Abstract: INFO14-SA
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Jade101 Administered Subcutaneously 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
- Lafayette, Richard A., Stanford University School of Medicine, Stanford, California, United States
- Rizk, Dana V., The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States
- Barbour, Sean, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada
- Liew, Adrian, Mount Elizabeth Hospital, Singapore, Singapore
- Wong, Muh Geot, Concord Repatriation General Hospital, Concord, New South Wales, Australia
- Trimarchi, Hernan, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina
- Suzuki, Hitoshi, Juntendo Daigaku Igakubu Fuzoku Urayasu Byoin, Urayasu, Chiba Prefecture, Japan
- Zhang, Hong, Peking University First Hospital, Beijing, China
- 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
- Barratt, Jonathan, University of Leicester, Leicester, England, United Kingdom
Description
Background: 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 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 multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to characterize the efficacy and safety of JADE101 in participants with biopsy-confirmed primary IgAN.
Methods: This Phase 3 study will enroll approximately 420 participants with IgAN from approximately 30 countries. Up to an additional 60 participants may be enrolled in two exploratory cohorts (UPCR ≥0.5 to <0.75 g/g and eGFR ≥20 to <30 mL/min/1.73 m2 at screening), for a total of approximately 480 participants.
Eligibility: Adults aged ≥18 years with biopsy-confirmed primary IgAN, UPCR ≥0.75 g/g or urine protein excretion ≥ 1 g/day (24-hour urine collection), and eGFR ≥30 mL/min/1.73 m2 on optimized and stable supportive care.
Design: Eligible participants will be randomized 2:1 to receive JADE101 or placebo. Randomized participants will receive a 700mg loading dose of JADE101 or placebo on Day 1 followed by 350mg maintenance doses starting at Week 4 and subsequently either every 8 weeks or every 12 weeks for a total treatment duration of 52 weeks. All participants will then receive open-label JADE101 for another 48 weeks. Total treatment period is approximately 2 years.
Primary Endpoint: Change from baseline in UPCR (measured from 24-hour urine collection) at Month 12
Secondary Endpoint: Change from baseline in eGFR at Month 12
Exploratory Endpoints: Percentage of participants with hematuria resolution over time, pharmacokinetics, pharmacodynamic biomarker changes (free APRIL, serum immunoglobulins, including, Gd-IgA1), immunogenicity and patient reported outcomes.
Status: The study is expected to start in Q4 2026.
Funding: Sponsored by Jade Biosciences, Inc.
Funding
- Funding: Sponsored by Jade Biosciences, Inc.