Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT03451851
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Russia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588857', 'term': 'guselkumab'}, {'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Study Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52', 'description': 'Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.', 'eventGroups': [{'id': 'EG000', 'title': 'PCP-Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 17, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PCP-Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 17, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PCP-Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 15, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Withdrawal and Re-treatment Period-Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)', 'description': 'Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 16, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Withdrawal and Re-treatment Period-Group 2 (Part 1): Guselkumab (Week 16-52)', 'description': 'Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 29, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Withdrawal and Re-treatment Period- Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)', 'description': 'Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 13, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 23, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Conjunctivitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Aphthous Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Application Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 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'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Tonsillar Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Diffuse Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Lichen Planus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Night Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Skin Hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}], 'seriousEvents': [{'term': 'Chronic Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Multiple Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.9', 'ciLowerLimit': '25.9', 'ciUpperLimit': '69.4', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the full analysis set (FAS) which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'PRIMARY', 'title': 'Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '75.6', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '55.6', 'ciLowerLimit': '32.1', 'ciUpperLimit': '74.0', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \\[%\\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '56.1', 'groupId': 'OG001'}, {'value': '53.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.1', 'ciLowerLimit': '15.6', 'ciUpperLimit': '61.3', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in the PASI score.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35', 'ciLowerLimit': '10.5', 'ciUpperLimit': '56.8', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '25', 'paramValue': '34.1', 'ciLowerLimit': '9.7', 'ciUpperLimit': '56.1', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \\[%\\] to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 100 response represented participants who achieved a 100 % improvement from baseline in the PASI score.', 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': "Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'spread': '6.323', 'groupId': 'OG000'}, {'value': '-7.12', 'spread': '7.633', 'groupId': 'OG001'}, {'value': '-6.08', 'spread': '5.692', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.4', 'ciLowerLimit': '-7.33', 'ciUpperLimit': '-3.06', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Mixed model repeated measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': "CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Change from baseline is defined as post baseline score minus baseline score.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2 (Part 1): Guselkumab (Week 16-52)', 'description': 'Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': '4 weeks after retreatment of guselkumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks after retreatment of guselkumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)', 'description': 'PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in PASI score.', 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2 (Part 1): Guselkumab (Week 16-52)', 'description': 'Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': '4 weeks after retreatment: >=50% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks after retreatment: >=75% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks after retreatment:>= 90% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks after retreatment: 100% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks after retreatment: >=50% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks after retreatment: >=75% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks after retreatment:>= 90% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks after retreatment: 100% improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90 and 100 response represented at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.', 'unitOfMeasure': 'At 4 and 8 weeks post retreatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2 (Part 1): Guselkumab (Week 16-52)', 'description': 'Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': '4 Weeks after retreatment: IGA-0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4 Weeks after retreatment: IGA-0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': '4 Weeks after retreatment: IGA-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': '8 Weeks after retreatment: IGA-0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': '8 Weeks after retreatment: IGA-0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': '8 Weeks after retreatment: IGA- 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.'}, {'type': 'SECONDARY', 'title': 'Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2 (Part 1): Guselkumab (Week 16-52)', 'description': 'Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'Cumulative rate of loss of at least 50% of PASI improvement was defined as percentage of participants with a loss of \\>=50% of Week 16 PASI improvement after treatment is withdrawn. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.'}, {'type': 'SECONDARY', 'title': 'Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2 (Part 1): Guselkumab (Week 16-52)', 'description': 'Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 20', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '50.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 52 among guselkumab PASI 90 responders at Week 16. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90% improvement from baseline in PASI score.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}, {'value': '76.