Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT03370133
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2017-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625981', 'term': 'bimekizumab'}, {'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'UCBCares@ucb.com', 'phone': '+1844 599', 'title': 'UCB', 'phoneExt': '2273', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)', 'description': 'Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \\[SFU\\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Initial Period (SS)', 'description': 'During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 17, 'seriousNumAtRisk': 83, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Bimekizumab 320 mg Q4W Initial Period (SS)', 'description': 'During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS.', 'otherNumAtRisk': 321, 'deathsNumAtRisk': 321, 'otherNumAffected': 87, 'seriousNumAtRisk': 321, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Ustekinumab Initial Period (SS)', 'description': 'During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS.', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 37, 'seriousNumAtRisk': 163, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Any Bimekizumab 320 mg Q4W (AMS)', 'description': 'This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab 320 mg Q4W after the 16-week Initial Treatment Period. Participants formed the SS.', 'otherNumAtRisk': 395, 'deathsNumAtRisk': 395, 'otherNumAffected': 192, 'seriousNumAtRisk': 395, 'deathsNumAffected': 2, 'seriousNumAffected': 24}, {'id': 'EG004', 'title': 'Any Ustekinumab (AMS)', 'description': 'This arm consisted of all participants who received ustekinumab 45 mg or 90 mg (depending on participants weight) at any time in the study (up to Week 52). Participants formed the SS.', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 73, 'seriousNumAtRisk': 163, 'deathsNumAffected': 1, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 121, 'numAffected': 86}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 53, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 98, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 48, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Infective tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Subglottic laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Heart injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'False positive tuberculosis test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 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'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Vocal cord paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Haemorrhage in pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Metabolic surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '85.0', 'groupId': 'OG001'}, {'value': '49.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.869', 'ciLowerLimit': '34.020', 'ciUpperLimit': '293.175', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.056', 'ciLowerLimit': '3.874', 'ciUpperLimit': '9.466', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '84.1', 'groupId': 'OG001'}, {'value': '53.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '118.762', 'ciLowerLimit': '36.701', 'ciUpperLimit': '384.307', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.809', 'ciLowerLimit': '3.096', 'ciUpperLimit': '7.470', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] or almost clear \\[1\\] with at least a two-category improvement from Baseline at Week 16.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI100 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '58.6', 'groupId': 'OG001'}, {'value': '20.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.590', 'ciLowerLimit': '9.063', 'ciUpperLimit': '72.253', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an IGA 0 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '58.6', 'groupId': 'OG001'}, {'value': '22.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.471', 'ciLowerLimit': '9.020', 'ciUpperLimit': '71.925', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] with at least a two-category improvement from Baseline at Week 16.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI75 Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '76.9', 'groupId': 'OG001'}, {'value': '15.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '123.020', 'ciLowerLimit': '29.394', 'ciUpperLimit': '514.862', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.202', 'ciLowerLimit': '10.998', 'ciUpperLimit': '30.123', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': "The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '77.3', 'groupId': 'OG001'}, {'value': '68.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.258', 'ciLowerLimit': '7.356', 'ciUpperLimit': '35.931', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'As Patient-Reported-Outcome (PRO) measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.\n\nPSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '76.6', 'groupId': 'OG001'}, {'value': '65.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.279', 'ciLowerLimit': '9.795', 'ciUpperLimit': '50.674', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.\n\nPSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '78.5', 'groupId': 'OG001'}, {'value': '59.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.049', 'ciLowerLimit': '10.201', 'ciUpperLimit': '52.077', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}, {'value': '70.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.696', 'ciLowerLimit': '16.920', 'ciUpperLimit': '83.987', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score \\>0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score of at least 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI90 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '85.0', 'groupId': 'OG001'}, {'value': '43.