Tests SHR-2173 injection in people with active lupus nephritis
Tests an injection called SHR-2173 in adults with active kidney inflammation from lupus.
Plain-language title generated from the registry record
Registry title: A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07229742, who can take part
Where in China
- The General Hospital of the Eastern Theater Command of the People's Liberation Army of ChinaNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Trial code
- NCT07229742
- Record updated
- 1 December 2025
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Active Lupus Nephritis
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.
Inclusion: 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: Received renal dialysis within 12 months preceding screening, or anticipated requirement for dialysis/renal transplantation within 6 months post-enrollment; 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; Renal biopsy demonstrating > 50% globally sclerosed glomeruli; Active severe/unstable neuropsychiatric SLE (NPSLE).