Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-02 @ 11:38 AM
Study NCT ID:
NCT04735432
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2021-01-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'regulatory@argenx.com', 'phone': '+32 9 310 34 00', 'title': 'Regulatory Manager', 'organization': 'argenx BV'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'None reported.'}}, 'adverseEventsModule': {'timeFrame': 'up to 12 weeks (throughout the treatment period)', 'description': 'AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, legally authorized representative). The investigator are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE and remain responsible for following up AEs that are serious, considered related to the study intervention or study procedures, or that caused the participant to discontinue the study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving efgartigimod PH20 subcutaneous (SC) treatment\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 37, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving efgartigimod intravenous (IV) treatment\n\nefgartigimod IV: Intravenous infusion of efgartigimod', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 23, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Testicular cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.4', 'groupId': 'OG000', 'lowerLimit': '-68.91', 'upperLimit': '-63.86'}, {'value': '-62.2', 'groupId': 'OG001', 'lowerLimit': '-64.67', 'upperLimit': '-59.72'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-7.73', 'ciUpperLimit': '-0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.782', 'groupDescription': 'The primary endpoint was analyzed using an ANCOVA model with treatment as a factor and total IgG levels at baseline as a covariate. The NI evaluation was based on a percent reduction from baseline in total IgG levels at day 29 (week 4) using an NI margin of 10%. Only the results for mITT analysis set are entered.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'This was a phase 3, multicenter, randomized, open-label, parallel-group, 12-week study to evaluate the noninferiority of the pharmacodynamic effect of efgartigimod PH20 SC 1000 mg compared with efgartigimod IV 10 mg/kg in patients with generalized myasthenia gravis.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From week 0 to week 4', 'description': 'ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration).', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-40.1', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-39.6', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-56.9', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-55.1', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-62.2', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-59', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-64.7', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '-62.3', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-57.4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-49.9', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-44', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-38.9', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-31.2', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '-25.3', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-8.9', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '3.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '7.8', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '3.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 10', 'description': 'Total IgG level percent change from baseline over time for the overall population.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline timepoint.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-42.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-43.7', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-57.4', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-55.1', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-61.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-59.2', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-62.2', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '-59.6', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-55.3', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-47.2', 'spread': '2.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-40.4', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '-29.9', 'spread': '4.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-26.7', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '-15.8', 'spread': '5.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-14.5', 'spread': '7.82', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '6.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '13.5', 'spread': '23.16', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '7.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 10', 'description': 'Percent reduction from baseline in AChR-Ab levels over time in AChR-Ab positive patients measured in mITT Analysis Set.\n\nDescriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Percent change from baseline at week 4 IgG1', 'categories': [{'measurements': [{'value': '-71', 'groupId': 'OG000', 'lowerLimit': '-79.3', 'upperLimit': '-56.6'}, {'value': '-68.4', 'groupId': 'OG001', 'lowerLimit': '-73', 'upperLimit': '-61.5'}]}]}, {'title': 'Percent change from baseline at week 4 IgG2', 'categories': [{'measurements': [{'value': '-65.6', 'groupId': 'OG000', 'lowerLimit': '-72.2', 'upperLimit': '-58.1'}, {'value': '-64.5', 'groupId': 'OG001', 'lowerLimit': '-73', 'upperLimit': '-57.4'}]}]}, {'title': 'Percent change from baseline at week 4 IgG3', 'categories': [{'measurements': [{'value': '-69.6', 'groupId': 'OG000', 'lowerLimit': '-78.3', 'upperLimit': '-58.4'}, {'value': '-64.7', 'groupId': 'OG001', 'lowerLimit': '-76.9', 'upperLimit': '-59.5'}]}]}, {'title': 'Percent change from baseline at week 4 IgG4', 'categories': [{'measurements': [{'value': '-56.4', 'groupId': 'OG000', 'lowerLimit': '-64.4', 'upperLimit': '-37.2'}, {'value': '-55.5', 'groupId': 'OG001', 'lowerLimit': '-64.2', 'upperLimit': '-42.