Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-26 @ 8:14 AM
Study NCT ID:
NCT03517566
Status:
TERMINATED
Last Update Posted:
2021-10-08
First Post:
2018-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Estonia', 'France', 'Latvia', 'Lithuania', 'Spain'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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 until end of study treatment plus 4 weeks post treatment, up to maximum duration of 20 weeks', 'description': 'Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 27, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'ZPL389 3 mg', 'description': 'ZPL389 3 mg oral powder', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 14, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 8, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'ZPL389 30 mg', 'description': 'ZPL389 30 mg oral powder', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 30, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'ZPL389 50 mg', 'description': 'ZPL389 50 mg oral powder', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 26, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'All Patients', 'description': 'All Patients', 'otherNumAtRisk': 291, 'deathsNumAtRisk': 291, 'otherNumAffected': 105, 'seriousNumAtRisk': 291, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 41}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Herpes dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Risk of future pregnancy miscarriage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 291, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of IGA Responders at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'OG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'OG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'OG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '5.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '10.9'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '-2.3', 'upperLimit': '16.8'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '-2.0', 'upperLimit': '3.7'}, {'value': '6.9', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '13.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject.\n\nIGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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 IGA as covariates.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'OG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'OG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'OG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.0', 'groupId': 'OG000', 'lowerLimit': '-66.9', 'upperLimit': '-43.1'}, {'value': '-49.4', 'groupId': 'OG001', 'lowerLimit': '-67.4', 'upperLimit': '-31.4'}, {'value': '-50.7', 'groupId': 'OG002', 'lowerLimit': '-67.3', 'upperLimit': '-34.1'}, {'value': '-46.2', 'groupId': 'OG003', 'lowerLimit': '-58.8', 'upperLimit': '-33.6'}, {'value': '-52.7', 'groupId': 'OG004', 'lowerLimit': '-65.0', 'upperLimit': '-40.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', '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.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in EASI Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'OG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'OG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'OG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-17.1', 'groupId': 'OG000', 'lowerLimit': '-26.6', 'upperLimit': '-7.5'}, {'value': '-20.1', 'groupId': 'OG001', 'lowerLimit': '-34.2', 'upperLimit': '-6.1'}, {'value': '-10.3', 'groupId': 'OG002', 'lowerLimit': '-23.8', 'upperLimit': '3.1'}, {'value': '-14.2', 'groupId': 'OG003', 'lowerLimit': '-24.0', 'upperLimit': '-4.3'}, {'value': '-16.7', 'groupId': 'OG004', 'lowerLimit': '-26.4', 'upperLimit': '-7.1'}]}]}, {'title': 'week 4', 'categories': [{'measurements': [{'value': '-19.7', 'groupId': 'OG000', 'lowerLimit': '-30.6', 'upperLimit': '-8.9'}, {'value': '-36.1', 'groupId': 'OG001', 'lowerLimit': '-51.4', 'upperLimit': '-20.9'}, {'value': '-25.6', 'groupId': 'OG002', 'lowerLimit': '-40.6', 'upperLimit': '-10.7'}, {'value': '-17.7', 'groupId': 'OG003', 'lowerLimit': '-29.0', 'upperLimit': '-6.4'}, {'value': '-30.0', 'groupId': 'OG004', 'lowerLimit': '-40.6', 'upperLimit': '-19.4'}]}]}, {'title': 'week 6', 'categories': [{'measurements': [{'value': '-42.8', 'groupId': 'OG000', 'lowerLimit': '-53.0', 'upperLimit': '-32.6'}, {'value': '-47.6', 'groupId': 'OG001', 'lowerLimit': '-62.3', 'upperLimit': '-32.9'}, {'value': '-43.2', 'groupId': 'OG002', 'lowerLimit': '-57.3', 'upperLimit': '-29.0'}, {'value': '-33.2', 'groupId': 'OG003', 'lowerLimit': '-44.0', 'upperLimit': '-22.3'}, {'value': '-43.5', 'groupId': 'OG004', 'lowerLimit': '-54.0', 'upperLimit': '-33.0'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '-49.3', 'groupId': 'OG000', 'lowerLimit': '-61.1', 'upperLimit': '-37.4'}, {'value': '-50.1', 'groupId': 'OG001', 'lowerLimit': '-66.8', 'upperLimit': '-33.4'}, {'value': '-47.4', 'groupId': 'OG002', 'lowerLimit': '-63.9', 'upperLimit': '-30.9'}, {'value': '-38.1', 'groupId': 'OG003', 'lowerLimit': '-50.5', 'upperLimit': '-25.7'}, {'value': '-45.5', 'groupId': 'OG004', 'lowerLimit': '-57.4', 'upperLimit': '-33.6'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-55.4', 'groupId': 'OG000', 'lowerLimit': '-66.0', 'upperLimit': '-44.8'}, {'value': '-48.7', 'groupId': 'OG001', 'lowerLimit': '-64.2', 'upperLimit': '-33.2'}, {'value': '-54.1', 'groupId': 'OG002', 'lowerLimit': '-69.2', 'upperLimit': '-39.1'}, {'value': '-45.1', 'groupId': 'OG003', 'lowerLimit': '-56.4', 'upperLimit': '-33.8'}, {'value': '-52.7', 'groupId': 'OG004', 'lowerLimit': '-63.7', 'upperLimit': '-41.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Week 8, Week 12', '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.