Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: IgAN

In brief

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.

Key facts

Study ID

NCT07606352

Run by

Sitala Bio LTD

People needed

15

Starts

2026-08-04

Expected to finish

2027-09-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Woolloongabba, Queensland, Australia (enrolling)
• Research Site — Saint Albans, Victoria, Australia (enrolling)
• Research Site — Clayton, Victoria, Australia

Full record on ClinicalTrials.gov

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