Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT03948334
Status:
TERMINATED
Last Update Posted:
2021-10-08
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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 (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from first dose of study treatment in this extension study until end of study treatment plus 4 weeks post treatment, up to maximum duration of 67 weeks (week 16 to week 83 referring to core study).', 'description': 'Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment', 'eventGroups': [{'id': 'EG000', 'title': 'ZPL389 30mg in the First 16 Weeks of This Extension Study', 'description': 'AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 6, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'ZPL389 50mg in the First 16 Weeks of This Extension Study', 'description': 'AEs starting up to week 16 of this extension study (week 16 to week 32 referring to core study)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 8, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study', 'description': 'AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 9, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study', 'description': 'AEs from week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 6, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZPL389 30mg', 'description': 'Dose 1 of ZPL389 + TCS and/or TCI'}, {'id': 'OG001', 'title': 'ZPL389 50mg', 'description': 'Dose 2 of ZPL389 + TCS and/or TCI'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks (week 16 to week 32 referring to core study)', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZPL389 30mg', 'description': '30mg of ZPL389 + TCS and/or TCI'}, {'id': 'OG001', 'title': 'ZPL389 50mg', 'description': '50mg of ZPL389 + TCS and/or TCI'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.'}, {'type': 'SECONDARY', 'title': "Percentage of Investigator's Global Assessment (IGA) Responders Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ZPL389 30mg Re-randomized After Core Study', 'description': '30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)'}, {'id': 'OG001', 'title': 'ZPL389 50mg Re-randomized After Core Study', 'description': '50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)'}, {'id': 'OG002', 'title': 'ZPL389 30mg Continuing After Core Study', 'description': '30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study'}, {'id': 'OG003', 'title': 'ZPL389 50mg Continuing After Core Study', 'description': '50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study'}], 'classes': [{'title': 'week 4 (week 20 referring to core study)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '8.6'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '13.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '-2.8', 'upperLimit': '8.9'}]}]}, {'title': 'Week 8 (week 24 referring to core study)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '8.6'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '-3.9', 'upperLimit': '13.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '-2.8', 'upperLimit': '9.0'}]}]}, {'title': 'Week 12 (week 28 referring to core study)', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '10.1'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '-4.4', 'upperLimit': '12.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '1.1'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '-2.8', 'upperLimit': '8.9'}]}]}, {'title': 'Week 16 (week 32 referring to core study)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '11.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '15.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '1.9'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-2.0', 'upperLimit': '2.4'}]}]}, {'title': 'Week 28 (week 44 referring to core study)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '6.4'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '18.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '1.6'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '-3.8', 'upperLimit': '6.9'}]}]}, {'title': 'Week 40 (week 56 referring to core study)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '-4.4', 'upperLimit': '11.2'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '20.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-4.3', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-4.2', 'upperLimit': '7.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)', 'description': "IGA score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The scale ranges from 0=clear to 4=severe. It is a static scale and doesn't refer to previous status of the subject. IGA response is an achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy up to the assessment time point. Treatment discontinuations for lack of efficacy or AE are considered non-responders.Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study, in addition to the timeframe referring to the start in this extension study, the timeframe corresponding to the start in the core study (+16 weeks) are provided in parenthesis. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.'