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to week 10', 'description': 'Median (IQR) Percent Change From Baseline for the IgG Subtypes (IgG1, IgG2, IgG3, and IgG4) in the Overall Population.\n\nThe highest number of patients among all weeks for the analysis is chosen for each arm.\n\nDescriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline timepoint.'}, {'type': 'SECONDARY', 'title': 'AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Days 1-8 (baseline-week 1)', 'categories': [{'measurements': [{'value': '-138.9', 'spread': '5.48', 'groupId': 'OG000'}, {'value': '-139.1', 'spread': '5.67', 'groupId': 'OG001'}]}]}, {'title': 'Days 8-15 (week 1-week 2)', 'categories': [{'measurements': [{'value': '-341.9', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-328.3', 'spread': '10.98', 'groupId': 'OG001'}]}]}, {'title': 'Days 15-22 (week 2-week 3)', 'categories': [{'measurements': [{'value': '-416.0', 'spread': '12.06', 'groupId': 'OG000'}, {'value': '-399.8', 'spread': '14.46', 'groupId': 'OG001'}]}]}, {'title': 'Days 22-29 (week 3-week 4)', 'categories': [{'measurements': [{'value': '-447.3', 'spread': '9.24', 'groupId': 'OG000'}, {'value': '-427.0', 'spread': '9.76', 'groupId': 'OG001'}]}]}, {'title': 'Days 1-29 (baseline-week 4)', 'categories': [{'measurements': [{'value': '-1332.5', 'spread': '30.78', 'groupId': 'OG000'}, {'value': '-1311.6', 'spread': '26.35', 'groupId': 'OG001'}]}]}, {'title': 'Days 1-57 (baseline-week 8)', 'categories': [{'measurements': [{'value': '-2515.9', 'spread': '96.98', 'groupId': 'OG000'}, {'value': '-2387.6', 'spread': '77.61', 'groupId': 'OG001'}]}]}, {'title': 'Days 1-71 (baseline-week 10)', 'categories': [{'measurements': [{'value': '-2562.9', 'spread': '171.86', 'groupId': 'OG000'}, {'value': '-2500.3', 'spread': '116.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 10', 'description': 'AUEC of the percent reduction from baseline total IgG per dosing interval (days 1-8, days 8-15, days 15-22, and days 22-29), days 1-29, days 1-57 and over the entire study (days 1-71).\n\nThe highest number of patients among all weeks for the analysis is chosen for each arm.\n\nDescriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'percent days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Ctrough week 1', 'categories': [{'measurements': [{'value': '18.3', 'spread': '8.05', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '33.0', 'groupId': 'OG001'}]}]}, {'title': 'Ctrough week 2', 'categories': [{'measurements': [{'value': '21.4', 'spread': '8.36', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '6.92', 'groupId': 'OG001'}]}]}, {'title': 'Ctrough week 3', 'categories': [{'measurements': [{'value': '22.5', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '8.05', 'groupId': 'OG001'}]}]}, {'title': 'Ctrough week 4', 'categories': [{'measurements': [{'value': '22.0', 'spread': '8.12', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '6.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Week 1 to Week 4.', 'description': 'Evaluation of observed predose concentration (Ctrough) (after all doses for the IV and SC treatment arms). The analysis will present data from Week 1 to Week 4.\n\nDescriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efgartigimod IV Serum Pharmacokinetic Parameter Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Cmax Baseline', 'categories': [{'measurements': [{'value': '199', 'spread': '62.8', 'groupId': 'OG000'}]}]}, {'title': 'Cmax week 1', 'categories': [{'measurements': [{'value': '215', 'spread': '63.0', 'groupId': 'OG000'}]}]}, {'title': 'Cmax week 2', 'categories': [{'measurements': [{'value': '211', 'spread': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Cmax week 3', 'categories': [{'measurements': [{'value': '206', 'spread': '59.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 3', 'description': 'Evaluation of maximum observed concentration (Cmax) (after all doses for the IV treatment arm). The analysis will present data from Baseline to Week 3.\n\nDescriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of ADA Against Efgartigimod (Safety Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 10', 'description': 'Incidence of antidrug antibodies (ADA) against Efgartigimod in the overall population. ADA analysis is performed with a validated ELISA in a 3-tiered approach (ADA screening analysis, confirmatory analysis and a titration assay). Descriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'Percent of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 10', 'description': 'Incidence of antibodies against rHuPH20 in the Efgartigimod PH20 SC Arm. antibody analysis is performed with a validated ELISA in a 3-tiered approach (screening analysis, confirmatory analysis and a titration assay) Descriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'Percent of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence and Severity of AEs and SAEs (Safety Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': '≥1 AE', 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000'}, {'value': '50.9', 'groupId': 'OG001'}]}]}, {'title': '≥1 SAE', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': '≥1 Grade 3 or higher AE', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': '≥1 AESI', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': '≥1 Injection site reaction (localized)', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': '≥1 Infusion- or injection-related reaction', 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': '≥1 Fatal AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥1 Treatment-related AE according to PI', 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': '≥1 Procedure-related AE according to PI', 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': '≥1 Treatment-related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥1 AE for which the IMP was interrupted', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥1 AE for which the IMP was discontinued', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 10', 'description': 'Evaluation of incidence and severity of treatment-emergent adverse events (TEAEs) and incidence of serious AEs (SAEs).