Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT04804605
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2021-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
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infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abscess jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Application site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eczema infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrointestinal bacterial overgrowth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 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'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ARQ-151-311/312: RC/RC 0.15% Group', 'description': 'Participants who received roflumilast cream 0.15% in parent studies received 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Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000', 'lowerLimit': '35.61', 'upperLimit': '44.83'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '29.60', 'upperLimit': '42.36'}, {'value': '37.7', 'groupId': 'OG002', 'lowerLimit': '32.98', 'upperLimit': '42.77'}, {'value': '40.8', 'groupId': 'OG003', 'lowerLimit': '33.88', 'upperLimit': '48.20'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '37.42', 'upperLimit': '47.08'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '30.55', 'upperLimit': '43.68'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '35.10', 'upperLimit': '45.07'}, {'value': '53.0', 'groupId': 'OG003', 'lowerLimit': '45.62', 'upperLimit': '60.25'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000', 'lowerLimit': '43.25', 'upperLimit': '53.18'}, {'value': '46.3', 'groupId': 'OG001', 'lowerLimit': '39.27', 'upperLimit': '53.48'}, {'value': '46.4', 'groupId': 'OG002', 'lowerLimit': '41.25', 'upperLimit': '51.54'}, {'value': '54.3', 'groupId': 'OG003', 'lowerLimit': '46.72', 'upperLimit': '61.75'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '38.75', 'upperLimit': '52.33'}, {'value': '49.6', 'groupId': 'OG001', 'lowerLimit': '39.36', 'upperLimit': '59.82'}, {'value': '42.5', 'groupId': 'OG002', 'lowerLimit': '37.31', 'upperLimit': '47.82'}, {'value': '47.6', 'groupId': 'OG003', 'lowerLimit': '39.94', 'upperLimit': '55.45'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000', 'lowerLimit': '40.82', 'upperLimit': '55.07'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '34.99', 'upperLimit': '55.41'}, {'value': '50.4', 'groupId': 'OG002', 'lowerLimit': '44.86', 'upperLimit': '55.99'}, {'value': '56.9', 'groupId': 'OG003', 'lowerLimit': '48.53', 'upperLimit': '64.83'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': "The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With vIGA-AD Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ARQ-151-311/312: RC/RC 0.15% Group', 'description': 'Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'OG001', 'title': 'ARQ-151-311/312: VC/RC 0.15% Group', 'description': 'Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'OG002', 'title': 'ARQ-151-315: RC/RC 0.05% or 0.15% Group', 'description': 'Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}, {'id': 'OG003', 'title': 'ARQ-151-315: VC/RC 0.05% or 0.15% Group', 'description': 'Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '26.65', 'upperLimit': '35.33'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '4.86', 'upperLimit': '12.23'}, {'value': '28.7', 'groupId': 'OG002', 'lowerLimit': '24.38', 'upperLimit': '33.48'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '7.32', 'upperLimit': '16.57'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '29.25', 'upperLimit': '38.46'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '11.46', 'upperLimit': '21.48'}, {'value': '29.5', 'groupId': 'OG002', 'lowerLimit': '25.12', 'upperLimit': '34.33'}, {'value': '24.9', 'groupId': 'OG003', 'lowerLimit': '19.01', 'upperLimit': '31.93'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '35.02', 'upperLimit': '44.67'}, {'value': '21.6', 'groupId': 'OG001', 'lowerLimit': '16.30', 'upperLimit': '28.15'}, {'value': '36.1', 'groupId': 'OG002', 'lowerLimit': '31.31', 'upperLimit': '41.13'}, {'value': '24.1', 'groupId': 'OG003', 'lowerLimit': '18.16', 'upperLimit': '31.22'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000', 'lowerLimit': '31.01', 'upperLimit': '44.30'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '15.60', 'upperLimit': '33.77'}, {'value': '34.4', 'groupId': 'OG002', 'lowerLimit': '29.50', 'upperLimit': '39.61'}, {'value': '22.4', 'groupId': 'OG003', 'lowerLimit': '16.45', 'upperLimit': '29.70'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '35.78', 'upperLimit': '50.01'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '16.20', 'upperLimit': '34.53'}, {'value': '42.5', 'groupId': 'OG002', 'lowerLimit': '37.11', 'upperLimit': '48.15'}, {'value': '28.5', 'groupId': 'OG003', 'lowerLimit': '21.41', 'upperLimit': '36.79'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': 'The percentage of participants with vIGA-AD "success" is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ARQ-151-311/312: RC/RC 0.15% Group', 'description': 'Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'OG001', 'title': 'ARQ-151-311/312: VC/RC 0.15% Group', 'description': 'Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'OG002', 'title': 'ARQ-151-315: RC/RC 0.05% or 0.15% Group', 'description': 'Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}, {'id': 'OG003', 'title': 'ARQ-151-315: VC/RC 0.05% or 0.15% Group', 'description': 'Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': 'Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from \'0 to 10\' ("no itch" to "worst imaginable itch"), with lower scores indicating reduced symptom severity and vice versa.', 'unitOfMeasure': 'WI-NRS Score Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were ≥12 years of age at the start of the parent studies are included.