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

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 join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ADX-097, given as a shot under the skin, in people age 16 or older with IgA nephropathy (IgAN), lupus nephritis (LN), or C3 glomerulopathy (C3G). These are kidney diseases. Researchers will check its safety, how the body handles it, and how it affects the disease.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 16 or older.
  • Your urine protein-to-creatinine ratio (uPCR) must be at least 0.5 g/g, based on 3 first-morning urine samples.
  • Your estimated kidney filtering rate (eGFR) must be at least 30 at screening.
  • If you take a RAAS inhibitor, SGLT2 inhibitor, sparsentan, or atrasenten, your dose must be stable for at least 8 weeks before starting and expected to stay stable during the study. It must be the highest recommended dose or the highest dose you can tolerate.
  • For IgAN: A kidney biopsy (small tissue sample) must confirm IgAN within the past 10 years, or 5 years if kidney damage from diabetes is known or suspected.
  • For LN: You must have lupus and active class III or IV lupus kidney disease, confirmed by a kidney biopsy within 24 weeks before starting.
  • For C3G: A kidney biopsy within 52 weeks before starting must confirm dense deposit disease (DDD) or C3 glomerulonephritis (C3GN), two forms of C3G.
  • For C3G: If taking mycophenolate mofetil (MMF), mycophenolic acid, or prednisone at 10 mg a day or more (or a similar steroid dose), your dose must be stable for at least 12 weeks before starting and expected to stay stable during the study.

Who can't join

  • Kidney inflammation with a 50% drop in kidney filtering rate within 12 weeks of screening, or another major kidney disease, as judged by the study doctor.
  • Current or past anti-factor H antibodies, which are immune proteins that target factor H.
  • Uncontrolled high blood pressure: an average top number of 160 or higher, or bottom number of 100 or higher, on seated readings.
  • A past or expected kidney, other solid organ, or bone marrow transplant during the study; or past surgery to remove your spleen.
  • For IgAN: IgAN caused by another condition, or use of steroids that act throughout the body, oral budesonide, or other immune-suppressing drugs within 12 weeks before starting.
  • For LN: A lymphocyte count (a type of white blood cell) below 0.5 × 10⁹/L, or certain recent treatments. These include cyclophosphamide, calcineurin inhibitors, methylprednisolone or immune globulin through a vein, belimumab, obinutuzumab, or rituximab. The study sets the timing limits.
  • For C3G: Evidence that C3G is caused by another condition, such as an abnormal blood protein condition called MGUS, infection, cancer, or a disease in which the immune system attacks the body.
  • For C3G: Use of steroids that act throughout the body, eculizumab, iptacopan, pegcetacoplan, or other immune-suppressing drugs within 12 weeks before starting. MMF or mycophenolic acid is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: All participants 1. Male or female participants aged ≥16 years. 2. uPCR ≥0.5 g/g (from the average of 3 first morning voids \[FMVs\]). 3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR). 4. 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. Participants with IgAN only 5. 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. Participants with LN only 6. Clinical diagnosis of systemic lupus erythematosus (SLE) 7. Kidney biopsy-proven diagnosis of LN with a kidney biopsy that is obtained within 24 weeks of Day 1. 8. Diagnosis of active focal or diffuse LN class III or IV Participants with C3G only 9. Kidney biopsy-proven diagnosis of C3G, either dense deposit disease (DDD) or complement component 3 glomerulonephritis (C3GN), with a kidney biopsy that is obtained within 52 weeks of Day 1. 10. Participants receiving mycophenolate mofetil (MMF) (or mycophenolic acid) or prednisone ≥10 mg/d or equivalent must have been on a stable dose for at least 12 weeks before Day 1 that is projected to remain stable until completion of the study. Key Exclusion Criteria All participants 1. Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening. 2. Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion. 3. Participants with a history of and/or presence of anti-factor H antibodies at screening. 4. 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. 5. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study. 6. History of splenectomy. Participants with IgAN only 7. Secondary forms of IgAN 8. Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1. Participants with LN only 9. Lymphocyte count below 0.5 × 109/L at screening. 10. Received any of Cyclophosphamide, Calcineurin inhibitors, IV methylprednisolone, IV immunoglobulin therapy, Belimumab, Obinutuzumab and Rituximab treatments at protocol specified time points. Participants with C3G only 11. Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary. 12. Received systemic corticosteroid therapy, eculizumab, iptacopan, pegcetacoplan, or any other form of immunosuppressive therapy ≤12 weeks before Day 1, except for MMF (or mycophenolic acid), which is permitted.

Study sites (3)

FL

GA

SC