Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-28 @ 7:59 PM
Study NCT ID:
NCT02156466
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2014-05-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'As AUCextra was more than 20% of AUC0-inf after first dose, AUCextra and all values derived from λz were regarded as implausible and "AUC0-inf", "MRT0-inf", "t1/2", "λz", "CL/f", and "Vz/f" were not calculated after first dose.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Day 85', 'eventGroups': [{'id': 'EG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood creatine phosphokinase MB increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood iron decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urine ketone body present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Catarrh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Acute vestibular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 85', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Local Injection Site Reactions (ISRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': 'Day 1 Bruising: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Indurations: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Indurations: mild (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Itching: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Itching: mild (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Redness: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Redness: mild (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Swelling: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 Swelling: mild (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 2 Bruising: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 2 Bruising: mild (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 2 Indurations: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 2 Itching: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 2 Redness: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 2 Swelling: none (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 8 Bruising: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 8 Indurations: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 8 Itching: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 8 Redness: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 8 Redness: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 8 Swelling: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 Bruising: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 Indurations: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 Itching: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 Redness: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 Redness: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 Redness: moderate (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 Swelling: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Bruising: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Bruising: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Indurations: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Itching: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Redness: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Redness: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Swelling: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 Swelling: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Bruising: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Bruising: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Indurations: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Indurations: severe (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Itching: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Itching: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Redness: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Redness: severe (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Swelling: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 Swelling: severe (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Bruising: none (n=8,8,8,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Indurations: none (n=8,8,7,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Itching: none (n=8,8,8,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Redness: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Redness: mild (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Redness: moderate (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Swelling: none (n=8,8,8,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 Swelling: mild (n=8,8,8,7,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 Bruising: none (n=8,8,8,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 Bruising: mild (n=8,8,8,7,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 Indurations: none (n=8,8,7,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 Itching: none (n=8,8,7,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 Redness: none (n==8,8,7,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 Redness: moderate (n=8,8,7,7,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 Swelling: none (n=8,8,7,7,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 36 Bruising: none (n=7,8,7,7,8)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 36 Bruising: mild (n=7,8,7,7,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 36 Indurations: none (n=8,8,7,7,7)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Day 36 Itching: none (n=7,8,7,6,8)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 43 Bruising: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 43 Indurations: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 43 Itching: none (8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 43 Redness: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Day 43 Redness: moderate (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 43 Swelling: none (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43', 'description': "The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to \\[\\<=\\] 2.0 centimeters \\[cm\\] redness or bruising area); Moderate (greater than \\[\\>\\] 2 to \\<=5.0 cm redness or bruising area); Severe (\\>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (\\<= 4 cm swelling); Severe (\\>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.", 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here "n" signifies those subjects who were evaluable for the specified injection site reaction. Subjects may be represented in more than 1 category.'}, {'type': 'PRIMARY', 'title': 'Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': 'Day 1 (n=3,2,3,2,0)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 2 (n=1,1,1,1,0)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 8 (n=1,1,0,0,0)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 15 (n=2,1,3,0,0)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 16 (n=0,0,0,0,2)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Day 22 (1,0,1,0,0)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 29 (n=1,1,1,0,0)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 30 (1,0,1,1,0)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 36 (n=0,0,0,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}, {'title': 'Day 43 (n=0,0,0,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Data could not be calculated as there were no subjects with amount of pain value of \\> 0 at the specified time point', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43', 'description': 'Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value \\> 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.', 'unitOfMeasure': 'mm', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint and "n" signifies those subjects who were evaluable at the specified time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 Combined', 'description': 'All subjects who received MSB0010841 (Anti-IL-17A/F Nanobody) at a dose of 30 mg, 60 mg, 120 mg or 240 mg as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 85', 'description': 'Data were presented for MSB0010841 combined group and placebo.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).'}, {'type': 'PRIMARY', 'title': 'Levels of Anti-MSB0010841 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ADA Positive Subjects', 'description': 'All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.'}], 'classes': [{'title': 'Day 8 Subject 1: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 1: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '5.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (pre-dose) Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 1: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 1: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (pre-dose) Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 1: Placebo', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not assessed as no sample was collected at this time point', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not assessed as no sample was collected at this time point', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 36 Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 1: Placebo', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 43 Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 1: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 63 Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 1: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85', 'unitOfMeasure': 'log10titer', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.'}, {'type': 'PRIMARY', 'title': 'Levels of Pre-existing Anti-MSB0010841 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ADA Positive Subjects', 'description': 'All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.'}], 'classes': [{'title': 'Subject 1: Placebo', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Subject 2: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Subject 3: Placebo', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Subject 4: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Subject 5: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject 6: MSB0010841 30 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject 7: MSB0010841 60 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject 8: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Subject 9: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '5.08', 'groupId': 'OG000'}]}]}, {'title': 'Subject 10: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Subject 11: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Subject 12: MSB0010841 120 mg', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Subject 13: MSB0010841 240 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose on Day 1', 'unitOfMeasure': 'log10titer', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.'