Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-02 @ 1:30 PM
Study NCT ID:
NCT05781750
Status:
TERMINATED
Last Update Posted:
2025-12-05
First Post:
2023-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Croatia', 'Peru', 'Portugal', 'Puerto Rico', 'Serbia', 'Singapore', 'Spain', 'Taiwan', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712054', 'term': 'KZR-616'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@kezarbio.com', 'phone': '650-822-5600', 'title': 'Regulatory Affairs', 'organization': 'Kezar Life Sciences, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "The study was terminated early for strategic business reasons following the temporary halt of the study per the Independent Data Monitoring Committee's (IDMC's) recommendation. At the time of termination, no participants had completed the full 52-week treatment period. Due to early termination, safety was the primary focus of this study and only limited efficacy data were analyzed."}}, 'adverseEventsModule': {'timeFrame': 'Through end of study visit, up to 52 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 23, 'seriousNumAtRisk': 27, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 25, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 17, 'seriousNumAtRisk': 28, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 28, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 28, 'numAffected': 9}, {'groupId': 'EG002', 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27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 19, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 18, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 35, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Injection related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Lupus vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Achieving Complete Renal Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 37', 'description': 'Proportion of patients achieving complete renal response (CRR), defined as:\n\n* A UPCR ≤0.5 in one 24-hour urine sample (for primary endpoint and Week 53) or 2 consecutive first morning void urine samples (for all other time points)\n* An eGFR ≥60 mL/min/1.73 m\\^2 or no confirmed decrease of \\>20% from Baseline eGFR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat analysis set who reached Week 37 of treatment. Intent-to-treat set was defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the 37 week timepoint for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving Partial Renal Response (PRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 25 and Week 37', 'description': 'Proportion of patients achieving PRR, defined as a:\n\n≥50% reduction of UPCR from Baseline, and to \\<1.0 if the Baseline UPCR was \\<3.0 or to \\<3.0 if the Baseline value was ≥3.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving Complete Renal Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 25', 'description': 'Proportion of patients achieving complete renal response (CRR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in UPCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-33.08', 'spread': '34.37', 'groupId': 'OG000'}, {'value': '-46.33', 'spread': '55.16', 'groupId': 'OG001'}, {'value': '-32.27', 'spread': '35.24', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-37.27', 'spread': '45.00', 'groupId': 'OG000'}, {'value': '-61.56', 'spread': '50.85', 'groupId': 'OG001'}, {'value': '-40.33', 'spread': '42.47', 'groupId': 'OG002'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-68.39', 'spread': 'NA', 'comment': 'Only one participant receiving 30 mg zetomipzomib was analyzed.', 'groupId': 'OG000'}, {'value': '-72.59', 'spread': '29.91', 'groupId': 'OG001'}, {'value': '-23.08', 'spread': '17.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit', 'unitOfMeasure': 'percent change in 24-hr UPCR value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Complete Renal Response and Partial Renal Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'title': 'Complete Renal Response', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '26.9', 'comment': 'NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Partial Renal Response', 'categories': [{'measurements': [{'value': '24.3', 'comment': 'NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': 'NA'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '24.0'}, {'value': '25.1', 'comment': 'NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation due to early study termination.', 'groupId': 'OG002', 'lowerLimit': '12.4', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.2', 'ciUpperLimit': '3.3', 'groupDescription': 'Time to complete renal response for zetomipzomib 30 mg + standard-of-care versus placebo + standard-of-care', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Trial was early terminated.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '6.7', 'groupDescription': 'Time to complete renal response for zetomipzomib 60 mg + standard-of-care versus placebo + standard-of-care', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Trial was early terminated.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.5', 'ciUpperLimit': '3.0', 'groupDescription': 'Time to partial renal response for zetomipzomib 30 mg + standard-of-care versus placebo + standard-of-care', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Trial was early terminated.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.1', 'ciUpperLimit': '5.9', 'groupDescription': 'Time to partial renal response zetomipzomib 60 mg + standard-of-care versus placebo + standard-of-care', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Trial was early terminated.