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.8', 'ciLowerLimit': '36.9', 'ciUpperLimit': '77.6', 'pValueComment': 'p-value is nominal', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 50 response represented at least a 50% improvement from baseline in the PASI score.', 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percent Improvement From Baseline in PASI Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.37', 'spread': '30.074', 'groupId': 'OG000'}, {'value': '39.12', 'spread': '27.907', 'groupId': 'OG001'}, {'value': '42.53', 'spread': '26.013', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.61', 'spread': '40.734', 'groupId': 'OG000'}, {'value': '71.25', 'spread': '28.018', 'groupId': 'OG001'}, {'value': '64.27', 'spread': '29.314', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.67', 'spread': '52.391', 'groupId': 'OG000'}, {'value': '79.79', 'spread': '28.570', 'groupId': 'OG001'}, {'value': '77.30', 'spread': '24.735', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.02', 'spread': '55.538', 'groupId': 'OG000'}, {'value': '79.83', 'spread': '30.468', 'groupId': 'OG001'}, {'value': '82.05', 'spread': '23.225', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 12, and 16', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.', 'unitOfMeasure': 'Percent improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, n (number analyzed): number of participants evaluable for each arm at specified time points.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percent Improvement From Baseline in PASI Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.33', 'spread': '26.781', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.05', 'spread': '21.177', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.40', 'spread': '15.541', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.96', 'spread': '11.177', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.10', 'spread': '14.851', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.44', 'spread': '12.948', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.77', 'spread': '7.848', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.95', 'spread': '7.430', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.32', 'spread': '7.478', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.', 'unitOfMeasure': 'Percent improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'title': 'Week 4: >= 50% improvement', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '38.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 4: >= 75% improvement', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4: >= 90% improvement', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 4: 100% improvement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: >= 50% improvement', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '78.0', 'groupId': 'OG001'}, {'value': '73.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: >= 75% improvement', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '51.2', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: >= 90% improvement', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: 100% improvement', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: >= 50% improvement', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '85.4', 'groupId': 'OG001'}, {'value': '76.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: >= 75% improvement', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '73.2', 'groupId': 'OG001'}, {'value': '61.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: >= 90% improvement', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '56.1', 'groupId': 'OG001'}, {'value': '38.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: 100% improvement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: >= 50% improvement', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}, {'value': '76.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: >= 75% improvement', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '75.6', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: >= 90% improvement', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '56.1', 'groupId': 'OG001'}, {'value': '53.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: 100% improvement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, and 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.', 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 4: >= 50% improvement', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: >= 75% improvement', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: >= 90% improvement', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: 100% improvement', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: >= 50% improvement', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: >= 75% improvement', 'categories': [{'measurements': [{'value': '67.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: >= 90% improvement', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: 100% improvement', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: >= 50% improvement', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: >= 75% improvement', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: >= 90% improvement', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: 100% improvement', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: >= 50% improvement', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: >= 75% improvement', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: >= 90% improvement', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: 100% improvement', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: >= 50% improvement', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: >= 75% improvement', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: >= 90% improvement', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: 100% improvement', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: >= 50% improvement', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: >= 75% improvement', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: >= 90% improvement', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: 100% improvement', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: >= 50% improvement', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: >= 75% improvement', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: >= 90% improvement', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: 100% improvement', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: >= 50% improvement', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: >= 75% improvement', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: >= 90% improvement', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: 100% improvement', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: >= 50% improvement', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: >= 75% improvement', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: >= 90% improvement', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: 100% improvement', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.', 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'title': 'Week 4 : IGA of cleared (0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 : IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 :IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '63.4', 'groupId': 'OG001'}, {'value': '73.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 : IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '58.5', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 :IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '78.0', 'groupId': 'OG001'}, {'value': '88.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '43.9', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 : IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '70.7', 'groupId': 'OG001'}, {'value': '65.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 :IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}, {'value': '84.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 : IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 :IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}, {'value': '92.7', 'groupId': 'OG001'}, {'value': '84.