A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis

Official title

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

Overview

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.

Interventions

• Drug SHR-2173 Injection
  SHR-2173 injection.
• Drug SHR-2173 Injection Blank Preparation
  SHR-2173 injection blank preparation.

Primary outcome measures

• The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline. [Time frame: At Week 24.]

Secondary outcome measures (10)

• The proportion of subjects achieving complete renal response (CRR). [Time frame: At Week 24 and Week 52.]
• The proportion of subjects achieving partial renal response (PRR). [Time frame: At Week 24 and Week 52.]
• The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline. [Time frame: At Week 24 and Week 52.]
• The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline. [Time frame: At Week 24 and Week 52.]
• The proportion of subjects whose 24-hour UPCR was less than 0.5 g/g. [Time frame: At Week 24 and Week 52.]
• The proportion of subjects whose 24-hour UPCR was less than 0.7 g/g. [Time frame: At Week 24 and Week 52.]
• The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg/day. [Time frame: At Week 24 and Week 52.]
• The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg/day. [Time frame: At Week 24 and Week 52.]
• The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline. [Time frame: At Week 24 and Week 52.]
• Adverse events (AEs). [Time frame: Up to 52 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The General Hospital of the Eastern Theater Command of the People's Liberation Army of Chi — Nanjing

Identifiers

NCT: NCT07229742 · SHR-2173-204

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