Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN

NCT07363460 | Recruiting Phase 2

• 1 other identifier: HSK39297-205
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lupus Nephritis (LN)

Outcome Measures

Primary Outcomes (1)

• Ratio of 24h-UPCR compared to Baseline

  Urine Protein Creatinine Ratio

  24 weeks

Secondary Outcomes (24)

• Proportion achieving CRR/PRR

  12,24,52 weeks

• Proportion achieving CRR/PRR without renal recurrence

  24,52 weeks

• Proportion achieving CRR/PRR with glucocorticoid ≤ 5mg/d

  24,52weeks

• Proportion achieving 25%/50% reduction in 24h-UPCR

  12,24,52 weeks

• Time to first achievement of CRR, 25%/50% proteinuria reduction

  from baseline to 52 weeks

Study Arms (3)

200mg QD

ACTIVE COMPARATOR

Patients take double-blind HSK39297 tablets 200mg for 52 weeks

Drug: HSK39297 200mgQD

300mg QD

ACTIVE COMPARATOR

Patients take double-blind HSK39297 tablets 300mg for 52 weeks

Drug: HSK39297 300mgQD

Placebo

PLACEBO COMPARATOR

Patients take double-blind placebo for 52 weeks

Drug: Placebo

Interventions

HSK39297 200mgQD DRUG

once daily, oral administration of HSK39297 tablets 200mg from Day 1 to Week 52.

200mg QD

HSK39297 300mgQD DRUG

once daily, oral administration of HSK39297 tablets 300mg from Day 1 to Week 52.

300mg QD

Placebo DRUG

once daily, oral administration of placebo from Day 1 to Week 52.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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:
• a) Proteinuria:
• a) 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).
• 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%.
• 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:

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• bicheng Liu

  Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

fangqiong Li

CONTACT

+86028-67258840; lifangq@haisco.com

Study Design

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

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 23, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): November 5, 2027
• Study Completion (Estimated): July 6, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (1)