Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT05024058
Status:
TERMINATED
Last Update Posted:
2024-06-18
First Post:
2021-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Italy', 'Lebanon', 'Netherlands', 'Singapore', 'Slovenia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094482', 'term': 'Chronic Inducible Urticaria'}, {'id': 'C536612', 'term': 'Familial dermographism'}, {'id': 'D000096703', 'term': 'Cold Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'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': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598891', 'term': 'ligelizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '(862) 778-8300', 'title': 'Study Director', '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 (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment).', 'description': 'AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.', 'eventGroups': [{'id': 'EG000', 'title': 'Ligelizumab 72mg', 'description': '72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ligelizumab 120mg', 'description': 'symptomatic dermographism 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo - Ligelizumab 72mg', 'description': 'symptomatic dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo - Ligelizumab 120mg', 'description': 'symptomatic dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Total', 'description': 'Total number of participants who participated in the trial', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 13, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypopituitarism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Post-acute COVID-19 syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '72 mg Ligelizumab, Symptomatic Dermographism', 'description': '72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism'}, {'id': 'OG001', 'title': '120 mg Ligelizumab, Symptomatic Dermographism', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism'}, {'id': 'OG002', 'title': 'Placebo - 72 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'OG003', 'title': 'Placebo -120 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}], 'timeFrame': 'Baseline, Week 12', 'description': 'Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)\n\nNone of the participants completed Week 12 and hence at Week 12 was not analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Analysis Set (RAN) consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '72 mg Ligelizumab Cold Urticaria', 'description': '72 mg ligelizumab subcutaneous injection every 4 weeks in participants with cold urticaria'}, {'id': 'OG001', 'title': '120 mg Ligelizumab, Cold Urticaria', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'OG002', 'title': 'Placebo - 72 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria'}, {'id': 'OG003', 'title': 'Placebo - 120 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria'}], 'classes': [{'categories': [{'measurements': [{'value': '-26', 'groupId': 'OG000'}, {'value': '-15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.', 'unitOfMeasure': 'Temperature (degrees celcius)', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Ligelizumab, Cholinergic Urticaria', 'description': '120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}, {'id': 'OG001', 'title': 'Placebo - 120 mg Ligelizumab, Cholinergic Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}], 'classes': [{'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")', 'unitOfMeasure': 'Scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '72 mg Ligelizumab, Symptomatic Dermographism', 'description': '72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism'}, {'id': 'OG001', 'title': '120 mg Ligelizumab, Symptomatic Dermographism', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism'}, {'id': 'OG002', 'title': 'Placebo - 72 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'OG003', 'title': 'Placebo - 120 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}], 'timeFrame': 'Week 12', 'description': 'Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)\n\nNone of the participants completed Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '72 mg Ligelizumab, Symptomatic Dermographism', 'description': '72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism'}, {'id': 'OG001', 'title': '120 mg Ligelizumab, Symptomatic Dermographism', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism'}, {'id': 'OG002', 'title': 'Placebo - 72 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'OG003', 'title': 'Placebo - 120 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}], 'timeFrame': 'Baseline, Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nNo participants completed week 12.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '72 mg Ligelizumab, Cold Urticaria', 'description': '72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'OG001', 'title': '120 mg Ligelizumab, Cold Urticaria', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'OG002', 'title': 'Placebo - 72 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria'}, {'id': 'OG003', 'title': 'Placebo - 120 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'The TempTest® is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '72 mg Ligelizumab Cold Urticaria', 'description': '72 mg ligelizumab subcutaneous injection every 4 weeks in participants with cold urticaria'}, {'id': 'OG001', 'title': '120 mg Ligelizumab, Cold Urticaria', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'OG002', 'title': 'Placebo - 72 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'OG003', 'title': 'Placebo -120 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria'}], 'classes': [{'categories': [{'measurements': [{'value': '-9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")', 'unitOfMeasure': 'Scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Ligelizumab, Cholinergic Urticaria', 'description': '120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}, {'id': 'OG001', 'title': 'Placebo - 120 mg Ligelizumab, Cholinergic Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Ligelizumab, Cholinergic Urticaria', 'description': '120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}, {'id': 'OG001', 'title': 'Placebo - 120 mg Ligelizumab, Cholinergic Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Physician global assessment of severity of hives\n\nPGA is an assessment of all lesions scored on a scale from 0-5 (with 0 = No hives and 5 = Very severe hives)', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned.