Active Lupus NephritisPhase 2NCT07229742
A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis
A Phase 2 study testing SHR-2173 Injection and SHR-2173 Injection Blank Preparation in people with Active Lupus Nephritis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Lupus Nephritis
- What is being tested?
- SHR-2173 Injection and SHR-2173 Injection Blank Preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2025to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
Nanjing, Jiangsu, 210002
Zhihong Liu, +86-025-80862022, zhliunj@vip.163.com
Zhihong Liu
About this study
Official title: 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.
- Conditions
- Active Lupus Nephritis
- Being tested
- SHR-2173 Injection, SHR-2173 Injection Blank Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2173 InjectionDrug
SHR-2173 injection.
SHR-2173 Injection Blank PreparationDrug
SHR-2173 injection blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| SHR-2173 Injection Group | Experimental | Not described Receives: Drug: SHR-2173 Injection |
| SHR-2173 Injection Placebo Group | Placebo comparator | Not described Receives: Drug: SHR-2173 Injection Blank Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.
Measured: At Week 24.
Secondary outcomes (10)
The proportion of subjects achieving complete renal response (CRR).
Measured: At Week 24 and Week 52.
The proportion of subjects achieving partial renal response (PRR).
Measured: At Week 24 and Week 52.
The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline.
Measured: At Week 24 and Week 52.
The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline.
Measured: At Week 24 and Week 52.
The proportion of subjects whose 24-hour UPCR was less than 0.5 g/g.
Measured: At Week 24 and Week 52.
The proportion of subjects whose 24-hour UPCR was less than 0.7 g/g.
Measured: At Week 24 and Week 52.
The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg/day.
Measured: At Week 24 and Week 52.
The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg/day.
Measured: At Week 24 and Week 52.
The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline.
Measured: At Week 24 and Week 52.
Adverse events (AEs).
Measured: Up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start22 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229742
- Sponsor's protocol ID
- SHR-2173-204
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07229742
- Acronym / sponsor ID
- SHR-2173-204
- Conditions
- Active Lupus Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-2173 Injection Group | Experimental | Drug: SHR-2173 Injection |
| SHR-2173 Injection Placebo Group | Placebo comparator | Drug: SHR-2173 Injection Blank Preparation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2173 InjectionSHR-2173 injection. | Drug | SHR-2173 Injection Group |
| SHR-2173 Injection Blank PreparationSHR-2173 injection blank preparation. | Drug | SHR-2173 Injection Placebo Group |
Primary outcome
The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.
Time frame: At Week 24.
10 secondary outcomes
The proportion of subjects achieving complete renal response (CRR).
Time frame: At Week 24 and Week 52.
The proportion of subjects achieving partial renal response (PRR).
Time frame: At Week 24 and Week 52.
The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline.
Time frame: At Week 24 and Week 52.
The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline.
Time frame: At Week 24 and Week 52.
The proportion of subjects whose 24-hour UPCR was less than 0.5 g/g.
Time frame: At Week 24 and Week 52.
The proportion of subjects whose 24-hour UPCR was less than 0.7 g/g.
Time frame: At Week 24 and Week 52.
The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg/day.
Time frame: At Week 24 and Week 52.
The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg/day.
Time frame: At Week 24 and Week 52.
The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline.
Time frame: At Week 24 and Week 52.
Adverse events (AEs).
Time frame: Up to 52 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-2173 Injection and SHR-2173 Injection Blank Preparation in people with Active Lupus Nephritis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Su Zhang (+86-0518-82342973, su.zhang.sz3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline. (time frame: At Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.