Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 9:40 AM
Study NCT ID:
NCT00717769
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2008-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538783', 'term': '6-(5-chloro-2-methoxybenzyl)-4-alarkylaminocarbonyl-1,4-diazepane-2,5-dione'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '908-992-6400', 'title': 'Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks.', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 46, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) tid orally 3 times a day (tid) for 28 days.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 44, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) tid orally 3 times a day (tid) for 28 days.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}, {'id': 'OG002', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Eczema Area and Severity Index (EASI) Score', 'categories': [{'measurements': [{'value': '12.59', 'spread': '10.02', 'groupId': 'OG000'}, {'value': '12.45', 'spread': '8.75', 'groupId': 'OG001'}, {'value': '6.01', 'spread': '5.98', 'groupId': 'OG002'}]}]}, {'title': "Investigator's Global Assessment (IGA) Score", 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.93', 'groupId': 'OG002'}]}]}, {'title': 'Pruritus Score', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.80', 'groupId': 'OG002'}]}]}, {'title': 'Insomnia Score', 'categories': [{'measurements': [{'value': '3.2', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.06', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '3.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose', 'description': "Eczema Area and Severity Index (EASI) Score is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The total EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). Investigator's Global Assessment (IGA) score consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). Higher scores indicate a worse outcome and lower scores indicate a better outcome for all scales.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline disease characteristics were assessed using the Intent-to-Treat (ITT) population. All enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-1.66', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '-1.94', 'spread': '3.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-2.88', 'spread': '4.82', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-3.83', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '-5.67', 'spread': '6.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-4.70', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '-6.70', 'spread': '6.82', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-4.64', 'spread': '6.70', 'groupId': 'OG000'}, {'value': '-6.41', 'spread': '7.86', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-4.41', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '-6.73', 'spread': '7.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.519', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EASI score was assessed using the Intent-to-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'PRIMARY', 'title': 'Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: % Change from Baseline', 'categories': [{'measurements': [{'value': '-12.62', 'spread': '30.45', 'groupId': 'OG000'}, {'value': '-15.52', 'spread': '27.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: % Change from Baseline', 'categories': [{'measurements': [{'value': '-23.42', 'spread': '33.34', 'groupId': 'OG000'}, {'value': '-28.46', 'spread': '59.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: % Change from Baseline', 'categories': [{'measurements': [{'value': '-30.83', 'spread': '42.61', 'groupId': 'OG000'}, {'value': '-39.11', 'spread': '42.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: % Change from Baseline', 'categories': [{'measurements': [{'value': '-38.33', 'spread': '43.89', 'groupId': 'OG000'}, {'value': '-47.46', 'spread': '39.89', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: % Change from Baseline', 'categories': [{'measurements': [{'value': '-37.29', 'spread': '56.64', 'groupId': 'OG000'}, {'value': '-45.35', 'spread': '45.55', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: % Change from Baseline', 'categories': [{'measurements': [{'value': '-37.89', 'spread': '53.35', 'groupId': 'OG000'}, {'value': '-48.06', 'spread': '44.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EASI score was assessed using the Intent-to-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-1.94', 'spread': '5.08', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-3.28', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '-5.13', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-4.26', 'spread': '6.91', 'groupId': 'OG000'}, {'value': '-7.08', 'spread': '6.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-5.26', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '-8.19', 'spread': '6.90', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-5.38', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '-7.99', 'spread': '8.29', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-5.09', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '-8.49', 'spread': '7.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.533', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from Baseline to Day 29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EASI was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'PRIMARY', 'title': 'Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: % Change from Baseline', 'categories': [{'measurements': [{'value': '-13.65', 'spread': '29.51', 'groupId': 'OG000'}, {'value': '-16.03', 'spread': '23.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: % Change from Baseline', 'categories': [{'measurements': [{'value': '-23.67', 'spread': '31.94', 'groupId': 'OG000'}, {'value': '-33.64', 'spread': '31.26', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: % Change from Baseline', 'categories': [{'measurements': [{'value': '-29.29', 'spread': '45.21', 'groupId': 'OG000'}, {'value': '-44.40', 'spread': '35.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: % Change from Baseline', 'categories': [{'measurements': [{'value': '-37.58', 'spread': '46.18', 'groupId': 'OG000'}, {'value': '-52.84', 'spread': '35.90', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: % Change from Baseline', 'categories': [{'measurements': [{'value': '-40.69', 'spread': '46.07', 'groupId': 'OG000'}, {'value': '-50.86', 'spread': '42.50', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: % Change from Baseline', 'categories': [{'measurements': [{'value': '-40.16', 'spread': '47.42', 'groupId': 'OG000'}, {'value': '-54.35', 'spread': '40.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EASI score was assessed using the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': "Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IGA Score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': "Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: % Change from Baseline', 'categories': [{'measurements': [{'value': '-6.10', 'spread': '18.51', 'groupId': 'OG000'}, {'value': '-8.83', 'spread': '18.