Actively Recruiting
A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-12-01
51
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with lupus nephritis (LN). It adopts a randomized, double-blind, placebo-controlled, multicenter trial design.
CONDITIONS
Official Title
A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years (inclusive) at informed consent signing, regardless of sex
- Body weight 240.0 kg and body mass index (BMI) 16 kg/m2 to 28 28 kg/m2 at screening
- Diagnosed with systemic lupus erythematosus (SLE) per 1997 ACR criteria or 2019 EULAR/ACR classification criteria
- Positive antinuclear antibody (titer 1:80) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening
- Histologically confirmed active lupus nephritis (LN) class III or IV 2 class V by renal biopsy, per 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) standards within 1 year preceding or during screening
You will not qualify if you...
- Received renal dialysis within 12 months preceding screening, or anticipated requirement for dialysis/renal transplantation within 6 months post-enrollment
- Renal biopsy demonstrating > 50% globally sclerosed glomeruli
- Active severe/unstable neuropsychiatric SLE (NPSLE)
- Catastrophic antiphospholipid syndrome (APS) within 12 months pre-screening, or APS-related thrombotic events (except non-catastrophic/mild APS cases with stable anticoagulation 212 weeks prior to screening)
- Non-LN renal diseases potentially confounding disease assessment (e.g., diabetic nephropathy per investigator judgment)
- Inflammatory/autoimmune diseases beyond SLE/LN that may interfere with efficacy/safety interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
Nanjing, Jiangsu, China, 210002
Actively Recruiting
Research Team
S
Su Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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