Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-06-26 @ 5:08 AM
Study NCT ID:
NCT03113760
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'C564469', 'term': 'Lymphoproliferative Syndrome, X-Linked, 2'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118370', 'term': 'interleukin-18 binding protein'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eduardo.schiffrin@ab2bio.com', 'phone': '+41 21 694 00 40', 'title': 'Eduardo Schiffrin', 'organization': 'AB2 Bio Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study).', 'description': 'Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Randomized Double-Blind Placebo-Controlled - Placebo Arm', 'description': 'The Randomized Double-Blind Placebo-Controlled (RDBPC) Analysis Set includes 1 patient treated with Placebo in the first treatment phase.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Screening Phase', 'description': 'Time from informed consent signature up to day prior to first dose of study treatment', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Secretion discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Red blood cell sedimentation rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Adenovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Coronavirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Human rhinovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Interleukin-2 receptor increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sapovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Serum ferritin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 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'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevention of Flares', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'OG001', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'comment': 'Median time to first occurrence of DR was 2.71 weeks for the placebo group and not applicable in the Tadekinig alfa group due to the small number of patients with a disease reactivation.', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to first occurrence of DR was 2.71 weeks for the placebo group and not applicable in the Tadekinig alfa group due to the small number of patients with a disease reactivation.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks', 'description': 'The primary outcome measure is the time to first occurrence of disease reactivation during the 16-week RW phase.\n\nMethod of assessment: Biomarkers (CRP / Ferritin) and clinical manifestations of systemic inflammation and end-organ damage.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Partial response', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Disease improvement', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 weeks', 'description': 'Best response to therapy during the SAOL phase including either complete response, partial response or disease improvement.\n\nMethod of assessment: Biomarkers (CRP / Ferritin) and clinical manifestations of systemic inflammation and end-organ damage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Response During the SAOL Phase (Until End of Phase or Disease Reactivation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa - With a Complete or Partial Response to Therapy', 'description': 'Including all patients treated with Tadekinig alfa in the first treatment phase and achieving a complete or partial response to therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The actual mean treatment duration in the SAOL phase was 17.6 weeks (minimum / maximum 5.9 / 22.1 weeks).', 'description': 'Duration of response to therapy during the SAOL phase is assessed for patients having achieved a complete or partial response to therapy during the SAOL phase. It is defined as the time from first evaluation of partial or complete response until the time of subsequent disease reactivation or end of SAOL phase, whichever occurs first.\n\nOf the 11 patients achieving partial or complete response during the SAOL phase, 8 maintained treatment response until the end of the SAOL phase.\n\n2 of the 11 patients had a temporary disease reactivation during the protocol mandated steroid weaning in the SAOL phase; 1 of the 11 patients was withdrawn from blinded treatment following a disease reactivation.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in mAIDAI Total Score in the SAOL Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'The mAIDAI (modified autoinflammatory disease activitiy index) is an assessment of global disease activity that measures 14 different components for disease as either absent (0 points) or present (2 points for Uveitis 3+/4+ and 1 point for all other symptoms) at each visit. The mAIDAI total score is the sum of the points assigned across all components and ranges from 0 to 15, with a higher score indicating more severe disease activity.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change from Baseline to Week 18 in mAIDAI Total Score. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}, {'id': 'OG001', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'OG002', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8558.7', 'spread': '15700.51', 'groupId': 'OG000'}, {'value': '-109.5', 'spread': '167.4', 'groupId': 'OG001'}, {'value': '211.8', 'spread': '359.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '34 weeks', 'description': 'Laboratory measure', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values indicate change from Baseline to End of Phase results. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}, {'id': 'OG001', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'OG002', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.28', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '34 weeks', 'description': 'Laboratory measure', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Values indicate change from Baseline to End of Phase results. