Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT02649218
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '+1 (862) 778-8300', 'title': 'Study Lead', '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': 'Within 16 weeks after Week 48', 'description': 'Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'QGE031 240 mg q4w (TEAE)', 'description': 'QGE031 240 mg every four weeks (TEAE)', 'otherNumAtRisk': 226, 'deathsNumAtRisk': 226, 'otherNumAffected': 133, 'seriousNumAtRisk': 226, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'QGE031 240 mg q4w (Non-TEAE)', 'description': 'QGE031 240 mg every four weeks (non-TEAE)', 'otherNumAtRisk': 226, 'deathsNumAtRisk': 226, 'otherNumAffected': 38, 'seriousNumAtRisk': 226, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Mouth cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Complicated appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment Emergent Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab', 'description': 'QGE031 240 mg s.c. q4w x 13 treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 16 weeks after Week 48', 'description': 'The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: All 226 subjects who received at least one dose of study drug during this open-label study were included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Having Achieved UAS7 ≤ 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab', 'description': 'QGE031 240 mg s.c. q4w x 13 treatments'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.4'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '61.06', 'groupId': 'OG000', 'lowerLimit': '54.4', 'upperLimit': '67.5'}]}]}, {'title': 'Week 100', 'categories': [{'measurements': [{'value': '28.32', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '34.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52 and Week 100', 'description': 'The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations:\n\nSustained remission defined as maintaining (Urticaria Activity Score) UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Number and Proportion of Participants Who Achieved UAS7≤ 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab', 'description': 'QGE031 240 mg s.c. q4w x 13 treatments'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}, {'title': 'Week 100', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 52, Week 100', 'description': 'Summary of subjects with UAS7 ≤ 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7≤ 6) at end of the treatment period (Week 52) and end of follow up period (Week 100).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ligelizumab', 'description': 'QGE031 240 mg s.c. q4w x 13 treatments'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Of the subjects who completed core study (NCT02477332) that were eligible for extension study, 237 were screened; 226 were enrolled to open-label treatment epoch; 201 (88.9%) completed treatment epoch; 209 (92.5%) entered the post-treatment follow-up epoch and 152 (67.3%) completed the post-treatment follow-up epoch'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ligelizumab', 'description': 'QGE031 240 mg s.c. q4w x 13 treatments'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44.5', 'spread': '12.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}]}]}, {'title': '>= 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Percentage of Participants', 'populationDescription': 'The Safety set (SS) included all subjects who received at least one dose of study drug during this open-label study.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'BG000'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'BG000'}]}]}, 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'2021-10-07', 'studyFirstSubmitDate': '2015-12-15', 'resultsFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-11', 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least One Treatment Emergent Adverse Event (AE)', 'timeFrame': 'Within 16 weeks after Week 48', 'description': 'The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Having Achieved UAS7 ≤ 6', 'timeFrame': 'Baseline, Week 52 and Week 100', 'description': 'The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations:\n\nSustained remission defined as maintaining (Urticaria Activity Score) UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.'}, {'measure': 'Number and Proportion of Participants Who Achieved UAS7≤ 6', 'timeFrame': 'Baseline, Week 52, Week 100', 'description': 'Summary of subjects with UAS7 ≤ 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7≤ 6) at end of the treatment period (Week 52) and end of follow up period (Week 100).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QGE031', 'chronic', 'spontaneous', 'Urticaria', 'CSU', 'adults', 'Safety', 'ligelizumab'], '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.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/NCT02477332?term=cqge031c2201&draw=2&rank=2', 'label': 'Core study'}, {'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=771', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201', 'detailedDescription': 'A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients eligible for inclusion in this study have to fulfill all of the following criteria:\n\n 1. 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Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.\n\nExclusion Criteria:\n\nClearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria\n\n* Evidence of parasitic infection\n* Any other skin diseases than chronic spontaneous urticaria with chronic itching\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 Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02649218', 'briefTitle': 'A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. 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