}, {'type': 'PRIMARY', 'title': 'MSB0010841 Serum Concentration Over Time After First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': '0 hour (n=8,8,8,9)', 'categories': [{'measurements': [{'value': '12.6', 'spread': '35.71', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': '6 hour (n=8,8,8,9)', 'categories': [{'measurements': [{'value': '907.5', 'spread': '523.16', 'groupId': 'OG000'}, {'value': '2097.1', 'spread': '1391.43', 'groupId': 'OG001'}, {'value': '2315.5', 'spread': '787.02', 'groupId': 'OG002'}, {'value': '4858.8', 'spread': '2326.35', 'groupId': 'OG003'}]}]}, {'title': '12 hour (n=8,8,8,9)', 'categories': [{'measurements': [{'value': '1793.3', 'spread': '761.23', 'groupId': 'OG000'}, {'value': '3339.6', 'spread': '1671.29', 'groupId': 'OG001'}, {'value': '4983.1', 'spread': '1501.41', 'groupId': 'OG002'}, {'value': '9780.3', 'spread': '4698.97', 'groupId': 'OG003'}]}]}, {'title': '24 hour (n=8,8,8,9)', 'categories': [{'measurements': [{'value': '2788.4', 'spread': '895.89', 'groupId': 'OG000'}, {'value': '5047.8', 'spread': '1600.25', 'groupId': 'OG001'}, {'value': '9131.3', 'spread': '2838.02', 'groupId': 'OG002'}, {'value': '15357.6', 'spread': '5295.18', 'groupId': 'OG003'}]}]}, {'title': '32 hour (n=8,8,8,9)', 'categories': [{'measurements': [{'value': '3037.3', 'spread': '820.76', 'groupId': 'OG000'}, {'value': '6028.1', 'spread': '2269.66', 'groupId': 'OG001'}, {'value': '11372.4', 'spread': '3499.37', 'groupId': 'OG002'}, {'value': '17135.2', 'spread': '6032.66', 'groupId': 'OG003'}]}]}, {'title': '72 hour (n=8,8,7,8)', 'categories': [{'measurements': [{'value': '3190.4', 'spread': '810.18', 'groupId': 'OG000'}, {'value': '6492.9', 'spread': '1472.29', 'groupId': 'OG001'}, {'value': '11284.1', 'spread': '2562.84', 'groupId': 'OG002'}, {'value': '20536.6', 'spread': '6716.38', 'groupId': 'OG003'}]}]}, {'title': '96 hour (n=8,8,8,8)', 'categories': [{'measurements': [{'value': '3155.8', 'spread': '879.56', 'groupId': 'OG000'}, {'value': '6423.8', 'spread': '1824.46', 'groupId': 'OG001'}, {'value': '11790.0', 'spread': '3319.36', 'groupId': 'OG002'}, {'value': '18732.9', 'spread': '4670.66', 'groupId': 'OG003'}]}]}, {'title': '168 hour (n=8,8,8,8)', 'categories': [{'measurements': [{'value': '2665.5', 'spread': '605.89', 'groupId': 'OG000'}, {'value': '5179.5', 'spread': '1126.74', 'groupId': 'OG001'}, {'value': '10318.6', 'spread': '2837.81', 'groupId': 'OG002'}, {'value': '17761.9', 'spread': '3072.48', 'groupId': 'OG003'}]}]}, {'title': '336 hour (n=8,8,8,8)', 'categories': [{'measurements': [{'value': '1704.3', 'spread': '429.78', 'groupId': 'OG000'}, {'value': '3951.0', 'spread': '1353.92', 'groupId': 'OG001'}, {'value': '6768.4', 'spread': '2846.24', 'groupId': 'OG002'}, {'value': '11605.8', 'spread': '2065.58', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received first dose of MSB0010841 without protocol deviations affecting PK, and who provide evaluable PK data. Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.'}, {'type': 'PRIMARY', 'title': 'MSB0010841 Serum Concentration Over Time After Second Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': '0 hour', 'categories': [{'measurements': [{'value': '1704.3', 'spread': '429.78', 'groupId': 'OG000'}, {'value': '3951.0', 'spread': '1353.92', 'groupId': 'OG001'}, {'value': '6768.4', 'spread': '2846.24', 'groupId': 'OG002'}, {'value': '11605.8', 'spread': '2065.58', 'groupId': 'OG003'}]}]}, {'title': '24 hour', 'categories': [{'measurements': [{'value': '3808.0', 'spread': '980.68', 'groupId': 'OG000'}, {'value': '7268.9', 'spread': '3771.98', 'groupId': 'OG001'}, {'value': '15120.6', 'spread': '3393.84', 'groupId': 'OG002'}, {'value': '27664.8', 'spread': '9231.41', 'groupId': 'OG003'}]}]}, {'title': '72 hour', 'categories': [{'measurements': [{'value': '4309.0', 'spread': '1265.45', 'groupId': 'OG000'}, {'value': '9095.5', 'spread': '2115.16', 'groupId': 'OG001'}, {'value': '17454.4', 'spread': '4152.32', 'groupId': 'OG002'}, {'value': '29902.4', 'spread': '7523.13', 'groupId': 'OG003'}]}]}, {'title': '96 hour', 'categories': [{'measurements': [{'value': '4020.5', 'spread': '923.65', 'groupId': 'OG000'}, {'value': '8514.4', 'spread': '1849.44', 'groupId': 'OG001'}, {'value': '17081.4', 'spread': '5056.17', 'groupId': 'OG002'}, {'value': '29223.5', 'spread': '8336.26', 'groupId': 'OG003'}]}]}, {'title': '168 hour', 'categories': [{'measurements': [{'value': '3517.8', 'spread': '877.96', 'groupId': 'OG000'}, {'value': '7180.4', 'spread': '1705.24', 'groupId': 'OG001'}, {'value': '14806.6', 'spread': '5632.99', 'groupId': 'OG002'}, {'value': '22972.5', 'spread': '11219.87', 'groupId': 'OG003'}]}]}, {'title': '336 hour', 'categories': [{'measurements': [{'value': '2306.5', 'spread': '588.50', 'groupId': 'OG000'}, {'value': '4492.9', 'spread': '1398.63', 'groupId': 'OG001'}, {'value': '10468.9', 'spread': '4376.75', 'groupId': 'OG002'}, {'value': '16454.5', 'spread': '4548.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure at the specified time points.'