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 37', 'description': 'The comparison of the time to Complete Renal Response and Partial Renal Response for the zetomipzomib treatment groups (zetomipzomib 30mg and zetomipzomib 60mg) versus placebo. Hazard ratio (HR) and associated two-sided CIs are estimated using the Cox proportional hazards model. The model includes terms for treatment, the randomization stratification factors, and baseline UPCR (continuous).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With UPCR ≤0.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Proportion of patients with UPCR ≤0.5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}, {'type': 'SECONDARY', 'title': 'Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'spread': '45.4', 'groupId': 'OG000'}, {'value': '-56.4', 'spread': '24.1', 'groupId': 'OG001'}, {'value': '-19.5', 'spread': '33.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-18.6', 'spread': '45.9', 'groupId': 'OG000'}, {'value': '-59.2', 'spread': '33.6', 'groupId': 'OG001'}, {'value': '-27.2', 'spread': '32.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-28.6', 'spread': 'NA', 'comment': 'Only one participant reached this timepoint.', 'groupId': 'OG000'}, {'value': '-36.4', 'spread': '51.4', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '32.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Percent change from Baseline in clinical SLEDAI-2K score. The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity.', 'unitOfMeasure': 'percent change of SLEDAI-2K score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}, {'type': 'POST_HOC', 'title': 'Change in UPCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-33.08', 'spread': '34.37', 'groupId': 'OG000'}, {'value': '-46.33', 'spread': '55.16', 'groupId': 'OG001'}, {'value': '-34.63', 'spread': '36.01', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-37.27', 'spread': '45.00', 'groupId': 'OG000'}, {'value': '-61.56', 'spread': '50.85', 'groupId': 'OG001'}, {'value': '-40.33', 'spread': '42.47', 'groupId': 'OG002'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-68.39', 'spread': 'NA', 'comment': 'Only one participant receiving 30 mg zetomipzomib was analyzed.', 'groupId': 'OG000'}, {'value': '-72.59', 'spread': '29.91', 'groupId': 'OG001'}, {'value': '-23.08', 'spread': '17.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit', 'unitOfMeasure': 'percent change in 24-hr UPCR value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set defined as the participants with Class III/IV ± Class V lupus nephritis including the participant who was actually diagnosed as Class IV and was mistakenly stratified to Pure Class V. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}, {'type': 'POST_HOC', 'title': 'Proportion of Participants With UPCR ≤0.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'OG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'classes': [{'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Proportion of Participants With UPCR ≤0.5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intent to treat set defined as the participants with Class III/IV ± Class V lupus nephritis including the participant who was actually diagnosed as Class IV and was mistakenly stratified to Pure Class V. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'FG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'FG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '28'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Zetomipzomib 30 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'BG001', 'title': 'Zetomipzomib 60 mg + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.'}, {'id': 'BG002', 'title': 'Placebo + Standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'spread': '10.54', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '9.44', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '9.10', 'groupId': 'BG002'}, {'value': '32.1', 'spread': '9.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Average 24-hour UPCR at Screening', 'classes': [{'title': '≤3.0 mg/mg', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': '>3.0 mg/mg', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average 24-hour UPCR at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '3.5', 'spread': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SLEDAI-2K', 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '5.28', 'groupId': 'BG000'}, {'value': '11.7', 'spread': '5.48', 'groupId': 'BG001'}, {'value': '10.5', 'spread': '5.02', 'groupId': 'BG002'}, {'value': '11.3', 'spread': '5.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Scale from 0-105, higher scores indicate worse disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from SLE diagnosis to Screening', 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '5.8', 'groupId': 'BG002'}, {'value': '6.5', 'spread': '5.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from LN diagnosis to Screening', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '4.5', 'groupId': 'BG002'}, {'value': '3.7', 'spread': '4.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LN Class', 'classes': [{'title': 'Class III/IV ± V', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Pure Class V', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Among the 11 participants who were stratified to Pure Class V LN, one was actually diagnosed as Class IV and was mistakenly stratified to Pure Class V. All primary and secondary outcome measures are presented as stratified, whereas the post-hoc outcome measures include the participant who was stratified incorrectly.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-27', 'size': 2136071, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-07T16:04', 'hasProtocol': True}, {'date': '2024-07-24', 'size': 4494218, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-07T16:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'Sponsor Decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-03-12', 'resultsFirstSubmitDate': '2025-11-07', 'studyFirstSubmitQcDate': '2023-03-12', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Achieving Complete Renal Response', 'timeFrame': 'Week 37', 'description': 'Proportion of patients achieving complete renal response (CRR), defined as:\n\n* A UPCR ≤0.5 in one 24-hour urine sample (for primary endpoint and Week 53) or 2 consecutive first morning void urine samples (for all other time points)\n* An eGFR ≥60 mL/min/1.73 m\\^2 or no confirmed decrease of \\>20% from Baseline eGFR.