}, {'type': 'SECONDARY', 'title': 'Percentage of EASI50 Responders Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ZPL389 30mg Re-randomized After Core Study', 'description': '30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)'}, {'id': 'OG001', 'title': 'ZPL389 50mg Re-randomized After Core Study', 'description': '50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)'}, {'id': 'OG002', 'title': 'ZPL389 30mg Continuing After Core Study', 'description': '30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study'}, {'id': 'OG003', 'title': 'ZPL389 50mg Continuing After Core Study', 'description': '50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study'}], 'classes': [{'title': 'week 4 (week 20 referring to core study)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '26.6'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '25.2'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '-2.6', 'upperLimit': '17.9'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '23.3'}]}]}, {'title': 'Week 8 (week 24 referring to core study)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '30.5'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '29.0'}, {'value': '11.5', 'groupId': 'OG002', 'lowerLimit': '-0.7', 'upperLimit': '23.8'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '23.3'}]}]}, {'title': 'Week 12 (week 28 referring to core study)', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '36.6'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '29.3'}, {'value': '10.7', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '23.0'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '23.3'}]}]}, {'title': 'Week 16 (week 32 referring to core study)', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '33.4'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '32.6'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '-2.0', 'upperLimit': '22.2'}, {'value': '11.9', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '23.3'}]}]}, {'title': 'Week 28 (week 44 referring to core study)', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '22.6'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '28.8'}, {'value': '14.0', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '27.8'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '26.8'}]}]}, {'title': 'Week 40 (week 56 referring to core study)', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '28.2'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '36.1'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '25.5'}, {'value': '13.8', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '26.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)', 'description': 'Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.\n\nEASI50 response is defined as achieving ≥ 50% improvement (reduction) in EASI score compared to baseline.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\n\nPresentation of the results is stratified by if patients were re-randomized from the core study or not.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.\n\nPercentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.'}, {'type': 'SECONDARY', 'title': 'Percentage of EASI75 Responders Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ZPL389 30mg Re-randomized After Core Study', 'description': '30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)'}, {'id': 'OG001', 'title': 'ZPL389 50mg Re-randomized After Core Study', 'description': '50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ ZPL389 3mg/ 10mg in the core study)'}, {'id': 'OG002', 'title': 'ZPL389 30mg Continuing After Core Study', 'description': '30mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study'}, {'id': 'OG003', 'title': 'ZPL389 50mg Continuing After Core Study', 'description': '50mg of ZPL389 + TCS and/or TCI for patients continuing in the same arm from the core study'}], 'classes': [{'title': 'week 4 (week 20 referring to core study)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '13.8'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '19.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '23.3'}]}]}, {'title': 'Week 8 (week 24 referring to core study)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '13.8'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '27.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '-0.7', 'upperLimit': '18.9'}]}]}, {'title': 'Week 12 (week 28 referring to core study)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '23.1'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '23.4'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '-4.0', 'upperLimit': '13.2'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '23.3'}]}]}, {'title': 'Week 16 (week 32 referring to core study)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '18.7'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '22.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-4.2', 'upperLimit': '6.6'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '-3.0', 'upperLimit': '12.8'}]}]}, {'title': 'Week 28 (week 44 referring to core study)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '18.5'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '20.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-4.0', 'upperLimit': '5.9'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '-4.6', 'upperLimit': '9.9'}]}]}, {'title': 'Week 40 (week 56 referring to core study)', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '22.3'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '27.3'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '-4.0', 'upperLimit': '16.2'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '-4.4', 'upperLimit': '10.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)', 'description': 'Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.\n\nEASI75 response is defined as a reduction from baseline of ≥ 75% in EASI score. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders.\n\nPresentation of the results is stratified by if patients were re-randomized from the core study or not.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.\n\nPercentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ZPL389 30mg', 'description': 'Dose 1 of ZPL389 + TCS and/or TCI'}, {'id': 'FG001', 'title': 'ZPL389 50mg', 'description': 'Dose 2 of ZPL389 + TCS and/or TCI'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Subject Decision /Guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': 'Subjects who had received ZPL389 30 mg or 50 mg doses in the core study, continued to receive the same doses in double-blinded fashion.\n\nSubjects who had received ZPL389 3 mg, 10 mg or placebo in the core study were randomized to 30 mg or 50 mg ZPL389 in a 1:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ZPL389 30mg', 'description': 'Dose 1 of ZPL389 + TCS and/or TCI'}, {'id': 'BG001', 'title': 'ZPL389 50mg', 'description': 'Dose 2 of ZPL389 + TCS and/or TCI'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '12.18', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '11.24', 'groupId': 'BG001'}, {'value': '34.6', 'spread': '11.