}, {'type': 'PRIMARY', 'title': 'MSB0010841 Serum Concentration Over Time After Third Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': '0 hour', 'categories': [{'measurements': [{'value': '2306.5', 'spread': '588.50', 'groupId': 'OG000'}, {'value': '4492.9', 'spread': '1398.63', 'groupId': 'OG001'}, {'value': '10417.7', 'spread': '4724.84', 'groupId': 'OG002'}, {'value': '16173.6', 'spread': '4837.78', 'groupId': 'OG003'}]}]}, {'title': '6 hour', 'categories': [{'measurements': [{'value': '3483.9', 'spread': '1566.88', 'groupId': 'OG000'}, {'value': '6200.1', 'spread': '1391.38', 'groupId': 'OG001'}, {'value': '12725.0', 'spread': '5573.11', 'groupId': 'OG002'}, {'value': '20452.3', 'spread': '6683.19', 'groupId': 'OG003'}]}]}, {'title': '12 hour', 'categories': [{'measurements': [{'value': '3557.9', 'spread': '1004.43', 'groupId': 'OG000'}, {'value': '8615.5', 'spread': '3093.46', 'groupId': 'OG001'}, {'value': '13361.0', 'spread': '5959.26', 'groupId': 'OG002'}, {'value': '26051.4', 'spread': '8770.65', 'groupId': 'OG003'}]}]}, {'title': '24 hour', 'categories': [{'measurements': [{'value': '4533.3', 'spread': '1178.14', 'groupId': 'OG000'}, {'value': '9969.9', 'spread': '2494.60', 'groupId': 'OG001'}, {'value': '17523.1', 'spread': '6140.31', 'groupId': 'OG002'}, {'value': '33651.7', 'spread': '11590.56', 'groupId': 'OG003'}]}]}, {'title': '32 hour', 'categories': [{'measurements': [{'value': '4934.5', 'spread': '1256.47', 'groupId': 'OG000'}, {'value': '10762.5', 'spread': '2377.88', 'groupId': 'OG001'}, {'value': '18634.9', 'spread': '5713.14', 'groupId': 'OG002'}, {'value': '38278.4', 'spread': '13391.40', 'groupId': 'OG003'}]}]}, {'title': '72 hour', 'categories': [{'measurements': [{'value': '4936.0', 'spread': '1387.50', 'groupId': 'OG000'}, {'value': '10345.6', 'spread': '4586.24', 'groupId': 'OG001'}, {'value': '19813.1', 'spread': '6381.27', 'groupId': 'OG002'}, {'value': '37166.4', 'spread': '10103.58', 'groupId': 'OG003'}]}]}, {'title': '96 hour', 'categories': [{'measurements': [{'value': '4994.9', 'spread': '1448.53', 'groupId': 'OG000'}, {'value': '9047.6', 'spread': '2760.25', 'groupId': 'OG001'}, {'value': '18260.1', 'spread': '6602.90', 'groupId': 'OG002'}, {'value': '33909.3', 'spread': '10219.54', 'groupId': 'OG003'}]}]}, {'title': '168 hour', 'categories': [{'measurements': [{'value': '4368.1', 'spread': '1201.56', 'groupId': 'OG000'}, {'value': '7715.4', 'spread': '3019.93', 'groupId': 'OG001'}, {'value': '15585.3', 'spread': '5625.65', 'groupId': 'OG002'}, {'value': '31375.9', 'spread': '6826.50', 'groupId': 'OG003'}]}]}, {'title': '336 hour', 'categories': [{'measurements': [{'value': '2680.5', 'spread': '859.35', 'groupId': 'OG000'}, {'value': '5602.1', 'spread': '3057.34', 'groupId': 'OG001'}, {'value': '12257.6', 'spread': '7468.85', 'groupId': 'OG002'}, {'value': '20011.9', 'spread': '6248.98', 'groupId': 'OG003'}]}]}, {'title': '504 hour', 'categories': [{'measurements': [{'value': '1802.0', 'spread': '505.42', 'groupId': 'OG000'}, {'value': '3109.1', 'spread': '1519.66', 'groupId': 'OG001'}, {'value': '8610.6', 'spread': '5991.68', 'groupId': 'OG002'}, {'value': '12472.4', 'spread': '4176.00', 'groupId': 'OG003'}]}]}, {'title': '816 hour', 'categories': [{'measurements': [{'value': '933.1', 'spread': '376.76', 'groupId': 'OG000'}, {'value': '1378.1', 'spread': '834.66', 'groupId': 'OG001'}, {'value': '4309.3', 'spread': '4044.88', 'groupId': 'OG002'}, {'value': '5064.6', 'spread': '2070.93', 'groupId': 'OG003'}]}]}, {'title': '1056 hour', 'categories': [{'measurements': [{'value': '464.5', 'spread': '257.13', 'groupId': 'OG000'}, {'value': '658.5', 'spread': '391.39', 'groupId': 'OG001'}, {'value': '2599.7', 'spread': '2937.08', 'groupId': 'OG002'}, {'value': '2475.9', 'spread': '1391.08', 'groupId': 'OG003'}]}]}, {'title': '1344 hour', 'categories': [{'measurements': [{'value': '244.8', 'spread': '162.24', 'groupId': 'OG000'}, {'value': '326.3', 'spread': '230.87', 'groupId': 'OG001'}, {'value': '1611.3', 'spread': '2199.92', 'groupId': 'OG002'}, {'value': '1345.7', 'spread': '879.15', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure at the specified time points.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '126.3', 'spread': '28.5', 'groupId': 'OG002'}, {'value': '216.5', 'spread': '23.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).', 'unitOfMeasure': 'day*microgram per milliliter (day*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.7', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '170.3', 'spread': '39.5', 'groupId': 'OG001'}, {'value': '371.7', 'spread': '62.0', 'groupId': 'OG002'}, {'value': '663.4', 'spread': '31.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.', 'unitOfMeasure': 'day*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '68.3', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '114.6', 'spread': '24.2', 'groupId': 'OG002'}, {'value': '222.2', 'spread': '19.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).', 'unitOfMeasure': 'day*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '104.1', 'spread': '33.9', 'groupId': 'OG001'}, {'value': '203.2', 'spread': '43.6', 'groupId': 'OG002'}, {'value': '397.6', 'spread': '27.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)', 'description': 'Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).', 'unitOfMeasure': 'day*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.6', 'spread': '42.2', 'groupId': 'OG000'}, {'value': '174.9', 'spread': '39.9', 'groupId': 'OG001'}, {'value': '392.6', 'spread': '68.8', 'groupId': 'OG002'}, {'value': '680.9', 'spread': '32.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.', 'unitOfMeasure': 'day*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hours) on Day 1', 'description': 'The observed serum concentration immediately before the first dose.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.31', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '10.42', 'spread': '4.72', 'groupId': 'OG002'}, {'value': '16.17', 'spread': '4.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hours) on Day 29', 'description': 'The observed serum concentration immediately before the third dose.