Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-04 @ 11:34 PM
Study NCT ID:
NCT02472795
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709569', 'term': 'cenerimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'viatrisinnovationclinicaltrials@viatris.com', 'phone': '+1 908 435 2675', 'title': 'Viatris Innovation Clinical Trial Information', 'organization': 'Viatris Innovation GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study is the first to investigate short-term cenerimod treatment in patients with mild to moderate systemic lupus erythematosus (SLE).'}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Cenerimod 0.5 mg', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cenerimod 1 mg', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cenerimod 2 mg', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cenerimod 4 mg', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Matching Placebo', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 9, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Electrocardiogram T wave amplitude decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nitrituria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nail dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Post cholecystectomy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Cenerimod 1 mg (Part A)', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Cenerimod 2 mg (Part A)', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Cenerimod 4 mg (Part B)', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG004', 'title': 'Matching Placebo', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-0.87', 'spread': '1.24', 'groupId': 'OG003'}, {'value': '-0.33', 'spread': '0.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.06', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end-of-treatment (EOT) (up to 12 weeks)', 'description': 'The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).\n\nThe change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline.\n\nA negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.\n\nThe reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.\n\nThe value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.\n\nEnd-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment.'}, {'type': 'PRIMARY', 'title': 'Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Cenerimod 1 mg (Part A)', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Cenerimod 2 mg (Part A)', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Cenerimod 4 mg (Part B)', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG004', 'title': 'Matching Placebo', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '1.62', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '1.88', 'spread': '0.77', 'groupId': 'OG003'}, {'value': '1.65', 'spread': '0.88', 'groupId': 'OG004'}]}]}, {'title': 'Week 2 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-0.52', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-1.09', 'spread': '0.65', 'groupId': 'OG003'}, {'value': '-0.16', 'spread': '0.75', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '-0.68', 'spread': '1.32', 'groupId': 'OG003'}, {'value': '-0.33', 'spread': '0.69', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '-1.03', 'spread': '1.12', 'groupId': 'OG003'}, {'value': '-0.09', 'spread': '0.82', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-0.87', 'spread': '1.24', 'groupId': 'OG003'}, {'value': '-0.29', 'spread': '0.73', 'groupId': 'OG004'}]}]}, {'title': 'End-of-treatment visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-0.87', 'spread': '1.24', 'groupId': 'OG003'}, {'value': '-0.30', 'spread': '0.71', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)', 'description': 'The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).\n\nThe change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline.\n\nA negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.\n\nThe reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.\n\nThe value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.\n\nEnd-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment.'}, {'type': 'POST_HOC', 'title': 'Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) Based on Pharmacokinetic Cthrough Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Cenerimod 1 mg (Part A)', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Cenerimod 2 mg (Part A)', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Cenerimod 4 mg (Part B)', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG004', 'title': 'Matching Placebo', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-1.48', 'spread': '0.73', 'groupId': 'OG003'}, {'value': '-0.32', 'spread': '0.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2837', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.145', 'ciLowerLimit': '-0.413', 'ciUpperLimit': '0.123', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.134', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.515', 'ciLowerLimit': '-0.797', 'ciUpperLimit': '-0.234', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.140', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.565', 'ciLowerLimit': '-0.825', 'ciUpperLimit': '-0.305', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.130', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.880', 'ciLowerLimit': '-1.173', 'ciUpperLimit': '-0.586', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end-of-treatment (EOT) (up to 12 weeks)', 'description': 'The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline.\n\nA negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.\n\nThe value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.\n\nEnd-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.\n\nThe modified pharmacodynamics analysis set includes all participants who:\n\n* received at least 21 days of study treatment \\&\n* with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) \\&\n* with cenerimod plasma concentrations at Week 4 consistent with expectations.