\n\nDue to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '72 mg Ligelizumab, Symptomatic Dermographism', 'description': '72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism'}, {'id': 'FG001', 'title': '120 mg Ligelizumab, Symptomatic Dermographism', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism'}, {'id': 'FG002', 'title': 'Placebo - 72 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'FG003', 'title': 'Placebo - 120 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'FG004', 'title': '72 mg Ligelizumab Cold Urticaria', 'description': '72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'FG005', 'title': '120 mg Ligelizumab, Cold Urticaria', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'FG006', 'title': 'Placebo - 72 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria'}, {'id': 'FG007', 'title': 'Placebo - 120 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria'}, {'id': 'FG008', 'title': '120 mg Ligelizumab, Cholinergic Urticaria', 'description': '120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria'}, {'id': 'FG009', 'title': 'Placebo - 120 mg Ligelizumab, Cholinergic Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}], 'periods': [{'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '39 participants were randomized. None completed study.', 'preAssignmentDetails': 'There were no pre-assignment details for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '39', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': '72 mg Ligelizumab, Symptomatic Dermographism', 'description': '72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism'}, {'id': 'BG001', 'title': '120 mg Ligelizumab, Symptomatic Dermographism', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism'}, {'id': 'BG002', 'title': 'Placebo - 72 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'BG003', 'title': 'Placebo - 120 mg Ligelizumab, Symptomatic Dermographism', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism'}, {'id': 'BG004', 'title': '72 mg Ligelizumab Cold Urticaria', 'description': '72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'BG005', 'title': '120 mg Ligelizumab, Cold Urticaria', 'description': '120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria'}, {'id': 'BG006', 'title': 'Placebo - 72 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria'}, {'id': 'BG007', 'title': 'Placebo - 120 mg Ligelizumab, Cold Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria'}, {'id': 'BG008', 'title': '120 mg Ligelizumab, Cholinergic Urticaria', 'description': '120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria'}, {'id': 'BG009', 'title': 'Placebo - 120 mg Ligelizumab, Cholinergic Urticaria', 'description': 'Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '34', 'groupId': 'BG010'}]}, {'title': '>=65 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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '9.81', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '12.74', 'groupId': 'BG001'}, {'value': '40.8', 'spread': '18.86', 'groupId': 'BG002'}, {'value': '36.5', 'spread': '12.02', 'groupId': 'BG003'}, {'value': '35.3', 'spread': '12.50', 'groupId': 'BG004'}, {'value': '31.7', 'spread': '16.17', 'groupId': 'BG005'}, {'value': '60.0', 'spread': 'NA', 'comment': 'Not evaluable', 'groupId': 'BG006'}, {'value': '32.3', 'spread': '26.58', 'groupId': 'BG007'}, {'value': '28.8', 'spread': '9.62', 'groupId': 'BG008'}, {'value': '25.2', 'spread': '5.56', 'groupId': 'BG009'}, {'value': '27.0', 'spread': '7.73', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '19', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '20', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '36', 'groupId': 'BG010'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}]}]}, {'title': 'Asian', 'categories': [{'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Randomized Analysis Set (RAN) consisted of all randomized participants, regardless of whether or not they received a dose of study drug. Participants were analyzed according to the treatment they were assigned. Data could not be analyzed because no subject completed Week 12 in the sympomatic dermographism cohort, 1 subject each completed the Week 12 in 72 mg ligelizumab and 120 mg ligelizumab groups in cold urticaria cohort, 1 subject completed Week 12 in cholinergic urticaria cohort.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-07', 'size': 4483730, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-09T18:50', 'hasProtocol': True}, {'date': '2022-07-20', 'size': 1879098, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-09T18:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Phase III PEARL studies (CQGE031C2302 and CQGE031C2303) with ligelizumab met their primary endpoint of superiority vs placebo at Week 12 for treatment of CSU, but not versus omalizumab. Decision to discontinue was not based on safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2021-08-23', 'resultsFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-11', 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism', 'timeFrame': 'Baseline, Week 12', 'description': 'Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)\n\nNone of the participants completed Week 12 and hence at Week 12 was not analyzed'}, {'measure': 'Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria', 'timeFrame': 'Baseline, Week 12', 'description': 'The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.'