A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G

NCT06419205 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ADX-097-CI-0053
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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)

Conditions

C3 (Complement Component 3) Glomerulopathy; Lupus Nephritis (LN); IgA Nephropathy

Keywords

Immunoglobulin A Nephropathy; Lupus Nephritis; Complement Component 3 Glomerulopathy; ADX-097; C3G

Outcome Measures

Primary Outcomes (1)

• Number of participants reporting treatment emergent adverse events (TEAEs)

  Up to 30 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Open Label: ADX-097

OTHER

Participants will be administered ADX-097 weekly once

Drug: ADX-097

Interventions

ADX-097 DRUG

Subcutaneous Infusions

Open Label: ADX-097

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (2)

Investigator Site #1

Lawrenceville, Georgia, 30046, United States

RECRUITING

Investigator Site #2

São Paulo, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA; Lupus Nephritis; Complement Component 3 Deficiency, Autosomal Recessive

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Akebia Therapeutics

CONTACT

16178446128; trials@akebia.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 17, 2024
• Study Start: July 30, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-08

Locations

BR (1); US (1)