Actively Recruiting
A Study of Telitacicept in Lupus Nephritis
Led by RemeGen Co., Ltd. · Updated on 2024-09-23
120
Participants Needed
45
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
CONDITIONS
Official Title
A Study of Telitacicept in Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18-75 years, 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 Class V, or pure Class V according to 2003 ISN/RPS classification, with biopsy done within 1 year before screening or during screening
- Positive serum antibody results defined as positive anti-nuclear antibody (ANA) and/or positive anti-dsDNA based on central lab results
- Active renal disease at screening requiring induction therapy with high dose corticosteroids and mycophenolate mofetil or other oral mycophenolate
- Induction therapy with high dose corticosteroids and mycophenolate mofetil or other oral mycophenolate started within 60 days prior to or on Day 1 (baseline)
- Able to understand study requirements and provide written informed consent
You will not qualify if you...
- Known allergy or contraindication to planned drug products (e.g., MMF, corticosteroids)
- History of allergy to parenteral contrast agents, human or murine proteins, or monoclonal antibodies
- Received B cell targeted therapy (e.g., rituximab) unless B cells have returned to baseline
- Received tumor necrosis factor inhibitors, interleukin receptor blockers, other small molecules or biologics (including Belimumab) within 12 weeks prior to screening or 5 drug half-lives
- Received any experimental drugs within 12 weeks prior to screening or 5 drug half-lives
- Received plasma separation or exchange within 6 weeks prior to screening
- Required dialysis within 1 year prior to screening
- Received live or live-attenuated vaccines within 4 weeks prior to screening or expected vaccination during study
- Received BCG vaccine within 1 year prior to screening
- History of severe active central nervous system lupus requiring intervention within 60 days before baseline
- History of major organ or hematopoietic stem cell/marrow transplant or planned transplantation
- Significant unstable or uncontrolled acute or chronic diseases not due to SLE that may confound study or pose risk
- Planned surgery or medical conditions making subject unsuitable
- History of drug or alcohol abuse within 364 days prior to baseline
- Nursing or pregnant females, or males/females preparing for parenthood during study
- History of malignant tumors within 5 years except adequately treated skin cancer or carcinoma in situ of cervix
- Acute or chronic infection requiring treatment
- HIV positive
- Hepatitis B surface antigen positive; patients positive for anti-HBc require HBV DNA testing and are excluded if HBV DNA positive
- Hepatitis C antibody positive
- History of COVID-19 within 4 weeks prior to screening or hospitalization due to severe COVID-19 within 12 months prior
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2
- Renal biopsy showing 50% glomerulosclerosis
- Grade 3 or greater laboratory abnormalities based on adverse event grading
- Investigator’s judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230001
Actively Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
The First Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, China, 400038
Actively Recruiting
4
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
5
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China, 361004
Actively Recruiting
6
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
7
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
8
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
9
Liuzhou Workers' Hospital
Liuzhou, Guangxi, China, 545005
Actively Recruiting
10
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Actively Recruiting
11
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 071000
Actively Recruiting
12
Handan First Hospital
Handan, Hebei, China, 056002
Actively Recruiting
13
Hebei General Hospital
Shijiazhuang, Hebei, China, 050051
Actively Recruiting
14
The Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050051
Actively Recruiting
15
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
16
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
17
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
18
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, China, 014017
Actively Recruiting
19
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
20
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Actively Recruiting
21
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Actively Recruiting
22
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
23
The Second Hospital of Jilin University
Changchun, Jilin, China, 130042
Actively Recruiting
24
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
25
General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, Liaoning, China, 110015
Actively Recruiting
26
The Affiliated Hospital of Qinghai University
Xining, Qinghai, China, 810001
Actively Recruiting
27
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710004
Actively Recruiting
28
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
29
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
30
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
31
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
32
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
33
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China, 030012
Actively Recruiting
34
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
35
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
36
People's Hospital of Sichuan Province
Chengdu, Sichuan, China, 610072
Actively Recruiting
37
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
38
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
39
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China, 830001
Actively Recruiting
40
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
Actively Recruiting
41
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
42
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
43
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China, 317000
Actively Recruiting
44
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
45
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, China, 322000
Actively Recruiting
Research Team
B
Binghua Xiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here