Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-01-17 @ 2:02 AM
Study NCT ID:
NCT02074020
Status:
WITHDRAWN
Last Update Posted:
2015-08-13
First Post:
2014-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D009393', 'term': 'Nephritis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C573858', 'term': 'AMG623 peptibody'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-11', 'studyFirstSubmitDate': '2014-02-26', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline', 'timeFrame': '52 Weeks'}], 'primaryOutcomes': [{'measure': 'Proportion of responders to the SRI-8 composite responder index', 'timeFrame': '52 Weeks'}], 'secondaryOutcomes': [{'measure': 'Time to first severe SLE flare', 'timeFrame': 'Baseline through 52 weeks'}, {'measure': 'Change in the number of actively tender or swollen joints and in mucocutaneous disease activity', 'timeFrame': '52 Weeks'}, {'measure': 'Change in proteinuria from baseline', 'timeFrame': 'Week 52'}, {'measure': 'Proportion of subjects able to reduce oral steroid dose', 'timeFrame': 'Baseline through 52 weeks'}, {'measure': 'Proportion of subjects with improved patient-reported outcomes', 'timeFrame': 'Week 52'}, {'measure': 'Time to treatment failure', 'timeFrame': 'Through week 52'}, {'measure': 'Change from baseline in B cell subsets, anti-dsDNA, C3, C4', 'timeFrame': 'Through week 52'}, {'measure': 'Safety profile (AEs, vital signs, labs, physical exams)', 'timeFrame': 'Through week 52'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SLE', 'Lupus', 'Lupus Erythematosus, Systemic', 'Autoimmune Diseases', 'A-623', 'Blisibimod', 'Nephritis'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '33687069', 'type': 'DERIVED', 'citation': 'Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology\n* Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)\n* Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy\n* Subjects with stable nephritis may be enrolled\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes\n* Malignancy within past 5 years\n* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C\n* Liver disease\n* Anemia, neutropenia, or thrombocytopenia\n* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections\n* History of active tuberculosis or a history of tuberculosis infection\n* Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT02074020', 'briefTitle': 'CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anthera Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis', 'orgStudyIdInfo': {'id': 'AN-SLE3332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blisibimod', 'interventionNames': ['Drug: Blisibimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Blisibimod', 'type': 'DRUG', 'description': 'Administered via subcutaneous injection once per week', 'armGroupLabels': ['Blisibimod']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered via subcutaneous injection once per week', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anthera Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}