Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05817669
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718373', 'term': 'efgartigimod alfa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'regulatory@argenx.com', 'phone': 'Please email:', 'title': 'Regulatory manager', 'organization': 'Argenx'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 32 weeks.', 'description': 'The SAF included all participants exposed to the study treatment. Any abnormal laboratory results or changes in vital signs are captured in the adverse event listings.', 'eventGroups': [{'id': 'EG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 20, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': "Sjogren's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '26.92', 'upperLimit': '65.34'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '1.99', 'upperLimit': '43.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "A Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responder is defined as improvements in at least 3 of the 5 items of CRESS (systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function and serology. The score ranges from 0 to 9 (higher score = worse symptoms).", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Set (EAS) included all participants eligible for efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs, AESI, and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any AESI', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 32 weeks', 'description': "A treatment-emergent adverse event (TEAE): adverse events reported from the first dose up to and including 60 days after the final dose were considered treatment-emergent. Serious adverse event (SAE): adverse event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other situations. Adverse event of special interest (AESI): adverse event related to 'Infections and infestations'.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set (SAF) included all participants exposed to the study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With MCII in ESSDAI at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '51.85', 'upperLimit': '86.85'}, {'value': '55.6', 'groupId': 'OG001', 'lowerLimit': '26.67', 'upperLimit': '81.12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Minimally clinically important improvement (MCII) in ESSDAI was defined as improvement of at least 3 points in ESSDAI score at Week 24.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity in ESSDAI at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000', 'lowerLimit': '38.73', 'upperLimit': '76.74'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '6.32', 'upperLimit': '54.74'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Low disease activity in ESSDAI was defined as ESSDAI score of less than 5 at Week 24.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With MCII in clinESSDAI at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000', 'lowerLimit': '56.56', 'upperLimit': '89.88'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '45.26', 'upperLimit': '93.68'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Clinical (clin)ESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Minimal clinically important improvement (MCII) in clinESSDAI was defined as improvement of at least 3 points in clinESSDAI score at Week 24.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000', 'lowerLimit': '38.73', 'upperLimit': '76.74'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '12.06', 'upperLimit': '64.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Low disease activity in clinESSDAI was defined as clinESSDAI score of less than 5 at Week 24.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With MCII in ESSPRI at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '16.36', 'upperLimit': '52.68'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '12.06', 'upperLimit': '64.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Minimal clinically important improvement in ESSPRI was defined as decrease of 1 point or at least ≥15% at Week 24. ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ESSDAI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '-4.0'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '-1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score = worse symptoms).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS - Only participants with data collected at baseline and Week 24 are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in clinESSDAI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '-3.0'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-17.0', 'upperLimit': '-3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS - Only participants with data collected at baseline and Week 24 are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ESSPRI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.500', 'groupId': 'OG000', 'lowerLimit': '-1.333', 'upperLimit': '0.333'}, {'value': '-0.833', 'groupId': 'OG001', 'lowerLimit': '-1.333', 'upperLimit': '-0.333'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS - Only participants with data collected at Baseline and Week 24 are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With STAR Score of at Least 5 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '34.66', 'upperLimit': '73.08'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '12.06', 'upperLimit': '64.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "Sjögren's Tool for Assessing Response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a score of at least 5 points. Due to the weighting, participants must be a responder on either systemic disease activity (ESSDAI), patient-reported symptoms (ESSPRI), or both to be an overall STAR responder. The score ranges between 0 and 9 (higher score = worse outcome).", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Efgartigimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'title': 'Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation could not be calculated as the values were below the lower limit of quantification (LLOQ). LLOQ was 200 ng/mL.', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '179391', 'spread': '79751', 'groupId': 'OG000'}]}]}, {'title': 'Week 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17238', 'spread': '37356', 'groupId': 'OG000'}]}]}, {'title': 'Week 