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic analysis set to form a modified pharmacodynamics analysis set.'}, {'type': 'POST_HOC', 'title': 'Absolute Values of Total Lymphocyte Count at Each Analysis Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Cenerimod 1 mg (Part A)', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Cenerimod 2 mg (Part A)', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Cenerimod 4 mg (Part B)', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG004', 'title': 'Matching Placebo', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '1.62', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '2.04', 'spread': '0.80', 'groupId': 'OG003'}, {'value': '1.66', 'spread': '0.91', 'groupId': 'OG004'}]}]}, {'title': 'Week 2 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.24', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '0.79', 'spread': '0.44', 'groupId': 'OG003'}, {'value': '1.44', 'spread': '0.44', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '0.71', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '1.31', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '0.51', 'spread': '0.28', 'groupId': 'OG003'}, {'value': '1.49', 'spread': '0.73', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '0.76', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '0.57', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '1.33', 'spread': '0.54', 'groupId': 'OG004'}]}]}, {'title': 'End-of-treatment visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '0.76', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '0.57', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '1.34', 'spread': '0.51', 'groupId': 'OG004'}]}]}, {'title': 'End-of-study visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.35', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '1.14', 'spread': '0.52', 'groupId': 'OG003'}, {'value': '1.71', 'spread': '0.86', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment (EOT - up to 12 weeks), end-of-study (6 weeks after EOT)', 'description': 'The primary objective of the clinical study was to see whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).\n\nThe reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.\n\nThe modified pharmacodynamics analysis set includes all participants who:\n\n* received at least 21 days of study treatment \\&\n* with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) \\&\n* with cenerimod plasma concentrations at Week 4 consistent with expectations.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for which data was available. Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomised to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the PD set to form a modified pharmacodynamic analysis set.'}, {'type': 'POST_HOC', 'title': 'Total Lymphocyte Count Percent Change From Baseline to End-of-treatment (EOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Cenerimod 1 mg (Part A)', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Cenerimod 2 mg (Part A)', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Cenerimod 4 mg (Part B)', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.'}, {'id': 'OG004', 'title': 'Matching Placebo', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.23', 'spread': '34.29', 'groupId': 'OG000'}, {'value': '-47.76', 'spread': '20.37', 'groupId': 'OG001'}, {'value': '-51.52', 'spread': '22.53', 'groupId': 'OG002'}, {'value': '-69.27', 'spread': '13.68', 'groupId': 'OG003'}, {'value': '-5.04', 'spread': '39.22', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1755', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.214', 'ciLowerLimit': '-32.513', 'ciUpperLimit': '6.085', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.626', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.311', 'ciLowerLimit': '-59.552', 'ciUpperLimit': '-19.069', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.096', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.278', 'ciLowerLimit': '-65.981', 'ciUpperLimit': '-28.574', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.329', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.452', 'ciLowerLimit': '-77.585', 'ciUpperLimit': '-35.320', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.541', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to End of Treatment (EOT) (up to 12 weeks)', 'description': 'Percentage change in total lymphocyte count from baseline to end-of-treatment (EOT).\n\nPercent change from baseline is defined as the absolute change from baseline divided by the baseline value (if the baseline value is \\> 0) and then multiplied by 100.\n\nA negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.\n\nThe reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.\n\nThe modified pharmacodynamics analysis set includes all participants who:\n\n* received at least 21 days of study treatment \\&\n* with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) \\&\n* with cenerimod plasma concentrations at Week 4 consistent with expectations.', 'unitOfMeasure': 'Percent change of total lymphocyte count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic set to form a modified pharmacodynamic analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Cenerimod 1 mg (Part A)', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.'}, {'id': 'FG002', 'title': 'Cenerimod 2 mg (Part A)', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.'}, {'id': 'FG003', 'title': 'Cenerimod 4 mg (Part B)', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.'