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.047', 'ciLowerLimit': '5.107', 'ciUpperLimit': '12.679', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI90 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG001', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000'}, {'value': '55.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.795', 'ciLowerLimit': '2.442', 'ciUpperLimit': '5.899', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG002', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '81.9', 'groupId': 'OG001'}, {'value': '52.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.379', 'ciLowerLimit': '2.850', 'ciUpperLimit': '6.730', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] or almost clear \\[1\\] with at least a two-category improvement from Baseline at Week 12.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the RS.'}, {'id': 'OG001', 'title': 'Ustekinumab (RS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000'}, {'value': '60.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.412', 'ciLowerLimit': '1.573', 'ciUpperLimit': '3.699', 'pValueComment': 'P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] or almost clear \\[1\\] with at least a two-category improvement from Baseline at Week 52.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (SS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (SS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS.'}, {'id': 'OG002', 'title': 'Ustekinumab (SS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.'}], 'classes': [{'categories': [{'measurements': [{'value': '238.41', 'groupId': 'OG000', 'lowerLimit': '169.53', 'upperLimit': '325.91'}, {'value': '287.26', 'groupId': 'OG001', 'lowerLimit': '246.93', 'upperLimit': '332.29'}, {'value': '247.62', 'groupId': 'OG002', 'lowerLimit': '197.23', 'upperLimit': '306.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.', 'unitOfMeasure': 'no. of new events per 100 subject-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (SS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (SS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS.'}, {'id': 'OG002', 'title': 'Ustekinumab (SS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.97', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '28.80'}, {'value': '5.06', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '11.80'}, {'value': '10.14', 'groupId': 'OG002', 'lowerLimit': '3.29', 'upperLimit': '23.66'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.', 'unitOfMeasure': 'no. of new events per 100 subject-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (SS)', 'description': 'Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (SS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS.'}, {'id': 'OG002', 'title': 'Ustekinumab (SS)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.39', 'groupId': 'OG000', 'lowerLimit': '8.95', 'upperLimit': '53.09'}, {'value': '6.08', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '13.24'}, {'value': '5.99', 'groupId': 'OG002', 'lowerLimit': '1.24', 'upperLimit': '17.52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.', 'unitOfMeasure': 'no. of new events per 100 subject-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bimekizumab 320 mg Q4W (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.'}, {'id': 'OG002', 'title': 'Ustekinumab/Ustekinumab (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS.'}], 'classes': [{'categories': [{'measurements': [{'value': '149.35', 'groupId': 'OG000', 'lowerLimit': '114.24', 'upperLimit': '191.85'}, {'value': '127.84', 'groupId': 'OG001', 'lowerLimit': '111.58', 'upperLimit': '145.81'}, {'value': '111.24', 'groupId': 'OG002', 'lowerLimit': '90.80', 'upperLimit': '134.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 16 to Safety Follow-Up (up to 52 weeks duration)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.', 'unitOfMeasure': 'no. of new events per 100 subject-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bimekizumab 320 mg Q4W (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.'}, {'id': 'OG002', 'title': 'Ustekinumab/Ustekinumab (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.88', 'groupId': 'OG000', 'lowerLimit': '3.21', 'upperLimit': '23.05'}, {'value': '6.19', 'groupId': 'OG001', 'lowerLimit': '3.30', 'upperLimit': '10.58'}, {'value': '7.46', 'groupId': 'OG002', 'lowerLimit': '3.22', 'upperLimit': '14.70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 16 to Safety Follow-Up (up to 52 weeks duration)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.', 'unitOfMeasure': 'no. of new events per 100 subject-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bimekizumab 320 mg Q4W (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.'}, {'id': 'OG002', 'title': 'Ustekinumab/Ustekinumab (MS)', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.91', 'groupId': 'OG000', 'lowerLimit': '1.22', 'upperLimit': '17.27'}, {'value': '5.72', 'groupId': 'OG001', 'lowerLimit': '2.95', 'upperLimit': '9.99'}, {'value': '3.71', 'groupId': 'OG002', 'lowerLimit': '1.01', 'upperLimit': '9.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 16 to Safety Follow-Up (up to 52 weeks duration)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.', 'unitOfMeasure': 'no. of new events per 100 subject-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.'}, {'id': 'FG001', 'title': 'Bimekizumab (BKZ) 320 Milligrams (mg) Q4W', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks.'}, {'id': 'FG002', 'title': 'Ustekinumab (Uste)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.'}, {'id': 'FG003', 'title': 'Placebo/Bimekizumab 320 mg Q4W', 'description': 'After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period (Maintenance Period).'}, {'id': 'FG004', 'title': 'Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period.'