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.30', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '10.03', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '16.17', 'spread': '4.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '25.6', 'groupId': 'OG002'}, {'value': '20.8', 'spread': '30.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.14', 'spread': '34.5', 'groupId': 'OG000'}, {'value': '11.32', 'spread': '29.7', 'groupId': 'OG001'}, {'value': '19.74', 'spread': '31.3', 'groupId': 'OG002'}, {'value': '37.93', 'spread': '32.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Average Concentration (Cav) Post First Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.315', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '4.881', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '8.187', 'spread': '24.2', 'groupId': 'OG002'}, {'value': '15.868', 'spread': '19.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Average Concentration (Cav) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.87', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '33.9', 'groupId': 'OG001'}, {'value': '14.51', 'spread': '43.6', 'groupId': 'OG002'}, {'value': '28.40', 'spread': '27.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Mean Residence Time (MRT0-t) Post First Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.528', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '6.691', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '6.638', 'spread': '5.7', 'groupId': 'OG002'}, {'value': '6.771', 'spread': '5.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).', 'unitOfMeasure': 'day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.57', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '15.68', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '19.26', 'spread': '32.0', 'groupId': 'OG002'}, {'value': '16.38', 'spread': '11.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)', 'description': 'MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).', 'unitOfMeasure': 'day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.57', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '15.68', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '19.26', 'spread': '32.0', 'groupId': 'OG002'}, {'value': '16.38', 'spread': '11.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.', 'unitOfMeasure': 'day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.39', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '97.4'}, {'value': '71.68', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '335.8'}, {'value': '52.00', 'groupId': 'OG002', 'lowerLimit': '32.0', 'upperLimit': '96.2'}, {'value': '72.23', 'groupId': 'OG003', 'lowerLimit': '72.0', 'upperLimit': '168.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '72.0', 'upperLimit': '97.5'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '96.6'}, {'value': '83.4', 'groupId': 'OG002', 'lowerLimit': '71.8', 'upperLimit': '168.0'}, {'value': '72.0', 'groupId': 'OG003', 'lowerLimit': '24.0', 'upperLimit': '168.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '95.8'}, {'value': '31.0', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '72.4'}, {'value': '72.0', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '72.5'}, {'value': '72.0', 'groupId': 'OG003', 'lowerLimit': '31.1', 'upperLimit': '168.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.63', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '10.50', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '12.19', 'spread': '27.9', 'groupId': 'OG002'}, {'value': '10.25', 'spread': '13.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': "Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\\*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.", 'unitOfMeasure': 'day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Terminal Rate Constant (λz) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '27.9', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '13.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve', 'unitOfMeasure': '1/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Apparent Clearance (CL/f) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '33.9', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '43.6', 'groupId': 'OG002'}, {'value': '0.60', 'spread': '27.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.', 'unitOfMeasure': 'L/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.49', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '8.73', 'spread': '38.6', 'groupId': 'OG001'}, {'value': '10.39', 'spread': '21.9', 'groupId': 'OG002'}, {'value': '8.92', 'spread': '18.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant \\[λz\\]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '140.28', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '152.47', 'spread': '20.4', 'groupId': 'OG001'}, {'value': '144.37', 'spread': '13.0', 'groupId': 'OG002'}, {'value': '135.89', 'spread': '12.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\\[Cmax - Cmin\\]/Cav ) multiplied by 100', 'unitOfMeasure': 'percentage fluctuation', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.26', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '95.65', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '71.17', 'spread': '33.1', 'groupId': 'OG002'}, {'value': '76.03', 'spread': '28.