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, and 16', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 4: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4:IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8:IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12:IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 16:IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 20:IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 28:IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 36:IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: IGA of cleared (0)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: IGA of cleared (0) or minimal (1)', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: IGA of mild or better (<=2)', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in CDLQI Score Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '6.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '6.32', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '6.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '6.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '6.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, 28, 36, and 52', 'description': "Change from baseline in CDLQI score through Week 52 were reported. CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '64.1', 'groupId': 'OG001'}, {'value': '38.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.7', 'ciLowerLimit': '21.9', 'ciUpperLimit': '67.3', 'pValueComment': 'p-value is nominal', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 16, 28, 36, and 52', 'description': "CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}, {'value': '24.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.1', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '47.0', 'pValueComment': 'p-value is nominal', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled)."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example: emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 16, 28, 36, and 52', 'description': "The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.", 'unitOfMeasure': 'Percentages of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in FDLQI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '6.984', 'groupId': 'OG000'}, {'value': '-6.22', 'spread': '6.299', 'groupId': 'OG001'}, {'value': '-6.22', 'spread': '4.814', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.44', 'ciLowerLimit': '-8.00', 'ciUpperLimit': '-2.87', 'pValueComment': 'p-value is nominal', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': "The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in FDLQI Score Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '5.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '5.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '6.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '5.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '5.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8, 16, 28, 36, and 52', 'description': "The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.", 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'OG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.84', 'spread': '13.861', 'groupId': 'OG000'}, {'value': '-19.59', 'spread': '17.645', 'groupId': 'OG001'}, {'value': '-17.50', 'spread': '10.628', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.78', 'ciLowerLimit': '-20.28', 'ciUpperLimit': '-9.28', 'pValueComment': 'p-value is nominal', 'groupDescription': 'Guselkumab Vs Placebo', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': "Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Guselkumab (Week 0-52)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.9', 'spread': '7.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.8', 'spread': '12.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.6', 'spread': '12.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.7', 'spread': '13.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.0', 'spread': '13.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.0', 'spread': '14.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.3', 'spread': '14.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.5', 'spread': '14.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.4', 'spread': '14.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': "Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time', 'timeFrame': 'From Week 52 to End of the study (EOS) (December 2026)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] Over Time', 'timeFrame': 'From Week 52 to EOS (December 2026)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Percent Improvement From Baseline in PASI Over Time', 'timeFrame': 'From Week 52 to EOS (December 2026)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time', 'timeFrame': 'From Week 52 to EOS (Dec 2026)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90,and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Participants Who Were Withdrawn From Guselkumab at Week 16 and Retreated Upon Loss of Response or at Week 52', 'timeFrame': 'Week 60 and Week 84', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] at Weeks 60 and 84 After Retreatment', 'timeFrame': 'Week 60 and Week 84', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Percent Improvement in PASI Responses (PASI 50, 75, 90, and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52', 'timeFrame': 'Week 60 and Week 84', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'LTE Phase: Change From Baseline in BSA at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52', 'timeFrame': 'Week 60 and Week 84', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'FG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'FG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'FG003', 'title': 'Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)', 'description': 'Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}, {'id': 'FG004', 'title': 'Group 2 (Part 1): Guselkumab (Week 16-52)', 'description': 'Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \\>= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}, {'id': 'FG005', 'title': 'Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)', 'description': 'Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}, {'id': 'FG006', 'title': 'Part 2: Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and 16.'}, {'id': 'FG007', 'title': 'Part 2: Guselkumab (Week 16-52)', 'description': 'Participants who completed Week 16 during PCP continued to receive weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection q8w from Weeks 16 through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.'}], 'periods': [{'title': 'PCP: Week 0 -16', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '28'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '27'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Withdrawal and Retreament: Week 16-52', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Only eligible participants who crossed over to receive Guselkumab included in this period.', 'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'comment': 'Only eligible participants who crossed over to receive Guselkumab included in this period.', 'groupId': 'FG005', 'numSubjects': '22'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '35'}, {'groupId': 'FG005', 'numSubjects': '21'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other Unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other- completed safety follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This result is currently reported for primary analysis till clinical cut-off date 29-Mar-2024. In Part 1, the enrollment of participants aged greater than or equal to (\\>=) 6 to less than (\\<) 12 years started only after all participants aged \\>=12 to \\<18 years of age had finished Week 16 of the study. Long-term extension (LTE) phase is still ongoing, and results will be posted upon study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (Part 1): Placebo (Week 0-16)', 'description': 'Adolescent participants (aged \\>=12 to \\<18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'BG001', 'title': 'Group 2 (Part 1): Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'BG002', 'title': 'Group 3 (Part 1): Etanercept (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW \\<63 kg and 50 mg for BW \\>=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged \\>=6 to \\<12 years began receiving the same dose regimen starting from Week 0 until Week 16.'