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Achieving Partial Renal Response (PRR)', 'timeFrame': 'Week 25 and Week 37', 'description': 'Proportion of patients achieving PRR, defined as a:\n\n≥50% reduction of UPCR from Baseline, and to \\<1.0 if the Baseline UPCR was \\<3.0 or to \\<3.0 if the Baseline value was ≥3.0.'}, {'measure': 'Proportion of Patients Achieving Complete Renal Response', 'timeFrame': 'Week 25', 'description': 'Proportion of patients achieving complete renal response (CRR)'}, {'measure': 'Change in UPCR', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit'}, {'measure': 'Time to Complete Renal Response and Partial Renal Response', 'timeFrame': 'Baseline through Week 37', 'description': 'The comparison of the time to Complete Renal Response and Partial Renal Response for the zetomipzomib treatment groups (zetomipzomib 30mg and zetomipzomib 60mg) versus placebo. Hazard ratio (HR) and associated two-sided CIs are estimated using the Cox proportional hazards model. The model includes terms for treatment, the randomization stratification factors, and baseline UPCR (continuous).'}, {'measure': 'Proportion of Patients With UPCR ≤0.5', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Proportion of patients with UPCR ≤0.5'}, {'measure': 'Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K)', 'timeFrame': 'Week 13, Week 25, and Week 37', 'description': 'Percent change from Baseline in clinical SLEDAI-2K score. The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunoproteasome inhibition', 'selective immunoproteasome inhibition', 'complete renal response', 'partial renal response', 'glucocorticoids', 'steroids', 'SLE (systemic lupus erythematosus)', 'UPCR (urine protein to creatinine ratio)', 'eGFR (estimated glomerular filtration rate)'], 'conditions': ['Lupus Nephritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.kezarlifesciences.com', 'label': 'Corporate website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).', 'detailedDescription': 'This study aimed to investigate whether zetomipzomib, added to standard of care treatment in patients with active LN, was able to reduce disease activity over a treatment period of 52 weeks. The background standard of care therapy was mycophenolate mofetil (MMF) and initial optional treatment with IV methylprednisolone, followed by a tapering course of oral corticosteroids.\n\nPatients were required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis.\n\nPatients were randomized in a 2:1 ratio to receive either zetomipzomib (30 mg or 60 mg) or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up period. Efficacy was to be assessed by measuring the level of proteinuria (as measured by urine protein to creatinine ratio \\[UPCR\\]) and estimated glomerular filtration rate (eGFR) as compared to current standard of care treatment. Safety was also assessed throughout the study to ensure an acceptable safety profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body mass index of ≥18 kg/m\\^2\n* eGFR ≥30 mL/min/1.73 m\\^2\n* Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test\n* Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.\n* UPCR ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V)\n* Adequate hematologic, hepatic, and renal function\n\nKey Exclusion Criteria:\n\n* Current or medical history of:\n\n * Central nervous system manifestations of SLE\n * Overlapping autoimmune condition that may affect study assessments/outcomes\n * Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening\n * Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions\n * Solid organ transplant or planned transplant during study\n * Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers \\>5 years ago\n* Has received dialysis within the 52 weeks prior to Screening\n* Positive test at Screening for HIV, hepatitis B/C\n* Known intolerance to MMF or equivalent and corticosteroids'}, 'identificationModule': {'nctId': 'NCT05781750', 'briefTitle': 'A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kezar Life Sciences, Inc.'}, 'officialTitle': 'A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg With Placebo in Patients With Active Lupus Nephritis', 'orgStudyIdInfo': {'id': 'KZR-616-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zetomipzomib 30 mg + standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.', 'interventionNames': ['Drug: zetomipzomib']}, {'type': 'EXPERIMENTAL', 'label': 'zetomipzomib 60 mg + standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.', 'interventionNames': ['Drug: zetomipzomib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + standard-of-care', 'description': 'Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'zetomipzomib', 'type': 'DRUG', 'otherNames': ['KZR-616'], 'description': 'Subcutaneous injection of zetomipzomib', 'armGroupLabels': ['zetomipzomib 30 mg + standard-of-care', 'zetomipzomib 60 mg + standard-of-care']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['matching placebo'], 'description': 'Subcutaneous injection of placebo', 'armGroupLabels': ['placebo + standard-of-care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70605', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Accurate Clinical Research - Lake Charles', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '02914', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Nephrology Associates, Inc', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '76034', 