SHR-2173 injection for adults with active lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: su.zhang.sz3@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.