Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT03410992
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2018-01-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}}}, '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'}]}}, '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': 'Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration)', '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 Period).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (SS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 15, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Bimekizumab 320 mg Q4W (SS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.', 'otherNumAtRisk': 349, 'deathsNumAtRisk': 349, 'otherNumAffected': 66, 'seriousNumAtRisk': 349, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Placebo/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Bimekizumab 320 mg Q4W/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 34, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Bimekizumab 320 mg Q4W/Q8W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 40, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Bimekizumab 320 mg Q4W/Q4W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 34, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 8, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Bimekizumab 320 mg Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 5, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 11, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Bimekizumab 320 mg Q4W/Q8W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Bimekizumab 320 mg Q4W/Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.0'}, {'term': 'Mitral valve prolapse', 'stats': 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0}, {'groupId': 'EG005', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', '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': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '90.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '496.318', 'ciLowerLimit': '82.798', 'ciUpperLimit': '2975.086', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).", '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) Response at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '92.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '657.255', 'ciLowerLimit': '105.792', 'ciUpperLimit': '4083.333', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'e 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': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '220.038', 'ciLowerLimit': '28.757', 'ciUpperLimit': '1683.639', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': "A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).", '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 IGA Clear Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '224.744', 'ciLowerLimit': '30.130', 'ciUpperLimit': '1676.425', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 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 with at least \\>= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).", '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': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '75.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '316.641', 'ciLowerLimit': '39.423', 'ciUpperLimit': '2543.254', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': "A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders.", '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': '67', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '78.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.325', 'ciLowerLimit': '14.220', 'ciUpperLimit': '82.856', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 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.\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 RS consisted of all randomized 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': '72', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '75.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.497', 'ciLowerLimit': '15.728', 'ciUpperLimit': '120.295', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 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 RS consisted of all randomized 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': '70', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '78.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.946', 'ciLowerLimit': '20.560', 'ciUpperLimit': '180.669', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 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 RS consisted of all randomized 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 Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (RS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Randomized Set (RS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (RS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the RS.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '92.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '158.000', 'ciLowerLimit': '49.263', 'ciUpperLimit': '506.745', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimekizumab 320 mg Q4W/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W/Q8W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'OG002', 'title': 'Bimekizumab 320 mg Q4W/Q4W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}, {'id': 'OG003', 'title': 'Bimekizumab 320 mg Q4W/Q8W+Q4W/Q4W (WK16ResS)', 'description': 'This arm consists of participants who were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period and those who were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '91.0', 'groupId': 'OG001'}, {'value': '86.8', 'groupId': 'OG002'}, {'value': '88.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.192', 'ciLowerLimit': '18.622', 'ciUpperLimit': '109.672', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.297', 'ciLowerLimit': '18.887', 'ciUpperLimit': '128.673', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.406', 'ciLowerLimit': '22.087', 'ciUpperLimit': '101.750', 'pValueComment': 'P-values for the comparison of treatment groups were based on the CMH test from the general association.', 'groupDescription': 'Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 56', 'description': 'A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of IMP during Randomized-Withdrawal Period at Week 16 or later. The hypothesis test for PASI90 at Week 56, based on Wk16ResS, compared pooled BKZ regimens (BKZ 320mg Q4W/Q8W + 320mg Q4W/Q4W) versus placebo.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (SS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (SS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.'