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)

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)

CT.gov Identifier

NCT06419205

EudraCT Identifier

N/A

CTIS:

N/A

Collaborator

Q32 Bio

Study Contact Information

+1 617-871-2098

Recruiting

Study Details

Diseases

Alport syndrome

Glomerulonephritis and atypical hemolytic uremic syndrome (aHUS)

Atypical Hemolytic Uremic Syndrome; C3 Glomerulopathy; Complement Factor H Deficiency

IgA nephropathy

Study Drug

Ebribafusp alfa

Prednisone

Atrasentan hydrochloride

Sparsentan

Mycophenolate mofetil (Cytogan)

Sodium glucose co-transporter 2, unspecified

Renin angiotensin aldosterone system antagonist, unspecified

Genes

COL4A4

COL4A3

CFI

CFH

Study Dates

Jul 2026 - Feb 2028

Sex

Female & Male

Age

16+ years

Inclusion and Exclusion Criteria

Inclusion Criteria:

All participants
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.Participants with IgAN onlyKidney 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 onlyClinical 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 IVParticipants with C3G onlyKidney 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.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.

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.Participants with IgAN onlySecondary forms of IgANReceived systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1.Participants with LN onlyLymphocyte count below 0.5 × 109/L at screening.Received any of Cyclophosphamide, Calcineurin inhibitors, IV methylprednisolone, IV immunoglobulin therapy, Belimumab, Obinutuzumab and Rituximab treatments at protocol specified time points.Participants with C3G onlyEvidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary.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.

Protocol Summary

Study Locations

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