A Study of Telitacicept in Lupus Nephritis
Lupus Nephritis
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring lupus, nephritis, Telitacicept, RC 18
Eligibility Criteria
Main Inclusion Criteria: Males or females aged 18-75 years of age, inclusive. Diagnosis of systemic lupus erythematosus according to American College of Rheumatology criteria (1997). Active, biopsy-proven proliferative lupus nephritis Class III or IV with/without the presence of Class V, or pure Class V according to the 2003 ISN/RPS classification. The renal biopsy must be performed within 1 year prior to the screening visit or during screening period. The biopsy report will be used to confirm subject eligibility. Positive serum antibody results, defined as positive anti-nuclear antibody (ANA) and/or a positive anti-dsDNA serum antibody based on the study's central laboratory results. Active renal disease at screening requiring induction therapy with high dose corticosteroids (HDCS) with mycophenolate mofetil (MMF) or other oral forms of mycophenolate. Induction therapy for active renal disease: HDCS with mycophenolate mofetil (MMF) or other oral forms of mycophenolate should be initiated within 60 days prior to or on Day 1 (baseline). Initiation of induction is when both HDCS and MMF have been started. Able to understand the requirements of the study and provide written informed consent. Main Exclusion Criteria: Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids). History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies. Received any of the following therapies: Treatment with any B cell targeted therapy (e.g., rituximab), unless it can be shown that B cells have returned to baseline level or normal; Received tumor necrosis factor inhibitors, interleukin receptor blockers, or other small molecules or biologics (including Belimumab) during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer; Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer; Received plasma separation or plasma exchange during the 6 weeks prior to screening; Subjects who required dialysis within 1 year prior to screening. Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study. Received BCG Vaccine within 1 year prior to screening. History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1). History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or are due to receive transplantation. Significant, unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk. Plan to undergo surgery or have any medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study. History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1). Nursing or pregnant female, or male or female who prepared for parenthood during the study. History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix. Have acute or chronic infection requiring treatment. HIV positive. Hepatitis B: Patients positive for HBsAg are excluded; Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require test for HBV DNA: if HBV DNA positive, patients will be excluded; if HBV DNA negative, patients will be eligible to enroll. Hepatitis C antibody positive. History of COVID-19 within 4 weeks prior to screening or history of hospitalization due to severe Covid-19 within 12 months prior to screening. eGFR<30 mL/min/1.73 m2 using CKD-EPI. Renal biopsy showed 50% glomerulosclerosis. Subjects who in the opinion of the investigator are not suitable to participate.
Sites / Locations
- The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)Recruiting
- Peking University People's HospitalRecruiting
- The First Hospital Affiliated to the Army Medical UniversityRecruiting
- The First Affiliated Hospital of Xiamen UniversityRecruiting
- Zhongshan Hospital Affiliated to Xiamen UniversityRecruiting
- Guangdong Provincial People's HospitalRecruiting
- The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- Liuzhou Workers' HospitalRecruiting
- Guizhou Provincial People's HospitalRecruiting
- Affiliated Hospital of Hebei UniversityRecruiting
- Handan First HospitalRecruiting
- Hebei General HospitalRecruiting
- The Third Affiliated Hospital of Hebei Medical UniversityRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Xiangya Hospital of Central South UniversityRecruiting
- The Third Xiangya Hospital of Central South UniversityRecruiting
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyRecruiting
- Zhongda Hospital Southeast UniversityRecruiting
- Wuxi People's HospitalRecruiting
- Jiangxi Provincial People's HospitalRecruiting
- The First Hospital of Jilin UniversityRecruiting
- The Second Hospital of Jilin UniversityRecruiting
- Shengjing Hospital of China Medical UniversityRecruiting
- General Hospital of Northern Theater Command of the Chinese People's Liberation ArmyRecruiting
- The Affiliated Hospital of Qinghai UniversityRecruiting
- Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- Qilu Hospital of Shandong UniversityRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- Huashan Hospital Affiliated to Fudan UniversityRecruiting
- Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting
- Second Hospital of Shanxi Medical UniversityRecruiting
- Shanxi Provincial People's HospitalRecruiting
- Shanxi Bethune HospitalRecruiting
- West China Hospital Sichuan UniversityRecruiting
- People's Hospital of Sichuan ProvinceRecruiting
- Tianjin Medical University General HospitalRecruiting
- Tianjin Medical University Second HospitalRecruiting
- People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting
- The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
- The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- Taizhou Hospital of Zhejiang ProvinceRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
- The Fourth Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Telitacicept 240 mg
Telitacicept 160 mg
Placebo
Telitacicept 240 mg given SC weekly plus standard therapy through week 48.
Telitacicept 160 mg given SC weekly plus standard therapy through week 48.
Placebo given SC weekly plus standard therapy through week 48.