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

24 de maio de 2026 atualizado por: Sitala Bio LTD

A Multicenter, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

15

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Clinical Operations Manager
  • Número de telefone: +61 421 585707
  • E-mail: studies@sitala.com

Locais de estudo

  • Austrália
    • Queensland
      • Woolloongabba, Queensland, Austrália, 4102
        • Research Site
    • Victoria
      • Clayton, Victoria, Austrália, 3168
        • Research Site
      • Saint Albans, Victoria, Austrália, 3021
        • Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Os participantes receberão placebo
Medicamento: Placebo capsule
Placebo arm participants will receive placebo capsules
Experimental: STL303 dose level 1
Participants will receive STL303 dose level 1
Medicamento: STL303
STL303 arm participants will receive a specific dose of STL303
Experimental: STL303 Dose Level 2
Participants will receive STL303 dose level 2
Medicamento: STL303
STL303 arm participants will receive a specific dose of STL303

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs)
Prazo: 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.
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.
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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in blood creatinine level
Prazo: Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180
Peripheral blood sampling
Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180
Change in eGFR slope
Prazo: Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180
Peripheral blood sampling
Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180
Maximum Concentration at steady-state (Tmax, ss) of STL303
Prazo: Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Measure time to reach maximum concentration at steady-state (Tmax, ss) at steady state.
Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Maximum plasma concentration at steady-state (Cmax, ss) of STL303
Prazo: Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Measure maximum plasma concentration at steady-state (Cmax, ss) at steady state.
Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Trough plasma concentration at steady-state of STL303
Prazo: Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Measure trough plasma concentration at steady-state (Cmin, ss /Ctrough, ss),
Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Area under plasma concentration-time curve for STL303
Prazo: Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Measure the area under the plasma concentration-time curve over one dosing interval at steady state (AUCtau)
Pre-dose on Days 1, 7, 14, 60, 90, 135, and 180. On Day 30 pre-dose and at 1 hour (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes), 6 hours (± 10 minutes), 8 hours (± 10 minutes), 12 hours (± 10 minutes), and 24 hours (± 1 hour) after dosing
Alternative Pathway Activity (Wieslab Assay)
Prazo: Pre-dose and post-dose on Day 1 and Day 14; pre-dose on Days 7, 60, 90, 135, and 180; intensive time points (pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post-dose) on Day 30
Change from baseline in complement alternative pathway (AP) functional activity as measured by the Wieslab assay in serum
Pre-dose and post-dose on Day 1 and Day 14; pre-dose on Days 7, 60, 90, 135, and 180; intensive time points (pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post-dose) on Day 30
Urinary Complement Biomarker C3a
Prazo: Day 1, Day 7 (FMV only), Day 14 (FMV only), Day 30, Day 60, Day 90, Day 135 (FMV only), and Day 180 (all pre-dose)
Change from baseline in urinary levels of C3a, measured in first morning void (FMV) and 24-hour urine samples collected midstream first morning void (FMV) Urine sampling
Day 1, Day 7 (FMV only), Day 14 (FMV only), Day 30, Day 60, Day 90, Day 135 (FMV only), and Day 180 (all pre-dose)
Plasma Soluble Terminal Complement Complex (sC5b-9)
Prazo: Day 1 through Day 180 (pre-dose at scheduled visits)
Change from baseline in plasma levels of soluble terminal complement complex (sC5b-9), a marker of terminal complement activation
Day 1 through Day 180 (pre-dose at scheduled visits)
Complement Factor B Cleavage Fragment (Bb)
Prazo: Day 1 through Day 180 (pre-dose at scheduled visits)
Change from baseline in plasma levels of complement factor B cleavage fragment (Bb), a marker of alternative pathway activation
Day 1 through Day 180 (pre-dose at scheduled visits)
Change from baseline urine protein-to-creatinine ratio (UPCR)
Prazo: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change in baseline 24-hour urine collection
24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change in UPCR
Prazo: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60 and 90
Change in baseline 24-hour urine collection
24-hour urine collection pre-dose on Days 1 (baseline), 30, 60 and 90
Change in urine albumin-to-creatinine ratio (UACR)
Prazo: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change in baseline 24-hour urine collection
24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change urine protein excretion (UPE),
Prazo: 24-hour urine collection pre-dose Days 1 (baseline), 30, 60, 90 and 180
Change in baseline 24-hour urine collection
24-hour urine collection pre-dose Days 1 (baseline), 30, 60, 90 and 180

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sitala Bio LTD

Investigadores

  • Investigador principal: Eugenia Pedagogos, Western Health (Sunshine Hospital)

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • STL303-201

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be shared because participant consent and ethics approvals do not permit public data sharing. A clinical study report will be prepared at the end of the study and result will be shared with research sites and investigators will be able to discuss results with participants if needed.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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