\n\nDescriptive statistics have been used for this secondary end point.', 'unitOfMeasure': 'Percent of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MG-ADL Responders (ITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000'}, {'value': '69.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 10', 'description': "Evaluation of number and percentage of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders in the overall population. The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks. Descriptive statistics have been used for this secondary end point.", 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QMG Responders (ITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 10', 'description': 'Evaluation of number and percentage of Quantitative Myasthenia Gravis (QMG) responders in the overall population (ITT Analysis Set).\n\nDescriptive statistics have been used for this secondary end point. One subject in the EFG IV arm had no post-baseline QMG assessment and thus was excluded from the denominator.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': "One patient from Efgartigimod IV didn't have any post-baseline QMG assessment."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MG-ADL Total Score Over Time (ITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 10', 'description': "Evaluation of MG-ADL Total Score Change from baseline over time for the overall population (ITT Analysis Set). Descriptive statistics have been used for this secondary end point.\n\nThe MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks.", 'unitOfMeasure': 'Total score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QMG Score Over Time (ITT Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'OG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-3', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-2', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-5.7', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-6.1', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-5.9', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-5', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-5', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 10', 'description': 'Evaluation of QMG Total Score change from baseline over time for the overall population (ITT Analysis Set). The QMG (Quantitative Myasthenia Gravis) quantifies disease severity based on impairments of body function and structures as defined by the International Classification of Functioning, Disability and Health. The QMG consists of 13 items that assess ocular, bulbar, and limb function. Six of the 13 items are timed endurance tests measured in seconds. Each item has a possible score from 0 to 3. The total possible score is 39, where higher total scores indicate more severe impairments. It is based on qualitative testing of specific muscle groups to assess limb function.\n\nDescriptive statistics have been used for this secondary end point. A participant was considered a QMG responder if he/she showed a reduction of at least 3 points from baseline on the QMG score for at least 4 consecutive weeks.', 'unitOfMeasure': 'Total score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with 1000 mg efgartigimod PH20 SC'}, {'id': 'FG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other - due to personal reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participant's evaluation of eligibility was performed at screening and confirmed at randomization visit 1. The overall study duration per subject was approximately 12 weeks spanning the study periods - 2 weeks for screening, 3 weeks for treatment, and 7 weeks for follow-up.", 'preAssignmentDetails': '153 patients were screened, 111 patients were randomized 1:1 to receive efgartigimod PH20 SC 1000 mg (55) or efgartigimod IV 10 mg/kg (56) once weekly for 4 administrations (4 doses on days 1, 8, 15, and 22). 110 patients started in the study (received treatment) as one participant randomized to the efgartigimod IV arm did not receive treatment due to an AE. 55 patients received study treatment in each treatment arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Efgartigimod PH20 SC', 'description': 'Patients receiving 1000 mg efgartigimod PH20 subcutaneous (SC) treatment.\n\nefgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC'}, {'id': 'BG001', 'title': 'Efgartigimod IV', 'description': 'Patients receiving 10 mg/kg efgartigimod intravenous (IV) treatment.\n\nefgartigimod IV: Intravenous infusion of efgartigimod'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '84'}, {'value': '59.0', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '83'}, {'value': '53.5', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT analysis set: All randomized participants who were exposed to the IMP. mITT analysis set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline time point. Safety analysis set: All randomized participants who were exposed to IMP. PK analysis set: A subset of the safety analysis set with at least 1 post dose PK measurement.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-02', 'size': 3620737, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-22T04:55', 'hasProtocol': True}, {'date': '2022-08-16', 'size': 4338047, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-22T04:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2021-01-26', 'resultsFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2021-02-01', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-31', 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)', 'timeFrame': 'From week 0 to week 4', 'description': 'ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration).'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': 'Total IgG level percent change from baseline over time for the overall population.'}, {'measure': 'Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': 'Percent reduction from baseline in AChR-Ab levels over time in AChR-Ab positive patients measured in mITT Analysis Set.