Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 10:50 PM
Study NCT ID:
NCT02477332
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D014581', 'term': 'Urticaria'}], 'ancestors': [{'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598891', 'term': 'ligelizumab'}, {'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '(862) 778-8300', 'title': 'Clinical Disclosure Office', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 44 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 24, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 45, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 46, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 44, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Placebo s.c. q4w', 'description': 'placebo injection subcutaneous every 4 weeks', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 30, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'QGE031 120 mg s.c. s.d.', 'description': 'ligelizumab 120 mg injection subcutaneous single dose', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 28, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Colon dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Fractured coccyx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': "Sjogren's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Benign lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Haemangioma of liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Hives Response (HSS7=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo s.c. q4w', 'description': 'placebo injection subcutaneous every 4 weeks'}, {'id': 'OG005', 'title': 'QGE031 120 mg s.c. s.d.', 'description': 'ligelizumab 120 mg injection subcutaneous single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '46.1'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '40.0', 'upperLimit': '62.3'}, {'value': '42.4', 'groupId': 'OG002', 'lowerLimit': '31.7', 'upperLimit': '53.6'}, {'value': '25.9', 'groupId': 'OG003', 'lowerLimit': '17.0', 'upperLimit': '36.5'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '19.0', 'groupId': 'OG005', 'lowerLimit': '8.6', 'upperLimit': '34.1'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Estimated target dose', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '60', 'paramValue': '32.5', 'ciLowerLimit': '27.5', 'ciUpperLimit': '42.5', 'estimateComment': 'Min dose with effect size \\>15%', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks).\n\nHives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)\n\nTo confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered.'}, {'type': 'SECONDARY', 'title': 'Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete hives response defined as HSS7 = 0.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)', 'unitOfMeasure': 'Particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.75', 'groupId': 'OG000', 'lowerLimit': '-15.75', 'upperLimit': '-2.50'}, {'value': '-15.50', 'groupId': 'OG001', 'lowerLimit': '-20.00', 'upperLimit': '-6.00'}, {'value': '-13.50', 'groupId': 'OG002', 'lowerLimit': '-19.00', 'upperLimit': '-9.00'}, {'value': '-11.00', 'groupId': 'OG003', 'lowerLimit': '-16.50', 'upperLimit': '-4.50'}, {'value': '-6.50', 'groupId': 'OG004', 'lowerLimit': '-13.00', 'upperLimit': '-2.33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'HSS7=0 Response: at Week 20 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 20', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete hives response defined as HSS7 = 0.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.00', 'groupId': 'OG000', 'lowerLimit': '-12.50', 'upperLimit': '-3.50'}, {'value': '-16.50', 'groupId': 'OG001', 'lowerLimit': '-20.50', 'upperLimit': '-6.83'}, {'value': '-14.00', 'groupId': 'OG002', 'lowerLimit': '-19.50', 'upperLimit': '-9.00'}, {'value': '-11.00', 'groupId': 'OG003', 'lowerLimit': '-16.00', 'upperLimit': '-4.25'}, {'value': '-7.50', 'groupId': 'OG004', 'lowerLimit': '-13.50', 'upperLimit': '-2.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 20', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.50', 'groupId': 'OG000', 'lowerLimit': '-12.75', 'upperLimit': '-3.50'}, {'value': '-9.50', 'groupId': 'OG001', 'lowerLimit': '-14.50', 'upperLimit': '-6.00'}, {'value': '-9.00', 'groupId': 'OG002', 'lowerLimit': '-14.00', 'upperLimit': '-4.50'}, {'value': '-8.00', 'groupId': 'OG003', 'lowerLimit': '-11.50', 'upperLimit': '-4.50'}, {'value': '-5.50', 'groupId': 'OG004', 'lowerLimit': '-8.50', 'upperLimit': '-2.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.00', 'groupId': 'OG000', 'lowerLimit': '-11.00', 'upperLimit': '-2.00'}, {'value': '-10.25', 'groupId': 'OG001', 'lowerLimit': '-14.00', 'upperLimit': '-6.50'}, {'value': '-10.00', 'groupId': 'OG002', 'lowerLimit': '-14.00', 'upperLimit': '-5.50'}, {'value': '-8.83', 'groupId': 'OG003', 'lowerLimit': '-11.50', 'upperLimit': '-3.50'}, {'value': '-5.00', 'groupId': 'OG004', 'lowerLimit': '-9.50', 'upperLimit': '-2.