Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT04015518
Status:
COMPLETED
Last Update Posted:
2025-10-16
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712973', 'term': 'spesolimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events: first until the last day of study drug administration + 112 days, up to 68 weeks.', 'description': 'Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 24, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Spesolimab Post Placebo', 'description': 'Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 22, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 17, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 17, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 17, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 31, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pustulotic arthro-osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palmoplantar pustulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Retinal artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumothorax traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyshidrotic eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palmoplantar pustulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pustular psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.6', 'groupId': 'OG000', 'lowerLimit': '-43.5', 'upperLimit': '-23.7'}, {'value': '-44.2', 'groupId': 'OG001', 'lowerLimit': '-57.8', 'upperLimit': '-30.6'}, {'value': '-48.3', 'groupId': 'OG002', 'lowerLimit': '-61.8', 'upperLimit': '-34.7'}, {'value': '-46.2', 'groupId': 'OG003', 'lowerLimit': '-59.9', 'upperLimit': '-32.6'}, {'value': '-38.9', 'groupId': 'OG004', 'lowerLimit': '-48.5', 'upperLimit': '-29.3'}]}]}], 'analyses': [{'pValue': '0.2179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.5', 'ciLowerLimit': '-27.4', 'ciUpperLimit': '6.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.5', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.0883', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.6', 'ciLowerLimit': '-31.5', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.5', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1414', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-29.4', 'ciUpperLimit': '4.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.5', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.4514', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-19.1', 'ciUpperLimit': '8.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.0', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.2120', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1057', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 70% of the maximum effect was achieved at the "low dose" regimen.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.5241', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 25% of the maximum effect was achieved at the "medium-low dose" regimen.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.2773', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Logistic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 20% of maximum effect was achieved at the "low dose", 95% of maximum effect was achieved at "medium high dose".', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.3867', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 10% of the maximum effect was achieved at "low dose", 80% of the maximum effect was achieved at the "medium-high dose".', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0 (baseline) and week 16', 'description': 'The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline \\* 100%.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Percentage of change in PPP ASI', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo matching Spesolimab 150 milligram (mg)/syringe, Loading period with 4 injections per visit (weekly up to Week 4).'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.3', 'groupId': 'OG000', 'lowerLimit': '-17.0', 'upperLimit': '-1.6'}, {'value': '-15.4', 'groupId': 'OG001', 'lowerLimit': '-26.1', 'upperLimit': '-4.8'}, {'value': '-14.7', 'groupId': 'OG002', 'lowerLimit': '-25.7', 'upperLimit': '-3.8'}, {'value': '-12.8', 'groupId': 'OG003', 'lowerLimit': '-23.5', 'upperLimit': '-2.1'}, {'value': '-18.7', 'groupId': 'OG004', 'lowerLimit': '-26.3', 'upperLimit': '-11.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-19.3', 'ciUpperLimit': '7.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.7', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.4', 'ciLowerLimit': '-18.8', 'ciUpperLimit': '8.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.8', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-16.6', 'ciUpperLimit': '9.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.6', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-20.3', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.5', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0 (baseline) and week 4.', 'description': 'Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 4. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \\| ) mark on the horizontal line to indicate the severity of the pain.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.7', 'groupId': 'OG000', 'lowerLimit': '-22.7', 'upperLimit': '-6.7'}, {'value': '-18.7', 'groupId': 'OG001', 'lowerLimit': '-29.8', 'upperLimit': '-7.7'}, {'value': '-13.8', 'groupId': 'OG002', 'lowerLimit': '-24.8', 'upperLimit': '-2.8'}, {'value': '-18.9', 'groupId': 'OG003', 'lowerLimit': '-30.0', 'upperLimit': '-7.8'}, {'value': '-22.4', 'groupId': 'OG004', 'lowerLimit': '-30.2', 'upperLimit': '-14.6'}]}]}], 'analyses': [{'pValue': '0.5595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '9.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.9', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.8968', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '14.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.9', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.5456', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-17.9', 'ciUpperLimit': '9.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.9', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1762', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.7', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1726', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.2353', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 70% of the maximum effect was achieved at the "low dose" regimen.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1346', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 25% of the maximum effect was achieved at the "medium-low dose" regimen.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1950', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Logistic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 20% of maximum effect was achieved at the "low dose", 95% of maximum effect was achieved at "medium high dose".', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1681', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 10% of the maximum effect was achieved at "low dose", 80% of the maximum effect was achieved at the "medium-high dose".', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0 (baseline) and week 16.', 'description': 'Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 16. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \\| ) mark on the horizontal line to indicate the severity of the pain.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included.'}, {'type': 'SECONDARY', 'title': 'Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '-2.0'}, {'value': '-3.3', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '-2.4'}, {'value': '-3.2', 'groupId': 'OG002', 'lowerLimit': '-4.2', 'upperLimit': '-2.3'}, {'value': '-3.5', 'groupId': 'OG003', 'lowerLimit': '-4.4', 'upperLimit': '-2.5'}, {'value': '-2.8', 'groupId': 'OG004', 'lowerLimit': '-3.4', 'upperLimit': '-2.1'}]}]}], 'analyses': [{'pValue': '0.2812', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.3357', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.1809', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.8322', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger was used to estimate denominator degrees of freedom.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.4035', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.2563', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 70% of the maximum effect was achieved at the "low dose" regimen.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.6810', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 25% of the maximum effect was achieved at the "medium-low dose" regimen.', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.4665', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Logistic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 20% of maximum effect was achieved at the "low dose", 95% of maximum effect was achieved at "medium high dose".', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'pValue': '0.5565', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 10% of the maximum effect was achieved at "low dose", 80% of the maximum effect was achieved at the "medium-high dose".', 'nonInferiorityComment': "Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0 (baseline) and week 16.', 'description': 'PPP SI change from baseline at Week 16. The PPP SI is based on the severity score of individual components (erythema, pustules, and scaling/desquamation) of PPP ASI assessments. The most severely affected area based on pustules was identified by the investigator at baseline and assessed at all subsequent visits. The PPP SI was calculated by summing up the individual components of PPP ASI assessment (range 0 (best) to 12 (worst)) at each visit for the identified location.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '-0.170', 'ciUpperLimit': '0.281', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.195', 'ciLowerLimit': '-0.048', 'ciUpperLimit': '0.432', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.270', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.496', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.129', 'ciLowerLimit': '-0.067', 'ciUpperLimit': '0.314', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0613', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0628', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 70% of the maximum effect was achieved at the "low dose" regimen.', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.1449', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 25% of the maximum effect was achieved at the "medium-low dose" regimen.', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0460', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Logistic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 20% of maximum effect was achieved at the "low dose", 95% of maximum effect was achieved at "medium high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0677', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 10% of the maximum effect was achieved at "low dose", 80% of the maximum effect was achieved at the "medium-high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0 (baseline) and week 16', 'description': 'Number of patients achieving a 50% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI50). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \\* 100% \\>= 50%, PPP ASI50 = 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.063', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.256', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.188', 'ciLowerLimit': '0.018', 'ciUpperLimit': '0.405', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.102', 'ciLowerLimit': '-0.042', 'ciUpperLimit': '0.303', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.113', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.250', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0536', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0476', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 70% of the maximum effect was achieved at the "low dose" regimen.', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.1076', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 25% of the maximum effect was achieved at the "medium-low dose" regimen.', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0606', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Logistic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 20% of maximum effect was achieved at the "low dose", 95% of maximum effect was achieved at "medium high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0824', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 10% of the maximum effect was achieved at "low dose", 80% of the maximum effect was achieved at the "medium-high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0 (baseline) and week 16', 'description': 'Number of patients achieving a 75% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI75). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \\* 100% \\>= 75%, PPP ASI75 = 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.211', 'ciLowerLimit': '0.040', 'ciUpperLimit': '0.422', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.130', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.339', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.125', 'ciLowerLimit': '-0.022', 'ciUpperLimit': '0.328', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.144', 'ciLowerLimit': '0.009', 'ciUpperLimit': '0.282', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0333', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0221', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 70% of the maximum effect was achieved at the "low dose" regime', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0707', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 25% of the maximum effect was achieved at the "medium-low dose" regimen.', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0578', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Logistic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 20% of maximum effect was achieved at the "low dose", 95% of maximum effect was achieved at "medium high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0771', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 10% of the maximum effect was achieved at "low dose", 80% of the maximum effect was achieved at the "medium-high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0 (baseline) and week 16', 'description': "Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules, and scaling/crusting) from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. PPP PGA categorization is based on the mean of the four individual components.