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Resolution of Fevers, Hepato/Splenomegaly and Skin Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'title': 'Resolution of Fever', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Resolution of Organomegaly', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Resolution of Skin rash', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': 'Clinical assessments if present at Baseline; number displays percentage of patients with resolution of individual disease component at Week 18 or early termination visit based on the number of patients with a baseline assessment for the component of interest.', 'unitOfMeasure': 'Percentage of patients with resolution', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - AST (SGOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-286.2', 'spread': '727.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - ALT (SGPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-581.2', 'spread': '1324.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '5.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'spread': '18.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '143.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'cells x 10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '10.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'mm/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - Fibrinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '108.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement in Laboratory Markers - D-Dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.85', 'spread': '5.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}, {'id': 'OG001', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'OG002', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'classes': [{'title': 'Baseline hospitalization', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '63.5'}, {'value': 'NA', 'comment': 'No patient hospitalized at start of RW-phase', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No patient hospitalized at start of RW-phase', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Subsequent hospitalization', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '32.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '34 weeks', 'description': 'Length of hospitalisation; emergency room attendance and unscheduled visits for treatment of disease reactivations not included', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Physician Global Assessment (PGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}, {'id': 'OG001', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'OG002', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '3.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '34 weeks', 'description': 'The PGA is a direct surrogate of how a patient functions and assesses the severity of disease-related (auto-inflammatory) symptoms by selecting an integer score from 0 (no impact on subject; no symptoms) to 10 (no normal activities possible; highest severity of symptoms possible).\n\nThe outcome lists the change from baseline of treatment phase to end of treatment phase/study in the PGA symptom severity score.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Patient/Caregiver Qualitative Evaluation of Health Status in Randomized Withdrawal Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'OG001', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'classes': [{'title': 'Start of RW phase', 'categories': [{'measurements': [{'value': '11.3', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'End of RW phase', 'categories': [{'measurements': [{'value': '7.7', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from start to end of RW phase', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '44.0', 'spread': '17.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'The individual disease-related symptoms score is the sum of (x) individual symptom scores within domain each ranging from 0 (None) to 5 (Very severe) for: general wellbeing (5), gastrointestinal (7), musculoskeletal (5), skin (2), eye (2), central nervous system (3), and lymphatic (2). Highest values indicate more severe disease-related symptoms within total score range from 0-130.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Evaluation', 'timeFrame': '34 weeks (SAOL + RW phases)', 'description': 'Generation of anti-recombinant human IL-18BP (anti-rhIL-18BP) antibodies', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}, {'type': 'SECONDARY', 'title': 'Local Tolerability at the Injection Site (as Defined by Number of Participants With Adverse Events of Special Interest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}, {'id': 'OG001', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'OG002', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '34 weeks (SAOL + RW phases)', 'description': 'Adverse events of special interest (AESIs) are defined for this protocol as injection site reactions (including pruritus, erythema, swelling).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients reporting at least one AESI. The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Disease Reactivation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Disease reactivation rate for individual subjects (number of disease reactivations experienced per week while each subject is on the study treatment during the SAOL phase)', 'unitOfMeasure': 'Disease reactivation rate per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'type': 'SECONDARY', 'title': 'Treatment Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 weeks', 'description': 'Treatment failures (i.e. patients who experience at least one disease reactivation) during the SAOL phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment failures were defined as patients who experienced at least 1 disease reactivation. Disease reactivation includes full or partial disease reactivation after the first assessment indicating partial or complete response during the SAOL phase as defined in the statistical analysis plan.