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of EASI50 Responders Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'OG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'OG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'OG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '12.9'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '27.0'}, {'value': '12.6', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '24.1'}, {'value': '5.8', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '11.2'}, {'value': '10.1', 'groupId': 'OG004', 'lowerLimit': '3.1', 'upperLimit': '17.2'}]}]}, {'title': 'week 4', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '21.9'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '32.5'}, {'value': '20.1', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '34.1'}, {'value': '9.5', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '16.7'}, {'value': '20.7', 'groupId': 'OG004', 'lowerLimit': '11.4', 'upperLimit': '30.1'}]}]}, {'title': 'week 6', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '27.4'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '27.5'}, {'value': '15.1', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '27.7'}, {'value': '9.5', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '16.8'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '8.0', 'upperLimit': '25.4'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '28.0'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '31.5'}, {'value': '16.4', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '29.5'}, {'value': '9.4', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '16.6'}, {'value': '12.8', 'groupId': 'OG004', 'lowerLimit': '4.8', 'upperLimit': '20.7'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '29.7'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '23.1'}, {'value': '20.3', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': '34.9'}, {'value': '12.6', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '20.9'}, {'value': '12.0', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '19.7'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '25.8'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '27.3'}, {'value': '22.7', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '37.9'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '3.9', 'upperLimit': '20.3'}, {'value': '12.7', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '20.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, Week 4, Week 6, Week 8, Week 12, Week 16', '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 without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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': 'Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of EASI75 Responders Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'OG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'OG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'OG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'classes': [{'title': 'week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '4.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-3.1', 'upperLimit': '4.4'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '-1.3', 'upperLimit': '4.1'}, {'value': '1.5', 'groupId': 'OG004', 'lowerLimit': '-1.4', 'upperLimit': '4.3'}]}]}, {'title': 'week 4', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '6.6'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '16.0'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '-3.9', 'upperLimit': '7.2'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '-1.6', 'upperLimit': '5.2'}, {'value': '1.4', 'groupId': 'OG004', 'lowerLimit': '-1.3', 'upperLimit': '4.2'}]}]}, {'title': 'week 6', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '10.9'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '21.0'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '-1.9', 'upperLimit': '16.1'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '-2.0', 'upperLimit': '5.7'}, {'value': '7.4', 'groupId': 'OG004', 'lowerLimit': '1.2', 'upperLimit': '13.6'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.6'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '21.9'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '-1.8', 'upperLimit': '18.8'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '-1.8', 'upperLimit': '6.8'}, {'value': '6.1', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '11.9'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '9.6'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '15.6'}, {'value': '10.6', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '22.0'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '-1.6', 'upperLimit': '7.2'}, {'value': '5.8', 'groupId': 'OG004', 'lowerLimit': '-0.0', 'upperLimit': '11.7'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '16.8'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '16.9'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '25.5'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '-1.7', 'upperLimit': '7.8'}, {'value': '9.3', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '16.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, Week 4, Week 6, Week 8, Week 12, Week 16', '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 achieving ≥ 75% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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': 'Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of IGA Responders Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'OG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'OG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'OG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'classes': [{'title': 'week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.7', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}]}]}, {'title': 'week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '0.0'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '8.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '1.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-0.6', 'upperLimit': '0.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-0.4', 'upperLimit': '0.4'}]}]}, {'title': 'week 6', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '4.1'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '14.4'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '-2.0', 'upperLimit': '13.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-1.9', 'upperLimit': '2.9'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-1.2', 'upperLimit': '1.6'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '4.5'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '10.7'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '-2.1', 'upperLimit': '15.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-1.7', 'upperLimit': '2.7'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '-1.6', 'upperLimit': '5.6'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '4.4'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '11.3'}, {'value': '5.6', 'groupId': 'OG002', 'lowerLimit': '-3.1', 'upperLimit': '14.2'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '-1.6', 'upperLimit': '5.5'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '-2.1', 'upperLimit': '4.