NCT06419205RecruitingPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Akebia Therapeutics
- Enrollment
- 30
- Locations
- 7
- Primary Endpoint
- Incidence of adverse events (AEs) to evaluate the safety of ADX-097
Study Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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
- •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
- •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.
Arms & Interventions
Open Label: ADX-097
Other
Participants will be administered ADX-097 weekly once
Intervention: ADX-097 (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events (AEs) to evaluate the safety of ADX-097
Time Frame: 42 weeks
Incidence of adverse events (AEs) to evaluate the safety of ADX-097 when administered to participants with IgAN, LN, or C3G
Number of participants reporting treatment emergent adverse events (TEAEs)
Time Frame: Up to 30 weeks
Secondary Outcomes
- Change from baseline in urine protein-to-creatinine ratio (uPCR)(26 weeks)
- Change from baseline in estimated glomerular filtration rate (eGFR)(26 weeks)
- Change from baseline in urine protein-to-creatinine ratio (uPCR)(Baseline and up to 26 weeks)
- Change from baseline in estimated glomerular filtration rate (eGFR)(Baseline and up to 26 weeks)
- Trough plasma Concentration of ADX-097(At Days 1, 8, 22, 50, 78, 106, 134 and 176)
Investigators
Study Sites (7)
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