Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT03526861
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2018-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
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': 'C574065', 'term': 'tralokinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'phone': '+45 44945888', 'title': 'Disclosure Specialist', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': 'LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.', 'eventGroups': [{'id': 'EG000', 'title': 'Initial Treatment Period - Tralokinumab 300 Q2W', 'description': 'Initial Treatment Period - Tralokinumab 300 Q2W (n=97, PYE=29.48)', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 44, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Initial Treatment Period - Tralokinumab 150 Q2W', 'description': 'Initial Treatment Period - Tralokinumab 150 Q2W (n=98, PYE=29.33)', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 47, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Initial Treatment Period - Placebo (n=94, PYE=27.93)', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 36, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Maintenance Treatment Period - Tralokinumab 300 Q2W', 'description': 'Maintenance Treatment Period - Tralokinumab 300 Q2W (n=11, PYE=5.61)', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Maintenance Treatment Period - Tralokinumab 300 Q4W', 'description': 'Maintenance Treatment Period - Tralokinumab 300 Q4W (n=13, PYE=6.78)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Maintenance Treatment Period - Tralokinumab 150 Q2W', 'description': 'Maintenance Treatment Period - Tralokinumab 150 Q2W (n=12, PYE=6.40)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Maintenance Treatment Period - Tralokinumab 150 Q4W', 'description': 'Maintenance Treatment Period - Tralokinumab 150 Q4W (n=14, PYE=6.53)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Maintenance Treatment Period - Placebo', 'description': 'Maintenance Treatment Period - Placebo (n=6, PYE=2.98)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Open-label Treatment - Tralokinumab 300 Q2W + Optional TCS', 'description': 'Open-label Treatment - Tralokinumab 300 Q2W + optional TCS (n=234, PYE=151.12)', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 100, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG009', 'title': 'Safety Follow-up', 'description': 'Safety Follow-up (n=234, PYE=54.00)', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 16, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 12, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 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'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Obsessive-compulsive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '5.3', 'ciUpperLimit': '22.3', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and baseline disease severity.', 'groupDescription': 'Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Primary endpoint tested sequentially at a 5% significance level'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.5', 'ciLowerLimit': '8.4', 'ciUpperLimit': '26.6', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and baseline disease severity.', 'groupDescription': 'Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Primary endpoint tested sequentially at a 5% significance level'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': "The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'PRIMARY', 'title': 'Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.0', 'ciLowerLimit': '12.0', 'ciUpperLimit': '32.0', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and baseline disease severity.', 'groupDescription': 'Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Primary endpoint tested sequentially at a 5% significance level'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.5', 'ciLowerLimit': '12.4', 'ciUpperLimit': '32.6', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and baseline disease severity.', 'groupDescription': 'Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Primary endpoint tested sequentially at a 5% significance level'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.7', 'ciLowerLimit': '12.3', 'ciUpperLimit': '31.1', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and baseline disease severity.', 'groupDescription': 'Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Secondary endpoint tested sequentially at a 2.5% significance level'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.9', 'ciLowerLimit': '10.6', 'ciUpperLimit': '29.2', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and baseline disease severity.', 'groupDescription': 'Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Secondary endpoint tested sequentially at a 5% significance level'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': "The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.'}, {'type': 'SECONDARY', 'title': 'Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-27.5', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.7', 'ciLowerLimit': '-27.1', 'ciUpperLimit': '-12.2', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.0', 'ciLowerLimit': '-25.6', 'ciUpperLimit': '-10.4', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 0 to Week 16', 'description': 'The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'SECONDARY', 'title': "Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '-0.7', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.'