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, Week 4, Week 6, Week 8, Week 12', 'description': "Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject.\n\nIGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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 IGA as covariates.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'OG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'OG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'OG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 20', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all subjects who received at least one dose of study medication. Subjects were analyzed according to treatment received. The safety analyses were based on safety sets (SAF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'FG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'FG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'FG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'FG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Subject Decision /Guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'There were 293 subjects randomized at baseline to one of the five treatment arms.\n\nTwo mis-randomized subjects in the placebo arm were excluded from the baseline analysis population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '291', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG001', 'title': 'ZPL389 3mg', 'description': 'ZPL389 3 mg oral powder'}, {'id': 'BG002', 'title': 'ZPL389 10 mg', 'description': 'ZPL389 10 mg oral powder'}, {'id': 'BG003', 'title': 'ZPL389 30mg', 'description': 'ZPL389 30 mg oral powder'}, {'id': 'BG004', 'title': 'ZPL389 50mg', 'description': 'ZPL389 50 mg oral powder'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '12.79', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '11.86', 'groupId': 'BG001'}, {'value': '32.1', 'spread': '9.93', 'groupId': 'BG002'}, {'value': '34.9', 'spread': '11.69', 'groupId': 'BG003'}, {'value': '35.2', 'spread': '11.91', 'groupId': 'BG004'}, {'value': '35.0', 'spread': '11.87', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '125', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '166', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '208', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "All subjects to whom study treatment was assigned. Two Mis-randomized (mis-randomized in Interactive Response Technology (IRT)) subjects in the placebo group were excluded. Mis-randomized subjects were defined as cases where IRT was contacted by the site either prematurely or inappropriately prior to confirmation of the subject's final randomization eligibility and no study medication was administered to the subject."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-02', 'size': 1140052, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-07T13:28', 'hasProtocol': True}, {'date': '2020-09-29', 'size': 589427, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-29T02:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'whyStopped': 'Lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2018-03-27', 'resultsFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-29', 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of IGA Responders at Week 16', 'timeFrame': 'Week 16', 'description': "Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject.\n\nIGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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 IGA as covariates."}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in EASI Score at Week 16', 'timeFrame': 'Baseline, Week 16', '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.'}, {'measure': 'Percent Change From Baseline in EASI Score Over Time', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Week 8, Week 12', '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.'}, {'measure': 'Percentage of EASI50 Responders Over Time', 'timeFrame': 'Week 2, Week 4, Week 6, Week 8, Week 12, Week 16', '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 without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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 2, Week 4, Week 6, Week 8, Week 12, Week 16', '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 achieving ≥ 75% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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 IGA Responders Over Time', 'timeFrame': 'Week 2, Week 4, Week 6, Week 8, Week 12', 'description': "Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject.\n\nIGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.\n\nTreatment discontinuations for lack of efficacy or adverse event are considered non-responders.\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 IGA as covariates."}, {'measure': 'Number of Patients With Adverse Events', 'timeFrame': 'Up to week 20', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'AD', 'eczema', 'atopic eczema', 'itch, pruritus', 'histamine 4 receptor', 'antagonist', 'H4R', 'ZPL389', 'ZPL389A2203', 'dermatitis'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=723', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks', 'detailedDescription': 'A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period.\n\nAfter the end of treatment visit, subjects were offered the possibility of ongoing treatment in the extension study (CZPL389A2203E1/ NCT03948334), or of entering the 4 week treatment-free follow-up period.'}, '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* Chronic atopic dermatitis present for at least 1 year before Baseline\n* Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.\n* Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable\n* Candidate for systemic treatment\n\nExclusion Criteria:\n\n* Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity\n* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n* History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.\n* Participation in prior ZPL389 studies'}, 'identificationModule': {'nctId': 'NCT03517566', 'briefTitle': 'A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial)', 'orgStudyIdInfo': {'id': 'CZPL389A2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo', 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