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.202', 'ciLowerLimit': '-0.005', 'ciUpperLimit': '0.427', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.170', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '0.401', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.248', 'ciLowerLimit': '0.032', 'ciUpperLimit': '0.471', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.202', 'ciLowerLimit': '0.024', 'ciUpperLimit': '0.367', 'estimateComment': 'Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0158', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod linear model fit', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0120', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 70% of the maximum effect was achieved at the "low dose" regimen.', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0429', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Exponential model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 25% of the maximum effect was achieved at the "medium-low dose" regimen.', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0229', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Logistic model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 20% of maximum effect was achieved at the "low dose", 95% of maximum effect was achieved at "medium high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}, {'pValue': '0.0300', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Adjusted for multiplicity.', 'groupDescription': 'A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).', 'statisticalMethod': 'MCP-Mod Sigmoid Emax model fit', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Assumed 10% of the maximum effect was achieved at "low dose", 80% of the maximum effect was achieved at the "medium-high dose".', 'nonInferiorityComment': "Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0 (baseline) and week 16', 'description': "Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) pustules clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the pustules from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug and who had a baseline for the primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo & Spesolimab', 'description': 'Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.'}, {'id': 'OG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'OG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-54.6', 'groupId': 'OG000', 'lowerLimit': '-65.8', 'upperLimit': '-43.3'}, {'value': '-73.3', 'groupId': 'OG001', 'lowerLimit': '-87.9', 'upperLimit': '-58.6'}, {'value': '-73.8', 'groupId': 'OG002', 'lowerLimit': '-89.1', 'upperLimit': '-58.6'}, {'value': '-81.2', 'groupId': 'OG003', 'lowerLimit': '-96.4', 'upperLimit': '-66.1'}, {'value': '-60.0', 'groupId': 'OG004', 'lowerLimit': '-70.9', 'upperLimit': '-49.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.7', 'ciLowerLimit': '-37.2', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.3', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.3', 'ciLowerLimit': '-38.3', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.6', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.6', 'ciLowerLimit': '-45.5', 'ciUpperLimit': '-7.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.5', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.4', 'ciLowerLimit': '-21.1', 'ciUpperLimit': '10.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.9', 'estimateComment': 'Difference was calculated as Speso - placebo.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\\*treatment' and 'visit\\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured."}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0 (baseline) and week 52', 'description': 'The percentage change in PPP ASI at Week 52 from baseline. The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation).\n\nLS means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Percentage of change in PPP ASI', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all patients who were randomised and received at least one dose of study drug. Only subjects with non missing endpoint data were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo & Spesolimab', 'description': 'Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.'}, {'id': 'FG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'FG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'FG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'FG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '44'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Patient did not come for consecutive visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'not willing to travel due to Covid-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Patient wants to discontinue treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Difficult for patient to come to the hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Prostate carcinoma', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Could not keep appointments due to work', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a randomised, placebo-controlled, double-blind, parallel-design trial comparing 5 treatment arms over 52 weeks. Randomisation was stratified for Japan versus non-Japan. Patients who completed the treatment period without premature discontinuation and obtained an individual health benefit, per investigator judgement, could continue treatment with spesolimab in the open-label extension trial 1368-0024.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '152', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo & Spesolimab', 'description': 'Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.'}, {'id': 'BG001', 'title': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'BG002', 'title': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.'