Abstract: SA-PO0637
Design of a Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 in Adult Patients with Primary IgAN
Session Information
- Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - Other
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Rovin, Brad, Department of Internal Medicine, Ohio State University College of Medicine, Columbus, Ohio, United States
- Meizlik, Paige, argenx, Ghent, Belgium
- Bolca, Selin, argenx, Ghent, Belgium
- Flouri, Marilena, argenx, Ghent, Belgium
- Dosne, Anne-Gaelle, argenx, Ghent, Belgium
- Floege, Jürgen, Department of Nephrology and Clinical Immunology, Rheinisch Westfälische Technische Hochschule (RWTH) Aachen University Hospital, Aachen, Germany
- Heerspink, Hiddo Jan L., Department of Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, Netherlands
- Haas, Mark, Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California, United States
- Barratt, Jonathan, University of Leicester, Leicester, England, United Kingdom
Background
Primary immunoglobulin (Ig) A nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, with a significant lifetime risk of kidney failure. ARGX-121, a one-armed monoclonal IgG1 antibody that targets IgA, is engineered to diminish effector functions and increase binding affinity to the neonatal Fc receptor (FcRn). Through pH-dependent IgA binding and enhanced FcRn binding, ARGX-121 actively removes IgA from circulation. ARGX-121 can also block the interaction of IgA with its main Fc receptor (FcαRI; CD89). Targeting IgA with ARGX-121 through this dual mechanism of action could provide therapeutic opportunities in IgAN. ARGX-121 was well tolerated in healthy adults in a phase 1 study and will be further evaluated in IgAN.
Methods
The multicenter, randomized, placebo-controlled Verdant study (EU CT: 2026-525638-43) will enroll ≤120 adults with biopsy-confirmed IgAN into 2 cohorts based on baseline proteinuria (Figure). Participants will be randomized 2:1 to receive ARGX-121 or placebo. ≤2 dosing regimens may be evaluated, including subcutaneous ARGX-121 once every 4 weeks. The primary endpoint is change in proteinuria from baseline to Week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-hour urine samples. Secondary endpoints include total annualized rate of change (slope) in the estimated glomerular filtration rate at Week 52, safety and tolerability, and pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity parameters.
Results
Study is expected to begin recruitment in the second half of 2026.
Conclusion
This study will evaluate the efficacy, safety, tolerability, PK, PD, and immunogenicity of ARGX-121 in adults with primary IgAN.
Funding
- Commercial Support – argenx