}, {'id': 'BG003', 'title': 'Part 2: Guselkumab (Week 0-16)', 'description': 'Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight \\[BW\\] \\<70 kg, 100 mg for BW \\>=70 kg) as SC injection at Weeks 0, 4, and 16.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=6 to <12 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': '>=12 to <18 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'NETHERLANDS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'AgeContinuous', 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '3.63', 'groupId': 'BG000'}, {'value': '13.4', 'spread': '2.86', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '3.29', 'groupId': 'BG002'}, {'value': '15.1', 'spread': '1.59', 'groupId': 'BG003'}, {'value': '13.4', 'spread': '3.05', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-29', 'size': 5052988, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-29T03:23', 'hasProtocol': True}, {'date': '2023-12-04', 'size': 1280959, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-29T03:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2024-07-16', 'completionDateStruct': {'date': '2026-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2018-02-26', 'resultsFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2018-02-26', 'dispFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-27', 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16", 'timeFrame': 'At Week 16', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease."}, {'measure': 'Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \\[%\\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in the PASI score.'}, {'measure': 'Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16', 'timeFrame': 'At Week 16', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease."}, {'measure': 'Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \\[%\\] to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 100 response represented participants who achieved a 100 % improvement from baseline in the PASI score.'}, {'measure': "Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16", 'timeFrame': 'Baseline and Week 16', 'description': "CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Change from baseline is defined as post baseline score minus baseline score."}, {'measure': 'Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment', 'timeFrame': 'At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)', 'description': 'PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in PASI score.'}, {'measure': 'Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment', 'timeFrame': 'At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90 and 100 response represented at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.'}, {'measure': 'Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment', 'timeFrame': 'At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease."}, {'measure': 'Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16', 'timeFrame': 'Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'Cumulative rate of loss of at least 50% of PASI improvement was defined as percentage of participants with a loss of \\>=50% of Week 16 PASI improvement after treatment is withdrawn. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease.'}, {'measure': 'Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16', 'timeFrame': 'Week 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 52 among guselkumab PASI 90 responders at Week 16. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90% improvement from baseline in PASI score.'}, {'measure': 'Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16', 'timeFrame': 'At Week 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 50 response represented at least a 50% improvement from baseline in the PASI score.'}, {'measure': 'Part 1: Percent Improvement From Baseline in PASI Through Week 16', 'timeFrame': 'Weeks 4, 8, 12, and 16', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.'}, {'measure': 'Part 2: Percent Improvement From Baseline in PASI Through Week 52', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.'}, {'measure': 'Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16', 'timeFrame': 'Weeks 4, 8, 12, and 16', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.'}, {'measure': 'Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': 'The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.'}, {'measure': 'Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16', 'timeFrame': 'Weeks 4, 8, 12, and 16', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease."}, {'measure': 'Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': "The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \\>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease."}, {'measure': 'Part 2: Change From Baseline in CDLQI Score Through Week 52', 'timeFrame': 'Baseline, Weeks 8, 16, 28, 36, and 52', 'description': "Change from baseline in CDLQI score through Week 52 were reported. CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children."}, {'measure': 'Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1', 'timeFrame': 'At Week 16', 'description': "CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children."}, {'measure': 'Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1', 'timeFrame': 'Weeks 8, 16, 28, 36, and 52', 'description': "CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children."}, {'measure': 'Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1', 'timeFrame': 'At Week 16', 'description': "The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example: emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL."}, {'measure': 'Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1', 'timeFrame': 'Weeks 8, 16, 28, 36, and 52', 'description': "The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL."}, {'measure': 'Part 1: Change From Baseline in FDLQI Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL."}, {'measure': 'Part 2: Change From Baseline in FDLQI Score Through Week 52', 'timeFrame': 'Baseline, Weeks 8, 16, 28, 36, and 52', 'description': "The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL."}, {'measure': 'Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis."}, {'measure': 'Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52', 'description': "Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis."}, {'measure': 'LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time', 'timeFrame': 'From Week 52 to End of the study (EOS) (December 2026)'}, {'measure': 'LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] Over Time', 'timeFrame': 'From Week 52 to EOS (December 2026)'}, {'measure': 'LTE Phase: Percent Improvement From Baseline in PASI Over Time', 'timeFrame': 'From Week 52 to EOS (December 2026)'}, {'measure': 'LTE Phase: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time', 'timeFrame': 'From Week 52 to EOS (Dec 2026)'}, {'measure': 'LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90,and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Participants Who Were Withdrawn From Guselkumab at Week 16 and Retreated Upon Loss of Response or at Week 52', 'timeFrame': 'Week 60 and Week 84'}, {'measure': 'LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] at Weeks 60 and 84 After Retreatment', 'timeFrame': 'Week 60 and Week 84'}, {'measure': 'LTE Phase: Percent Improvement in PASI Responses (PASI 50, 75, 90, and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52', 'timeFrame': 'Week 60 and Week 84'}, {'measure': 'LTE Phase: Change From Baseline in BSA at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52', 'timeFrame': 'Week 60 and Week 84'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '41152645', 'type': 'DERIVED', 'citation': 'Crauwels H, Ringold S, Howard S, Van Hartingsveldt B, Smith V, Jett M, Baguet T, Adamson E, Chakravarty SD, Leu JH. Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data. Paediatr Drugs. 2025 Oct 28. doi: 10.1007/s40272-025-00725-2. Online ahead of print.'}, {'pmid': '39708367', 'type': 'DERIVED', 'citation': 'Prajapati VH, Seyger MMB, Wilsmann-Theis D, Szakos E, Kaszuba A, van Hartingsveldt B, Jett M, Jiang G, Li S, Sinha V, Crauwels H, DeKlotz CMC, Paller AS. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study. Br J Dermatol. 2025 Mar 18;192(4):618-628. doi: 10.1093/bjd/ljae502.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis \\[PsA\\]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (\\>=) 3, Psoriasis Area and Severity Index (PASI) \\>=12, \\>=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI\\>=20, \\>20% BSA involvement, or IGA=4\n* Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment)\n* Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy\n* Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling\n* Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator\n* Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention\n\nExclusion Criteria:\n\n* Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)\n* Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)\n* Has previously received guselkumab or etanercept\n* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers\n* Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly"}, 'identificationModule': {'nctId': 'NCT03451851', 'acronym': 'PROTOSTAR', 'briefTitle': 'A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)', 'orgStudyIdInfo': {'id': 'CR108452'}, 'secondaryIdInfos': [{'id': 'CNTO1959PSO3011', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2023-503378-19-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Group 1: Guselkumab', 'description': 'Participants in Part 1a (age greater than or equal to (\\>=) 12 - less than (\\<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose \\>=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age \\>= 6 - \\<12 years) will follow the same dosing and commence after Part 1a data review.', 'interventionNames': ['Drug: Guselkumab', 'Drug: Placebo for guselkumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 Group 2: Placebo for Guselkumab', 'description': 'Participants in Part 1a (age \\>= 12 - \\<18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose \\>=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \\>= 6 - \\<12 years) will follow the same dosing and commence after Part 1a data review.', 'interventionNames': ['Drug: Guselkumab', 'Drug: Placebo for guselkumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 1 Group 3: Etanercept', 'description': 'Participants in Part 1a (age \\>= 12 - \\<18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \\>= 6 - \\<12 years) will follow the same dosing and commence after Part 1a data review.', 'interventionNames': ['Drug: Guselkumab', 'Drug: Etanercept']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Guselkumab', 'description': 'Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter.', 'interventionNames': ['Drug: Guselkumab']}], 'interventions': [{'name': 'Guselkumab', 'type': 'DRUG', 'otherNames': ['CNTO1959'], 'description': 'Participants will receive a weight-based dose of guselkumab subcutaneously.', 'armGroupLabels': ['Part 1 Group 1: Guselkumab', 'Part 1 Group 2: Placebo for Guselkumab', 'Part 1 Group 3: Etanercept', 'Part 2: Guselkumab']}, {'name': 'Placebo for guselkumab', 'type': 'DRUG', 'description': 'Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.', 'armGroupLabels': ['Part 1 Group 1: Guselkumab', 'Part 1 Group 2: Placebo for Guselkumab']}, {'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': 'Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.', 'armGroupLabels': ['Part 1 Group 3: Etanercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94306', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dermatologic Surgery Specialists', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Arlington Dermatology', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '08520-2505', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Windsor Dermatology', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45324', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State Physicians Health Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '76011-3800', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Center for Dermatology', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "Dell Children's Medical Center of Central Texas", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '3128', 'city': 'Box Hill', 'country': 'Australia', 'facility': 'Eastern Health Research', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '2065', 'city': 'St Leonards', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '4102', 'city': 'Woolloongabba', 'country': 'Australia', 'facility': 'Veracity Clinical Research', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'T2G 1B1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Kirk Barber Reseach Inc.', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2J 7E1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Dermatology Research Institute Inc', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 4E8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Skin Care Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitatsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitatsklinikum Carl Gustav Carcus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitatsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitatsklinikum Schleswig Holstein Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '89129', 'city': 'Langenau', 'country': 'Germany', 'facility': 'Praxis Dr. med. Beate Schwarz - Germany', 'geoPoint': {'lat': 48.49616, 'lon': 10.11849}}, {'zip': '56242', 'city': 'Selters', 'country': 'Germany', 'facility': 'Company for Medical Study & Service Selters', 'geoPoint': {'lat': 50.51681, 'lon': 8.28953}}, {'zip': '70178', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Hautarztpraxis Dr. Leitz & Kollegen', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Obudai Egeszsegugyi Centrum Kft', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '3526', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Szegedi Tudomanyegyetem', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '60026', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Ospedali Riuniti Di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Policlinico S. Orsola-Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '09124', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'AOU di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '42123', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova - IRCCS', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '90-265', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Dermed Centrum Medyczne Sp z o o', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '03-924', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50 556', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}