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

24. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Clinical Operations Manager
  • Telefonnummer: +61 421 585707
  • E-mail: studies@sitala.com

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Deltagerne vil modtage placebo
Medicin: Placebo capsule
Placebo arm participants will receive placebo capsules
Eksperimentel: STL303 dose level 1
Participants will receive STL303 dose level 1
Medicin: STL303
STL303 arm participants will receive a specific dose of STL303
Eksperimentel: STL303 Dose Level 2
Participants will receive STL303 dose level 2
Medicin: STL303
STL303 arm participants will receive a specific dose of STL303

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in blood creatinine level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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),
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sitala Bio LTD

Efterforskere

  • Ledende efterforsker: Eugenia Pedagogos, Western Health (Sunshine Hospital)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STL303-201

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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