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in EASI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ARQ-151-311/312: RC/RC 0.15% Group', 'description': 'Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'OG001', 'title': 'ARQ-151-311/312: VC/RC 0.15% Group', 'description': 'Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'OG002', 'title': 'ARQ-151-315: RC/RC 0.05% or 0.15% Group', 'description': 'Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}, {'id': 'OG003', 'title': 'ARQ-151-315: VC/RC 0.05% or 0.15% Group', 'description': 'Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-63.23', 'spread': '39.702', 'groupId': 'OG000'}, {'value': '-36.93', 'spread': '63.272', 'groupId': 'OG001'}, {'value': '-59.51', 'spread': '40.684', 'groupId': 'OG002'}, {'value': '-41.29', 'spread': '53.042', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-68.39', 'spread': '34.195', 'groupId': 'OG000'}, {'value': '-17.95', 'spread': '152.845', 'groupId': 'OG001'}, {'value': '-62.02', 'spread': '49.438', 'groupId': 'OG002'}, {'value': '-16.11', 'spread': '241.787', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-72.81', 'spread': '34.462', 'groupId': 'OG000'}, {'value': '-33.34', 'spread': '116.997', 'groupId': 'OG001'}, {'value': '-71.04', 'spread': '36.124', 'groupId': 'OG002'}, {'value': '-32.65', 'spread': '16.532', 'groupId': 'OG003'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-73.81', 'spread': '31.300', 'groupId': 'OG000'}, {'value': '-39.20', 'spread': '104.744', 'groupId': 'OG001'}, {'value': '-69.75', 'spread': '40.467', 'groupId': 'OG002'}, {'value': '-39.39', 'spread': '148.094', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-74.57', 'spread': '35.160', 'groupId': 'OG000'}, {'value': '-27.94', 'spread': '137.809', 'groupId': 'OG001'}, {'value': '-77.78', 'spread': '35.095', 'groupId': 'OG002'}, {'value': '-52.36', 'spread': '74.751', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': "EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.", 'unitOfMeasure': 'Percent change in EASI score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with data available are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ARQ-151-311/312: RC/RC 0.15% Group', 'description': 'Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'FG001', 'title': 'ARQ-151-311/312: VC/RC 0.15% Group', 'description': 'Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'FG002', 'title': 'ARQ-151-315: RC/RC 0.05% or 0.15% Group', 'description': 'Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}, {'id': 'FG003', 'title': 'ARQ-151-315: VC/RC 0.05% or 0.15% Group', 'description': 'Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'groupId': 'FG001', 'numSubjects': '219'}, {'groupId': 'FG002', 'numSubjects': '382'}, {'groupId': 'FG003', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '254'}, {'groupId': 'FG003', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '128'}, {'groupId': 'FG003', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were rolled over upon completion of parent studies ARQ-151-311 (NCT04773587), ARQ-151-312 (NCT03638258), and ARQ-151-315 (NCT04845620). Rollovers from 311/312 were analyzed separately from 315 rollovers.', 'preAssignmentDetails': 'Participants with atopic dermatitis were enrolled at 153 sites in the United States (US), Canada, and Poland.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}, {'value': '1219', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'ARQ-151-311/312: RC/RC 0.15% Group', 'description': 'Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'BG001', 'title': 'ARQ-151-311/312: VC/RC 0.15% Group', 'description': 'Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study.'}, {'id': 'BG002', 'title': 'ARQ-151-315: RC/RC 0.05% or 0.15% Group', 'description': 'Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}, {'id': 'BG003', 'title': 'ARQ-151-315: VC/RC 0.05% or 0.15% Group', 'description': 'Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '20.5', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.11', 'groupId': 'BG002'}, {'value': '3.4', 'spread': '1.17', 'groupId': 'BG003'}, {'value': '12.2', 'spread': '14.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '642', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '577', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '204', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}, {'value': '1008', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}, {'value': '810', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One participant discontinued from the VC/RC Group prior to dosing.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-17', 'size': 7697171, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-03T10:56', 'hasProtocol': True}, {'date': '2022-12-20', 'size': 838352, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-03T10:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2025-05-07', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2021-03-16', 'resultsFirstSubmitDate': '2025-11-03', 'studyFirstSubmitQcDate': '2021-03-17', 'dispFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-08', 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'Up to 52 weeks', 'description': 'The number of participants with ≥1 TEAE(s) is reported.'}], 'secondaryOutcomes': [{'measure': 'Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': "The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts."}, {'measure': 'Percentage of Participants With vIGA-AD Success', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': 'The percentage of participants with vIGA-AD "success" is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.'}, {'measure': 'Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': 'Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from \'0 to 10\' ("no itch" to "worst imaginable itch"), with lower scores indicating reduced symptom severity and vice versa.'}, {'measure': 'Percent Change From Baseline in EASI Score', 'timeFrame': 'Weeks 4, 12, 24, 36, and 52', 'description': "EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis Eczema']}, 'descriptionModule': {'briefSummary': 'This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.\n2. Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)\n3. Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.\n4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.\n5. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).\n6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.\n\nExclusion Criteria:\n\n1. Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.\n2. Subjects that use any Excluded Medications and Treatments.\n3. Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.