}, {'pValue': '0.040', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '-0.1', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 0 to Week 16', 'description': "The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis set with non-missing baseline CDLQI score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 0 to Week 16', 'description': 'Number of AEs during the Initial treatment period is presented. For a summary of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.', 'unitOfMeasure': 'number of adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the safety analysis set. The safety analysis set comprised all subjects randomised to initial treatment and exposed to IMP, except for subjects randomised at the investigational sites where substantial quality/GCP issues were identified . The safety analysis set was identical to the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Presence of Anti-drug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 0 to Week 16', 'description': 'Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the safety analysis set. The safety analysis set comprised all subjects randomised to initial treatment, except for subjects randomised at the investigational sites where substantial quality/GCP issues were identified and subjects for whom no post-baseline safety data were available. The safety analysis set was identical to the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.5', 'ciLowerLimit': '26.8', 'ciUpperLimit': '50.2', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.4', 'ciLowerLimit': '20.6', 'ciUpperLimit': '44.1', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.7', 'ciLowerLimit': '5.2', 'ciUpperLimit': '22.2', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '6.5', 'ciUpperLimit': '24.1', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-8.7', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '-5.3', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-13.6', 'ciUpperLimit': '-5.3', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 0 to Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.5', 'ciLowerLimit': '4.5', 'ciUpperLimit': '18.4', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.6', 'ciLowerLimit': '7.8', 'ciUpperLimit': '23.3', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': 'The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.2', 'ciLowerLimit': '16.1', 'ciUpperLimit': '36.3', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '15.3', 'ciUpperLimit': '35.7', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': 'The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.6', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.3', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 0 to Week 16', 'description': "The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.'}, {'type': 'SECONDARY', 'title': 'Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.3', 'ciLowerLimit': '9.7', 'ciUpperLimit': '31.0', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.8', 'ciLowerLimit': '10.9', 'ciUpperLimit': '32.7', 'pValueComment': "Based on the primary analysis of the primary estimand 'composite'.", 'estimateComment': 'Mantel-Haenszel risk difference, stratified by region and disease severity.', 'groupDescription': 'Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 16', 'description': "The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.0', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '-3.6', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.4', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '-3.0', 'pValueComment': "Based on the primary analysis of the primary estimand 'hypothetical'.", 'groupDescription': 'Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.', 'statisticalMethod': 'Repeated measurements model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The statistical test was not controlled for multiplicity.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 0 to Week 16', 'description': "The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6' days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis set with non-missing baseline POEM score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.'}, {'type': 'SECONDARY', 'title': 'Tralokinumab Serum Trough Concentration at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.7', 'spread': '39.0', 'groupId': 'OG000'}, {'value': '56.4', 'spread': '35.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Week 16', 'description': 'Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.', 'unitOfMeasure': 'microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis set who were randomised to tralokinumab. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.'}, {'type': 'SECONDARY', 'title': "Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injection (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'OG002', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG003', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 52', 'description': "The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects in the full analysis set (FAS) who were re-randomised to maintenance treatment and achieved an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 without use of rescue medication from Week 2 to Week 16."}, {'type': 'SECONDARY', 'title': 'Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injection (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'OG002', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG003', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 52', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis set (FAS) who were re-randomised to maintenance treatment and achieved at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 without use of rescue medication from Week 2 to Week 16.'}, {'type': 'SECONDARY', 'title': 'Tralokinumab Serum Trough Concentration at Week 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '234', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'OG001', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injection (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'OG002', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'OG003', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'OG004', 'title': 'Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS', 'description': 'Week 16 to Week 52:\n\nSubjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if\n\n* IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16.\n* IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16.\n* Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': 'NA', 'comment': '1 subject provided data at Week 66, hence coefficient of variation could not be calculated.', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '458.