Active Lupus Nephritis
Conditions
Brief summary
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
SHR-2173 injection.
DRUGSHR-2173 Injection Blank Preparation
SHR-2173 injection blank preparation.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline. | At Week 24. |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving partial renal response (PRR). | At Week 24 and Week 52. |
| The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline. | At Week 24 and Week 52. |
| The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline. | At Week 24 and Week 52. |
| The proportion of subjects whose 24-hour UPCR was less than 0.5 g/g. | At Week 24 and Week 52. |
| The proportion of subjects achieving complete renal response (CRR). | At Week 24 and Week 52. |
| The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg/day. | At Week 24 and Week 52. |
| The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg/day. | At Week 24 and Week 52. |
| The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline. | At Week 24 and Week 52. |
| Adverse events (AEs). | Up to 52 weeks. |
| The proportion of subjects whose 24-hour UPCR was less than 0.7 g/g. | At Week 24 and Week 52. |
Countries
China
Contacts
Primary ContactSu Zhang
Outcome results
None listed