}], 'classes': [{'categories': [{'measurements': [{'value': '177.38', 'groupId': 'OG000', 'lowerLimit': '123.55', 'upperLimit': '246.69'}, {'value': '323.61', 'groupId': 'OG001', 'lowerLimit': '281.60', 'upperLimit': '370.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Initial Treatment Period (up to Week 16)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 who received at least 1 dose of the IMP.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (SS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (SS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.66', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '27.68'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '2.05', 'upperLimit': '12.17'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Initial Treatment Period (up to Week 16)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 who received at least 1 dose of the IMP.'}, {'type': 'SECONDARY', 'title': 'Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (SS)', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W (SS)', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '8.12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Initial Treatment Period (up to Week 16)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 who received at least 1 dose of the IMP.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}, {'id': 'OG002', 'title': 'Bimekizumab 320 mg Q4W/Q8W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'OG003', 'title': 'Bimekizumab 320 mg Q4W/Q4W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}], 'classes': [{'categories': [{'measurements': [{'value': '144.37', 'groupId': 'OG000', 'lowerLimit': '3.66', 'upperLimit': '804.36'}, {'value': '242.11', 'groupId': 'OG001', 'lowerLimit': '189.44', 'upperLimit': '304.90'}, {'value': '224.87', 'groupId': 'OG002', 'lowerLimit': '177.46', 'upperLimit': '281.05'}, {'value': '208.88', 'groupId': 'OG003', 'lowerLimit': '165.11', 'upperLimit': '260.69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}, {'id': 'OG002', 'title': 'Bimekizumab 320 mg Q4W/Q8W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'OG003', 'title': 'Bimekizumab 320 mg Q4W/Q4W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.20', 'groupId': 'OG001', 'lowerLimit': '1.96', 'upperLimit': '18.43'}, {'value': '4.04', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '11.80'}, {'value': '6.64', 'groupId': 'OG003', 'lowerLimit': '2.16', 'upperLimit': '15.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.'}, {'type': 'SECONDARY', 'title': 'Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W/Placebo (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}, {'id': 'OG002', 'title': 'Bimekizumab 320 mg Q4W/Q8W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'OG003', 'title': 'Bimekizumab 320 mg Q4W/Q4W (WK16ResS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.33', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '15.58'}, {'value': '2.69', 'groupId': 'OG002', 'lowerLimit': '0.33', 'upperLimit': '9.71'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}, {'id': 'OG002', 'title': 'Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}, {'id': 'OG003', 'title': 'Bimekizumab 320 mg Q4W/Q8W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'OG004', 'title': 'Bimekizumab 320 mg Q4W/Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}], 'classes': [{'categories': [{'measurements': [{'value': '235.86', 'groupId': 'OG000', 'lowerLimit': '164.29', 'upperLimit': '328.03'}, {'value': '287.19', 'groupId': 'OG001', 'lowerLimit': '143.36', 'upperLimit': '513.86'}, {'value': '180.89', 'groupId': 'OG002', 'lowerLimit': '115.90', 'upperLimit': '269.15'}, {'value': '491.37', 'groupId': 'OG003', 'lowerLimit': '101.33', 'upperLimit': '1435.98'}, {'value': '349.52', 'groupId': 'OG004', 'lowerLimit': '95.23', 'upperLimit': '894.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Escape Study Participant Set (ESS) consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}, {'id': 'OG002', 'title': 'Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}, {'id': 'OG003', 'title': 'Bimekizumab 320 mg Q4W/Q8W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'OG004', 'title': 'Bimekizumab 320 mg Q4W/Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.24', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '29.22'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.", 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.'}, {'type': 'SECONDARY', 'title': 'Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS).'}, {'id': 'OG001', 'title': 'Bimekizumab 320 mg Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}, {'id': 'OG002', 'title': 'Bimekizumab 320 mg Q4W/ Placebo Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}, {'id': 'OG003', 'title': 'Bimekizumab 320 mg Q4W/Q8W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'OG004', 'title': 'Bimekizumab 320 mg Q4W/Q4W Escape (ESS)', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '18.77', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '104.58'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': "Here, 'NA' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.", 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}, {'id': 'FG001', 'title': 'Bimekizumab 320 mg Q4W', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}, {'id': 'FG002', 'title': 'Placebo/Placebo', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period.'}, {'id': 'FG003', 'title': 'Bimekizumab 320 mg Q4W/Placebo', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period.'}, {'id': 'FG004', 'title': 'Bimekizumab 320 mg Q4W/Q8W', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'FG005', 'title': 'Bimekizumab 320 mg Q4W/Q4W', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period.'}, {'id': 'FG006', 'title': 'Placebo Escape', 'description': 'Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}, {'id': 'FG007', 'title': 'Bimekizumab 320 mg Q4W Escape', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}, {'id': 'FG008', 'title': 'Bimekizumab 320 mg Q4W/ Placebo Escape', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}, {'id': 'FG009', 'title': 'Bimekizumab 320 mg Q4W/Q8W Escape', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding.'