'city': 'Colleyville', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Comprehensive Clinical Research Solutions', 'geoPoint': {'lat': 32.88096, 'lon': -97.15501}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Prolato Clinical Research Center (PCRC)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'T4000', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Mayo Clinic of UCMB SRL', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'B1902ADW', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Framingham Medical Center', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1015', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Medical Research Organization', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1406AGA', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Aprillus Assistance and Research by Arcis Health', 'geoPoint': {'lat': -34.61315, 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of SJRP', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinical Hospital FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510280', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '080020', 'city': 'Barranquilla', 'state': 'Atlántico', 'country': 'Colombia', 'facility': 'Costa Clinica', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Laiko General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '01009', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Center for Advanced Health Clinical Studies', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01010', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Clinical Research Center, S.A.', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01010', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Medical Clinic Specialized in Internal Medicine and Rheumatology', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01011', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Medical Clinic Specialized in Internal Medicine and Rheumatology', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '492099', 'city': 'Raipur', 'state': 'Chhattisgarh', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 21.23333, 'lon': 81.63333}}, {'zip': '395002', 'city': 'Surat', 'state': 'Guajrat', 'country': 'India', 'facility': 'Nirmal Hospital', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '395010', 'city': 'Surat', 'state': 'Guajrat', 'country': 'India', 'facility': 'Unity Hospital', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '380005', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Panchshil Hospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '680007', 'city': 'Thrissur', 'state': 'Kerala', 'country': 'India', 'facility': 'Elite Mission Hospital', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}, {'zip': '431003', 'city': 'Aurangabad', 'state': 'Maharashtra', 'country': 'India', 'facility': 'MGM Medical College and Hospital', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'zip': '440001', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Kingsway Hospital', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '440012', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Jasleen Hospital', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '422101', 'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Assured Care Plus Hospital', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '110060', 'city': 'New Delhi', 'state': 'NCT of Delhi', 'country': 'India', 'facility': 'Sir Ganga Ram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '302001', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'SMS Medical College', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': 'India', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Yashoda Hospitals', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500003', 'city': 'Secunderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Krishna Institute of Medical Science', 'geoPoint': {'lat': 17.50427, 'lon': 78.54263}}, {'zip': '50450', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Prince Court Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '30450', 'city': 'Ipoh', 'state': 'Perak', 'country': 'Malaysia', 'facility': 'Hospital Raja Permaisuri Bainun', 'geoPoint': {'lat': 4.5841, 'lon': 101.0829}}, {'zip': '68100', 'city': 'Batu Caves', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Hospital Selayang', 'geoPoint': {'lat': 3.238, 'lon': 101.682}}, {'zip': '43000', 'city': 'Kajang', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Hospital Sultan Idris Shah Serdang', 'geoPoint': {'lat': 2.99424, 'lon': 101.78875}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '4217', 'city': 'Lipa City', 'state': 'Batangas', 'country': 'Philippines', 'facility': 'Mary Mediatrix Medical Center', 'geoPoint': {'lat': 13.9411, 'lon': 121.1631}}, {'zip': '5000', 'city': 'Iloilo City', 'state': 'Iloilo', 'country': 'Philippines', 'facility': "Iloilo Doctors' Hospital", 'geoPoint': {'lat': 10.69694, 'lon': 122.56444}}, {'zip': '1000', 'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'ManilaMed - Medical Center Manila', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1102', 'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '1118', 'city': 'Quezon City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Far Eastern University Hospital Nicanor Reyes Medical Foundation', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '1015', 'city': 'Manila', 'country': 'Philippines', 'facility': 'University of Santo Tomas Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '6001', 'city': 'Port Elizabeth', 'state': 'Eastern Cape', 'country': 'South Africa', 'facility': 'Phoenix Pharma', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kezar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kezar Life Sciences, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kezar Life Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}