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

NCT07229742 | Recruiting Phase 2

• 1 other identifier: SHR-2173-204
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.

  At Week 24.

Secondary Outcomes (10)

• 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.

Study Arms (2)

SHR-2173 Injection Group

EXPERIMENTAL

Drug: SHR-2173 Injection

SHR-2173 Injection Placebo Group

PLACEBO COMPARATOR

Drug: SHR-2173 Injection Blank Preparation

Interventions

SHR-2173 Injection DRUG

SHR-2173 injection.

SHR-2173 Injection Group

SHR-2173 Injection Blank Preparation DRUG

SHR-2173 injection blank preparation.

SHR-2173 Injection Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The General Hospital of the Eastern Theater Command of the People's Liberation Army of China

Nanjing, Jiangsu, 210002, China

RECRUITING

Central Study Contacts

Su Zhang

CONTACT

+86-0518-82342973; su.zhang.sz3@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (1)