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\\[Cmax - Cmin\\]/Cav ) multiplied by 100', 'unitOfMeasure': 'percentage fluctuation', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Accumulation Ratio of Cmax (Racc (Cmax))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.56', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '1.56', 'spread': '34.1', 'groupId': 'OG002'}, {'value': '1.81', 'spread': '9.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Accumulation Ratio of AUC (Racc(AUC))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '27.4', 'groupId': 'OG002'}, {'value': '1.83', 'spread': '11.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.26', 'spread': '32.7', 'groupId': 'OG000'}, {'value': '9.06', 'spread': '24.2', 'groupId': 'OG001'}, {'value': '18.59', 'spread': '23.1', 'groupId': 'OG002'}, {'value': '30.98', 'spread': '25.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '3.74', 'spread': '37.9', 'groupId': 'OG001'}, {'value': '6.34', 'spread': '38.3', 'groupId': 'OG002'}, {'value': '11.44', 'spread': '18.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hours) on Day 15', 'description': 'The observed serum concentration immediately before second dose.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': 'PASI-50', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}]}, {'title': 'PASI-75', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 85', 'description': 'PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved \\>=50 or 75% improvement in PASI score from Baseline.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.91', 'spread': '5.75', 'groupId': 'OG000'}, {'value': '19.76', 'spread': '4.79', 'groupId': 'OG001'}, {'value': '23.35', 'spread': '6.60', 'groupId': 'OG002'}, {'value': '18.38', 'spread': '6.07', 'groupId': 'OG003'}, {'value': '25.49', 'spread': '5.58', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 43', 'categories': [{'measurements': [{'value': '-13.93', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '-17.99', 'spread': '5.52', 'groupId': 'OG001'}, {'value': '-21.70', 'spread': '8.52', 'groupId': 'OG002'}, {'value': '-16.68', 'spread': '8.38', 'groupId': 'OG003'}, {'value': '-5.43', 'spread': '7.04', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 43', 'description': 'PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved \\>=50 or 75% improvement in PASI score from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 was administered at a dose of 30 mg as SC injection every other week for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week for a total duration of 6 weeks.'}], 'classes': [{'title': 'Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 36', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 43', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8, 15, 22, 29, 36, 43, 50, 85', 'description': "The static Physician's Global Assessment (sPGA) scale rated the investigator's overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'title': 'Change at Day 8 (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-30.0', 'spread': '31.23', 'groupId': 'OG001'}, {'value': '-13.7', 'spread': '15.13', 'groupId': 'OG002'}, {'value': '-12.5', 'spread': '23.81', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '23.32', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 15 (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-33.1', 'spread': '35.97', 'groupId': 'OG001'}, {'value': '-20.5', 'spread': '10.98', 'groupId': 'OG002'}, {'value': '-51.1', 'spread': '43.17', 'groupId': 'OG003'}, {'value': '-4.2', 'spread': '12.21', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 22 (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '-11.6', 'spread': '24.90', 'groupId': 'OG000'}, {'value': '-40.2', 'spread': '40.68', 'groupId': 'OG001'}, {'value': '-42.6', 'spread': '27.15', 'groupId': 'OG002'}, {'value': '-68.5', 'spread': '38.71', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '12.69', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 29 (n=8,8,8,8,8)', 'categories': [{'measurements': [{'value': '-22.6', 'spread': '26.35', 'groupId': 'OG000'}, {'value': '-44.1', 'spread': '42.53', 'groupId': 'OG001'}, {'value': '-55.9', 'spread': '36.56', 'groupId': 'OG002'}, {'value': '-82.9', 'spread': '34.46', 'groupId': 'OG003'}, {'value': '-0.1', 'spread': '26.13', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 36 (8,8,7,7,7)', 'categories': [{'measurements': [{'value': '-31.4', 'spread': '22.96', 'groupId': 'OG000'}, {'value': '-52.7', 'spread': '37.57', 'groupId': 'OG001'}, {'value': '-64.6', 'spread': '37.65', 'groupId': 'OG002'}, {'value': '-83.5', 'spread': '31.60', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '27.92', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 43 (8,8,8,9,8)', 'categories': [{'measurements': [{'value': '-52.6', 'spread': '32.91', 'groupId': 'OG000'}, {'value': '-65.2', 'spread': '28.61', 'groupId': 'OG001'}, {'value': '-75.4', 'spread': '37.35', 'groupId': 'OG002'}, {'value': '-82.2', 'spread': '36.64', 'groupId': 'OG003'}, {'value': '-1.5', 'spread': '27.05', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 50 (n=8,8,8,9,8)', 'categories': [{'measurements': [{'value': '-56.2', 'spread': '34.71', 'groupId': 'OG000'}, {'value': '-69.4', 'spread': '25.85', 'groupId': 'OG001'}, {'value': '-79.1', 'spread': '32.30', 'groupId': 'OG002'}, {'value': '-82.2', 'spread': '36.64', 'groupId': 'OG003'}, {'value': '-10.0', 'spread': '17.87', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 85 (8,8,8,9,8)', 'categories': [{'measurements': [{'value': '-60.4', 'spread': '33.51', 'groupId': 'OG000'}, {'value': '-61.3', 'spread': '33.89', 'groupId': 'OG001'}, {'value': '-82.1', 'spread': '31.05', 'groupId': 'OG002'}, {'value': '-95.5', 'spread': '11.02', 'groupId': 'OG003'}, {'value': '-13.0', 'spread': '20.13', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85', 'description': "The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). Here "n" signifies those subjects who were evaluable for this outcome measure at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Exacerbation of Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 85', 'description': 'Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit \\>=125% of baseline PASI).