SHR-2173 injection for adults with active lupus nephritis

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

This Phase II trial will test whether SHR-2173 injections help adults with active lupus nephritis improve kidney inflammation and function compared with placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07229742 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase II trial enrolls adults with biopsy-confirmed class III or IV ± V lupus nephritis to compare SHR-2173 injections against a blinded placebo preparation. Participants are randomized to receive SHR-2173 or blank preparation across participating centers and are followed for measures of kidney response and safety. Primary outcomes focus on renal response/remission rates and adverse events, with secondary measures such as proteinuria and serologic markers. The goal is to determine whether SHR-2173 produces clinically meaningful kidney benefits that would support larger trials.

Who should consider this trial

Good fit: Adults aged 18–70 with biopsy-confirmed active class III or IV ± V lupus nephritis within the past year, positive lupus serology (e.g., ANA or anti-dsDNA), and meeting the study weight/BMI criteria are the intended participants.

Not a fit: Patients who recently required dialysis or are expected to need dialysis/transplant soon, those with >50% globally sclerosed glomeruli on biopsy, active severe neuropsychiatric SLE, or catastrophic antiphospholipid syndrome are excluded and unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If effective, SHR-2173 could reduce kidney inflammation and proteinuria, helping preserve kidney function and potentially lowering the need for more toxic therapies.

How similar studies have performed: Other targeted therapies for lupus nephritis (such as belimumab and voclosporin) have shown benefit in randomized trials, but SHR-2173 is a newer agent with limited published clinical data so far.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years (inclusive) at informed consent signing, regardless of sex;
2. Body weight ≥ 40.0 kg and body mass index (BMI) ≥ 16 kg/m² to ≤ 28 kg/m² at screening;
3. Diagnosed with systemic lupus erythematosus (SLE) per 1997 ACR criteria or 2019 EULAR/ACR classification criteria;
4. Positive antinuclear antibody (titer ≥ 1:80) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening;
5. 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:

1. Received renal dialysis within 12 months preceding screening, or anticipated requirement for dialysis/renal transplantation within 6 months post-enrollment;
2. Renal biopsy demonstrating \> 50% globally sclerosed glomeruli;
3. Active severe/unstable neuropsychiatric SLE (NPSLE);
4. 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);
5. Non-LN renal diseases potentially confounding disease assessment (e.g., diabetic nephropathy per investigator judgment);
6. Inflammatory/autoimmune diseases beyond SLE/LN that may interfere with efficacy/safety interpretation.

Where this trial is running

Nanjing, Jiangsu

• The General Hospital of the Eastern Theater Command of the People's Liberation Army of China — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Su Zhang

Conditions Active Lupus Nephritis