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

24. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

15

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Die Teilnehmer erhalten ein Placebo
Arzneimittel: Placebo capsule
Placebo arm participants will receive placebo capsules
Experimental: STL303 dose level 1
Participants will receive STL303 dose level 1
Arzneimittel: STL303
STL303 arm participants will receive a specific dose of STL303
Experimental: STL303 Dose Level 2
Participants will receive STL303 dose level 2
Arzneimittel: STL303
STL303 arm participants will receive a specific dose of STL303

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in blood creatinine level
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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),
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sitala Bio LTD

Ermittler

  • Hauptermittler: Eugenia Pedagogos, Western Health (Sunshine Hospital)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. September 2027

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • STL303-201

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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