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

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.

Study Overview

• Status: Recruiting
• Conditions: Active Lupus Nephritis
• Intervention / Treatment: Drug: SHR-2173 Injection; Drug: SHR-2173 Injection Blank Preparation

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Su Zhang; Phone Number: +86-0518-82342973; Email: su.zhang.sz3@hengrui.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
      • Principal Investigator: Zhihong Liu
      • Contact: Zhihong Liu; Phone Number: +86-025-80862022; Email: zhliunj@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-2173 Injection Group	Drug: SHR-2173 Injection; SHR-2173 injection.
Placebo Comparator: SHR-2173 Injection Placebo Group	Drug: SHR-2173 Injection Blank Preparation; SHR-2173 injection blank preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.	At Week 24.

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects achieving complete renal response (CRR).	At Week 24 and Week 52.
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 whose 24-hour UPCR was less than 0.7 g/g.	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.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SHR-2173-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No