NCT07229742 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Condition | Active Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2025-11-22 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 51 participants in total. It began in 2025-11-22 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07229742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Active Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07229742 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07229742 currently recruiting?
Yes, NCT07229742 is actively recruiting participants. Contact the research team at su.zhang.sz3@hengrui.com for enrollment information.
Where is the NCT07229742 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07229742 clinical trial?
NCT07229742 is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. The trial plans to enroll 51 participants.
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