Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-01 @ 10:34 AM
Study NCT ID:
NCT05247203
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722462', 'term': 'telitacicept'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'Cmax is defined as peak plasma concentration of Telitacicept'}, {'measure': 'Time to reach Cmax (tmax) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'tmax is defined as time to reach Cmax of Telitacicept'}, {'measure': 'Observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval (Ctrough)', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval'}, {'measure': 'Average concentration (Cav) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'Average concentration of Telitacicept'}, {'measure': 'Area under the curve from time zero to last quantifiable concentration (AUC 0-t) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'AUC 0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept'}, {'measure': 'Area under the curve from time zero to tau (AUC 0-tau) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'AUC 0-tau is defined as area under the curve from time zero to tau of Telitacicept'}, {'measure': 'Terminal elimination rate constant (λz) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'λz is defined as terminal elimination rate constant'}, {'measure': 'Terminal elimination half-life (t1/2z) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 't1/2z is defined as terminal elimination half-life of Telitacicept'}, {'measure': 'Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'Vz/F is defined as apparent volume of distribution during the terminal phase after extravascular administration of Telitacicept'}, {'measure': 'Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Telitacicept', 'timeFrame': 'up to 42 days following the last dose of Telitacicept', 'description': 'CL/F is defined as apparent total body clearance of drug from plasma after extravascular administration of Telitacicept'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants achieving a SLE Responder Index (SRI)', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA-SLEDAI score, and no worsening (increase of \\< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.'}, {'measure': 'Percentage of participants achieving a SELENA-SLEDAI improvement of ≥4 points', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'SELENA-SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105.'}, {'measure': 'Change From Baseline to W24 in patient global assessment (PGA)', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).'}, {'measure': 'Change From Baseline to W24 in IgG', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.'}, {'measure': 'Change From Baseline to W24 in IgA', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.'}, {'measure': 'Change From Baseline to W24 in IgM', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.'}, {'measure': 'Change From Baseline to W24 in C3', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'Complement (C3/C4) are proteins that are part of the immune system.'}, {'measure': 'Change From Baseline to W24 in C4', 'timeFrame': 'Week 4, 8, 12, 16, 20, and 24', 'description': 'Complement (C3/C4) are proteins that are part of the immune system.'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'up to 28 days following the last dose of Telitacicept', 'description': 'Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Telitacicept', 'Pharmacokinetics', 'Lupus Erythematosus, Systemic', 'Connective Tissue Diseases', 'Autoimmune Diseases'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label, phase I study.', 'detailedDescription': 'The purpose of this study is to evaluate the pharmacokinetics, safety and efficacy of Telitacicept in Chinese patients with systemic lupus erythematosus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects who give consent to this study participation and sign informed consent form;\n2. Males and females, between the ages of 18 and 65 years old, inclusive, at the screening visit;\n3. Diagnosis of SLE as defined by the American College of Rheumatology (ACR) 1997 criteria, with 4 or more of the 11 ACR criteria present;\n4. SELENA-SLEDAI score ≥8 points with a clinical SELENA-SLEDAI score ≥6 points if low complement levels and/or anti-ds-DNA antibodies are present at the screening visit;\n5. Subjects with unequivocally positive test for anti-nuclear antibody (ANA) and/or anti-ds-DNA serum antibody;\n6. Be on a SLE standard treatment regimen (and remain stable) for a period of at least 30 days prior to Day 0. The standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.