Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-05 @ 3:47 AM
Study NCT ID:
NCT03396393
Status:
UNKNOWN
Last Update Posted:
2018-01-23
First Post:
2018-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C039060', 'term': 'artenimol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SRI,Response at Week 24 according to a combined response index', 'timeFrame': 'week 24', 'description': "The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status."}], 'secondaryOutcomes': [{'measure': 'Change from baseline in SLEDAI score', 'timeFrame': 'week 4,8,12,16,20,24', 'description': 'Change from baseline in SLEDAI score at week 4,8,12,16,20,24'}, {'measure': 'Change from baseline in PAG score', 'timeFrame': 'week 4,8,12,16,20,24', 'description': 'Change from baseline in PAG score at week 4,8,12,16,20,24'}, {'measure': 'Number of days of daily prednisone dose Less than or equal to 7.5 mg/day', 'timeFrame': 'Baseline, Week 24', 'description': 'Number of days of daily prednisone dose Less than or equal to 7.5 mg/day from baseline over 24 weeks'}, {'measure': 'Percent of subjects with UPRO <0.5g/24h', 'timeFrame': 'Week 4,12,24', 'description': 'Percent of subjects with UPRO \\<0.5g/24h from baseline at Week 4,12,24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dihydroartemisinin;Systemic Lupus Erythematosus'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the efficacy of DHA in patients with SLE.', 'detailedDescription': 'This is a Phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the Safety, Pharmacokinetics and Efficacy of four oral treatment regimens of DHA versus placebo while taking standard of care (SOC) treatment with corticosteroids in adult subjects with Systemic Lupus Erythematosus (SLE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology;\n2. Positive antinuclear antibodies (ANA);\n3. Activity Index (SLEDAI) score must be 6-11 points, inclusive;\n4. Stable dose of prednisone (\\<30mg/d) for at least one month ;\n5. Active mild to moderate SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG);\n6. Males or females between 18 and 65 years old;\n7. Weight of 45 kg or greater.\n\nKey Exclusion Criteria:\n\n1. Active Severe Lupus as defined by BILAG Index Level A or two or more of Level B in any body system/organ;\n2. Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections;\n3. Presence of active central nervous system (CNS) disease requiring treatment;\n4. Subjects with active, severe SLE disease activity which involves the renal system;\n5. Substance abuse or dependence;\n6. History of malignant cancer within the last 5 years;\n7. Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion;\n8. Subjects received any live vaccination within the 30 days prior to Visit 2;\n9. Subjects received intravenous immunoglobulin (IVIg) or,plasmapheresis,or High dose prednisone or equivalent (\\> 100 mg/day) within 90 days prior to Visit 2;\n10. Subjects who have had therapy with cyclophosphamide within 180 days prior to Visit 2 ."}, 'identificationModule': {'nctId': 'NCT03396393', 'briefTitle': 'Exploratory Study of DHA in Systemic Lupus Erythematosus Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kunming Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'KY41078-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dihydroartemisinin 40mg', 'description': 'Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC.', 'interventionNames': ['Drug: Dihydroartemisinin tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Dihydroartemisinin 80mg', 'description': 'Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC.', 'interventionNames': ['Drug: Dihydroartemisinin tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Dihydroartemisinin 120mg', 'description': 'Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC.', 'interventionNames': ['Drug: Dihydroartemisinin tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC.', 'interventionNames': ['Drug: Placebo tablet']}], 'interventions': [{'name': 'Dihydroartemisinin tablet', 'type': 'DRUG', 'otherNames': ['No other names'], 'description': 'DHA tablet', 'armGroupLabels': ['Dihydroartemisinin 120mg', 'Dihydroartemisinin 40mg', 'Dihydroartemisinin 80mg']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'otherNames': ['No other names'], 'description': 'Placebo tablet', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xinyan Li, Ph.D', 'role': 'CONTACT', 'email': 'xinyan.li@holley.cn', 'phone': '+86-13817688857'}, {'name': 'Wenyu Xu, Ph.D', 'role': 'CONTACT', 'email': 'wenyu.xu@holley.cn', 'phone': '+86-10-58611349'}], 'overallOfficials': [{'name': 'Fengchun Zhang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This study has not been decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kunming Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}