}, {'id': 'FG004', 'title': 'Matching Placebo (Part A and B)', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'Pharmacodynamic Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'Modified Pharmacodynamic Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 18 sites in 6 countries between 1 June 2015 and 28 February 2017, 105 patients signed consent and 67 were randomized to a study treatment: 49 in part A (randomized 1:1:1:1 to receive cenerimod 0.5, 1, 2 mg or placebo) and 18 in part B (randomized 3:1 to receive cenerimod 4 mg or placebo).', 'preAssignmentDetails': 'The screening period started when the informed consent was signed (up to 30 days before randomization), and ended with randomization. The period included Visit 1 (screening) and the pre-randomization (pre-dose) assessments at Visit 2 (Day 1). Thirty-two patients did not meet the inclusion/exclusion criteria and 6 patients withdrew from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Cenerimod 1 mg (Part A)', 'description': 'Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Cenerimod 2 mg (Part A)', 'description': 'Participants received cenerimod 2 mg capsules orally once daily for 12 weeks.'}, {'id': 'BG003', 'title': 'Cenerimod 4 mg (Part B)', 'description': 'Participants received cenerimod 4 mg capsules orally once daily for 12 weeks.'}, {'id': 'BG004', 'title': 'Matching Placebo (Part A and Part B)', 'description': 'Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '41.7', 'spread': '8.1', 'groupId': 'BG003'}, {'value': '41.0', 'spread': '9.5', 'groupId': 'BG004'}, {'value': '40.1', 'spread': '9.9', 'groupId': 'BG005'}]}]}, {'title': 'Pharmacodynamic analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '41.7', 'spread': '8.1', 'groupId': 'BG003'}, {'value': '41.8', 'spread': '9.2', 'groupId': 'BG004'}, {'value': '40.6', 'spread': '9.8', 'groupId': 'BG005'}]}]}, {'title': 'Modified pharmacodynamics analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '41.9', 'spread': '8.6', 'groupId': 'BG003'}, {'value': '41.8', 'spread': '9.2', 'groupId': 'BG004'}, {'value': '40.6', 'spread': '9.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Different population analysis sets.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Pharmacodynamic analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'Modified pharmacodynamic analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 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'12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 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'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '65', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Pharmacodynamic analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, 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'lowerLimit': '1.4', 'upperLimit': '23.7'}, {'value': '5.8', 'groupId': 'BG001', 'lowerLimit': '0.5', 'upperLimit': '22.3'}, {'value': '4.5', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '17.0'}, {'value': '1.3', 'groupId': 'BG003', 'lowerLimit': '0.6', 'upperLimit': '5.2'}, {'value': '5.0', 'groupId': 'BG004', 'lowerLimit': '0.5', 'upperLimit': '21.4'}, {'value': '3.6', 'groupId': 'BG005', 'lowerLimit': '0.5', 'upperLimit': '23.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Different population analysis sets.'}, {'title': 'Number of American College of Rheumatology criteria ongoing at screening', 'classes': [{'title': '0 to 3 ACR criteria ongoing at screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}, {'title': '4 to 11 ACR criteria ongoing at screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}]}, {'title': '0 to 3 ACR criteria more than 6 months ago', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'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': '4 to 11 ACR criteria more than 6 months ago', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The American College of Rheumatology (ACR) has designated 11 classification criteria incorporating major clinical features (mucocutaneous, articular, serosal, renal, and neurologic) and laboratory findings (hematologic and immunologic), which have been validated for the diagnosis of SLE. The presence of 4 or more criteria occurring either simultaneously or in succession is strongly suggestive of the diagnosis of SLE \\[Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997;40(9).\\]', 'unitOfMeasure': 'Participants'}, {'title': 'Systemic Lupus Erythematosus Disease Activity Index-2000, modified to exclude leucopenia', 'classes': [{'title': 'Full analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '8.7', 'spread': '3.1', 'groupId': 'BG003'}, {'value': '7.4', 'spread': '3.3', 'groupId': 'BG004'}, {'value': '7.7', 'spread': '3.1', 'groupId': 'BG005'}]}]}, {'title': 'Pharmacodynamic analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '7.0', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '8.7', 'spread': '3.1', 'groupId': 'BG003'}, {'value': '7.3', 'spread': '3.4', 'groupId': 'BG004'}, {'value': '7.5', 'spread': '2.9', 'groupId': 'BG005'}]}]}, {'title': 'Modified pharmacodynamic analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '7.0', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '8.1', 'spread': '2.5', 'groupId': 'BG003'}, {'value': '7.3', 'spread': '3.4', 'groupId': 'BG004'}, {'value': '7.3', 'spread': '2.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The SLEDAI-2K is a weighted, cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, 0 indicates inactive disease and the maximum theoretical score is 105 (Gladman D et al. J Rheumatol 2002;29;288-291). In this study the SLEDAI-2K was modified, to exclude leucopenia (1 point), due to the mechanism of action of cenerimod. A score of 6 or greater is clinically relevant and associated with requiring lupus-directed therapy (Nuttall A et al. Best Pract Res Clin Rheumatol. 2013 Jun; 27(3):309-18).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Different population analysis sets.'}], 'populationDescription': 'Full analysis set (N=67). Pharmacodynamic analysis set (PD set, N=64) at least 21 days of treatment, with lymphocyte count measurements at baseline and post-baseline.\n\nModified pharmacodynamic analysis set (N=60) excluded 4 patients from PD set with low, or below the lower limit of quantification (BLQ) Ctrough levels.