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti-Interleukin \\[IL\\]-17A/F Nanobody) was administered at a dose of 30 milligram (mg) as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'FG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'FG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'FG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Quantiferon Positivity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 41 subjects were randomized in the trial and included in the Safety analysis set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'MSB0010841 30 mg', 'description': 'MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'BG001', 'title': 'MSB0010841 60 mg', 'description': 'MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'BG002', 'title': 'MSB0010841 120 mg', 'description': 'MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'BG003', 'title': 'MSB0010841 240 mg', 'description': 'MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '13.24', 'groupId': 'BG000'}, {'value': '42.1', 'spread': '19.57', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '13.59', 'groupId': 'BG002'}, {'value': '44.8', 'spread': '15.65', 'groupId': 'BG003'}, {'value': '46.1', 'spread': '14.57', 'groupId': 'BG004'}, {'value': '45.1', 'spread': '14.87', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all 41 subjects who received at least 1 dose of investigational medicinal product (IMP) (MSB0010841 or placebo).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2014-05-23', 'resultsFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-28', 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline up to Day 85', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.'}, {'measure': 'Number of Subjects With Local Injection Site Reactions (ISRs)', 'timeFrame': 'Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43', 'description': "The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to \\[\\<=\\] 2.0 centimeters \\[cm\\] redness or bruising area); Moderate (greater than \\[\\>\\] 2 to \\<=5.0 cm redness or bruising area); Severe (\\>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (\\<= 4 cm swelling); Severe (\\>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported."}, {'measure': 'Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)', 'timeFrame': 'Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43', 'description': 'Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value \\> 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.'}, {'measure': 'Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])', 'timeFrame': 'Baseline up to Day 85', 'description': 'Data were presented for MSB0010841 combined group and placebo.'}, {'measure': 'Levels of Anti-MSB0010841 Antibody Titers', 'timeFrame': 'Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85'}, {'measure': 'Levels of Pre-existing Anti-MSB0010841 Antibody Titers', 'timeFrame': 'Pre-dose on Day 1'}, {'measure': 'MSB0010841 Serum Concentration Over Time After First Dose', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)'}, {'measure': 'MSB0010841 Serum Concentration Over Time After Second Dose', 'timeFrame': '0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)'}, {'measure': 'MSB0010841 Serum Concentration Over Time After Third Dose', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)', 'description': 'Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.'}, {'measure': 'Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841', 'timeFrame': 'Pre-dose (0 hours) on Day 1', 'description': 'The observed serum concentration immediately before the first dose.'}, {'measure': 'Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841', 'timeFrame': 'Pre-dose (0 hours) on Day 29', 'description': 'The observed serum concentration immediately before the third dose.'}, {'measure': 'Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.'}, {'measure': 'Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.'}, {'measure': 'Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)'}, {'measure': 'Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)'}, {'measure': 'Average Concentration (Cav) Post First Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).'}, {'measure': 'Average Concentration (Cav) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).'}, {'measure': 'Mean Residence Time (MRT0-t) Post First Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).'}, {'measure': 'Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)', 'description': 'MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).'}, {'measure': 'Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.'