A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis
Recruiting · NCT07229742 · Interventional (participants receive a specific treatment) · Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
View the official record on ClinicalTrials.gov →Interventions studied
SHR-2173 InjectionSHR-2173 Injection Blank Preparation
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 18-70 years (inclusive) at informed consent signing, regardless of sex;
- Body weight ≥ 40.0 kg and body mass index (BMI) ≥ 16 kg/m² to ≤ 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 ± class V by renal biopsy, per 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) standards within 1 year preceding or during screening.
Exclusion criteria
- 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 ≥12 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.
Where it is running
1 location listed.
- The General Hospital of the Eastern Theater Command of the People's Liberation Army of China - Nanjing, Jiangsu, China