\n\nDescriptive statistics have been used for this secondary end point.'}, {'measure': 'Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set)', 'timeFrame': 'Baseline to week 10', 'description': 'Median (IQR) Percent Change From Baseline for the IgG Subtypes (IgG1, IgG2, IgG3, and IgG4) in the Overall Population.\n\nThe highest number of patients among all weeks for the analysis is chosen for each arm.\n\nDescriptive statistics have been used for this secondary end point.'}, {'measure': 'AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': 'AUEC of the percent reduction from baseline total IgG per dosing interval (days 1-8, days 8-15, days 15-22, and days 22-29), days 1-29, days 1-57 and over the entire study (days 1-71).\n\nThe highest number of patients among all weeks for the analysis is chosen for each arm.\n\nDescriptive statistics have been used for this secondary end point.'}, {'measure': 'Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough', 'timeFrame': 'From Week 1 to Week 4.', 'description': 'Evaluation of observed predose concentration (Ctrough) (after all doses for the IV and SC treatment arms). The analysis will present data from Week 1 to Week 4.\n\nDescriptive statistics have been used for this secondary end point.'}, {'measure': 'Efgartigimod IV Serum Pharmacokinetic Parameter Cmax', 'timeFrame': 'From Baseline to Week 3', 'description': 'Evaluation of maximum observed concentration (Cmax) (after all doses for the IV treatment arm). The analysis will present data from Baseline to Week 3.\n\nDescriptive statistics have been used for this secondary end point.'}, {'measure': 'Incidence of ADA Against Efgartigimod (Safety Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': 'Incidence of antidrug antibodies (ADA) against Efgartigimod in the overall population. ADA analysis is performed with a validated ELISA in a 3-tiered approach (ADA screening analysis, confirmatory analysis and a titration assay). Descriptive statistics have been used for this secondary end point.'}, {'measure': 'Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': 'Incidence of antibodies against rHuPH20 in the Efgartigimod PH20 SC Arm. antibody analysis is performed with a validated ELISA in a 3-tiered approach (screening analysis, confirmatory analysis and a titration assay) Descriptive statistics have been used for this secondary end point.'}, {'measure': 'Incidence and Severity of AEs and SAEs (Safety Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': 'Evaluation of incidence and severity of treatment-emergent adverse events (TEAEs) and incidence of serious AEs (SAEs).\n\nDescriptive statistics have been used for this secondary end point.'}, {'measure': 'MG-ADL Responders (ITT Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': "Evaluation of number and percentage of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders in the overall population. The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks. Descriptive statistics have been used for this secondary end point."}, {'measure': 'QMG Responders (ITT Analysis Set)', 'timeFrame': 'From Baseline to Week 10', 'description': 'Evaluation of number and percentage of Quantitative Myasthenia Gravis (QMG) responders in the overall population (ITT Analysis Set).\n\nDescriptive statistics have been used for this secondary end point. One subject in the EFG IV arm had no post-baseline QMG assessment and thus was excluded from the denominator.'}, {'measure': 'Change From Baseline in MG-ADL Total Score Over Time (ITT Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': "Evaluation of MG-ADL Total Score Change from baseline over time for the overall population (ITT Analysis Set). Descriptive statistics have been used for this secondary end point.\n\nThe MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks."}, {'measure': 'Change From Baseline in QMG Score Over Time (ITT Analysis Set)', 'timeFrame': 'From baseline to week 10', 'description': 'Evaluation of QMG Total Score change from baseline over time for the overall population (ITT Analysis Set). The QMG (Quantitative Myasthenia Gravis) quantifies disease severity based on impairments of body function and structures as defined by the International Classification of Functioning, Disability and Health. The QMG consists of 13 items that assess ocular, bulbar, and limb function. Six of the 13 items are timed endurance tests measured in seconds. Each item has a possible score from 0 to 3. The total possible score is 39, where higher total scores indicate more severe impairments. It is based on qualitative testing of specific muscle groups to assess limb function.\n\nDescriptive statistics have been used for this secondary end point. A participant was considered a QMG responder if he/she showed a reduction of at least 3 points from baseline on the QMG score for at least 4 consecutive weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)', 'detailedDescription': 'Main objective of the trial: To demonstrate that the pharmacodynamic (PD) effect of injections of 1000 mg efgartigimod PH20 SC (efgartigimod co-formulated with recombinant humanhyaluronidase PH20 for subcutaneous administration), administered once weekly for 4 administrations, is NI (noninferior) to IV infusions of efgartigimod (efgartigimod formulation for intravenous infusion) at a dose of 10 mg/kg administered once weekly for 4 administrations.\n\nSecondary objectives: To compare the PD effect of efgartigimod PH20 SC and efgartigimod IV over time; To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC and efgartigimod IV; To evaluate the safety, tolerability, and immunogenicity of efgartigimod PH20 SC and efgartigimod IV; To evaluate the clinical efficacy of efgartigimod PH20 SC and efgartigimod IV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBullet list of each inclusion criterium:\n\n1. Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. At least 18 years of age at the time of signing the informed consent form.\n3. Diagnosed with generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by at least 1 of the following:\n\n 1. