A Study of Telitacicept in Lupus Nephritis
A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis
1 other identifier
interventional
120
1 country
45
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2023
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedSeptember 23, 2024
September 1, 2024
2.6 years
December 26, 2022
September 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Complete Renal Response (CRR)
CRR is defined as estimated glomerular filtration rate (GFR) is no more than 20% below the baseline value or ≥ 60 mL/min/1.73m\^2 and 24-hour urinary protein: creatinine ratio ≤ 0.5 mg/mg and did not receive prohibited or rescue therapy resulting in treatment failure.
Week 48
Secondary Outcomes (2)
Percentage of participants with Partial Renal Response (PRR)
Week 24 and Week 48
Incidence of AE, SAE
Up to Week 48
Study Arms (3)
Telitacicept 240 mg
EXPERIMENTALTelitacicept 240 mg given SC weekly plus standard therapy through week 48.
Telitacicept 160 mg
EXPERIMENTALTelitacicept 160 mg given SC weekly plus standard therapy through week 48.
Placebo
PLACEBO COMPARATORPlacebo given SC weekly plus standard therapy through week 48.
Interventions
Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.
Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230001, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
The First Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361004, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Liuzhou Workers' Hospital
Liuchow, Guangxi, 545005, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Handan First Hospital
Handan, Hebei, 056002, China
Hebei General Hospital
Shijiazhuang, Hebei, 050051, China
The Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, 014017, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Jilin University
Changchun, Jilin, 130042, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, Liaoning, 110015, China
The Affiliated Hospital of Qinghai University
Xining, Qinghai, 810001, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
People's Hospital of Sichuan Province
Chengdu, Sichuan, 610072, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
Related Publications (1)
Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
PMID: 40465397DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2022
First Posted
January 11, 2023
Study Start
April 17, 2023
Primary Completion
December 1, 2025
Study Completion
January 1, 2026
Last Updated
September 23, 2024
Record last verified: 2024-09