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-25', 'size': 3638032, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-17T09:35', 'hasProtocol': True}, {'date': '2017-04-20', 'size': 8484008, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-17T09:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'dispFirstSubmitDate': '2018-02-20', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2015-05-14', 'dispFirstSubmitQcDate': '2018-02-20', 'resultsFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2015-06-12', 'dispFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2020-02-12', 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)', 'timeFrame': 'Baseline to end-of-treatment (EOT) (up to 12 weeks)', 'description': 'The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).\n\nThe change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline.\n\nA negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.\n\nThe reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.\n\nThe value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.\n\nEnd-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.'}, {'measure': 'Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)', 'description': 'The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).\n\nThe change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline.\n\nA negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.\n\nThe reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.\n\nThe value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.\n\nEnd-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic lupus erythematosus'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '31798918', 'type': 'RESULT', 'citation': 'Hermann V, Batalov A, Smakotina S, Juif PE, Cornelisse P. First use of cenerimod, a selective S1P1 receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354. doi: 10.1136/lupus-2019-000354. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'https://lupus.bmj.com/content/lupusscimed/suppl/2019/11/12/6.1.e000354.DC4/lupus-2019-000354_lay_summary.pdf', 'label': 'Lay summary on results reference by Hermann V et al. First use of cenerimod, a selective S1P(1) receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354.'}]}, 'descriptionModule': {'briefSummary': 'International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.', 'detailedDescription': 'This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B).\n\nIn part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B.\n\nIn part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.\n\nAll participants will receive study medication for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.\n* Enrolled participants must be treated with background SLE medications.\n\nExclusion Criteria:\n\n* Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women.\n* Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study.'}, 'identificationModule': {'nctId': 'NCT02472795', 'briefTitle': 'Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'AC-064A201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cenerimod 0.5 mg (Part A)', 'description': 'Participants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks.', 'interventionNames': ['Drug: Cenerimod']}, {'type': 'EXPERIMENTAL', 'label': 'Cenerimod 1 mg (Part A)', 'description': 'Participants will receive cenerimod 1 mg capsules orally once daily for 12 weeks.', 'interventionNames': ['Drug: Cenerimod']}, {'type': 'EXPERIMENTAL', 'label': 'Cenerimod 2 mg (Part A)', 'description': 'Participants will receive cenerimod 2 mg capsules orally once daily for 12 weeks.', 'interventionNames': ['Drug: Cenerimod']}, {'type': 'EXPERIMENTAL', 'label': 'Cenerimod 4 mg (Part B)', 'description': 'Participants will received cenerimod 4 mg capsules orally once daily for 12 weeks. This treatment arm will start after all patients in Part A have completed 4 weeks of placebo, 0.5 mg, 1 mg and 2 mg cenerimod treatment.', 'interventionNames': ['Drug: Cenerimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo (Part A and B)', 'description': 'Capsules of matching placebo taken orally once daily for 12 weeks.', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'Matching placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).', 'armGroupLabels': ['Matching placebo (Part A and B)']}, {'name': 'Cenerimod', 'type': 'DRUG', 'otherNames': ['ACT-334441'], 'description': 'One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).', 'armGroupLabels': ['Cenerimod 0.5 mg (Part A)', 'Cenerimod 1 mg (Part A)', 'Cenerimod 2 mg (Part A)', 'Cenerimod 4 mg (Part B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '220116', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Investigator Site', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '223041', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Investigator Site', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '210037', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Investigator Site', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Investigator Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Investigator Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigator Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '650066', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '644111', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '460018', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '214025', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '600023', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '21018', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Investigator Site', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Investigator Site', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '69600', 'city': 'Zaporizhia', 'country': 'Ukraine', 'facility': 'Investigator Site'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Viatris Innovation GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viatris Innovation GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}