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: % Change from Baseline', 'categories': [{'measurements': [{'value': '-10.84', 'spread': '23.00', 'groupId': 'OG000'}, {'value': '-19.99', 'spread': '32.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: % Change from Baseline', 'categories': [{'measurements': [{'value': '-17.95', 'spread': '26.13', 'groupId': 'OG000'}, {'value': '-28.89', 'spread': '30.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: % Change from Baseline', 'categories': [{'measurements': [{'value': '-24.21', 'spread': '32.24', 'groupId': 'OG000'}, {'value': '-34.93', 'spread': '34.42', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: % Change from Baseline', 'categories': [{'measurements': [{'value': '-25.91', 'spread': '34.47', 'groupId': 'OG000'}, {'value': '-34.48', 'spread': '36.66', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: % Change from Baseline', 'categories': [{'measurements': [{'value': '-27.24', 'spread': '37.59', 'groupId': 'OG000'}, {'value': '-34.10', 'spread': '36.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IGA Score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': "Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IGA Score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': "Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: % Change from Baseline', 'categories': [{'measurements': [{'value': '-7.06', 'spread': '17.76', 'groupId': 'OG000'}, {'value': '-7.33', 'spread': '17.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: % Change from Baseline', 'categories': [{'measurements': [{'value': '-11.09', 'spread': '21.72', 'groupId': 'OG000'}, {'value': '-20.23', 'spread': '20.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: % Change from Baseline', 'categories': [{'measurements': [{'value': '-16.02', 'spread': '26.71', 'groupId': 'OG000'}, {'value': '-30.47', 'spread': '24.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: % Change from Baseline', 'categories': [{'measurements': [{'value': '-23.64', 'spread': '33.88', 'groupId': 'OG000'}, {'value': '-37.99', 'spread': '29.96', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: % Change from Baseline', 'categories': [{'measurements': [{'value': '-25.18', 'spread': '35.21', 'groupId': 'OG000'}, {'value': '-36.51', 'spread': '32.98', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: % Change from Baseline', 'categories': [{'measurements': [{'value': '-25.72', 'spread': '37.31', 'groupId': 'OG000'}, {'value': '-37.43', 'spread': '34.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IGA Score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pruritus score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: % Change from Baseline', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '99.05', 'groupId': 'OG000'}, {'value': '-7.68', 'spread': '48.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: % Change from Baseline', 'categories': [{'measurements': [{'value': '-11.53', 'spread': '101.25', 'groupId': 'OG000'}, {'value': '-22.22', 'spread': '48.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: % Change from Baseline', 'categories': [{'measurements': [{'value': '-13.89', 'spread': '104.86', 'groupId': 'OG000'}, {'value': '-25.99', 'spread': '54.76', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: % Change from Baseline', 'categories': [{'measurements': [{'value': '-18.75', 'spread': '103.37', 'groupId': 'OG000'}, {'value': '-33.34', 'spread': '51.94', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: % Change from Baseline', 'categories': [{'measurements': [{'value': '-11.95', 'spread': '109.12', 'groupId': 'OG000'}, {'value': '-28.11', 'spread': '55.80', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: % Change from Baseline', 'categories': [{'measurements': [{'value': '-15.14', 'spread': '106.67', 'groupId': 'OG000'}, {'value': '-27.82', 'spread': '53.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pruritus score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pruritus score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: % Change in Baseline', 'categories': [{'measurements': [{'value': '-10.03', 'spread': '31.19', 'groupId': 'OG000'}, {'value': '-7.45', 'spread': '44.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: % Change from Baseline', 'categories': [{'measurements': [{'value': '-17.92', 'spread': '38.01', 'groupId': 'OG000'}, {'value': '-23.45', 'spread': '50.45', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: % Change from Baseline', 'categories': [{'measurements': [{'value': '-20.25', 'spread': '44.70', 'groupId': 'OG000'}, {'value': '-22.61', 'spread': '57.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: % Change from Baseline', 'categories': [{'measurements': [{'value': '-24.73', 'spread': '45.75', 'groupId': 'OG000'}, {'value': '-33.34', 'spread': '56.78', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: % Change from Baseline', 'categories': [{'measurements': [{'value': '-21.69', 'spread': '55.60', 'groupId': 'OG000'}, {'value': '-24.72', 'spread': '57.34', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: % Change from Baseline', 'categories': [{'measurements': [{'value': '-22.76', 'spread': '46.81', 'groupId': 'OG000'}, {'value': '-22.41', 'spread': '54.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pruritus score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Insomnia score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Day 8: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.66', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 2: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Week 4: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Insomnia score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.'}, {'type': 'SECONDARY', 'title': 'Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.565', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '0.100', 'spread': 'NA', 'comment': 'Mean plasma SUN13834 at pre-dose for the PK-ITT population is \\<0.100. Below the level of detection.', 'groupId': 'OG001'}]}]}, {'title': '0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.8', 'spread': '119', 'groupId': 'OG000'}, {'value': '452', 'spread': '691', 'groupId': 'OG001'}]}]}, {'title': '2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.6', 'spread': '86.7', 'groupId': 'OG000'}, {'value': '367', 'spread': '237', 'groupId': 'OG001'}]}]}, {'title': '5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.4', 'spread': '69.8', 'groupId': 'OG000'}, {'value': '120', 'spread': '122', 'groupId': 'OG001'}]}]}, {'title': '8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.2', 'spread': '98.1', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '34.