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 20', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.50', 'groupId': 'OG000', 'lowerLimit': '-26.75', 'upperLimit': '-6.25'}, {'value': '-26.50', 'groupId': 'OG001', 'lowerLimit': '-33.00', 'upperLimit': '-12.00'}, {'value': '-21.75', 'groupId': 'OG002', 'lowerLimit': '-32.50', 'upperLimit': '-14.00'}, {'value': '-19.00', 'groupId': 'OG003', 'lowerLimit': '-29.00', 'upperLimit': '-8.50'}, {'value': '-12.00', 'groupId': 'OG004', 'lowerLimit': '-21.00', 'upperLimit': '-6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.00', 'groupId': 'OG000', 'lowerLimit': '-23.00', 'upperLimit': '-7.00'}, {'value': '-27.00', 'groupId': 'OG001', 'lowerLimit': '-33.00', 'upperLimit': '-15.00'}, {'value': '-22.92', 'groupId': 'OG002', 'lowerLimit': '-32.50', 'upperLimit': '-13.50'}, {'value': '-18.50', 'groupId': 'OG003', 'lowerLimit': '-28.50', 'upperLimit': '-11.00'}, {'value': '-13.00', 'groupId': 'OG004', 'lowerLimit': '-21.00', 'upperLimit': '-5.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 20', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.\n\nComplete urticaria activity response is defined as UAS7 = 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'UAS7=0 Response: at Week 20 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 20', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.\n\nComplete urticaria activity response is defined as UAS7 = 0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete itch response defined as ISS7 = 0.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}, {'type': 'SECONDARY', 'title': 'ISS7=0 Response: at Week 20 Measured Over 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'OG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'OG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'OG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'placebo injection subcutaneous every 4 week'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 20', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete itch response defined as ISS7 = 0.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \\& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'FG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'FG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'FG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'FG004', 'title': 'Placebo s.c. q4w', 'description': 'placebo injection subcutaneous every 4 weeks'}, {'id': 'FG005', 'title': 'QGE031 120 mg s.c. s.d.', 'description': 'ligelizumab 120 mg injection subcutaneous single dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '85'}, {'groupId': 'FG003', 'numSubjects': '85'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '574 subjects screened; 382 subjects randomized; 338 (88.5%) subjects completed treatment epoch; 349 (91.4%) subjects entered follow-up phase and 320 (83.8%) completed the follow-up epoch'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '382', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks'}, {'id': 'BG001', 'title': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks'}, {'id': 'BG002', 'title': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks'}, {'id': 'BG003', 'title': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks'}, {'id': 'BG004', 'title': 'Placebo s.c. q4w', 'description': 'placebo injection subcutaneous every 4 weeks'}, {'id': 'BG005', 'title': 'QGE031 120 mg s.c. s.d.', 'description': 'ligelizumab 120 mg injection subcutaneous single dose'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '360', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '14.36', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '12.38', 'groupId': 'BG001'}, {'value': '42.9', 'spread': '10.51', 'groupId': 'BG002'}, {'value': '41.8', 'spread': '13.06', 'groupId': 'BG003'}, {'value': '45.4', 'spread': '11.22', 'groupId': 'BG004'}, {'value': '42.4', 'spread': '14.54', 'groupId': 'BG005'}, {'value': '43.3', 'spread': '12.49', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '286', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '96', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2015-06-11', 'resultsFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-13', 'studyFirstPostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Hives Response (HSS7=0)', 'timeFrame': 'Week 12', 'description': 'The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks).\n\nHives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)\n\nTo confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.'}], 'secondaryOutcomes': [{'measure': 'Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days', 'timeFrame': 'Week 12', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete hives response defined as HSS7 = 0.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)'}, {'measure': 'Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days', 'timeFrame': 'Week 12', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)'}, {'measure': 'HSS7=0 Response: at Week 20 Measured Over 7 Days', 'timeFrame': 'Week 20', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete hives response defined as HSS7 = 0.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)'}, {'measure': 'Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days', 'timeFrame': 'Week 20', 'description': 'Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nHives Severity Score scale:\n\n0 - None\n\n1. \\- Mild (1-6 hives/12 hours)\n2. \\- Moderate (7-12 hives/12 hours)\n3. \\- Severe (\\>12 hives/12 hours)'}, {'measure': 'Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days', 'timeFrame': 'Week 12', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)'}, {'measure': 'Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days', 'timeFrame': 'Week 20', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)'}, {'measure': 'Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days', 'timeFrame': 'Week 12', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.'