Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT01838694
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mitchell.glass@inviongroup.com', 'phone': '+61 7 3295 0500', 'title': 'Mitchell Glass, M.D., EVP of R&D', 'organization': 'Invion, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Up to 30 days following each patient's discontinuation of the study, for up to 9 weeks", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.\n\nPlacebo', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ala-Cpn10', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range (0.16mg/kg \\[10mg twice weekly\\] to 5mg/kg \\[300mg twice weekly\\]) administered intravenously by infusion over 60 minutes.\n\nAla-Cpn10', 'otherNumAtRisk': 22, 'otherNumAffected': 6, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'cutaneous lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.\n\nPlacebo'}, {'id': 'OG001', 'title': 'Ala-Cpn10 - 10mgs in Mild SLE', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) 10mg twice weekly administered intravenously by infusion over 60 minutes.\n\nAla-Cpn10'}, {'id': 'OG002', 'title': 'Ala-Cpn10 - 30mgs in Mild SLE', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.\n\nAla-Cpn10'}, {'id': 'OG003', 'title': 'Ala-Cpn10 - 100mgs in Mild SLE', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) 100mg twice weekly administered intravenously by infusion over 60 minutes.\n\nAla-Cpn10'}, {'id': 'OG004', 'title': 'Ala-Cpn10 - 30mgs in Moderate SLE', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.\n\nAla-Cpn10'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '987.7', 'spread': '2202.1', 'groupId': 'OG001'}, {'value': '-82.5', 'spread': '20.4', 'groupId': 'OG002'}, {'value': '-29.7', 'spread': '59.1', 'groupId': 'OG003'}, {'value': '5000', 'spread': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population reflects participants for whom adequate analyzable samples were collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.\n\nPlacebo'}, {'id': 'FG001', 'title': 'Ala-Cpn10', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.\n\nAla-Cpn10'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.\n\nPlacebo'}, {'id': 'BG001', 'title': 'Ala-Cpn10', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.\n\nAla-Cpn10'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '18', 'groupId': 'BG000'}, {'value': '43', 'spread': '15', 'groupId': 'BG001'}, {'value': '45', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2013-04-17', 'resultsFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2013-04-19', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-05', 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lupus Erythematosus, Systemic']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (ALL must be met):\n\nTo be entered on study, subjects must meet the following criteria:\n\n1. Male or female\n2. Age 18 - 75 years\n3. Patients fulfilling at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR)\n4. Laboratory values as follows:\n\n Documented ANA titer ≥ 1:160 or positive anti-dsDNA antibodies at, or any time prior to screening (verifiable laboratory result)\n5. Not pregnant or breast-feeding\n6. If corticosteroids are required for disease stability prior to study entry, able to tolerate a stable dose of ≤ 0.3 mg/kg/day of prednisone or equivalent for the duration of the study.\n7. Agreement to use an effective form of contraception for the duration of the study.\n8. Ability to understand and give consent.\n9. Willing to participate and able to comply with the study requirements, procedures and visits.\n\n Mild SLE only\n10. Present with mild active SLE disease\n\n Moderate SLE only\n11. Present with active SLE disease based on SLE disease activity score (SLEDAI) ≥4 and ≤10\n12. MCP-1 urinary level \\> 35 pg/ml\n13. IL-6 serum level \\> 10 pg/ml\n14. Meets the American College of Rheumatology (ACR) conditions for "renal disorder" as one of the diagnostic criteria for SLE i.e.\n\n 1. Persistent proteinuria between 0.5 and 1.0 grams per day or \\> than 3+ by dipstick OR\n 2. Cellular casts--may be red cell, hemoglobin, granular, tubular, or mixed\n\n OR\n15. Physician (Pathologist) diagnosis of lupus nephritis of no greater severity than:\n\n 1. Class I - Minimal mesangial lupus nephritis, OR\n 2. Class II - Mesangial proliferative lupus nephritis, in accordance with the International Society of Nephrology (ISN) and the Renal Pathology Society (RPS) 2003 histological classification.\n\n With diagnosis made ≥ 6 months prior to study commencement.\n16. If inclusion criteria #15 is met, subject must be receiving stable Standard of Care, including hydroxychloroquine, treatment appropriate for class I-II nephritis.\n\nExclusion Criteria (NONE can apply):\n\n1. Active severe SLE flare with central nervous system (CNS) and/or renal manifestations, pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol within 4 weeks of screening\n2. Pregnant or breast-feeding\n3. Lack of peripheral venous access.\n4. History of cardiovascular disease. An acute cardiovascular event within 12 months of study entry, including arterial or venous thrombosis (blood clots).\n5. Requirement for a stable dose of corticosteroid \\>0.3 mg/kg/day of prednisone or equivalent.\n6. Active therapy with human or murine monoclonal antibodies (i.e. belimumab), within 2 months of study entry.\n7. Any experimental therapy within 3 months of study entry.\n8. Therapy with cyclophosphamide p.o or parenteral; pulse methylprednisolone or IVIG within 4-6 weeks.\n9. Subjects being treated with sulfonylureas.\n10. Subjects with any the following laboratory abnormalities: serum creatinine \\>3.0 mg/dL, WBC \\<3,500/μL, ANC \\<3,000/μL, absolute lymphocyte count ≤500/μL, Hgb \\<8.0 g/dL, platelets \\<50,000/μL, ALT and/or AST \\>1.5 x upper limit of normal (ULN), alkaline phosphatase \\>1.5 ULN.\n11. Personal or psychiatric condition that precludes the subject being able to comply with the study requirements or understand and agree to the informed consent process.\n12. Recent systemic bacterial, fungal, viral, or parasitic infections. Have required management/treatment or hospitalization for any infection within the last 4 weeks before screening.\n13. History of malignancy - except completely excised basal cell carcinoma.\n14. Impaired hepatic function\n15. Body weight of 260lbs/120kg or more (BMI \\> 35)\n16. History of tuberculosis (TB) or active, continuing treatment for TB\n17. History of or current alcohol or substance abuse\n\n Mild SLE only\n18. Active lupus nephritis and/or severe renal impairment (estimated or measured GFR \\< 50% predicted for age and gender)\n\n Moderate SLE only\n19. Subjects with recently diagnosed lupus nephritis (diagnosis made \\<6 months prior to commencement of study\n20. Subjects with active urinary sediment'}, 'identificationModule': {'nctId': 'NCT01838694', 'briefTitle': 'Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Invion, Inc.'}, 'orgStudyIdInfo': {'id': 'IVXCpn001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ala-Cpn10', 'description': 'Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.', 'interventionNames': ['Biological: Ala-Cpn10']}], 'interventions': [{'name': 'Ala-Cpn10', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Ala-Cpn10']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Abel Buchheim Pharmaceutical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '16635', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Arthritis and Osteoporosis Center', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invion, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}