\n\nThe safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Response to Therapy - Key Secondary Efficacy Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 weeks', 'description': 'Response to therapy (including complete response and partial response) in the SAOL phase from Week 10 onwards and observed at least at 2 consecutive visits at least 2 weeks apart during the SAOL phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety and efficacy analyses during the SAOL phase is based on the SAOL-FAS as defined in the study protocol and statistical analysis plan. 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}, {'id': 'FG001', 'title': 'Randomized Double-Blind Placebo-Controlled - Placebo Arm', 'description': 'The Randomized Double-Blind Placebo-Controlled (RDBPC) Analysis Set includes 1 patient treated with Placebo in the first treatment phase under the initial protocol design starting with a randomized treatment phase. As defined in the study protocol and statistical analysis plan, this patient is excluded from the efficacy analysis due to the difference in treatment schedule but included in the safety analysis.'}, {'id': 'FG002', 'title': 'Randomized Withdrawal - Tadekinig Alfa Arm', 'description': 'The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}, {'id': 'FG003', 'title': 'Randomized Withdrawal - Placebo Arm', 'description': 'The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase.'}], 'periods': [{'title': 'Initial 18 Weeks Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Disease relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Randomized Withdrawal Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Open-Label - Tadekinig Alfa', 'description': 'The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment.'}, {'id': 'BG001', 'title': 'Randomized Double-Blind Placebo-Controlled - Placebo Arm', 'description': 'The Randomized Double-Blind Placebo-Controlled Analysis Set (RDBPC-AS) includes 1 patient treated with Placebo in the first treatment phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-03', 'size': 19286685, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-02T09:20', 'hasProtocol': True}, {'date': '2023-09-25', 'size': 8530907, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-02T09:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Initial phase of 18 weeks is a single arm, open-label (SAOL) period where Tadekinig alfa is administered in addition to the standard of care treatment used for the control of flares. The SAOL period will be followed by an up to 16-week randomized withdrawal phase (RW). All patients who showed response to treatment at the end of the SAOL phase will be enrolled in the RW phase. In the RW phase patients will be randomized to either Tadekinig alfa or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2017-02-28', 'resultsFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-13', 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Response to Therapy - Key Secondary Efficacy Endpoint', 'timeFrame': '18 weeks', 'description': 'Response to therapy (including complete response and partial response) in the SAOL phase from Week 10 onwards and observed at least at 2 consecutive visits at least 2 weeks apart during the SAOL phase'}], 'primaryOutcomes': [{'measure': 'Prevention of Flares', 'timeFrame': '16 weeks', 'description': 'The primary outcome measure is the time to first occurrence of disease reactivation during the 16-week RW phase.\n\nMethod of assessment: Biomarkers (CRP / Ferritin) and clinical manifestations of systemic inflammation and end-organ damage.'}], 'secondaryOutcomes': [{'measure': 'Best Response', 'timeFrame': '18 weeks', 'description': 'Best response to therapy during the SAOL phase including either complete response, partial response or disease improvement.\n\nMethod of assessment: Biomarkers (CRP / Ferritin) and clinical manifestations of systemic inflammation and end-organ damage.'}, {'measure': 'Duration of Response During the SAOL Phase (Until End of Phase or Disease Reactivation)', 'timeFrame': 'The actual mean treatment duration in the SAOL phase was 17.6 weeks (minimum / maximum 5.9 / 22.1 weeks).', 'description': 'Duration of response to therapy during the SAOL phase is assessed for patients having achieved a complete or partial response to therapy during the SAOL phase. It is defined as the time from first evaluation of partial or complete response until the time of subsequent disease reactivation or end of SAOL phase, whichever occurs first.\n\nOf the 11 patients achieving partial or complete response during the SAOL phase, 8 maintained treatment response until the end of the SAOL phase.\n\n2 of the 11 patients had a temporary disease reactivation during the protocol mandated steroid weaning in the SAOL phase; 1 of the 11 patients was withdrawn from blinded treatment following a disease reactivation.'}, {'measure': 'Change From Baseline in mAIDAI Total Score in the SAOL Phase', 'timeFrame': '18 weeks', 'description': 'The mAIDAI (modified autoinflammatory disease activitiy index) is an assessment of global disease activity that measures 14 different components for disease as either absent (0 points) or present (2 points for Uveitis 3+/4+ and 1 point for all other symptoms) at each visit. The mAIDAI total score is the sum of the points assigned across all components and ranges from 0 to 15, with a higher score indicating more severe disease activity.'