\n\nExclusion Criteria:\n\n1. Subjects with severe lupus kidney disease (defined by proteinuria \\>6g/24h or serum creatinine \\>2.5mg/dL or serum creatinine \\>221μmol/L) or active nephritis requiring prohibited medications, or subjects requiring hemodialysis or prednisone (or its equivalent)≥100mg/d for a period of ≥14 days within 8 weeks of Day 0;\n2. Central nervous system (CNS) disease associated with lupus or not \\[including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), encephalitis, CNS angiitis\\] within 8 weeks prior to the screening visit;\n3. Laboratory abnormalities including, but not limited to the following:\n\n 1. ALT/AST≥2×upper limit of normal (ULN);\n 2. endogenous creatinine clearance rate\\<30 mL/min;\n 3. white blood cell count\\<2.5×10\\^9/L;\n 4. hemoglobin\\<85 g/L;\n 5. platelet count\\<50×10\\^9/L;\n4. Active hepatitis or a history of severe liver disease at the screening visit. Positive test for Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb). If anti-HBcAb result is positive while HBsAg result is negative, hepatitis B virus (HBV)-(DNA) test will be performed. If HBV-DNA result is negative, the patient is eligible;\n5. Subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers;\n6. Pregnant or lactating female subjects or sexually active subjects who refuse to practice the protocol-specified contraception throughout the study;\n7. History of allergy to humanized biological products;\n8. Subjects who received live vaccine within 28 days of Day 0;\n9. Participation in any other investigational study drug trial in the past 28 days or 5 half-lives, whichever was longer, prior to Day 0. Subjects who participated in a clinical trial on B-cell-targeted drug, or tumor necrosis factor inhibitor, or interleukin receptor blocker within 12 months prior to Day 0 would be excluded;\n10. Subjects who received other B-cell targeted drugs, such as Belimumab, rituximab or Epratuzumab within 12 months prior to Day 0;\n11. Subjects who received tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to Day 0;\n12. Subjects who received intravenous immune globulin (IVIG), or high dose prednisone or its equivalents (≥100mg/d) for a period of ≥ 14 days, or plasma exchange within 28 days prior to Day 0;\n13. Subjects who received IL-2, Thalidomide, Tripterygium wilfordii or Chinese medicinal preparations containing Tripterygium wilfordii within 28 days prior to Day 0;\n14. Subjects with active infections (herpes zoster, HIV infection, active tuberculosis, etc.) at the screening visit;\n15. Subjects with depression or suicidal thoughts;\n16. Any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.."}, 'identificationModule': {'nctId': 'NCT05247203', 'briefTitle': 'Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'RemeGen Co., Ltd.'}, 'officialTitle': 'A Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': '18C020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telitacicept Arm 1', 'description': 'Telitacicept 80mg, once a week for 24 weeks plus standard therapy', 'interventionNames': ['Biological: Telitacicept', 'Drug: standard therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Telitacicept Arm 2', 'description': 'Telitacicept 160mg, once a week for 24 weeks plus standard therapy', 'interventionNames': ['Biological: Telitacicept', 'Drug: standard therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Telitacicept Arm 3', 'description': 'Telitacicept 160mg, once a week for 12 weeks followed by once every two weeks for another 12 weeks plus standard therapy', 'interventionNames': ['Biological: Telitacicept', 'Drug: standard therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Telitacicept Arm 4', 'description': 'Telitacicept 240mg, once a week for 24 weeks plus standard therapy', 'interventionNames': ['Biological: Telitacicept', 'Drug: standard therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Telitacicept Arm 5', 'description': 'Telitacicept 240mg, once every two weeks for 24 weeks plus standard therapy', 'interventionNames': ['Biological: Telitacicept', 'Drug: standard therapy']}], 'interventions': [{'name': 'Telitacicept', 'type': 'BIOLOGICAL', 'otherNames': ['RC18'], 'description': 'subcutaneous injection', 'armGroupLabels': ['Telitacicept Arm 1', 'Telitacicept Arm 2', 'Telitacicept Arm 3', 'Telitacicept Arm 4', 'Telitacicept Arm 5']}, {'name': 'standard therapy', 'type': 'DRUG', 'description': 'A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.', 'armGroupLabels': ['Telitacicept Arm 1', 'Telitacicept Arm 2', 'Telitacicept Arm 3', 'Telitacicept Arm 4', 'Telitacicept Arm 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233004', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of University of Science and Technology of China', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '541001', 'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'Affiliated Hospital of Guilin Medical University', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'zip': '071000', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Affiliated Hospital of Hebei University', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '264200', 'city': 'Yantai', 'state': 'Shandong', 'country': 'China', 'facility': 'Yantai Yuhuangding Hospital', 'geoPoint': {'lat': 37.47649, 'lon': 121.44081}}, {'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'The Second Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '030032', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Bethune Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '830001', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': "The People's Hospital of Xinjiang Uygur Autonomous Region", 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '650011', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "The First People's Hospital of Yunnan Province", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RemeGen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}