Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 5:42 PM
Study NCT ID:
NCT05796206
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A and Part B:Percentage of participants achieving SRI-4 at Week 12', 'timeFrame': 'at Week 12'}], 'secondaryOutcomes': [{'measure': 'Part A and Part B:Proportion of participants achieving SRI-4 at Week 52', 'timeFrame': 'at Week 52'}, {'measure': 'Part A and Part B:Proportion of participants achieving SRI-4 at Week 24', 'timeFrame': 'at Week 24'}, {'measure': 'Part A and Part B:Proportion of participants achieving SRI-4 at Week76', 'timeFrame': 'at Week 76'}, {'measure': 'Part A and Part B:Change From Baseline in 24-hour urine protein in participants with elevated baseline urine protein (24-hour urine protein ≥ 0.5g) at Week 24,52,76', 'timeFrame': 'up to 76 weeks after randomization'}, {'measure': 'Part A and Part B:Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52', 'timeFrame': 'from Week 40 to Week 52 after randomization'}, {'measure': 'Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 24, 52, 76', 'timeFrame': 'up to 76 weeks after randomization'}, {'measure': 'Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM', 'timeFrame': 'up to 76 weeks after randomization'}, {'measure': 'Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)', 'timeFrame': 'up to 76 weeks after randomization'}, {'measure': 'Part A and Part B:Percentage of Participants with Adverse Events', 'timeFrame': 'up to 76 weeks after randomization'}, {'measure': 'Part A: Pharmacokinetic(PK) Parameters: AUC', 'timeFrame': 'up to 76 weeks after randomization', 'description': 'The area under the curve (AUC) of serum concentration of the drug after the administration'}, {'measure': 'Part A: Pharmacokinetic(PK) Parameters:Cmax', 'timeFrame': 'up to 76 weeks after randomization', 'description': 'Maximum concentration(Cmax) of the drug after administration'}, {'measure': 'Part A and Part B: Pharmacodynamics(PD) characteristics：summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells, CD3⁺CD4⁺ T cells, CD3⁺CD8⁺ T cells, NK cells, CD19⁺CD27⁺ B cells, and CD19⁺CD27- naïve B cells', 'timeFrame': 'up to 76 weeks after randomization'}, {'measure': 'Part Aand Part B: Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62', 'timeFrame': 'up to 76 weeks after randomization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-80 ;\n2. Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;\n3. Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;\n4. Low C3 and/or low C4 complement at screening ;\n5. High disease activity at screening ;\n6. On a stable SLE treatment regimen for at least 30 days prior to the first administration；\n7. Able and willing to provide written informed consent and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Unsufficient organ function;\n2. Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;\n3. Subjects with CD4+ T lymphocyte count \\< 200 cells/μL;\n4. Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first dose;\n5. Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 12 weeks prior to the first administration; TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first administration;\n6. Received live or attenuated vaccination within 28 days prior to the first administration;\n7. Participated in other clinical trials within 28 days prior to the first administration;\n8. Concomitant with other serious diseases;\n9. Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA titer above the normal range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV);\n10. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62 ;\n11. Breastfeeding or pregnant women;\n12. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;\n13. Other conditions unsuitable for participation in this study determined by the Investigator.'}, 'identificationModule': {'nctId': 'NCT05796206', 'briefTitle': 'A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Mabworks Biotech Co., Ltd.'}, 'officialTitle': 'A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.', 'orgStudyIdInfo': {'id': 'MIL62-CT308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIL62(Part A and B)', 'interventionNames': ['Drug: MIL62']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Part A and B)', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'MIL62', 'type': 'DRUG', 'description': 'MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1.', 'armGroupLabels': ['MIL62(Part A and B)']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1.', 'armGroupLabels': ['Placebo (Part A and B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Mabworks Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}