}, {'measure': 'Change From Baseline in Serum Ferritin', 'timeFrame': '34 weeks', 'description': 'Laboratory measure'}, {'measure': 'Change From Baseline in Serum CRP', 'timeFrame': '34 weeks', 'description': 'Laboratory measure'}, {'measure': 'Resolution of Fevers, Hepato/Splenomegaly and Skin Rash', 'timeFrame': '18 weeks', 'description': 'Clinical assessments if present at Baseline; number displays percentage of patients with resolution of individual disease component at Week 18 or early termination visit based on the number of patients with a baseline assessment for the component of interest.'}, {'measure': 'Improvement in Laboratory Markers - AST (SGOT)', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Improvement in Laboratory Markers - ALT (SGPT)', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Improvement in Laboratory Markers - Albumin', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Improvement in Laboratory Markers - Hemoglobin', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Improvement in Laboratory Markers - Platelets', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Improvement in Laboratory Markers - Erythrocyte Sedimentation Rate', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Improvement in Laboratory Markers - Fibrinogen', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Improvement in Laboratory Markers - D-Dimer', 'timeFrame': '18 weeks', 'description': 'Change from Baseline mean value to Week 18 mean value'}, {'measure': 'Hospital Length of Stay', 'timeFrame': '34 weeks', 'description': 'Length of hospitalisation; emergency room attendance and unscheduled visits for treatment of disease reactivations not included'}, {'measure': 'Change in Physician Global Assessment (PGA)', 'timeFrame': '34 weeks', 'description': 'The PGA is a direct surrogate of how a patient functions and assesses the severity of disease-related (auto-inflammatory) symptoms by selecting an integer score from 0 (no impact on subject; no symptoms) to 10 (no normal activities possible; highest severity of symptoms possible).\n\nThe outcome lists the change from baseline of treatment phase to end of treatment phase/study in the PGA symptom severity score.'}, {'measure': 'Change in Patient/Caregiver Qualitative Evaluation of Health Status in Randomized Withdrawal Phase', 'timeFrame': '16 weeks', 'description': 'The individual disease-related symptoms score is the sum of (x) individual symptom scores within domain each ranging from 0 (None) to 5 (Very severe) for: general wellbeing (5), gastrointestinal (7), musculoskeletal (5), skin (2), eye (2), central nervous system (3), and lymphatic (2). Highest values indicate more severe disease-related symptoms within total score range from 0-130.'}, {'measure': 'Immunogenicity Evaluation', 'timeFrame': '34 weeks (SAOL + RW phases)', 'description': 'Generation of anti-recombinant human IL-18BP (anti-rhIL-18BP) antibodies'}, {'measure': 'Local Tolerability at the Injection Site (as Defined by Number of Participants With Adverse Events of Special Interest)', 'timeFrame': '34 weeks (SAOL + RW phases)', 'description': 'Adverse events of special interest (AESIs) are defined for this protocol as injection site reactions (including pruritus, erythema, swelling).'}, {'measure': 'Disease Reactivation Rate', 'timeFrame': '18 weeks', 'description': 'Disease reactivation rate for individual subjects (number of disease reactivations experienced per week while each subject is on the study treatment during the SAOL phase)'}, {'measure': 'Treatment Failures', 'timeFrame': '18 weeks', 'description': 'Treatment failures (i.e. patients who experience at least one disease reactivation) during the SAOL phase'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NLRC4-MAS', 'XIAP Deficiency']}, 'referencesModule': {'references': [{'pmid': '33128796', 'type': 'DERIVED', 'citation': 'Krei JM, Moller HJ, Larsen JB. The role of interleukin-18 in the diagnosis and monitoring of hemophagocytic lymphohistiocytosis/macrophage activation syndrome - a systematic review. Clin Exp Immunol. 2021 Feb;203(2):174-182. doi: 10.1111/cei.13543. Epub 2020 Nov 23.'}], 'seeAlsoLinks': [{'url': 'http://www.ab2bio.com/en/home.8.html', 'label': 'Sponsor details'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 study to assess the safety and efficacy of Tadekinig alfa in patients with monogenic, interleukin-18 (IL 18) driven autoinflammation due to Nucleotide-binding oligomerization domain, leucine-rich repeat and caspase recruiting domain (CARD domain) containing 4 (NLRC4) - Macrophage activation syndrome (MAS) mutation (NLRC4-MAS mutation) or X-linked inhibitor of apoptosis (XIAP) deficiency. Because of the likelihood for pathogenic IL-18 in certain monogenic diseases, patients known to harbor deleterious mutations in NLRC4-MAS or XIAP and who have a history of ongoing inflammation will be enrolled if they have ferritin ≥ 500 ng/mL or persistent C reactive protein (CRP) elevation ≥ 2 times the upper limit of normal (ULN) and the patients should have a Modified Autoinflammatory Disease Activity Index (mAIDAI) ≥ 4.', 'detailedDescription': 'The study is designed with single-arm, open-label phase (SAOL) of Tadekinig alfa treatment duration for 18-week followed by an up to 16-week Randomized Withdrawal (RW) period for efficacy and safety evaluation, with no interruption between the two phases of treatment. The screening period will occur before the SAOL phase and before the first dose of Investigational Medicinal Product (IMP)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n1. Patients with genetic diagnosis of NLRC4-MAS mutation or XIAP deficiency (caused by BIRC4 gene mutation) as confirmed by analysis performed at the central genetics laboratory. If possible, flow cytometry assay will be performed in parallel to confirm diagnosis of XIAP deficiency. (Note: Previous flow cytometry assay results will be permitted for confirmation of XIAP deficiency diagnosis.)