1: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '187300', 'spread': '73091', 'groupId': 'OG000'}]}]}, {'title': 'Week 2: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22470', 'spread': '42838', 'groupId': 'OG000'}]}]}, {'title': 'Week 2: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '205148', 'spread': '52448', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38595', 'spread': '65900', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '206414', 'spread': '102089', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14193', 'spread': '5753', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '203505', 'spread': '89762', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13096', 'spread': '4523', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '200856', 'spread': '138766', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12676', 'spread': '5835', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '261647', 'spread': '215940', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12942', 'spread': '4472', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '194944', 'spread': '81722', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: 30 minutes post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14284', 'spread': '4987', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, and 20; 30 minutes post-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': 'Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod.', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all randomized participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point. Only participants with data collected at specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Total IgG Levels in Serum at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.172', 'spread': '17.7376', 'groupId': 'OG000'}, {'value': '0.279', 'spread': '9.5193', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF - Only participants with data available at baseline and Week 24 are reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ADA Against Efgartigimod in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'classes': [{'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-induced ADA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-unaffected ADA', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. Treatment-boosted ADA was defined as participants who had a baseline positive sample and the titer value increased 4-fold or more compared to baseline. Treatment-induced ADA was defined as participants who had a baseline negative sample and at least 1 positive post-baseline samples. Treatment-unaffected ADA was defined as participants who had a baseline positive sample, but the titer value did not increase 4-fold or more compared to baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 milligram per kilogram (mg/kg) once weekly via intravenous (IV) infusion for up to 24 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'comment': 'Completed 24-week treatment period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Prohibited medication used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "This Phase 2, double-blinded study was conducted in adult participants with primary Sjögren's disease (pSjD) at 15 investigational sites in 3 countries (Belgium, Hungary, and Poland) between 08-May-2023 and 12-Feb-2024.", 'preAssignmentDetails': 'A total of 34 participants were enrolled in the study. The study consisted of screening (≤4 weeks), treatment period (24 weeks), and follow-up period (56 days). Participants were randomized in a 2:1 ratio to either receive efgartigimod or placebo for 24 weeks. At the end of treatment period, eligible participants rolled over to an open-label extension (OLE) study (ARGX-113-2211 \\[NCT06203457\\]) or remained in the study for the post-treatment follow-up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Efgartigimod', 'description': 'Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '12.57', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '12.42', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '12.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment and who were classified according to the planned treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-05', 'size': 1806867, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-25T11:15', 'hasProtocol': True}, {'date': '2024-02-12', 'size': 3591593, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-25T11:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants will be randomized to receive efgartigimod 10 mg/kg or placebo in a 2:1 ratio, respectively. All participants will receive efgartigimod IV 10 mg/kg or placebo once weekly for 24 weeks during the treatment period'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2023-02-01', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-30', 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24', 'timeFrame': 'Week 24', 'description': "A Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responder is defined as improvements in at least 3 of the 5 items of CRESS (systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function and serology. The score ranges from 0 to 9 (higher score = worse symptoms)."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With TEAEs, AESI, and SAEs', 'timeFrame': 'Up to 32 weeks', 'description': "A treatment-emergent adverse event (TEAE): adverse events reported from the first dose up to and including 60 days after the final dose were considered treatment-emergent. Serious adverse event (SAE): adverse event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other situations. Adverse event of special interest (AESI): adverse event related to 'Infections and infestations'."}, {'measure': 'Percentage of Participants With MCII in ESSDAI at Week 24', 'timeFrame': 'Week 24', 'description': "European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Minimally clinically important improvement (MCII) in ESSDAI was defined as improvement of at least 3 points in ESSDAI score at Week 24."}, {'measure': 'Percentage of Participants With Low Disease Activity in ESSDAI at Week 24', 'timeFrame': 'Week 24', 'description': 'ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Low disease activity in ESSDAI was defined as ESSDAI score of less than 5 at Week 24.'