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A Study of Telitacicept in Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Telitacicept 240 mg
Telitacicept 160 mg
Placebo
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring lupus, nephritis, Telitacicept, RC 18

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Telitacicept 240 mg

Telitacicept 160 mg

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of participants with Partial Renal Response (PRR)
PRR is defined as 24-hour urinary protein: creatinine ratio reduced by 50% compared to baseline value.
Incidence of AE, SAE
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment.

Full Information

First Posted
December 26, 2022
Last Updated
October 10, 2023
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05680480
Brief Title
A Study of Telitacicept in Lupus Nephritis
Official Title
A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
Detailed Description
This is a phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept versus placebo while taking standard of care (SOC) treatment in adult subjects with active proliferative lupus nephritis (LN).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
lupus, nephritis, Telitacicept, RC 18

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telitacicept 240 mg
Arm Type
Experimental
Arm Description
Telitacicept 240 mg given SC weekly plus standard therapy through week 48.
Arm Title
Telitacicept 160 mg
Arm Type
Experimental
Arm Description
Telitacicept 160 mg given SC weekly plus standard therapy through week 48.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given SC weekly plus standard therapy through week 48.
Intervention Type
Biological
Intervention Name(s)
Telitacicept 240 mg
Other Intervention Name(s)
RC18 240 mg
Intervention Description
Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.
Intervention Type
Biological
Intervention Name(s)
Telitacicept 160 mg
Other Intervention Name(s)
RC18 160 mg
Intervention Description
Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo weekly in addition to SOC for 48 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants with Complete Renal Response (CRR)
Description
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.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of participants with Partial Renal Response (PRR)
Description
PRR is defined as 24-hour urinary protein: creatinine ratio reduced by 50% compared to baseline value.
Time Frame
Week 24 and Week 48
Title
Incidence of AE, SAE
Description
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment.
Time Frame
Up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghua Xiao
Phone
86-010-58076833
Email
Binghua.xiao@remegen.com
Facility Information:
Facility Name
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital Affiliated to the Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital Affiliated to Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Name
Liuzhou Workers' Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545005
Country
China
Individual Site Status
Recruiting
Facility Name
Guizhou Provincial People's Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550002
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Individual Site Status
Recruiting
Facility Name
Handan First Hospital
City
Handan
State/Province
Hebei
ZIP/Postal Code
056002
Country
China
Individual Site Status
Recruiting
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Affiliated Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014017
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130042
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Northern Theater Command of the Chinese People's Liberation Army
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110015
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Qinghai University
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810001
Country
China
Individual Site Status
Recruiting
Facility Name
Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030012
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Sichuan Province
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Second Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Taizhou Hospital of Zhejiang Province
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
City
Yiwu
State/Province
Zhejiang
ZIP/Postal Code
322000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of Telitacicept in Lupus Nephritis

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