\n4. Subjects with known genetic dermatological conditions that overlap with AD.\n5. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.\n6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.\n7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house."}, 'identificationModule': {'nctId': 'NCT04804605', 'acronym': 'INTEGUMENT-OLE', 'briefTitle': 'Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcutis Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ARQ-151-313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARQ-151 Cream 0.05%', 'description': 'Participants applied ARQ-151 Cream 0.05% once daily (qd) for up to 52 weeks.', 'interventionNames': ['Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%']}], 'interventions': [{'name': 'ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%', 'type': 'DRUG', 'otherNames': ['Roflumilast'], 'description': 'ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%', 'armGroupLabels': ['ARQ-151 Cream 0.05%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Arcutis Clinical Site 112', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Arcutis Clinical Site 73', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arcutis Clinical Site 63', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72022', 'city': 'Bryant', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 106', 'geoPoint': {'lat': 34.59593, 'lon': -92.48905}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arcutis Clinical Site 116', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 69', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 81', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '94132', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 08', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 31', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91320', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Site 130', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Arcutis Clinical Site 123', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 59', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 72', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 79', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 103', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 04', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 15', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33162', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 67', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 95', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33174', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 68', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 29', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 01', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33449', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Site 138', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Arcutis Clinical Site 47', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Arcutis Clinical Site 145', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '33770', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Arcutis Clinical Site 13', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '47129', 'city': 'Clarksville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Arcutis Clinical Site 93', 'geoPoint': {'lat': 38.29674, 'lon': -85.75996}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Clinical Site 22', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '47906', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Arcutis Clinical Site 114', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Clinical Site 03', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arcutis Clinical Site 80', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '70605', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arcutis Clinical Site 85', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arcutis Clinical Site 24', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Arcutis Clinical Site 76', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 94', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48346', 'city': 'Clarkston', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 88', 'geoPoint': {'lat': 42.73586, 'lon': -83.41883}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 58', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 66', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcutis Clinical Site 132', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55112', 'city': 'New Brighton', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Site 10', 'geoPoint': {'lat': 45.06552, 'lon': -93.20189}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Arcutis Clinical Site 102', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '89509', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Arcutis Clinical Site 62', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Arcutis Clinical Site 71', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '11415', 'city': 'Kew Gardens', 'state': 'New York', 'country': 'United States', 'facility': 'Arcutis Clinical Site 96', 'geoPoint': {'lat': 40.71427, 'lon': -73.83097}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Arcutis Clinical Site 82', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Arcutis Clinical Site 19', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '97030', 'city': 'Gresham', 'state': 'Oregon', 'country': 'United States', 'facility': 'Arcutis Clinical Site 17', 'geoPoint': {'lat': 45.49818, 'lon': -122.43148}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Arcutis Clinical Site 108', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Arcutis Clinical Site 16', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Arcutis Clinical Site 14', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Arcutis Clinical Site 53', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19073', 'city': 'Newtown Square', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Arcutis Clinical Site 64', 'geoPoint': {'lat': 39.98678, 'lon': -75.40103}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Arcutis Clinical Site 25', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Arcutis Clinical Site 101', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Arcutis Clinical Site 77', 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