}, {'id': 'FG005', 'title': 'Ustekinumab/Ustekinumab', 'description': 'After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participant weight) continued to receive ustekinumab during the 36-week Maintenance Treatment Period.'}], 'periods': [{'title': 'Initial Treatment Period (WK 16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '321'}, {'groupId': 'FG002', 'numSubjects': '163'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '306'}, {'groupId': 'FG002', 'numSubjects': '157'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', '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'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Treatment Period (WK 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '306'}, {'groupId': 'FG005', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '69'}, {'groupId': 'FG004', 'numSubjects': '283'}, {'groupId': 'FG005', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Non-compliance', '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'}]}, {'type': 'Consent Withdrawn for IMP Not Procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study started to enroll participants in December 2017 and concluded in December 2019.', 'preAssignmentDetails': 'The study included a 2-5 week Screening Period, a 16-week Initial Period and a 36-week Maintenance Period. After the Maintenance Period participants either enrolled in an open-label study or had a SFU Visit 20 weeks after their final dose (including those withdrawn from IMP). Participant Flow refers to the Randomized Set and Maintenance Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '567', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.'}, {'id': 'BG001', 'title': 'Bimekizumab (BKZ) 320 Milligrams (mg) Q4W', 'description': 'Participants received bimekizumab 320 mg Q4W for 52 weeks.'}, {'id': 'BG002', 'title': 'Ustekinumab (Uste)', 'description': 'Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.'}, {'id': 'BG003', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '502', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '13.6', 'groupId': 'BG002'}, {'value': '46.1', 'spread': '13.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian/Alaskan native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '420', 'groupId': 'BG003'}]}, {'title': 'Other/mixed', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics refer to the Randomized Set (RS) consisting of all participants randomized into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-21', 'size': 2988408, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-13T04:56', 'hasProtocol': True}, {'date': '2019-09-13', 'size': 2321524, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-13T04:57', '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': 567}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2020-01-07', 'completionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2017-12-07', 'dispFirstSubmitQcDate': '2020-01-07', 'resultsFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2017-12-07', 'dispFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-01-05', 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16', 'timeFrame': 'Week 16', 'description': "The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease."}, {'measure': "Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16", 'timeFrame': 'Week 16', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] or almost clear \\[1\\] with at least a two-category improvement from Baseline at Week 16."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a PASI100 Response at Week 16', 'timeFrame': 'Week 16', 'description': "The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease."}, {'measure': 'Percentage of Participants With an IGA 0 Response at Week 16', 'timeFrame': 'Week 16', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] with at least a two-category improvement from Baseline at Week 16."}, {'measure': 'Percentage of Participants With a PASI75 Response at Week 4', 'timeFrame': 'Week 4', 'description': "The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease."}, {'measure': 'Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16', 'timeFrame': 'Week 16', 'description': 'As Patient-Reported-Outcome (PRO) measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.\n\nPSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.'}, {'measure': 'Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16', 'timeFrame': 'Week 16', 'description': 'A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.\n\nPSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.'}, {'measure': 'Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16', 'timeFrame': 'Week 16', 'description': 'As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.'}, {'measure': 'Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline', 'timeFrame': 'Week 16', 'description': 'Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score \\>0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.'}, {'measure': 'Percentage of Participants With a PASI90 Response at Week 12', 'timeFrame': 'Week 12', 'description': "The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease."}, {'measure': 'Percentage of Participants With a PASI90 Response at Week 52', 'timeFrame': 'Week 52', 'description': "The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease."}, {'measure': 'Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12', 'timeFrame': 'Week 12', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] or almost clear \\[1\\] with at least a two-category improvement from Baseline at Week 12."}, {'measure': 'Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52', 'timeFrame': 'Week 52', 'description': "The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \\[0\\] or almost clear \\[1\\] with at least a two-category improvement from Baseline at Week 52."}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period', 'timeFrame': 'From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.'