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean of SUN13834 Plasma Concentrations were assessed from the Pharmacokinetic-Intent-to-Treat (PK-ITT) population, those with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.747', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '0.100', 'spread': 'NA', 'comment': 'Mean plasma SUN13834 at pre-dose for the PK-EE population is \\<0.100. Below level of detection.', 'groupId': 'OG001'}]}]}, {'title': '0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '122', 'groupId': 'OG000'}, {'value': '741', 'spread': '1090', 'groupId': 'OG001'}]}]}, {'title': '2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.7', 'spread': '86.7', 'groupId': 'OG000'}, {'value': '508', 'spread': '270', 'groupId': 'OG001'}]}]}, {'title': '5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.5', 'spread': '78.5', 'groupId': 'OG000'}, {'value': '103', 'spread': '76.4', 'groupId': 'OG001'}]}]}, {'title': '8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '51.7', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '4.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean of SUN13834 Plasma Concentrations were assessed from the Pharmacokinetic-Efficacy Evaluable (PK-EE) population, those with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.'}], 'classes': [{'title': 'M-3: Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.500', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is \\<0.500. Below level of detection.', 'groupId': 'OG000'}, {'value': '0.500', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is \\<0.500. Below level of detection.', 'groupId': 'OG001'}]}]}, {'title': 'M-3: 0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.59', 'spread': '8.77', 'groupId': 'OG000'}, {'value': '32.9', 'spread': '48.4', 'groupId': 'OG001'}]}]}, {'title': 'M-3: 2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.01', 'spread': '6.27', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '28.4', 'groupId': 'OG001'}]}]}, {'title': 'M-3:5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.36', 'spread': '5.10', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'M-3: 8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.33', 'spread': '6.79', 'groupId': 'OG000'}, {'value': '6.11', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'M-5: Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.513', 'spread': '0.132', 'groupId': 'OG000'}, {'value': '0.500', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is \\<0.500. Below level of detection.', 'groupId': 'OG001'}]}]}, {'title': 'M-5: 0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '76.9', 'spread': '122', 'groupId': 'OG001'}]}]}, {'title': 'M-5: 2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '68.1', 'spread': '70.9', 'groupId': 'OG001'}]}]}, {'title': 'M-5:5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'M-5: 8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.91', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'M-6: Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.500', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is \\<0.500. Below level of detection.', 'groupId': 'OG000'}, {'value': '0.500', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is \\<0.500. Below level of detection.', 'groupId': 'OG001'}]}]}, {'title': 'M-6: 0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.8', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '69.5', 'spread': '83.7', 'groupId': 'OG001'}]}]}, {'title': 'M-6: 2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '96.6', 'spread': '67.4', 'groupId': 'OG001'}]}]}, {'title': 'M-6:5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '65.7', 'spread': '50.9', 'groupId': 'OG001'}]}]}, {'title': 'M-6: 8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '43.8', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '79.1', 'groupId': 'OG001'}]}]}, {'title': 'M-6G: Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.', 'groupId': 'OG001'}]}]}, {'title': 'M-6G: 0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '41.3', 'groupId': 'OG001'}]}]}, {'title': 'M-6G: 2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '85.3', 'spread': '63.6', 'groupId': 'OG001'}]}]}, {'title': 'M-6G:5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '61.8', 'groupId': 'OG001'}]}]}, {'title': 'M-6G: 8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '55.1', 'groupId': 'OG001'}]}]}, {'title': 'MG-1: Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0379', 'spread': '0.392', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.', 'groupId': 'OG001'}]}]}, {'title': 'MG-1: 0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '37.4', 'groupId': 'OG001'}]}]}, {'title': 'MG-1: 2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '67.1', 'groupId': 'OG001'}]}]}, {'title': 'MG-1:5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.51', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '21.4', 'groupId': 'OG001'}]}]}, {'title': 'MG-1: 8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'MG-2: Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0038', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.', 'groupId': 'OG001'}]}]}, {'title': 'MG-2: 0-2.5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '3.70', 'groupId': 'OG001'}]}]}, {'title': 'MG-2: 2.5-5.0 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '6.98', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'MG-2:5.0-10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '8.26', 'groupId': 'OG001'}]}]}, {'title': 'MG-2: 8-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.44', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '1.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.', 'description': 'Mean concentrations of SUN13834 metabolites M-3, M-5, M-6, M-6G, MG-1, and MG-2 in participant plasma samples were measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean of SUN13834 metabolite plasma concentrations were assessed using the Pharmacokinetic-Intent-to-Treat (PK-ITT) population, those with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'OG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}, {'id': 'OG002', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.'}], 'classes': [{'title': 'Number of participants with at least 1 Adverse Event', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Carbuncle', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Influenza', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Sinusitis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood creatine phosphokinase increased', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood IgE increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood pressure increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Paresthesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dermatitis atopic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Oropharyngeal pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary Congestion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Joint injury', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Accelerated hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Paranoia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Seasonal allergy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Cyst drainage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 8 post-dose, up to a total of 36 weeks.', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment-emergent adverse events were assessed using the Safety population. All enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'FG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.'