Lupus Nephritis (LN)Phase 2NCT07363460
Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN
A Phase 2 study testing HSK39297 200mgQD and HSK39297 300mgQD in people with Lupus Nephritis (LN), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis (LN)
- What is being tested?
- HSK39297 200mgQD and HSK39297 300mgQD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2025to 6 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and comply with the research requirements, voluntarily participate in the research and sign the informed consent form before starting the relevant procedures;
- Age ≥ 18 and < 75 years old at screening, gender not limited;
- Positive anti-ANA antibody and/or anti-dsDNA antibody (research center);
- Pathological type of active III or IV lupus nephritis confirmed by renal biopsy within 12 months before screening, with or without type V (adopting the 2003 International Society of Nephrology/Renal Pathology Working Group's lupus nephritis pathological classification criteria, see Appendix 2; for recurrent subjects, the investigator assesses whether a repeat renal biopsy is necessary; renal biopsy is conducted after confirming that the subject meets all other inclusion criterias and does not meet the exclusion criterias);
- Evidence of active lupus nephritis exists, and the investigator assesses that it is necessary to receive glucocorticoid combined with MMF treatment. Active lupus nephritis must meet the following two criterias:
- Proteinuria:
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- At screening: 24h-UPCR ≥ 1g/g or FMV-UPCR ≥ 1g/g or FMV-UACR ≥ 0.5g/g; b) Before randomization: 24h-UPCR ≥ 1g/g (central laboratory); b) At screening: SLEDAI-2000 ≥ 8;
- First onset or recurrence of lupus nephritis (for subjects who have received MMF treatment previously and have experienced recurrence, the investigator and the sponsor jointly assess the benefit based on the study's medication regimen to determine whether they can be enrolled);
- Female subjects with reproductive capacity [excluding those who have undergone surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 6 weeks prior to screening or who are postmenopausal (defined as having no menstruation for 12 months, with no other medical cause)]; a negative pregnancy test must be confirmed during the screening period. The subject must agree not to attempt pregnancy and not to donate oocytes from the date of signing the informed consent form until at least 30 days after the last administration of investigational product, and must use effective contraception; male subjects must agree not to donate sperm for at least 90 days from the date of signing the informed consent form until at least 90 days after the last administration of investigational product, and must use highly effective contraception with their female partners (see Appendix 3).
Who cannot join
- The subject has previously failed to respond to treatment with MMF or other mofetil mycophenolate drugs, as assessed by the investigator.
- Allergy to the investigational product or MMF, or contraindications to MMF and glucocorticoids.
- Currently receiving or requiring administration of any drug listed in Section 5.7.2.2 "Prohibited Concomitant Medications" during the study period.
- Receiving systemic glucocorticoid therapy for reasons other than systemic lupus erythematosus or lupus nephritis at screening (dose > 10 mg/day prednisone or equivalent; dosage conversion details see Appendix 4).
- Received treatment with other investigational drugs within 30 days prior to screening or within 5 half-lives (whichever is longer).
- Presence of rapidly progressive glomerulonephritis at screening (eGFR decline exceeding 50% within 3 months, or less than 50% but with rapid decline risk assessed by the investigator); renal biopsy showing crescents occupying more than 50% of glomeruli, or glomerulosclerosis exceeding 60%, or tubular atrophy/interstitial fibrosis exceeding 60%.
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- Presence of severe extra-renal manifestations of systemic lupus erythematosus at screening, including but not limited to severe pulmonary hypertension (WHO classification IV or higher), severe pulmonary interstitial fibrosis, severe myocarditis, severe heart failure (NYHA classification IV), or active central nervous system lupus.
- Major, unstable, or uncontrolled acute or chronic diseases affecting various systems (e.g., cardiovascular, respiratory, hematological, gastrointestinal, hepatic, renal, neurological systems) within 6 months prior to screening or at screening that may affect study results or place the subject at high risk, excluding those caused by SLE.