}, {'measure': 'Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period', 'timeFrame': 'From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.'}, {'measure': 'Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period', 'timeFrame': 'From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.'}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period', 'timeFrame': 'From Week 16 to Safety Follow-Up (up to 52 weeks duration)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.'}, {'measure': 'Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period', 'timeFrame': 'From Week 16 to Safety Follow-Up (up to 52 weeks duration)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.'}, {'measure': 'Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period', 'timeFrame': 'From Week 16 to Safety Follow-Up (up to 52 weeks duration)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bimekizumab', 'PSO', 'Psoriasis'], 'conditions': ['Chronic Plaque Psoriasis', 'Moderate to Severe Chronic Plaque Psoriasis', 'Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '36648594', 'type': 'RESULT', 'citation': 'Asahina A, Okubo Y, Morita A, Tada Y, Igarashi A, Langley RG, Deherder D, Matano M, Vanvoorden V, Wang M, Ohtsuki M, Nakagawa H. Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.'}, {'pmid': '35544084', 'type': 'RESULT', 'citation': 'Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.'}, {'pmid': '37950894', 'type': 'RESULT', 'citation': 'Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429.'}, {'pmid': '41060492', 'type': 'RESULT', 'citation': 'Strober B, Boehncke WH, Krueger JG, Magnolo N, Vender R, Warren RB, Lopez Pinto JM, Kavanagh S, Hoepken B, Gisondi P. Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3633-3650. doi: 10.1007/s13555-025-01557-1. Epub 2025 Oct 8.'}, {'pmid': '41359217', 'type': 'DERIVED', 'citation': 'Armstrong A, Papp KA, Lebwohl M, Savage LJ, Yamanaka K, Vlase DE, Warham R, Lambert J, Lopez Pinto JM, Wixted K, Thaci D. Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT. Dermatol Ther (Heidelb). 2025 Dec 8. doi: 10.1007/s13555-025-01595-9. Online ahead of print.'}, {'pmid': '40886218', 'type': 'DERIVED', 'citation': 'Merola JF, Warren RB, Thaci D, Gordon KB, Nishida E, Strober B, Conrad C, Kavanagh S, Lopez Pinto JM, Hoepken B, Gisondi P. Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Am J Clin Dermatol. 2025 Nov;26(6):967-979. doi: 10.1007/s40257-025-00968-2. Epub 2025 Aug 31.'}, {'pmid': '39578348', 'type': 'DERIVED', 'citation': 'Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.'}, {'pmid': '36751950', 'type': 'DERIVED', 'citation': 'Kokolakis G, Warren RB, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Korber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Nunez Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089.'}, {'pmid': '34260044', 'type': 'DERIVED', 'citation': 'Warren RB, Gottlieb AB, Merola JF, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Oct;11(5):1551-1569. doi: 10.1007/s13555-021-00570-4. Epub 2021 Jul 14.'}, {'pmid': '33549193', 'type': 'DERIVED', 'citation': 'Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, Gordon KB, Merola JF, Okubo Y, Madden C, Wang M, Cioffi C, Vanvoorden V, Lebwohl M. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021 Feb 6;397(10273):487-498. doi: 10.1016/S0140-6736(21)00125-2.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be at least 18 years of age\n* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n* Psoriasis Area Severity Index (PASI) \\>=12 and body surface area (BSA) affected by PSO \\>=10% and Investigator's Global Assessment (IGA) score \\>=3 on a 5-point scale\n* Subject is a candidate for systemic PSO therapy and/or phototherapy\n* Female subject of child bearing potential must be willing to use highly effective method of contraception\n\nExclusion Criteria:\n\n* Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections\n* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n* Presence of active suicidal ideation or positive suicide behavior\n* Presence of moderately severe major depression or severe major depression\n* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer"}, 'identificationModule': {'nctId': 'NCT03370133', 'acronym': 'BE VIVID', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'PS0009'}, 'secondaryIdInfos': [{'id': '2016-003425-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimekizumab cohort', 'description': 'Subjects will receive bimekizumab for 52 weeks.', 'interventionNames': ['Drug: Bimekizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ustekinumab cohort', 'description': 'Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.', 'interventionNames': ['Drug: Ustekinumab', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.', 'interventionNames': ['Drug: Bimekizumab', 'Other: Placebo']}], 'interventions': [{'name': 'Bimekizumab', 'type': 'DRUG', 'otherNames': ['UCB4940'], 'description': 'Bimekizumab will be provided at pre-specified time intervals.', 'armGroupLabels': ['Bimekizumab cohort', 'Placebo']}, {'name': 'Ustekinumab', 'type': 'DRUG', 'otherNames': ['Stelara®'], 'description': 'Ustekinumab will be provided as dose 1 for subjects weighing \\<=100 kg and as dose 2 for subjects weighing \\>100 kg at pre-specified time intervals.', 'armGroupLabels': ['Ustekinumab cohort']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['PBO'], 'description': 'Subjects will receive Placebo at pre-specified time points.', 'armGroupLabels': ['Placebo', 'Ustekinumab cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ps0009 946', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Ps0009 910', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Ps0009 919', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Ps0009 906', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ps0009 909', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 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