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

Sitala Bio LTD

Status and phase: Not yet enrolling; Phase 2

Conditions: IgAN

Treatments: Drug: STL303; Drug: Placebo capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT07606352

STL303-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups, including a placebo group

STL303 dose level 1

Experimental group

Description:

Participants will receive STL303 dose level 1

Treatment:

Drug: STL303

Drug: STL303

STL303 Dose Level 2

Experimental group

Description:

Participants will receive STL303 dose level 2

Treatment:

Drug: STL303

Drug: STL303

Placebo

Placebo Comparator group

Description:

Participants will receive placebo

Treatment:

Drug: Placebo capsule