- History of other autoimmune diseases.
- History of any of the following infections:
- 1) History of encapsulated bacterial infection (e.g., Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae) within 1 year prior to screening; 2) Active tuberculosis at screening; history of active tuberculosis within 2 years prior to screening; history of active tuberculosis currently cured but assessed by the investigator to be at risk for reactivation; positive interferon-gamma release assay with determination by the investigator or consulting specialist physician that it represents latent tuberculosis requiring prophylactic anti-tuberculosis treatment; 3) History of other active infections requiring antimicrobial treatment within 3 months prior to screening.
- 11. History of major organ (heart, lung, kidney, liver) transplantation or hematopoietic stem cell/bone marrow transplantation, or planned for transplantation.
- 12. Currently undergoing regular hemodialysis or planning to undergo hemodialysis during the study period.
- 13. History of gastrointestinal surgery that may significantly affect drug absorption, distribution, metabolism, and excretion, or history of severe gastrointestinal disease, or difficulty in swallowing, frequent vomiting leading to difficulty in eating or taking medication.
- 14. Diagnosis of malignancy within 5 years prior to screening, excluding basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
- 15. Major surgical procedures within 6 months prior to screening. 16. Laboratory tests at screening meet any of the following criteria:
- Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m² (calculated by CKD-EPI 2021 formula, see Appendix 5);
- Hematology: neutrophils < 1 × 10⁹/L; leukocytes < 2 × 10⁹/L; hemoglobin < 80 g/L; platelets < 50 × 10⁹/L;
- Liver function: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3 × ULN; Total Bilirubin (TBIL) ≥ 2 × ULN;
- Hepatitis B virus surface antigen (HBsAg) positive, or HBsAg negative but Hepatitis B virus core antibody (HBc-Ab) positive with HBV-DNA detection result higher than the quantitative lower limit; Hepatitis C virus antibody (HCV-Ab) positive;
- Human Immunodeficiency Virus antibody (HIV-Ab) positive. 17. Pregnant or lactating female subjects at screening. 18. Other situations deemed unsuitable for participation by the investigator.
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
Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine
Nanjing, Jiangsu, 210000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Lupus Nephritis
A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis
- Conditions
- Lupus Nephritis (LN)
- Being tested
- HSK39297 200mgQD, HSK39297 300mgQD, Placebo
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK39297 200mgQDDrug
once daily, oral administration of HSK39297 tablets 200mg from Day 1 to Week 52.
HSK39297 300mgQDDrug
once daily, oral administration of HSK39297 tablets 300mg from Day 1 to Week 52.
PlaceboDrug
once daily, oral administration of placebo from Day 1 to Week 52.
| Study group | Role | What they receive |
|---|---|---|
| 200mg QD | Active comparator | Patients take double-blind HSK39297 tablets 200mg for 52 weeks Receives: Drug: HSK39297 200mgQD |
| 300mg QD | Active comparator | Patients take double-blind HSK39297 tablets 300mg for 52 weeks Receives: Drug: HSK39297 300mgQD |
| Placebo | Placebo comparator | Patients take double-blind placebo for 52 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of 24h-UPCR compared to Baseline
Urine Protein Creatinine Ratio
Measured: 24 weeks
Secondary outcomes (24)
Proportion achieving CRR/PRR
Complete Renal Response,Partial Renal Response
Measured: 12,24,52 weeks
Proportion achieving CRR/PRR without renal recurrence
Complete Renal Response,Partial Renal Response
Measured: 24,52 weeks
Proportion achieving CRR/PRR with glucocorticoid ≤ 5mg/d
Complete Renal Response,Partial Renal Response
Measured: 24,52weeks
Proportion achieving 25%/50% reduction in 24h-UPCR
Urine Protein Creatinine Ratio
Measured: 12,24,52 weeks
Time to first achievement of CRR, 25%/50% proteinuria reduction
Complete Renal Response
Measured: from baseline to 52 weeks
Duration of sustained CRR/PRR
Complete Renal Response,Partial Renal Response
Measured: from baseline to 52 weeks
Change in 24h-UPCR from baseline.