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation\n 2. History of positive edrophonium chloride test\n 3. Demonstrated improvement in Myasthenia Gravis (MG) signs upon treatment with oral acetylcholinesterase (AChE) inhibitors as assessed by the treating physician\n4. Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa, or IVb\n\nExclusion Criteria:\n\nBullet list of each exclusion criterium:\n\n1. Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of Investigational Medicinal Product.\n2. Has any of the following medical conditions:\n\n 1. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening\n 2. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk.\n 3. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time:\n\n * adequately treated basal cell or squamous cell skin cancer\n * carcinoma in situ of the cervix\n * carcinoma in situ of the breast\n * incidental histological findings of prostate cancer (TNM Classification of Malignant Tumors stage T1a or T1b).\n 4. Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.'}, 'identificationModule': {'nctId': 'NCT04735432', 'acronym': 'ADAPTsc', 'briefTitle': 'Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': 'A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'ARGX-113-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'efgartigimod PH20 SC', 'description': 'Patients receiving efgartigimod PH20 subcutaneous (SC) treatment', 'interventionNames': ['Biological: efgartigimod PH20 SC']}, {'type': 'EXPERIMENTAL', 'label': 'efgartigimod', 'description': 'Patients receiving efgartigimod intravenous (IV) treatment', 'interventionNames': ['Biological: efgartigimod IV']}], 'interventions': [{'name': 'efgartigimod PH20 SC', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous injection with efgartigimod PH20 SC', 'armGroupLabels': ['efgartigimod PH20 SC']}, {'name': 'efgartigimod IV', 'type': 'BIOLOGICAL', 'description': 'Intravenous infusion of efgartigimod', 'armGroupLabels': ['efgartigimod']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Investigator site 2 - US0010032', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 41 - US0010004', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33428', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site 2 - US0010108', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator site 1 - US0010110', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '41076', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 27 - US0010006', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site 47 - US0010113', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '66205', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator Site 42 - 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GE9950016', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigator Site 30 - DE490006', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Investigator Site 29 - DE490009', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '1082', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigator site 15 - HU0360013', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Investigator Site 16 - HU0360020', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Investigator Site 17 - IT0390003', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00189', 'city': 'Roma', 'country': 'Italy', 'facility': 'Investigator Site 39 - IT0390008', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '063-0005', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Investigator Site 31 - JP0810055', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '260-8677', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Investigator Site 18 - JP0810002', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '025-0082', 'city': 'Hanamaki', 'country': 'Japan', 'facility': 'Investigator site 6 - JPN0810004', 'geoPoint': {'lat': 39.38333, 'lon': 141.11667}}, {'zip': '0810058', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Investigator Site 33 - JP0810058', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '565-0871', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Investigator Site 19 - JP0810007', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '983-8520', 'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigator Site 34 - JP0810005', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '143-8541', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Investigator Site 32 - JP0810059', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Investigator Site 20 - JP0810009', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '2333', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Investigator Site 7 - NL0310001', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Investigator Site 21 - PL0480001', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-123', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Investigator Site 8 - PL0480007', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-2002', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Investigator Site 9 - PL0480024', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-505', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Investigator Site 22 - PL0480005', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-093', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Investigator Site 23 - PL0480018', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Investigator Site 24 - PL0480022', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '630087', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Investigator Site 35 - RU0070002', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigator Site 36 - RU0070014', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Investigator Site 37 - ES0340021', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Investigator Site 26 - ES0340038', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigator Site 25 - ES0340002', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Investigator Site 10 - ES0340039', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'argenx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}