Actively Recruiting
Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-01-23
105
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and agree to participate by signing informed consent
- Aged 18 to less than 75 years at screening, any gender
- Positive anti-ANA antibody and/or anti-dsDNA antibody
- Active lupus nephritis of pathological type III or IV confirmed by renal biopsy within 12 months before screening
- Evidence of active lupus nephritis with proteinuria meeting defined thresholds and SLEDAI-2000 score ≥ 8
- First onset or recurrence of lupus nephritis; prior MMF treatment and recurrence assessed for eligibility
- Female participants with reproductive capacity must have a negative pregnancy test and agree to use effective contraception; male participants must agree to contraception use
You will not qualify if you...
- Previous failure to respond to MMF or related drugs
- Allergy or contraindication to investigational product, MMF, or glucocorticoids
- Use of prohibited concomitant medications during study
- Receiving systemic glucocorticoids > 10 mg/day prednisone or equivalent for other reasons
- Use of other investigational drugs within 30 days or 5 half-lives before screening
- Rapidly progressive glomerulonephritis or severe kidney pathology
- Severe extra-renal lupus manifestations or active central nervous system lupus
- Major unstable or uncontrolled diseases affecting key organ systems within 6 months
- History of other autoimmune diseases
- Recent serious infections including encapsulated bacterial infections, active or latent tuberculosis, or other infections requiring treatment
- History or planned major organ or bone marrow transplantation
- Current or planned regular hemodialysis
- History of gastrointestinal surgery or severe gastrointestinal disease affecting drug absorption
- Diagnosis of malignancy within 5 years prior to screening (excluding certain skin and cervical cancers)
- Major surgery within 6 months prior to screening
- Laboratory abnormalities including low eGFR, low blood counts, elevated liver enzymes, or positive tests for hepatitis B, C, or HIV
- Pregnant or lactating females
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
F
fangqiong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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