Urine Protein Creatinine Ratio
Measured: from baseline to 52 weeks
Change in eGFR from baseline
Estimated glomerular filtration rate
Measured: 12,24,52 weeks
Proportion with Glucocorticoid dose ≤ 5mg/d
Measured: 24,52 weeks
Annualized slope of eGFR
Estimated glomerular filtration rate
Measured: 52 weeks
Change in SLEDAI-2000 (Systemic lupus erythematosus disease activity index 2000，SLEDAI-2000)total score from baseline
SLEDAI-2000 scale ranges form 0 to 105 score. The higher scores indicate a higher disease activity level of the subject's systemic lupus erythematosus .
Measured: 12, 24, 52 weeks
Incidence and severity of adverse events (AEs)
Measured: 52 weeks
Pharmacokinetic characteristics(Cmax) of HSK39297 tablets in plasma.
Measured: 52 weeks
Pharmacokinetic characteristics(Cmin) of HSK39297 tablets in plasma.
Measured: 52 weeks
Pharmacokinetic characteristics(Cavg) of HSK39297 tablets in plasma.
Measured: 52 weeks
Pharmacokinetic characteristics(Tmax) of HSK39297 tablets in plasma.
Measured: 52 weeks
Pharmacokinetic characteristics(AUC0-τ) of HSK39297 tablets in plasma.
Measured: 52 weeks
Changes from baseline of pharmacodynamic indicators(Ap)
Measured: 52 weeks
Changes from baseline of pharmacodynamic indicators(Bb)
Measured: 52 weeks
Changes from baseline of pharmacodynamic indicators(sC5b-9)
Measured: 52 weeks
Changes from baseline in biological markers （C3）reflecting immunological activity of lupus nephritis
Measured: 52 weeks
Changes from baseline in biological markers （C4）reflecting immunological activity of lupus nephritis
Measured: 52 weeks
Changes from baseline in biological markers （anti-dsDNA antibody）reflecting immunological activity of lupus nephritis
Measured: 52 weeks
Change in FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue)score from baseline
FACIT-F scale ranges from 0 to 52 score,and the higher scores indicate a better condition of the subject and less fatigue.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start18 Nov 2025
- Primary completion5 Nov 2027 (estimated)
- Study completion6 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- bicheng Liu, Principal investigator, Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363460
- Sponsor's protocol ID
- HSK39297-205
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT07363460
- Acronym / sponsor ID
- HSK39297-205
- Conditions
- Lupus Nephritis (LN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 5 Nov 2027 (estimated)
- Study completion
- 6 Jul 2028 (estimated)
- First posted
- 23 Jan 2026 (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.
A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200mg QD | Active comparator | Drug: HSK39297 200mgQDPatients take double-blind HSK39297 tablets 200mg for 52 weeks |
| 300mg QD | Active comparator | Drug: HSK39297 300mgQDPatients take double-blind HSK39297 tablets 300mg for 52 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPatients take double-blind placebo for 52 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Understand and comply with the research requirements, voluntarily participate in the research and sign the informed consent form before starting the relevant procedures;
- Age ≥ 18 and < 75 years old at screening, gender not limited;
- Positive anti-ANA antibody and/or anti-dsDNA antibody (research center);
- Pathological type of active III or IV lupus nephritis confirmed by renal biopsy within 12 months before screening, with or without type V (adopting the 2003 International Society of Nephrology/Renal Pathology Working Group's lupus nephritis pathological classification criteria, see Appendix 2; for recurrent subjects, the investigator assesses whether a repeat renal biopsy is necessary; renal biopsy is conducted after confirming that the subject meets all other inclusion criterias and does not meet the exclusion criterias);
- Evidence of active lupus nephritis exists, and the investigator assesses that it is necessary to receive glucocorticoid combined with MMF treatment. Active lupus nephritis must meet the following two criterias:
Key exclusion criteria (21 listed)
- The subject has previously failed to respond to treatment with MMF or other mofetil mycophenolate drugs, as assessed by the investigator.
