Abstract: INFO13-SA
A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Jade101 in Participants with IgAN
Session Information
- Informational Posters - 3
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Kooienga, Laura, Colorado Kidney Care, Denver, Colorado, United States
- Han, Seung Hyeok, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Korea (the Republic of)
- Wong, Muh Geot, Concord Repatriation General Hospital, Concord, New South Wales, Australia
- Yalavarthy, Rajesh, Western Nephrology, Wheat Ridge, Colorado, United States
- Piscia-Nichols, Cheri, Jade Biosciences, Waltham, Massachusetts, United States
- DeVries, Todd, Jade Biosciences, Waltham, Massachusetts, United States
- Li, Li, Jade Biosciences, Waltham, Massachusetts, United States
- Conner, Edward, Jade Biosciences, Waltham, Massachusetts, United States
- King, Andrew J., Jade Biosciences, Waltham, Massachusetts, United States
Description
Background and Aims: Immunoglobulin A nephropathy (IgAN) is a progressive immune-mediated kidney disease with a high lifetime risk of kidney failure. Blocking A proliferation-inducing ligand (APRIL), a key driver of pathogenic IgA production, is potentially disease modifying in IgAN by reducing IgA, galactose-deficient IgA1 (Gd-IgA1) and proteinuria, ultimately stabilizing kidney function. JADE101 is a novel APRIL-neutralizing monoclonal antibody (mAb) designed with ultra-high affinity and extended half-life, with the goal of delivering a convenient, infrequent subcutaneous dosing profile. This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in adults with biopsy-confirmed IgAN at risk of progression.
Methods: This ongoing Phase 2 study will enroll approximately 30 eligible patients across 5 countries.
Eligibility: Adults aged 18 - 60 years with biopsy-confirmed primary IgAN within 5 years, 24 hour UPCR ≥0.75 g/g, and eGFR ≥30 mL/min/1.73 m2 on stable optimized supportive care. Secondary IgAN or IgA vasculitis, coexisting non-IgAN kidney disease, rapidly progressive glomerulonephritis, active infection will be excluded.
Design: All participants will receive JADE101 administered subcutaneously (SC) for 100 weeks. Participants will receive an induction dose of JADE101 700 mg at treatment onset followed by maintenance doses of 350 mg starting at Week 4 and subsequently either every 8 weeks (n=15) or every 12 weeks (n=15).
Primary Endpoint: Incidence of treatment-emergent adverse events.
Secondary Endpoint: Change from baseline in 24-hour UPCR over time.
Exploratory Endpoints: Percentage achieving 24-hour urine protein < 0.5g/day or <0.3 g/day, change in eGFR from baseline, pharmacokinetics, pharmacodynamic biomarker changes (free APRIL, serum immunoglobulins, including, Gd-IgA1) and immunogenicity.
Status: The study is currently enrolling.
Funding: Sponsored by Jade Biosciences, Inc.
Funding
- Sponsored by Jade Biosciences, Inc.