}, {'id': 'FG010', 'title': 'Bimekizumab 320 mg Q4W/Q4W Escape', 'description': 'Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}], 'periods': [{'title': 'Initial Treatment Period: up to Wk16', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '349'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '340'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Week 16 Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '340'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Received Escape Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '311'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'PASI90 Non-Response at Week 16', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Incorrect escapers', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Randomized-Withdrawal Period: up to Wk56', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '100'}, {'groupId': 'FG005', 'numSubjects': '106'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Received Escape Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '93'}, {'groupId': 'FG005', 'numSubjects': '94'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Relapse at Week 20 or later', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Escape Treatment: 12 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '81'}, {'groupId': 'FG007', 'numSubjects': '23'}, {'groupId': 'FG008', 'numSubjects': '67'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '81'}, {'groupId': 'FG007', 'numSubjects': '22'}, {'groupId': 'FG008', 'numSubjects': '66'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study started to enroll patients in February 2018 and concluded in January 2020.', 'preAssignmentDetails': 'Study has a 2-5 weeks Screening Period, a 16 weeks Initial Period, a 40 weeks Randomized-Withdrawal Period (RWP) and a SFU Period (20 weeks after final dose). Participants who did not achieve a PASI90 response at Wk16 or who relapsed at Wk20/later during the RWP, entered 12 weeks of escape treatment. Participant Flow refers to the Randomized Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}, {'id': 'BG001', 'title': 'Bimekizumab 320 mg Q4W', 'description': 'Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks.'}, {'id': 'BG002', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '327', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '44.3', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}, {'title': 'Other/mixed', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-21', 'size': 3050621, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-08T03:16', 'hasProtocol': True}, {'date': '2019-09-16', 'size': 2204661, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-08T03:26', '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': 435}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2020-01-06', 'completionDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2018-01-19', 'dispFirstSubmitQcDate': '2022-02-09', 'resultsFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2018-01-19', 'dispFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-02-09', 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16', 'timeFrame': 'At Week 16', 'description': "A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI)."}, {'measure': "Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16", 'timeFrame': 'At 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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI)."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a PASI100 Response at Week 16', 'timeFrame': 'At Week 16', 'description': "A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI)."}, {'measure': 'Percentage of Participants With a IGA Clear Response at Week 16', 'timeFrame': 'At 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 with at least \\>= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI)."}, {'measure': 'Percentage of Participants With a PASI75 Response at Week 4', 'timeFrame': 'At Week 4', 'description': "A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders."}, {'measure': 'Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16', 'timeFrame': 'At 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.\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': 'At 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': 'At 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 Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline', 'timeFrame': 'At 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 56 Among Week 16 PASI90 Responders', 'timeFrame': 'At Week 56', 'description': 'A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).'}, {'measure': 'Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period', 'timeFrame': 'From Baseline to end of Initial Treatment Period (up to Week 16)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Initial Treatment Period', 'timeFrame': 'From Baseline to end of Initial Treatment Period (up to Week 16)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Initial Treatment Period', 'timeFrame': 'From Baseline to end of Initial Treatment Period (up to Week 16)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Randomized-Withdrawal Period', 'timeFrame': 'From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Randomized-Withdrawal Period', 'timeFrame': 'From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Randomized-Withdrawal Period', 'timeFrame': 'From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Escape Treatment', 'timeFrame': 'From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)', 'description': 'The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Escape Treatment', 'timeFrame': 'From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)', 'description': 'The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Escape Treatment', 'timeFrame': 'From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)', 'description': 'The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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': False, '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': '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': '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': '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': '33549192', 'type': 'DERIVED', 'citation': 'Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4.'}], 'seeAlsoLinks': [{'url': 'https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf', 'label': 'Product Information'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.'}, '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, recurrent, or 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': 'NCT03410992', 'acronym': 'BE READY', 'briefTitle': 'A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'PS0013'}, 'secondaryIdInfos': [{'id': '2016-003426-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimekizumab cohort', 'description': 'Subjects will receive bimekizumab for 16 Weeks. 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