}, {'id': 'BG003', 'title': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'BG004', 'title': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '52.8', 'spread': '9.2', 'groupId': 'BG003'}, {'value': '53.4', 'spread': '13.0', 'groupId': 'BG004'}, {'value': '54.4', 'spread': '11.0', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '141', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Palmoplantar Pustulosis Area and Severity Index (PPP ASI)', 'classes': [{'categories': [{'measurements': [{'value': '27.07', 'spread': '12.44', 'groupId': 'BG000'}, {'value': '23.85', 'spread': '9.42', 'groupId': 'BG001'}, {'value': '23.62', 'spread': '11.02', 'groupId': 'BG002'}, {'value': '26.65', 'spread': '11.20', 'groupId': 'BG003'}, {'value': '24.00', 'spread': '10.25', 'groupId': 'BG004'}, {'value': '25.18', 'spread': '11.00', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The PPP ASI is an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety analysis set (SAF): This patient set includes all patients who were randomised and received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-03', 'size': 962491, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-28T03:07', 'hasProtocol': True}, {'date': '2020-07-22', 'size': 513889, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-28T03:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2021-03-17', 'completionDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2019-07-09', 'dispFirstSubmitQcDate': '2021-03-17', 'resultsFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2019-07-09', 'dispFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-07-01', 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline', 'timeFrame': 'week 0 (baseline) and week 16', 'description': 'The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline \\* 100%.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4', 'timeFrame': 'week 0 (baseline) and week 4.', 'description': 'Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 4. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \\| ) mark on the horizontal line to indicate the severity of the pain.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.'}, {'measure': 'Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16', 'timeFrame': 'week 0 (baseline) and week 16.', 'description': 'Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 16. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \\| ) mark on the horizontal line to indicate the severity of the pain.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.'}, {'measure': 'Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16', 'timeFrame': 'week 0 (baseline) and week 16.', 'description': 'PPP SI change from baseline at Week 16. The PPP SI is based on the severity score of individual components (erythema, pustules, and scaling/desquamation) of PPP ASI assessments. The most severely affected area based on pustules was identified by the investigator at baseline and assessed at all subsequent visits. The PPP SI was calculated by summing up the individual components of PPP ASI assessment (range 0 (best) to 12 (worst)) at each visit for the identified location.\n\nLeast square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.'}, {'measure': 'Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)', 'timeFrame': 'week 0 (baseline) and week 16', 'description': 'Number of patients achieving a 50% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI50). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \\* 100% \\>= 50%, PPP ASI50 = 1.'}, {'measure': 'Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)', 'timeFrame': 'week 0 (baseline) and week 16', 'description': 'Number of patients achieving a 75% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI75). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \\* 100% \\>= 75%, PPP ASI75 = 1.'}, {'measure': 'Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16', 'timeFrame': 'week 0 (baseline) and week 16', 'description': "Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules, and scaling/crusting) from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. PPP PGA categorization is based on the mean of the four individual components."}, {'measure': 'Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16', 'timeFrame': 'week 0 (baseline) and week 16', 'description': "Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) pustules clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the pustules from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe."}, {'measure': 'The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline', 'timeFrame': 'week 0 (baseline) and week 52', 'description': 'The percentage change in PPP ASI at Week 52 from baseline. The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation).\n\nLS means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palmoplantar Pustulosis (PPP)']}, 'referencesModule': {'references': [{'pmid': '39216969', 'type': 'DERIVED', 'citation': "Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available."}, {'pmid': '37731086', 'type': 'DERIVED', 'citation': 'Burden AD, Bissonnette R, Navarini AA, Murakami M, Morita A, Haeufel T, Ye B, Baehner F, Terui T. Spesolimab Efficacy and Safety in Patients with Moderate-to-Severe Palmoplantar Pustulosis: A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Phase IIb, Dose-Finding Study. Dermatol Ther (Heidelb). 2023 Oct;13(10):2279-2297. doi: 10.1007/s13555-023-01002-1. Epub 2023 Sep 20.'}], 'seeAlsoLinks': [{'url': 'http://mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.\n\nSupportive dose-ranging assessments will also be done on pre-specified secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 75 years of legal age (according to local legislation) at screening.\n* Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (\\>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body.\n* PPP PGA of at least moderate severity (≥3) at screening and baseline.\n* A minimum PPP ASI score of 12 at screening and baseline.\n* Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.\n* Further criteria apply.\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.\n* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.\n* Presence or known history of anti-TNF-induced PPP-like disease.\n* Patient with a transplanted organ (with exception of a corneal transplant \\>12 weeks Prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).\n* Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.\n* Further criteria apply.'}, 'identificationModule': {'nctId': 'NCT04015518', 'briefTitle': 'A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)', 'orgStudyIdInfo': {'id': '1368-0016'}, 'secondaryIdInfos': [{'id': '2018-003078-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Placebo & Spesolimab', 'description': 'Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.', 'interventionNames': ['Drug: Spesolimab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': "Spesolimab 'Speso Low'", 'description': 'Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': "Spesolimab 'Speso Medium-low'", 'description': 'Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': "Spesolimab 'Speso Medium-high'", 'description': 'Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': "Spesolimab 'Speso High'", 'description': 'Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.', 'interventionNames': ['Drug: Spesolimab']}], 'interventions': 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and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}