\n2. Patients with XIAP deficiency and a previous bone marrow transplantation are allowed, if they show evidence of primary or secondary graft failure, or failure to achieve phenotypic correction with evidence of XIAP-related disease recurrence or clinically significant mixed chimerism.\n3. Ferritin ≥ 500 ng/mL or persistent elevation of CRP ≥ 2x ULN and mAIDAI ≥4\n4. Patients receiving corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) or disease modifying anti-rheumatic drugs (DMARDs), and/or IL-1 blockade with insufficient response to treatment upon enrollment are allowed into the study. Patients not receiving any of these treatments before start of therapy are also allowed.\n5. Women of childbearing potential with negative urine pregnancy test (UPT) at all visits (if UPT is positive, a blood test for human chorionic gonadotropin (hCG) to be performed) and who agree to follow highly effective birth control recommendations during the study and until 1 month after the end of the treatment. Birth control methods considered highly effective are: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence. In each case of delayed menstrual period (over one month between menstruations, confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to women of childbearing potential with infrequent or irregular menstrual cycles. A post-study contraception duration of 4 weeks is recommended taking into account the median half-life of Tadekinig alfa of almost 40h and 5 half-lives representing a duration of 200 hours.\n\nEXCLUSION CRITERIA\n\n1. Patients with life-threatening co-morbidities not associated with the underlying NLRC4-mutation or XIAP deficiency\n2. Positive test for or prior history of HIV, Hepatitis B or Hepatitis C (serology)\n3. Presence of active infections or a history of pulmonary TB infection with or without documented adequate therapy\n4. Presence of life threatening infections\n5. Oncologic causes of symptoms; current or previous history of malignancy\n6. Presence of CNS manifestations (i.e. seizures, altered mental status, signs of increased intracranial pressure, chronic papilledema, loss of vision, other sensorineural deficiencies, etc.)\n7. Patients suffering from biallelic mutations in any of the following genes: PRF1/Perforin, UNC13D/Munc 13-4, STX11/Syntaxin11, STXB2/Munc 18-2, RAB27A/Rab27a (Griscelli syndrome type 2), LYST (Chediak-Higashi syndrome), AP3B1, ADTB3A, HPS2 mutations (Hermansky-Pudlak syndrome 2) and X-linked lymphoproliferative syndrome (XLP)-1 with SH2D1A mutation\n8. Patients who are pregnant or nursing, women of childbearing potential who are unwilling to use highly effective birth control methods (see definition in Inclusion Criteria above) through 4 weeks after the end of their participation in the study\n9. Concomitant use of immunosuppression therapies excluded by the protocol. Note: NSAIDs, glucocorticoids, cyclosporine, tacrolimus, and IL-1 inhibitors (anakinra, canakinumab, or rilonacept, or others) are allowed\n10. Patients and/or parents (or legal representative, if applicable) not willing to sign assent/informed consent\n11. Hypersensitivity to the active substance or one of the excipients of the investigational product'}, 'identificationModule': {'nctId': 'NCT03113760', 'briefTitle': 'Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB2 Bio Ltd.'}, 'officialTitle': 'Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial With Tadekinig Alfa (r-hIL-18BP) in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP Deficiency', 'orgStudyIdInfo': {'id': 'NLRC4/XIAP.2016.001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tadekinig alfa', 'description': 'Patients that showed response to treatment in the SAOL phase will receive Tadekinig alfa for up to 16 weeks.', 'interventionNames': ['Drug: Tadekinig alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% sodium chloride', 'description': 'Patients that showed response to treatment in the SAOL phase will receive placebo comparator for up to 16 weeks.', 'interventionNames': ['Other: 0.9% sodium chloride']}], 'interventions': [{'name': 'Tadekinig alfa', 'type': 'DRUG', 'otherNames': ['IL-18BP', 'r-hIL-18BP'], 'description': 'Tadekinig alfa is a soluble glycoprotein of 164 amino acids produced from Chinese Hamster Ovary cell line. Tadekinig alfa is supplied as a colorless to slightly yellow, sterile solution for injection in glass vials containing sodium chloride, and 0.02M sodium phosphate buffer as excipients. It is available in a concentration of 20mg/0.5mL.', 'armGroupLabels': ['Tadekinig alfa']}, {'name': '0.9% sodium chloride', 'type': 'OTHER', 'description': 'To ensure that the treatment remains blinded for the entire study period, the placebo solutions will be supplied in identical vials and similar labelling as the active drug and will be indistinguishable in terms of their texture, color, and smell.', 'armGroupLabels': ['0.9% sodium chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92056', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': "UCSD _ Department of Pediatrics / Rady Children's Hospital", 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta at Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Children Hospital of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital _ Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'ON M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'QC H3T 1C5', 'city': 'Montreal', 'state': 'Providence', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) - Paediatric Unit', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Ed M Behrens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Children Hospital of Philadelphia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This information will be provided soon'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB2 Bio Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}