}, {'measure': 'Percentage of Participants With MCII in clinESSDAI at Week 24', 'timeFrame': 'Week 24', 'description': 'Clinical (clin)ESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Minimal clinically important improvement (MCII) in clinESSDAI was defined as improvement of at least 3 points in clinESSDAI score at Week 24.'}, {'measure': 'Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24', 'timeFrame': 'Week 24', 'description': 'clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Low disease activity in clinESSDAI was defined as clinESSDAI score of less than 5 at Week 24.'}, {'measure': 'Percentage of Participants With MCII in ESSPRI at Week 24', 'timeFrame': 'Week 24', 'description': 'Minimal clinically important improvement in ESSPRI was defined as decrease of 1 point or at least ≥15% at Week 24. ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms).'}, {'measure': 'Change From Baseline in ESSDAI Score at Week 24', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score = worse symptoms).'}, {'measure': 'Change From Baseline in clinESSDAI Score at Week 24', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms).'}, {'measure': 'Change From Baseline in ESSPRI Score at Week 24', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms).'}, {'measure': 'Percentage of Participants With STAR Score of at Least 5 at Week 24', 'timeFrame': 'Week 24', 'description': "Sjögren's Tool for Assessing Response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a score of at least 5 points. Due to the weighting, participants must be a responder on either systemic disease activity (ESSDAI), patient-reported symptoms (ESSPRI), or both to be an overall STAR responder. The score ranges between 0 and 9 (higher score = worse outcome)."}, {'measure': 'Plasma Concentration of Efgartigimod', 'timeFrame': 'Pre-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, and 20; 30 minutes post-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': 'Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod.'}, {'measure': 'Percentage Change From Baseline in Total IgG Levels in Serum at Week 24', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': 'Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum.'}, {'measure': 'Number of Participants With ADA Against Efgartigimod in Serum', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. Treatment-boosted ADA was defined as participants who had a baseline positive sample and the titer value increased 4-fold or more compared to baseline. Treatment-induced ADA was defined as participants who had a baseline negative sample and at least 1 positive post-baseline samples. Treatment-unaffected ADA was defined as participants who had a baseline positive sample, but the titer value did not increase 4-fold or more compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Primary Sjögren's Syndrome"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.', 'detailedDescription': 'Primary Sjogren Syndrome (pSS) is an autoimmune disease with still unmet treatment needs. Efgartigimod, a human FcRn antagonist, has the potential to successfully treat pSS and improve disease manifestations by the reduction of IgG autoantibodies and immune complexes in pSS. The study design is randomized, double-blinded, and placebo-controlled to evaluate the effect of efgartigimod administered as an IV infusion compared to placebo. The study consists of a treatment period when all participants will receive infusions of IP/placebo for 24 weeks. At the end of the randomized treatment period, eligible participants may roll over to an OLE study or remain in this study through the end of the 56-day follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Is at least the legal age of consent for clinical trials when signing the informed consent form\n* Is capable of providing signed informed consent and complying with protocol requirements\n* Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol\n* Meets the following criteria at screening: ACR/EULAR 2016 pSS who met criteria ≤7 years before screening; ESSDAI ≥5; Anti-Ro/SS-A positive; Residual salivary flow (UWSF rate \\>0 and/or SWSF rate \\>0.10)\n\nExclusion Criteria:\n\n* Known autoimmune disease or any medical condition that, in the investigator's judgment,would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk\n* History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP.\n* Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection\n* Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of \\<200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of \\>200 cells/mm3 not adequately treated with antiviral therapy\n* Clinically significant disease, recent major surgery (within 3 months of screening), or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk\n* Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L)\n* Positive covid test at study start\n* Some of the medications such as vaccines with live components or medicines that may be prescribed cannot be taken either shortly before or during this study\n* Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with ≥1 dose of IMP\n* Known hypersensitivity to IMP or 1 of its excipients\n* History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator\n* Pregnant or lactating state or intention to become pregnant during the study\n* Secondary Sjögren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis\n* Chinese traditional medicine with known immunomodulatory action"}, 'identificationModule': {'nctId': 'NCT05817669', 'acronym': 'rho', 'briefTitle': "A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)", 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': "A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'ARGX-113-2106'}, 'secondaryIdInfos': [{'id': '2021-005911-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efgartigimod IV arm', 'description': 'patients receiving infusions of Efgartigimod IV', 'interventionNames': ['Biological: Efgartigimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'patients receiving infusions of placebo IV', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Efgartigimod', 'type': 'BIOLOGICAL', 'description': 'Patients receiving efgartigimod infusions', 'armGroupLabels': ['Efgartigimod IV arm']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Patients receiving placebo infusions', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 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