A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADX-097.
- Who it may be relevant to
- Registry conditions: IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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)
Interventions
- Drug ADX-097
Subcutaneous Infusions
Primary outcome measures
- Number of participants reporting treatment emergent adverse events (TEAEs) [Time frame: Up to 30 weeks]
Secondary outcome measures (3)
- Change from baseline in urine protein-to-creatinine ratio (uPCR) [Time frame: Baseline and up to 26 weeks]
- Change from baseline in estimated glomerular filtration rate (eGFR) [Time frame: Baseline and up to 26 weeks]
- Trough plasma Concentration of ADX-097 [Time frame: At Days 1, 8, 22, 50, 78, 106, 134 and 176]
Eligibility 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 only
- 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
- 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
Participants with C3G only
- 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.
- 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
- 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 only
- Secondary forms of IgAN
- Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1.
Participants with LN only
- Lymphocyte 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 only
- Evidence 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Investigator Site #1 — Lawrenceville
Brazil · 1 center
- Investigator Site #2 — São Paulo
Identifiers
NCT: NCT06419205 · ADX-097-CI-0053