}, {'id': 'FG002', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 270 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 27 clinic sites in the United States of America (USA).', 'preAssignmentDetails': 'Washout period for Atopic Dermatitis treatments such as topical corticosteroids, antihistamines, over the counter (OTC) sleep aids, and some FDA approved devices for 3 months up to 1 week prior to screening and for the duration of the study (including follow-up). After the initiation of the study, the protocol was amended to discontinue group 3 (200 mg three times a day \\[tid\\]). The efficacy outcomes and analyses were also redefined to compare the 50 mg tid group against the placebo group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.'}, {'id': 'BG001', 'title': 'SUN13834 50 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg;(2×50 mg) orally tid for 28 days.'}, {'id': 'BG002', 'title': 'SUN13834 200 mg Tid', 'description': 'Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) orally tid for 28 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '13.14', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '12.95', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '10.62', 'groupId': 'BG002'}, {'value': '37.8', 'spread': '12.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics were assessed using the Intent-to-treat (ITT) population.'}}, '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': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2011-04-04', 'completionDateStruct': {'date': '2009-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2008-07-16', 'dispFirstSubmitQcDate': '2011-04-04', 'resultsFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2008-07-16', 'dispFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-26', 'studyFirstPostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Pre-dose', 'description': "Eczema Area and Severity Index (EASI) Score is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The total EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). Investigator's Global Assessment (IGA) score consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). Higher scores indicate a worse outcome and lower scores indicate a better outcome for all scales."}, {'measure': 'Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.'}, {'measure': 'Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.'}], 'secondaryOutcomes': [{'measure': "Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis", 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).'}, {'measure': "Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis", 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).'}, {'measure': 'Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.'}, {'measure': 'Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.'}, {'measure': 'Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.', 'description': 'The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.'}, {'measure': 'Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.'}, {'measure': 'Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.', 'description': 'Mean concentrations of SUN13834 metabolites M-3, M-5, M-6, M-6G, MG-1, and MG-2 in participant plasma samples were measured.'}, {'measure': 'Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis', 'timeFrame': 'Baseline up to Week 8 post-dose, up to a total of 36 weeks.', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'SUN13834'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants between 18 and 65 years of age.\n* A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria\n* At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.\n\nExclusion Criteria:\n\n* Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).\n* Use of phototherapy or tanning beds within 6 weeks of screening\n* History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.\n* Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).'}, 'identificationModule': {'nctId': 'NCT00717769', 'briefTitle': 'A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ASBI 404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SUN13834', 'interventionNames': ['Drug: SUN13834']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SUN13834', 'type': 'DRUG', 'description': 'Low dose, orally 3 times a day (tid) for 28 days of SUN13834', 'armGroupLabels': ['SUN13834']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, orally (tid) for 28 days of SUN13834', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pivotal Research Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pivotal Research Center', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Horizons Clinical Research Center, LLC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Dermatology and Cosmetic Surgery', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Stedman Clinical Trials', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Northwest Clinical Trials', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic Downtown Research Institute', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'DermResearch, PLLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center for Skin Care Research', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Derm Research Center of New York, Inc.', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences - Dermatology Studies', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43560', 'city': 'Sylvania', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Center for Clinical Research', 'geoPoint': {'lat': 41.71894, 'lon': -83.71299}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Health Sciences Center, Dermatology Dept', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paddington Testing Co, Inc.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Clinical Partners, LLC', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Radiant Research, Inc', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J & S Studies, Inc', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute of Dermatology Department', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Associates of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Clinical Research', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '23233', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Commonwealth Clinical Research Specialists, Inc.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}