A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants … (NCT06419205) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
United States, Brazil30 participantsStarted 2026-07-30
Plain-language summary
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participants aged ≥16 years.
. uPCR ≥0.5 g/g (from the average of 3 first morning voids \[FMVs\]).
. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
. Participants receiving a renin-angiotensin-aldosterone system (RAAS) inhibitor, sodium-glucose cotransporter-2 (SGLT2) inhibitor, sparsentan, or atrasenten must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 8 weeks prior to Study Day 1 and the dose is projected to remain stable until completion of the study.
. Kidney biopsy-proven diagnosis of IgAN with a kidney biopsy that is obtained within 10 years of Day 1 or within 5 years of Day 1 if the participant is known or suspected of also having diabetic nephropathy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing ADX-097 in three different kidney diseases — IgA nephropathy, lupus nephritis, and C3 glomerulopathy — so is my specific diagnosis a good fit for what this study is actually designed to evaluate?
2Since this is a Phase 2 trial and the main thing being measured is how many people experience treatment-related side effects, does that mean we still have limited information about whether ADX-097 actually slows kidney damage, and how does that uncertainty compare to what's known about my current treatment options?
3ADX-097 appears to target the complement system — given my specific kidney disease and how active it is right now, would my doctor think it makes more sense to try an approved therapy first before considering an experimental complement-targeting drug?
4What would participating in this trial actually involve in terms of clinic visits, blood draws, or monitoring, and is that realistic given my current health and daily responsibilities?
5If I join this trial and experience a serious adverse event, what's the plan for managing that, and would I still be able to access standard treatments afterward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants reporting treatment emergent adverse events (TEAEs)
. Clinical diagnosis of systemic lupus erythematosus (SLE)
. Kidney biopsy-proven diagnosis of LN with a kidney biopsy that is obtained within 24 weeks of Day 1.
. Diagnosis of active focal or diffuse LN class III or IV
Exclusion criteria
. Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening.
. Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion.
. Participants with a history of and/or presence of anti-factor H antibodies at screening.
. Uncontrolled hypertension with mean seated systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.
. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
. History of splenectomy.
. Secondary forms of IgAN
. Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1.