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

Phase 2Not Yet RecruitingNCT07606352

Sitala Bio LTD15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

IgAN

Interventions

STL303DRUG

STL303 arm participants will receive a specific dose of STL303

STL303DRUG

STL303 arm participants will receive a specific dose of STL303

Placebo capsuleDRUG

Placebo arm participants will receive placebo capsules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy: 2. 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. 3. UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in. 4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose. 5. 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. 6. 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. Exclusion Criteria: 1. Secondary IgAN or unclear exclusion of secondary causes. 2. Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk). 3. Other systemic diseases causing proteinuria/CKD or severe urinary obstruction. 4. Known or suspected immunodeficiency or hereditary complement deficiency. 5. Any organ transplant recipients except corneal. 6. Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90). 7. Use of immunosuppressive drugs within 90 days or 5 half-lives. 8. Prior oral budesonide (Nefecon/Tarpeyo/Kinpeygo) within 6 months. 9. Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period. 10. Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease). 11. Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin). 12. QTcF greater than 500 ms. 13. History of malignancy within 5 years (exceptions apply). 14. History of meningococcal, pneumococcal, or Hib infection. 15. Chronic/recurrent infections in past year (e.g., liver abscess, pyelonephritis). 16. Active systemic infections within 2 weeks or fever greater than 38°C within 7 days.

Locations (3)

Research Site

Woolloongabba, Queensland, Australia

Research Site

Clayton, Victoria, Australia

Research Site

Saint Albans, Victoria, Australia

Outcomes

Primary Outcomes

Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs)

All participants will be observed for any AE during the clinical study, including abnormalities in clinical symptoms and vital signs, physical examination, laboratory tests, and 12-lead ECG. Incidence, severity, and relationship of TEAEs and serious adverse events (SAEs) to STL303. Possible adverse events include: palpitations, nausea, vomiting, dizziness, sore throat, upper respiratory infection, loss of appetite, high temperature, chest discomfort, weakness, rash, headache, lethargy (feeling tired and low on energy) and urinary tract infection.

Time frame: Adverse events will be closely monitored, and participants will report to the clinic on Days 7, 14, 30, 45, 60, 90, 135 and at end of treatment on Day 180. On Day 210 an End of study safety follow up will also be conducted.

Secondary Outcomes

Change from baseline urine protein-to-creatinine ratio (UPCR)

Change in baseline 24-hour urine collection

Time frame: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180

Change in UPCR

Change in baseline 24-hour urine collection

Time frame: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60 and 90

Change in urine albumin-to-creatinine ratio (UACR)

Change in baseline 24-hour urine collection

Time frame: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180

Change in blood creatinine level

Peripheral blood sampling

Time frame: Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180

Change in eGFR slope

Central Contacts

Clinical Operations Manager

CONTACT

+61 421 585707 studies@sitala.com

Data from ClinicalTrials.gov

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