A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis
NCT ID: NCT07229742
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
51 participants
INTERVENTIONAL
2025-11-22
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR-2173 Injection Group
SHR-2173 Injection
SHR-2173 injection.
SHR-2173 Injection Placebo Group
SHR-2173 Injection Blank Preparation
SHR-2173 injection blank preparation.
Interventions
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SHR-2173 Injection
SHR-2173 injection.
SHR-2173 Injection Blank Preparation
SHR-2173 injection blank preparation.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Guangdong Hengrui Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-2173-204
Identifier Type: -
Identifier Source: org_study_id
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