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '168.6', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '75.6', 'groupId': 'OG003'}, {'value': '4.4', 'spread': '136.5', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Week 66', 'description': 'Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.', 'unitOfMeasure': 'microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': '13 subjects in maintenance safety analysis set who were initially randomised to tralokinumab and completed the maintenance treatment period on treatment. 234 subjects in the open-label safety analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'FG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'FG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'FG003', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'FG004', 'title': 'Maintenance Treatment Period - Tralokinumab 300 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'FG005', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'FG006', 'title': 'Maintenance Treatment Period - Tralokinumab 150 mg Q4W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 from Week 2 to Week 16 and initially randomised to tralokinumab 150 mg Q2W, re-randomised to tralokinumab 150 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'FG007', 'title': 'Maintenance Treatment Period - Placebo Q2W', 'description': 'Week 16 to Week 52:\n\nSubjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to placebo, assigned to continue to placebo Q2W. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'FG008', 'title': 'Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS', 'description': 'Week 16 to Week 52:\n\nSubjects receiving initial treatment with tralokinumab 150 mg/tralokinumab 300 mg/placebo Q2W who did not achieve clinical response at Week 16 without use of rescue medication from Week 2 to Week 16, assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 150 mg Q2W/Q4W, tralokinumab 300 mg Q2W/Q4W, or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if\n\n* IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16.\n* IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16.\n* Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\\>1 at Week 16. At each visit, subjects received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.'}], 'periods': [{'title': 'Initial Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Randomised at site with quality/GCP issues identified, subject withdrawn from the trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Subject discontinued IMP before Week 16', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Maintenance treatment period was in parallel to the open-label treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '14'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Subject discontinued IMP between Week 16 and Week 52', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Subject transferred to open-label treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Randomised at site with quality/GCP issues identified, subject withdrawn from the trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Open-label Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Open-label treatment period was in parallel to the maintenance treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'comment': '226 subjects transferred to open-label treatment at Week 16. 24 subjects transferred to open-label treatment between Week 16 and Week 52.', 'groupId': 'FG008', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '214'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Subject discontinued IMP between Week 16 and Week 52', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '19'}]}, {'type': 'Completed treatment (received the last planned dose of IMP) and withdrew from the trial at Week 50', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Randomised at site with quality/GCP issues identified, subject withdrawn from the trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Initial Treatment Period - Tralokinumab 300 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 300 mg Q2W Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.'}, {'id': 'BG001', 'title': 'Initial Treatment Period - Tralokinumab 150 mg Q2W', 'description': 'Week 0 to Week 16:\n\nTralokinumab 150 mg Q2W. Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.\n\nAt Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab.'}, {'id': 'BG002', 'title': 'Initial Treatment Period - Placebo', 'description': 'Week 0 to Week 16:\n\nPlacebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.\n\nAt Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '14.8', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '14.4', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '14.6', 'spread': '1.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '269', '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/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Investigator's Global Assessment", 'classes': [{'title': 'Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Almost Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The Investigator's Global Assessment (IGA) is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).", 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index', 'classes': [{'categories': [{'measurements': [{'value': '31.90', 'spread': '13.74', 'groupId': 'BG000'}, {'value': '31.89', 'spread': '12.97', 'groupId': 'BG001'}, {'value': '31.25', 'spread': '14.19', 'groupId': 'BG002'}, {'value': '31.68', 'spread': '13.60', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Scoring Atopic Dermatitis', 'classes': [{'categories': [{'measurements': [{'value': '68.41', 'spread': '13.51', 'groupId': 'BG000'}, {'value': '67.42', 'spread': '14.51', 'groupId': 'BG001'}, {'value': '67.70', 'spread': '14.77', 'groupId': 'BG002'}, {'value': '67.84', 'spread': '14.