- Allergy to the investigational product or MMF, or contraindications to MMF and glucocorticoids.
- Currently receiving or requiring administration of any drug listed in Section 5.7.2.2 "Prohibited Concomitant Medications" during the study period.
- Receiving systemic glucocorticoid therapy for reasons other than systemic lupus erythematosus or lupus nephritis at screening (dose > 10 mg/day prednisone or equivalent; dosage conversion details see Appendix 4).
- Received treatment with other investigational drugs within 30 days prior to screening or within 5 half-lives (whichever is longer).
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 |
|---|---|---|
| HSK39297 200mgQDonce daily, oral administration of HSK39297 tablets 200mg from Day 1 to Week 52. | Drug | 200mg QD |
| HSK39297 300mgQDonce daily, oral administration of HSK39297 tablets 300mg from Day 1 to Week 52. | Drug | 300mg QD |
| Placeboonce daily, oral administration of placebo from Day 1 to Week 52. | Drug | Placebo |
Primary outcome
Ratio of 24h-UPCR compared to Baseline
Time frame: 24 weeks
Urine Protein Creatinine Ratio
24 secondary outcomes
Proportion achieving CRR/PRR
Time frame: 12,24,52 weeks
Proportion achieving CRR/PRR without renal recurrence
Time frame: 24,52 weeks
Proportion achieving CRR/PRR with glucocorticoid ≤ 5mg/d
Time frame: 24,52weeks
Proportion achieving 25%/50% reduction in 24h-UPCR
Time frame: 12,24,52 weeks
Time to first achievement of CRR, 25%/50% proteinuria reduction
Time frame: from baseline to 52 weeks
Duration of sustained CRR/PRR
Time frame: from baseline to 52 weeks
Change in 24h-UPCR from baseline.
Time frame: from baseline to 52 weeks
Change in eGFR from baseline
Time frame: 12,24,52 weeks
Proportion with Glucocorticoid dose ≤ 5mg/d
Time frame: 24,52 weeks
Annualized slope of eGFR
Time frame: 52 weeks
Change in SLEDAI-2000 (Systemic lupus erythematosus disease activity index 2000，SLEDAI-2000)total score from baseline
Time frame: 12, 24, 52 weeks
Incidence and severity of adverse events (AEs)
Time frame: 52 weeks
Pharmacokinetic characteristics(Cmax) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(Cmin) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(Cavg) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(Tmax) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(AUC0-τ) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Changes from baseline of pharmacodynamic indicators(Ap)
Time frame: 52 weeks
Changes from baseline of pharmacodynamic indicators(Bb)
Time frame: 52 weeks
Changes from baseline of pharmacodynamic indicators(sC5b-9)
Time frame: 52 weeks
Changes from baseline in biological markers （C3）reflecting immunological activity of lupus nephritis
Time frame: 52 weeks
Changes from baseline in biological markers （C4）reflecting immunological activity of lupus nephritis
Time frame: 52 weeks
Changes from baseline in biological markers （anti-dsDNA antibody）reflecting immunological activity of lupus nephritis
Time frame: 52 weeks
Change in FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue)score from baseline
Time frame: 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 23 Jan 2026.
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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.
bicheng Liu principal investigator
Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine
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 HSK39297 200mgQD and HSK39297 300mgQD in people with Lupus Nephritis (LN), run by Haisco Pharmaceutical Group 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 9 inclusion and 21 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 23 Jan 2026. 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 fangqiong Li (+86028-67258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of 24h-UPCR compared to Baseline (time frame: 24 weeks). 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 23 Jan 2026.