IgANPhase 2NCT07606352
Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy
A Phase 2 study testing STL303 in people with IgAN, run by Sitala Bio LTD at 8 sites in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgAN
- What is being tested?
- STL303
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 8 sitesAustralia
- Study dates
- 4 Aug 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy:
- 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.
- UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in.
- Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose.
- 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.
- 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.
Who cannot join
- Secondary IgAN or unclear exclusion of secondary causes.
- Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk).
- Other systemic diseases causing proteinuria/CKD or severe urinary obstruction.
- Known or suspected immunodeficiency or hereditary complement deficiency.
- Any organ transplant recipients except corneal.
- Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90).
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- Use of immunosuppressive drugs within 90 days or 5 half-lives.
- Prior oral budesonide (Nefecon/Tarpeyo/Kinpeygo) within 6 months.
- Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period.
- Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease).
- Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin).
- QTcF greater than 500 ms.
- History of malignancy within 5 years (exceptions apply).
- History of meningococcal, pneumococcal, or Hib infection.
- Chronic/recurrent infections in past year (e.g., liver abscess, pyelonephritis).
- Active systemic infections within 2 weeks or fever greater than 38°C within 7 days.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Australia8 sites, 8 recruiting
- Recruiting
Research Site
Clayton, Victoria, 3168
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
- Recruiting
Nepean Hospital
Penrith, New South Wales, 2747
- Not yet recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
- Recruiting
Research Site
Saint Albans, Victoria, 3021
- Not yet recruiting
Prince of Wales Hospital
Sydney, New South Wales, 2031
- Recruiting
Concord Hospital
Sydney, New South Wales, 2139
- Recruiting
Research Site
Woolloongabba, Queensland, 4102
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- IgAN
- Being tested
- STL303, Placebo capsule
- Keywords
- IgAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STL303Drug
STL303 arm participants will receive a specific dose of STL303
STL303Drug
STL303 arm participants will receive a specific dose of STL303
Placebo capsuleDrug
Placebo arm participants will receive placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| STL303 dose level 1 | Experimental | Participants will receive STL303 dose level 1 Receives: Drug: STL303 |
| STL303 Dose Level 2 | Experimental | Participants will receive STL303 dose level 2 Receives: Drug: STL303 |
| Placebo | Placebo comparator | Participants will receive placebo Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (14)
Change from baseline urine protein-to-creatinine ratio (UPCR)
Change in baseline 24-hour urine collection
Measured: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change in UPCR
Change in baseline 24-hour urine collection
Measured: 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
Measured: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change in blood creatinine level
Peripheral blood sampling
Measured: Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180
Change in eGFR slope
Peripheral blood sampling
Measured: 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.
Measured: 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.
Measured: 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),
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 through Day 180 (pre-dose at scheduled visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start4 Aug 2026
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgANStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sitala Bio LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugenia Pedagogos, Principal investigator, Western Health (Sunshine Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606352
- Sponsor's protocol ID
- STL303-201
- Status last verified
- Sep 2026
- First submitted
- 7 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy
- ClinicalTrials.gov ID
- NCT07606352
- Acronym / sponsor ID
- STL303-201
- Conditions
- IgAN
- Keywords
- IgAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sitala Bio LTDIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STL303 dose level 1 | Experimental | Drug: STL303Participants will receive STL303 dose level 1 |
| STL303 Dose Level 2 | Experimental | Drug: STL303Participants will receive STL303 dose level 2 |
| Placebo | Placebo comparator | Drug: Placebo capsuleParticipants will receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy:
- 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.
- UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in.
- Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose.
- 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.
Key exclusion criteria (16 listed)
- Secondary IgAN or unclear exclusion of secondary causes.
- Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk).
- Other systemic diseases causing proteinuria/CKD or severe urinary obstruction.
- Known or suspected immunodeficiency or hereditary complement deficiency.
- Any organ transplant recipients except corneal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STL303STL303 arm participants will receive a specific dose of STL303 | Drug | STL303 dose level 1 |
| STL303STL303 arm participants will receive a specific dose of STL303 | Drug | STL303 Dose Level 2 |
| Placebo capsulePlacebo arm participants will receive placebo capsules | Drug | Placebo |
Primary outcome
Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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.
14 secondary outcomes
Change from baseline urine protein-to-creatinine ratio (UPCR)
Time frame: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change in UPCR
Time frame: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60 and 90
Change in urine albumin-to-creatinine ratio (UACR)
Time frame: 24-hour urine collection pre-dose on Days 1 (baseline), 30, 60, 90 and 180
Change in blood creatinine level
Time frame: Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180
Change in eGFR slope
Time frame: Blood sampling pre-dose on Days 1 (baseline), 14, 30, 45, 60, 90 and 180
Maximum Concentration at steady-state (Tmax, ss) of STL303
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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),
Time frame: 24-hour urine collection pre-dose Days 1 (baseline), 30, 60, 90 and 180
Alternative Pathway Activity (Wieslab Assay)
Time frame: 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
Time frame: 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)
Time frame: Day 1 through Day 180 (pre-dose at scheduled visits)
Complement Factor B Cleavage Fragment (Bb)
Time frame: Day 1 through Day 180 (pre-dose at scheduled visits)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugenia Pedagogos principal investigator
Western Health (Sunshine Hospital)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STL303 in people with IgAN, run by Sitala Bio LTD at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations Manager (+61 421 585707, studies@sitala.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.