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Scoring Atopic Dermatitis (SCORAD) is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Children's Dermatology Life Quality Index", 'classes': [{'categories': [{'measurements': [{'value': '13.29', 'spread': '7.18', 'groupId': 'BG000'}, {'value': '12.86', 'spread': '6.27', 'groupId': 'BG001'}, {'value': '13.14', 'spread': '5.99', 'groupId': 'BG002'}, {'value': '13.10', 'spread': '6.48', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Children's Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor health-related quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Adolescent Worst Pruritus NRS (weekly average)', 'classes': [{'categories': [{'measurements': [{'value': '7.79', 'spread': '1.53', 'groupId': 'BG000'}, {'value': '7.49', 'spread': '1.58', 'groupId': 'BG001'}, {'value': '7.45', 'spread': '1.62', 'groupId': 'BG002'}, {'value': '7.58', 'spread': '1.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Subjects assessed their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Adolescent Worst Pruritus NRS') each morning, with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body surface area affected by atopic dermatitis (AD)', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '23.0', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '22.5', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '23.5', 'groupId': 'BG002'}, {'value': '50.9', 'spread': '23.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage affected', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age of onset of atopic dermatitis (AD)', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '2.4', 'spread': '3.5', 'groupId': 'BG002'}, {'value': '2.4', 'spread': '3.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of atopic dermatitis (AD)', 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '12.7', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '12.0', 'spread': '3.4', 'groupId': 'BG002'}, {'value': '12.3', 'spread': '3.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-06', 'size': 10142729, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-06T04:14', 'hasProtocol': True}, {'date': '2021-04-23', 'size': 1135906, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-31T05:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the investigational medicinal products (IMPs) will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded healthcare professional at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2021-03-24', 'completionDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2018-05-04', 'dispFirstSubmitQcDate': '2021-03-24', 'resultsFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2018-05-04', 'dispFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-30', 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16", 'timeFrame': 'At Week 16', 'description': "The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)."}, {'measure': 'Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16', 'timeFrame': 'At Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.'}], 'secondaryOutcomes': [{'measure': 'Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16', 'timeFrame': 'At Week 16', 'description': "The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'."}, {'measure': 'Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16', 'timeFrame': 'From Week 0 to Week 16', 'description': 'The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.'}, {'measure': "Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16", 'timeFrame': 'From Week 0 to Week 16', 'description': "The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life."}, {'measure': 'Number of Adverse Events', 'timeFrame': 'From Week 0 to Week 16', 'description': 'Number of AEs during the Initial treatment period is presented. For a summary of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.'}, {'measure': 'Presence of Anti-drug Antibodies', 'timeFrame': 'From Week 0 to Week 16', 'description': 'Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.'}, {'measure': 'Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.', 'timeFrame': 'At Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.'}, {'measure': 'Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.', 'timeFrame': 'At Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.'}, {'measure': 'Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16', 'timeFrame': 'From Week 0 to Week 16', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.'}, {'measure': 'Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16', 'timeFrame': 'At Week 16', 'description': 'The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.'}, {'measure': 'Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16', 'timeFrame': 'At Week 16', 'description': 'The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.'}, {'measure': 'Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16', 'timeFrame': 'From Week 0 to Week 16', 'description': "The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'."}, {'measure': 'Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16', 'timeFrame': 'At Week 16', 'description': "The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'."}, {'measure': 'Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16', 'timeFrame': 'From Week 0 to Week 16', 'description': "The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6' days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity."}, {'measure': 'Tralokinumab Serum Trough Concentration at Week 16', 'timeFrame': 'At Week 16', 'description': 'Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.'}, {'measure': "Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16", 'timeFrame': 'At Week 52', 'description': "The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)."}, {'measure': 'Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16', 'timeFrame': 'At Week 52', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.'}, {'measure': 'Tralokinumab Serum Trough Concentration at Week 66', 'timeFrame': 'At Week 66', 'description': 'Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '37074705', 'type': 'RESULT', 'citation': 'Paller AS, Flohr C, Cork M, Bewley A, Blauvelt A, Hong HC, Imafuku S, Schuttelaar MLA, Simpson EL, Soong W, Arlert P, Lophaven KW, Kurbasic A, Soldbro L, Vest NS, Wollenberg A. Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):596-605. doi: 10.1001/jamadermatol.2023.0627.'}, {'pmid': '40879371', 'type': 'DERIVED', 'citation': 'Reich K, Langley RG, Salvador JFS, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Oland CB, Tindberg AM, Gjerum L, Simpson EL. Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of 8 clinical trials. Br J Dermatol. 2025 Aug 29:ljaf309. doi: 10.1093/bjd/ljaf309. Online ahead of print.'}, {'pmid': '40721559', 'type': 'DERIVED', 'citation': 'Paller AS, Blauvelt A, Soong W, Chih-Ho Hong H, Schuttelaar MLA, Schneider SKR, Simpson EL. Clinically Meaningful Improvements in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab who did not Achieve Clear or Almost Clear Skin at Week 16. Dermatol Ther (Heidelb). 2025 Oct;15(10):2879-2896. doi: 10.1007/s13555-025-01484-1. Epub 2025 Jul 28.'}, {'pmid': '40555305', 'type': 'DERIVED', 'citation': 'Paller AS, Soong W, Boguniewicz M, Geng B, Thyssen JP, Bennike N, Schneider S, Wollenberg A. Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Oct;135(4):425-433.e4. doi: 10.1016/j.anai.2025.06.022. Epub 2025 Jun 22.'}, {'pmid': '35671038', 'type': 'DERIVED', 'citation': 'Soehoel A, Larsen MS, Timmermann S. Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clin Pharmacol Drug Dev. 2022 Aug;11(8):910-921. doi: 10.1002/cpdd.1113. Epub 2022 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nTo evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \\<18 years) with moderate-to-severe AD.\n\nSecondary objectives:\n\nTo evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.\n\nTo investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \\<18 years) with moderate-to-severe AD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12 to 17.\n* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.\n* History of AD for ≥1 year.\n* History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.\n* AD involvement of ≥10% body surface area at screening and baseline.\n* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.\n\nExclusion Criteria:\n\n* Active dermatologic conditions that may confound the diagnosis of AD.\n* Use of tanning beds or phototherapy within 6 weeks prior to randomisation.\n* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.\n* Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.\n* Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents.\n* Active skin infection within 1 week prior to randomisation.\n* Clinically significant infection within 4 weeks prior to randomisation.\n* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.\n* Tuberculosis requiring treatment within the 12 months prior to screening.\n* Known primary immunodeficiency disorder.'}, 'identificationModule': {'nctId': 'NCT03526861', 'briefTitle': 'Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy', 'orgStudyIdInfo': {'id': 'LP0162-1334'}, 'secondaryIdInfos': [{'id': '2017-005143-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA', 'description': 'Week 0 to 16 (initial period):\n\nTralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.\n\nWeek 16 to 52 (maintenance period):\n\nTralokinumab (Dose 1) maintenance SC injection regimen A.', 'interventionNames': ['Drug: Tralokinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB', 'description': 'Week 0 to 16 (initial period):\n\nTralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.\n\nWeek 16 to 52 (maintenance period):\n\nTralokinumab (Dose 1) maintenance SC injection regimen B.', 'interventionNames': ['Drug: Tralokinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA', 'description': 'Week 0 to 16 (initial period):\n\nTralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.\n\nWeek 16 to 52 (maintenance period):\n\nTralokinumab (Dose 2) maintenance SC injection regimen A.', 'interventionNames': ['Drug: Tralokinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB', 'description': 'Week 0 to 16 (initial period):\n\nTralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.\n\nWeek 16 to 52 (maintenance period):\n\nTralokinumab (Dose 2) maintenance SC injection regimen B.', 'interventionNames': ['Drug: Tralokinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo initial-> Placebo maintenance', 'description': 'Week 0 to 16 (initial period):\n\nPlacebo loading SC injection on Day 0 followed by placebo injection regimen A.\n\nWeek 16 to 52 (maintenance period):\n\nPlacebo continuation SC injection regimen A.', 'interventionNames': ['Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Tralokinumab (Dose1) initial-> Open-label tralokinumab', 'description': 'Week 0 to 16 (initial period):\n\nTralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.\n\nWeek 16 to 52:\n\nTralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids', 'interventionNames': ['Drug: Tralokinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tralokinumab (Dose2) initial-> Open-label tralokinumab', 'description': 'Week 0 to 16 (initial period):\n\nTralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.\n\nWeek 16 to 52:\n\nTralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids', 'interventionNames': ['Drug: Tralokinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo initial-> Open-label tralokinumab', 'description': 'Week 0 to 16 (initial period):\n\nPlacebo loading SC injection on Day 0 followed by placebo injection regimen A.\n\nWeek 16 to 52:\n\nTralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids', 'interventionNames': ['Drug: Tralokinumab', 'Drug: Placebos']}], 'interventions': [{'name': 'Tralokinumab', 'type': 'DRUG', 'description': 'Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.', 'armGroupLabels': ['Placebo initial-> Open-label tralokinumab', 'Tralokinumab (Dose1) initial-> Open-label tralokinumab', 'Tralokinumab (Dose2) initial-> Open-label tralokinumab', 'Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA', 'Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB', 'Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA', 'Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo contains the same excipients in the same concentration only lacking tralokinumab.', 'armGroupLabels': ['Placebo initial-> Open-label tralokinumab', 'Placebo initial-> Placebo maintenance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Leo Pharma Investigational Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma 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