}, {'measure': 'Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria', 'timeFrame': 'Baseline, Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0', 'timeFrame': 'Week 12', 'description': 'Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)\n\nNone of the participants completed Week 12'}, {'measure': 'Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism', 'timeFrame': 'Baseline, Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")'}, {'measure': 'Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest', 'timeFrame': 'Baseline, Week 12', 'description': 'The TempTest® is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.'}, {'measure': 'Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria', 'timeFrame': 'Baseline, Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")'}, {'measure': 'Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0', 'timeFrame': 'Week 12', 'description': 'Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.\n\nPatients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")'}, {'measure': 'Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0', 'timeFrame': 'Week 12', 'description': 'Physician global assessment of severity of hives\n\nPGA is an assessment of all lesions scored on a scale from 0-5 (with 0 = No hives and 5 = Very severe hives)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ligelizumab', 'anti-IgE', 'CINDU', 'chronic inducible urticaria', 'symptomatic dermographism', 'cold urticaria', 'cholinergic urticaria', 'urticaria', 'itch', 'hives'], 'conditions': ['Chronic Inducible Urticaria']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1527', 'label': 'Patient Lay Trial Summary'}]}, 'descriptionModule': {'briefSummary': 'This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines', 'detailedDescription': 'There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study was to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months.\n\n * Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:\n * Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH\n * Positive response (i.e. development of symptoms) to provocation test on day of randomization\n * Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.\n * Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.\n * Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests\n\n * Participants who have concomitant CSU at screening\n * Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study\n * Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study\n * Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).\n * Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism\n * Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies"}, 'identificationModule': {'nctId': 'NCT05024058', 'acronym': 'PEARL-PROVOKE', 'briefTitle': 'Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines', 'orgStudyIdInfo': {'id': 'CQGE031E12301'}, 'secondaryIdInfos': [{'id': '2020-003018-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ligelizumab low dose, symptomatic dermographism group', 'description': 'Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism', 'interventionNames': ['Drug: Ligelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ligelizumab high dose, symptomatic dermographism', 'description': 'Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism', 'interventionNames': ['Drug: Ligelizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SC q4W, symptomatic dermographism', 'description': 'Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ligelizumab low dose, cold urticaria', 'description': 'Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria', 'interventionNames': ['Drug: Ligelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ligelizumab high dose, cold urticaria', 'description': 'Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria', 'interventionNames': ['Drug: Ligelizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SC q4w, cold urticaria', 'description': 'Placebo subcutaneous injection every 4 weeks in participants with cold urticaria', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ligelizumab high dose, cholinergic urticaria', 'description': 'Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria', 'interventionNames': ['Drug: Ligelizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SC q4w, cholinergic urticaria', 'description': 'Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ligelizumab', 'type': 'DRUG', 'otherNames': ['QGE031'], 'description': 'Ligelizumab treated groups and arms', 'armGroupLabels': ['Ligelizumab high dose, cholinergic urticaria', 'Ligelizumab high dose, cold urticaria', 'Ligelizumab high dose, symptomatic dermographism', 'Ligelizumab low dose, cold urticaria', 'Ligelizumab low dose, symptomatic dermographism group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo treated groups and arms', 'armGroupLabels': ['Placebo SC q4W, symptomatic dermographism', 'Placebo SC q4w, cholinergic urticaria', 'Placebo SC q4w, cold urticaria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '29420', 'city': 'North Charleston', 'state': 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'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198260', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '355000', 'city': 'Stavropol', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'zip': '060 01', 'city': 'Kežmarok', 'country': 'Slovakia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.13571, 'lon': 20.43352}}, {'zip': '08901', 'city': 'Svidník', 'country': 'Slovakia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.30819, 'lon': 21.5703}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}