Targeting B Cells and Plasma Cells in Glomerular Disease.
Syeda Behjat Ahmad, J Ashley Jefferson
https://pubmed.ncbi.nlm.nih.gov/40465397Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID05680480
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis
Led by RemeGen Co., Ltd. · Updated on 2024-09-23
120
Participants Needed
45
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Telitacicept in adults with active lupus nephritis, a kidney inflammation caused by lupus. This phase 2, multicenter, randomized, double-blind, placebo-controlled study compares Telitacicept to a placebo while all participants receive standard of care treatment. The research aims to understand how well Telitacicept works and how safe it is for patients with this condition. Participants will be randomly assigned to one of three groups: Telitacicept 240 mg, Telitacicept 160 mg, or a placebo. Each group receives weekly subcutaneous injections along with standard therapy for 48 weeks. The study monitors participants throughout this period to observe treatment effects and safety. During the 48-week treatment, participants will undergo regular assessments including kidney function tests and monitoring for side effects. Researchers will measure the percentage of participants achieving complete renal response at week 48, along with partial response rates and any adverse events up to week 48. The study ensures careful follow-up to evaluate outcomes and participant safety over the full treatment duration.
CONDITIONS
Brief Title
A Study of Telitacicept in Lupus Nephritis
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Males or females aged 18-75 years.
- Diagnosis of systemic lupus erythematosus as per American College of Rheumatology criteria (1997).
- Active, biopsy-confirmed proliferative lupus nephritis Class III or IV with/without Class V, or pure Class V, with biopsy performed within 1 year before screening.
- Positive anti-nuclear antibody and/or anti-dsDNA antibody.
- Active kidney disease requiring induction therapy with high dose corticosteroids and mycophenolate mofetil or similar.
- Induction therapy started within 60 days before or on Day 1 of the study.
- Able to understand study requirements and provide written informed consent.
You will not qualify if you...
- Allergy or contraindication to planned drugs such as mycophenolate mofetil or corticosteroids.
- History of allergy to contrast agents, human or murine proteins, or monoclonal antibodies.
- Recent treatment with B cell targeted therapies, tumor necrosis factor inhibitors, interleukin receptor blockers, biologics, experimental drugs, or plasma exchange within specified timeframes.
- Dialysis within 1 year before screening.
- Recent live or BCG vaccination.
- Severe active central nervous system lupus requiring recent intervention.
- History of major organ or stem cell transplant.
- Unstable or uncontrolled serious diseases not related to lupus.
- Planned surgery or medical conditions making participation unsuitable.
- Drug or alcohol abuse within the past year.
- Pregnant or nursing females, or intending parenthood during the study.
- History of recent malignant tumors except treated skin or cervical carcinoma in situ.
- Acute or chronic infections needing treatment.
- HIV positive.
- Certain hepatitis B or C infection statuses.
- Recent COVID-19 infection or severe COVID-19 hospitalization.
- Poor kidney function (eGFR less than 30 mL/min/1.73 m2).
- Kidney biopsy showing more than 50% glomerulosclerosis.
- Significant laboratory abnormalities.
- Any condition deemed unsuitable by the investigator.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 48 weeks
Participants receive weekly injections of Telitacicept 240 mg, Telitacicept 160 mg, or placebo, in addition to standard therapy, for lupus nephritis.
Weekly visits for up to 48 weeks
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
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Research Team
B
Binghua Xiao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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