A Multicenter, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 12
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of STL303 capsules in IgAN patients. About 15 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of STL303 or placebo capsules orally according to protocol.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study in approximately 15 patients with primary IgA nephropathy (IgAN).
Participants receiving background therapy will be randomized in a 1:1:1 ratio to receive STL303 capsules dose 1, dose 2, or placebo, administered orally once daily.
The study aims to evaluate the efficacy and safety of STL303 in patients with primary IgAN and to identify the optimal clinical dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy:
- •eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) greater than or equal to 30 mL/min/1.73 m2 at screening and after completion of run-in.
- •UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in.
- •Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose.
- •Have received stable treatment with RASis (ACEi or ARB) at the maximum recommended dose or MTD for at least 90 days prior to the first dose.
- •If the patient has been treated with SGLT2i, diuretics, other antihypertensive treatments, ERA, and/or hydroxychloroquine for IgAN prior to the first dose, the drug should also be used stably for at least 90 days.
排除标准
- •Secondary IgAN or unclear exclusion of secondary causes.
- •Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk).
- •Other systemic diseases causing proteinuria/CKD or severe urinary obstruction.
- •Known or suspected immunodeficiency or hereditary complement deficiency.
- •Any organ transplant recipients except corneal.
- •Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90).
- •Use of immunosuppressive drugs within 90 days or 5 half-lives.
- •Prior oral budesonide (Nefecon/Tarpeyo/Kinpeygo) within 6 months.
- •Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period.
- •Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease).
- •Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin).
- •QTcF greater than 500 ms.
- •History of malignancy within 5 years (exceptions apply).
- •History of meningococcal, pneumococcal, or Hib infection.
- •Chronic/recurrent infections in past year (e.g., liver abscess, pyelonephritis).
- •Active systemic infections within 2 weeks or fever greater than 38°C within 7 days.
研究组 & 干预措施
Placebo
Participants will receive placebo
干预措施: Placebo capsule (Drug)
STL303 dose level 1
Participants will receive STL303 dose level 1
干预措施: STL303 (Drug)
STL303 Dose Level 2
Participants will receive STL303 dose level 2
干预措施: STL303 (Drug)