}, {'measure': 'Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days', 'timeFrame': 'Week 20', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.'}, {'measure': 'Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days', 'timeFrame': 'Week 12', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.\n\nComplete urticaria activity response is defined as UAS7 = 0.'}, {'measure': 'UAS7=0 Response: at Week 20 Measured Over 7 Days', 'timeFrame': 'Week 20', 'description': 'UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.\n\nComplete urticaria activity response is defined as UAS7 = 0.'}, {'measure': 'Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days', 'timeFrame': 'Week 12', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete itch response defined as ISS7 = 0.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)'}, {'measure': 'ISS7=0 Response: at Week 20 Measured Over 7 Days', 'timeFrame': 'Week 20', 'description': 'Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.\n\nComplete itch response defined as ISS7 = 0.\n\nItch Severity Score scale:\n\n0 - None\n\n1. \\- Mild (minimal awareness, easily tolerated)\n2. \\- Moderate (definite awareness, bothersome but tolerable)\n3. \\- Severe (difficult to tolerate)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QGE031', 'ligelizumab', 'omalizumab', 'chronic', 'spontaneous', 'urticaria', 'adults', 'CSU'], 'conditions': ['Chronic Spontaneous Urticaria']}, 'referencesModule': {'references': [{'pmid': '36440464', 'type': 'DERIVED', 'citation': 'Metz M, Bernstein JA, Gimenez-Arnau AM, Hide M, Maurer M, Sitz K, Soong W, Sussman G, Hua E, Barve A, Barbier N, Balp MM, Severin T. Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria. World Allergy Organ J. 2022 Nov 15;15(11):100716. doi: 10.1016/j.waojou.2022.100716. eCollection 2022 Nov.'}, {'pmid': '34773261', 'type': 'DERIVED', 'citation': 'Maurer M, Gimenez-Arnau A, Bernstein JA, Chu CY, Danilycheva I, Hide M, Makris M, Metz M, Savic S, Sitz K, Soong W, Staubach P, Sussman G, Barve A, Burciu A, Hua E, Janocha R, Severin T. Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study. Allergy. 2022 Jul;77(7):2175-2184. doi: 10.1111/all.15175. Epub 2021 Nov 22.'}, {'pmid': '31577874', 'type': 'DERIVED', 'citation': 'Maurer M, Gimenez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, Bernstein JA, Brehler R, Chu CY, Chung WH, Danilycheva I, Grattan C, Hebert J, Katelaris C, Makris M, Meshkova R, Savic S, Sinclair R, Sitz K, Staubach P, Wedi B, Loffler J, Barve A, Kobayashi K, Hua E, Severin T, Janocha R. Ligelizumab for Chronic Spontaneous Urticaria. N Engl J Med. 2019 Oct 3;381(14):1321-1332. doi: 10.1056/NEJMoa1900408.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=364', 'label': 'A Plain Language Trial Summary is available on novartisclinicatrials.com'}]}, 'descriptionModule': {'briefSummary': 'This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic spontaneous urticaria for at least 6 months\n* Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization\n\nExclusion Criteria:\n\n* Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria\n* Evidence of parasitic infection\n* Any other skin disease with chronic itching\n* Previous treatment with omalizumab or QGE031\n* Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine\n* History of anaphylaxis\n* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study\n* History of hypersensitivity to any of the study drugs or its components of similar chemical classes\n* Pregnant or nursing (lactating) women\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02477332', 'briefTitle': 'Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)', 'orgStudyIdInfo': {'id': 'CQGE031C2201'}, 'secondaryIdInfos': [{'id': '2014-005559-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QGE031 24 mg s.c. q4w', 'description': 'ligelizumab 24 mg injection subcutaneous every 4 weeks', 'interventionNames': ['Biological: QGE031']}, {'type': 'EXPERIMENTAL', 'label': 'QGE031 72 mg s.c. q4w', 'description': 'ligelizumab 72 mg injection subcutaneous every 4 weeks', 'interventionNames': ['Biological: QGE031']}, {'type': 'EXPERIMENTAL', 'label': 'QGE031 240 mg s.c. q4w', 'description': 'ligelizumab 240 mg injection subcutaneous every 4 weeks', 'interventionNames': ['Biological: QGE031']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab 300 mg s.c. q4w', 'description': 'omalizumab 300 mg injection subcutaneous every 4 weeks', 'interventionNames': ['Biological: Omalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo s.c. q4w', 'description': 'placebo injection subcutaneous every 4 weeks', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'QGE031 120 mg s.c. s.d.', 'description': 'ligelizumab 120 mg injection subcutaneous single dose', 'interventionNames': ['Biological: QGE031']}], 'interventions': [{'name': 'QGE031', 'type': 'BIOLOGICAL', 'armGroupLabels': ['QGE031 120 mg s.c. s.d.', 'QGE031 24 mg s.c. q4w', 'QGE031 240 mg s.c. q4w', 'QGE031 72 mg s.c. q4w']}, {'name': 'Omalizumab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Omalizumab 300 mg s.c. q4w']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo s.c. q4w']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United 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