timeFrame': 'Baseline, Day 127', 'description': 'Measurement of FeNO was performed in accordance with the guidelines published by American Thoracic Society/European Respiratory Society (ATS/ERS).'}, {'measure': 'Change From Baseline in Whole Blood Ex-vivo Induced Interferon Gamma (IFN-γ)', 'timeFrame': 'Baseline, Day 8, Day 36, Day 85, Day 106, and End of Study (up to Day 127)', 'description': 'Blood samples for ex vivo induced IFN-γ assessment were collected in a sodium heparin tube. The measurement of ex vivo induced IFN-γ was performed using validated assay method.'}, {'measure': 'Maximum Observed Concentration (Cmax) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, end of infusion (EOI), EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Cmax was obtained directly from the observed concentration versus time data.'}, {'measure': 'Time to Maximum Observed Concentration (Tmax) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Tmax was obtained directly from the observed concentration versus time data.'}, {'measure': 'Area Under the Concentration-time Curve in Serum From Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'AUC0-inf was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant.'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'AUC0-last was calculated by linear up/log down trapezoidal summation.'}, {'measure': 'Apparent Total Body Clearance (CL) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'CL was calculated as dose/ AUC0-inf.'}, {'measure': 'Apparent Terminal Rate Constant (λz) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'λz was determined by linear regression of the terminal points of the log-linear concentration-time curve.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Apparent terminal half-life was determined as (natural logarithm of 2 \\[ln2\\] divided by λz).'}, {'measure': 'Volume of Distribution During Terminal Phase (Vz) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Vz was estimated by dividing the systemic clearance by λz.'}, {'measure': 'Volume of Distribution at Steady State Following Intravenous Dosing (Vss) of Etokimab', 'timeFrame': 'pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion', 'description': 'Volume of distribution at steady state following intravenous dosing was calculated as \\[(\\[AUMClast + (\\[tlast\\*Clast\\]/λz) + Clast/λz\\^2\\]/ AUC(0-inf)) - TI/ 2\\]\\*CL, Clast is last observed (quantifiable) plasma concentration, where AUMClast is the area under the moment curve from the time of dosing to Clast, tlast is the time of Clast, and TI is infusion duration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Asthma']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Pavord ID, Marquette A, Kahm P, Pinkstaff J, Sacco N, Londei M. Single-dose Phase 2a trial of etokimab (anti-IL-33) in severe eosinophilic asthma. Paper presented at the European Academy of Allergy and Clinical Immunology (EEACI) Congress 2019; June 1-5, 2019; Lisbon, Portugal.'}]}, 'descriptionModule': {'briefSummary': 'This is a proof of concept study designed to assess the effects of a single intravenous dose of etokimab compared to placebo in adult participants with severe eosinophilic asthma. This study will also assess the safety and tolerability of etokimab in adult participants with severe eosinophilic asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with a confirmed clinical diagnosis of eosinophilic asthma\n* History of diagnosis of eosinophilic asthma\n* Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016\n* Body mass index (BMI) of 18 to 38 kilograms per squared meters (kg/m\\^2) (inclusive) and total body weight \\> 50 kg (110 pounds)\n* Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use highly effective methods of contraception throughout the study\n* Male participants must be willing to use effective methods of contraception during the entire study period.\n* Participant must be on high dose inhaled corticosteroids (ICS) plus long-acting beta-2-agonists (LABA)\n* Willing and able to comply with the study protocol requirements\n* Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff\n\nExclusion Criteria:\n\n* Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product (IP)\n* Have experienced severe life threatening anaphylactic reactions\n* Have received any IP within a period of 3 months or 5 half lives of an IP\n* Have received high dose systemic corticosteroids\n* Have received treatment with biologics, such as mepolizumab or omalizumab, within 3 months or 5 half lives (whichever is longer) before screening\n* Abnormal electrocardiogram (ECG) assessment at screening\n* Uncontrolled hypertension, or acute ischemic cardiovascular diseases\n* If female, is pregnant or lactating, or intend to become pregnant during the study period\n* History (or suspected history) of alcohol or substance abuse within 2 years before screening\n* Any comorbidity that the Investigator believes is a contraindication to study participation\n* Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments\n* Planned surgery during the study or 30 days before screening\n* History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease"}, 'identificationModule': {'nctId': 'NCT03469934', 'briefTitle': 'Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AnaptysBio, Inc.'}, 'officialTitle': 'Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Severe Eosinophilic Asthma', 'orgStudyIdInfo': {'id': 'ANB020-004'}, 'secondaryIdInfos': [{'id': '2017-000647-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etokimab', 'description': 'Participants received a single dose of 300 milligrams (mg) etokimab administered on Day 1 by intravenous (IV) infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.', 'interventionNames': ['Biological: Etokimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Etokimab', 'type': 'BIOLOGICAL', 'otherNames': ['ANB020'], 'description': 'Administered on Day 1 over 1 hour by IV infusion', 'armGroupLabels': ['Etokimab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered on Day 1 over 1 hour by IV infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Allergy Sinus Asthma', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '48375', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pulmonary & Critical Care Specialists', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OK Clinical Research, LLC', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Allergy & Asthma Center of Southern Oregon', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': 'M239Q', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Medicines Evaluation Unit', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'LE3 9QP', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Glenfield Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Bruce Randazzo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AnaptysBio, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AnaptysBio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}