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-27', 'size': 902827, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-07T13:39', 'hasProtocol': True}, {'date': '2020-09-29', 'size': 567999, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-07T13:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'whyStopped': 'Core terminated due to lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2019-04-04', 'resultsFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2019-05-10', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-29', 'studyFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study', 'timeFrame': '16 weeks (week 16 to week 32 referring to core study)', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.'}, {'measure': 'Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study', 'timeFrame': 'From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.'}], 'secondaryOutcomes': [{'measure': "Percentage of Investigator's Global Assessment (IGA) Responders Over Time", 'timeFrame': 'Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)', 'description': "IGA score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The scale ranges from 0=clear to 4=severe. It is a static scale and doesn't refer to previous status of the subject. IGA response is an achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy up to the assessment time point. Treatment discontinuations for lack of efficacy or AE are considered non-responders.Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study, in addition to the timeframe referring to the start in this extension study, the timeframe corresponding to the start in the core study (+16 weeks) are provided in parenthesis. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates."}, {'measure': 'Percentage of EASI50 Responders Over Time', 'timeFrame': 'Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)', 'description': 'Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.\n\nEASI50 response is defined as achieving ≥ 50% improvement (reduction) in EASI score compared to baseline.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\n\nPresentation of the results is stratified by if patients were re-randomized from the core study or not.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.\n\nPercentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates.'}, {'measure': 'Percentage of EASI75 Responders Over Time', 'timeFrame': 'Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)', 'description': 'Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.\n\nEASI75 response is defined as a reduction from baseline of ≥ 75% in EASI score. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders.\n\nPresentation of the results is stratified by if patients were re-randomized from the core study or not.\n\nAs all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.\n\nPercentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'AD', 'eczema', 'itch', 'pruritus', 'H4R', 'ZPL389'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=725', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI).', 'detailedDescription': 'Subjects who had received ZPL389 30 mg or 50 mg doses in the core study (CZPL389A2203), continued to receive the same doses in double-blinded fashion. Subjects who had received ZPL389 3 mg, 10 mg or placebo in the core study were randomized to 30 mg or 50 mg ZPL389 in a 1:1 ratio. All subjects received concomitant or intermittent TCS and/or TCI along with ZPL389. Short-term safety was assessed up to week 16 of this extension study (week 16 to week 32 referring to the start of core study treatment) and long-term safety was assessed after week 16 of this extension study (after week 32 referring to the start of core study treatment). The entire planned time frame (100 weeks) was not assessed as originally planned due to early termination of the core and extension studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must give a written, signed and dated informed consent\n* Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.\n\nExclusion Criteria:\n\n* Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).\n* Treatment discontinued subject from CZPL389A2203 study.\n* Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.'}, 'identificationModule': {'nctId': 'NCT03948334', 'acronym': 'ZESTExt', 'briefTitle': 'A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double Blind, Multicenter Extension to CZPL389A2203 Dose-ranging Study to Assess the Short-term and Long-term Safety and Efficacy of Oral ZPL389 With Concomitant Use of TCS and/or TCI in Adult Patients With Atopic Dermatitis.', 'orgStudyIdInfo': {'id': 'CZPL389A2203E1'}, 'secondaryIdInfos': [{'id': '2018-000595-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZPL389 30mg', 'description': '30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study', 'interventionNames': ['Drug: ZPL389 30mg', 'Drug: TCS and/or TCI']}, {'type': 'EXPERIMENTAL', 'label': 'ZPL389 50mg', 'description': '50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study', 'interventionNames': ['Drug: ZPL389 50mg', 'Drug: TCS and/or TCI']}], 'interventions': [{'name': 'ZPL389 30mg', 'type': 'DRUG', 'description': '30mg of ZPL389; once daily', 'armGroupLabels': ['ZPL389 30mg']}, {'name': 'ZPL389 50mg', 'type': 'DRUG', 'description': '50mg of ZPL389; once daily', 'armGroupLabels': ['ZPL389 50mg']}, {'name': 'TCS and/or TCI', 'type': 'DRUG', 'description': 'Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.', 'armGroupLabels': ['ZPL389 30mg', 'ZPL389 50mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85340', 'city': 'Litchfield Park', 'state': 'Arizona', 'country': 'United States', 'facility': 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