}, {'measure': 'Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)'}, {'measure': 'Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)'}, {'measure': 'Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)'}, {'measure': 'Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': "Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\\*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve."}, {'measure': 'Terminal Rate Constant (λz) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve'}, {'measure': 'Apparent Clearance (CL/f) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant \\[λz\\]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.'}, {'measure': 'Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)', 'description': 'The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\\[Cmax - Cmin\\]/Cav ) multiplied by 100'}, {'measure': 'Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\\[Cmax - Cmin\\]/Cav ) multiplied by 100'}, {'measure': 'Accumulation Ratio of Cmax (Racc (Cmax))', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.'}, {'measure': 'Accumulation Ratio of AUC (Racc(AUC))', 'timeFrame': '0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)', 'description': 'Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.'}, {'measure': 'Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841', 'timeFrame': '0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)'}, {'measure': 'Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841', 'timeFrame': 'Pre-dose (0 hours) on Day 15', 'description': 'The observed serum concentration immediately before second dose.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score', 'timeFrame': 'Baseline up to Day 85', 'description': 'PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved \\>=50 or 75% improvement in PASI score from Baseline.'}, {'measure': 'Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43', 'timeFrame': 'Baseline, Day 43', 'description': 'PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved \\>=50 or 75% improvement in PASI score from Baseline.'}, {'measure': "Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline", 'timeFrame': 'Day 8, 15, 22, 29, 36, 43, 50, 85', 'description': "The static Physician's Global Assessment (sPGA) scale rated the investigator's overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported."}, {'measure': 'Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85', 'timeFrame': 'Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85', 'description': "The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district."}, {'measure': 'Percentage of Subjects With Exacerbation of Psoriasis', 'timeFrame': 'Baseline up to Day 85', 'description': 'Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit \\>=125% of baseline PASI).'}]}, 'conditionsModule': {'keywords': ['Psoriasis', 'MSB0010841', 'Anti-IL17A/F Nanobody', 'M1095'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F \\[Anti-IL-17A/F\\] Nanobody).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic plaque psoriasis for at least 6 months before screening\n* Greater than or equal to (\\>=) 10% of BSA with plaques\n* Psoriasis Area and Severity Index (PASI) \\>=12\n* Static Physician's Global Assessment (sPGA) \\>=3 (where scores range from 0 \\[clear of disease\\] to 5 \\[severe disease\\]) at the screening and baseline visits\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation\n* Currently having a form of non-plaque psoriasis as specified in the protocol\n* Drug induced psoriasis\n* Biological treatments as specified in the protocol, within 3 months prior to Day 1\n* Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1\n* Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol\n* Use of aspirin as defined in the protocol\n* Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1\n* Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol\n* Other protocol defined exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT02156466', 'briefTitle': 'Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Multicenter, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL17A/F Nanobody) in Male and Female Subjects With Moderate to Severe Psoriasis', 'orgStudyIdInfo': {'id': '200574-003'}, 'secondaryIdInfos': [{'id': '2013-005436-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSB0010841 30 mg', 'interventionNames': ['Drug: MSB0010841']}, {'type': 'EXPERIMENTAL', 'label': 'MSB0010841 60 mg', 'interventionNames': ['Drug: MSB0010841']}, {'type': 'EXPERIMENTAL', 'label': 'MSB0010841 120 mg', 'interventionNames': ['Drug: MSB0010841']}, {'type': 'EXPERIMENTAL', 'label': 'MSB0010841 240 mg', 'interventionNames': ['Drug: MSB0010841']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MSB0010841', 'type': 'DRUG', 'otherNames': ['Anti-IL-17A/F Nanobody', 'M1095'], 'description': 'MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'armGroupLabels': ['MSB0010841 30 mg']}, {'name': 'MSB0010841', 'type': 'DRUG', 'otherNames': ['Anti-IL-17A/F Nanobody', 'M1095'], 'description': 'MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'armGroupLabels': ['MSB0010841 60 mg']}, {'name': 'MSB0010841', 'type': 'DRUG', 'otherNames': ['Anti-IL-17A/F Nanobody', 'M1095'], 'description': 'MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'armGroupLabels': ['MSB0010841 120 mg']}, {'name': 'MSB0010841', 'type': 'DRUG', 'otherNames': ['Anti-IL-17A/F Nanobody', 'M1095'], 'description': 'MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'armGroupLabels': ['MSB0010841 240 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Please contact the Merck KGaA Communication Center', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}