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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STL303 dose level 1 | Experimental | Participants will receive STL303 dose level 1 |
|
| STL303 Dose Level 2 | Experimental | Participants will receive STL303 dose level 2 |
|
| Placebo | Placebo Comparator | Participants will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STL303 | Drug | STL303 arm participants will receive a specific dose of STL303 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline urine protein-to-creatinine ratio (UPCR) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Manager | Contact | +61 421 585707 | studies@sitala.com |
| Name | Affiliation | Role |
|---|---|---|
| Eugenia Pedagogos | Western Health (Sunshine Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Woolloongabba | Queensland | 4102 | Australia | ||
| Research Site |
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.
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| STL303 |
| Drug |
STL303 arm participants will receive a specific dose of STL303 |
|
| Placebo capsule | Drug | Placebo arm participants will receive placebo capsules |
|
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) | Change in baseline 24-hour urine collection | 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180 |
| Change in blood creatinine level | Peripheral blood sampling | Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180 |
| Change in eGFR slope | 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 | 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 | 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 | 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 | 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 |
| Change urine protein excretion (UPE), | Change in baseline 24-hour urine collection | 24-hour urine collection pre-dose Days 1 (baseline), 30, 60, 90 and 180 |
| Alternative Pathway Activity (Wieslab Assay) | 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 | 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) | 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) | 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) |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Research Site | Saint Albans | Victoria | 3021 | Australia |