zigakibart (FUB523) / Novartis - LARVOL DELTA

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN) (clinicaltrials.gov) - P1/2 | N=103 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and safety outcomes after 124 weeks of zigakibart treatment in IgA nephropathy (IgAN) (ERA 2026) - No abstract available

Clinical • Glomerulonephritis • IgA Nephropathy • Renal Disease

ALIGN: Atrasentan in Patients With IgA Nephropathy (clinicaltrials.gov) - P3 | N=404 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2026 ➔ Apr 2028 | Trial primary completion date: Dec 2026 ➔ Apr 2028

Trial completion date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

Zigakibart Potently Inhibits A Proliferation-Inducing Ligand-Mediated IgA Production, Addressing IgAN Pathogenesis Root Causes. (PubMed, Kidney Int Rep) - P1/2, P3 | "Zigakibart therefore provides a potentially disease-modifying approach for IgAN treatment. Evaluation of the effects of zigakibart on proteinuria and long-term kidney function in adults with IgAN is ongoing in the ADU-CL-19 study and the phase 3 BEYOND study (NCT05852938)."

IO biomarker • Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease • TNFSF13

Novartis will present data from 15 abstracts from its kidney portfolio at this year’s European Renal Association (ERA) Congress in Glasgow, June 3-6. (The Manila Times)

Clinical protocol • P1/2 data • P3 data • Autosomal Dominant Polycystic Kidney Disease • IgA Nephropathy

CFUB523A12302B: A clinical trial to learn about the long-term safety of FUB523 (zigakibart) in people with immunoglobulin A (IgA) nephropathy who have completed previous zigakibart trials (clinicaltrialsregister.eu) - P2/3 | N=56 | Not yet recruiting | Sponsor: Novartis Pharma AG

New P2/3 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN) (clinicaltrials.gov) - P1/2 | N=103 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Oct 2025 ➔ Apr 2026

Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

SHIFT: A Study to Assess the Effects of Zigakibart on IgA Nephropathy. (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting | N=15 ➔ 32

Enrollment change • Enrollment open • Trial initiation date • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

BEYOND: A Study of Zigakibart in Adults With IgA Nephropathy (clinicaltrials.gov) - P3 | N=383 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2028 ➔ Jan 2028 | Trial primary completion date: Feb 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

SHIFT: A KIDNEY BIOPSY STUDY IN ADULTS WITH IGA NEPHROPATHY TREATED WITH ZIGAKIBART (ISN-WCN 2026) - No abstract available

Biopsy • Clinical • Glomerulonephritis • IgA Nephropathy • Renal Disease

LONG-TERM STABILIZATION OF KIDNEY FUNCTION REGARDLESS OF BASELINE EGFR AND UPCR IN PATIENTS WITH IGA NEPHROPATHY: SUBGROUP ANALYSES FROM THE ZIGAKIBART PHASE I/II TRIAL (ISN-WCN 2026) - P1/2 | "A similar trend was observed in pts stratified by baseline UPCR through Wk 100 (Figure B).Download: Download high-res image (237KB)Download: Download full-size imageConclusion Sustained eGFR stabilization was observed over 100 wks of zigakibart treatment, demonstrating efficacy irrespective of disease severity. This abstract was also submitted for presentation at the American Society of Nephrology 2025 congress and re-submitting the abstract has been permitted by the congress.I have potential conflict of interest to disclose.Jonathan Barratt has had grants or contracts from Alexion, Biogen, Calliditas Therapeutics, Novartis, Otsuka Pharmaceuticals, Travere Therapeutics, Vera Therapeutics, and Vertex Pharmaceuticals; and has received consulting fees from Alexion, AstraZeneca, Biogen, Calliditas Therapeutics, Novartis, Otsuka Pharmaceuticals, Roche, Takeda, Travere Therapeutics, Vera Therapeutics, and Vertex Pharmaceuticals.I did not use generative AI and..."

Clinical • P1/2 data • Glomerulonephritis • IgA Nephropathy • Renal Disease • EGFR

CFUB523A12201: A study to assess the effects of zigakibart on IgA nephropathy. (clinicaltrialsregister.eu) - P1/2 | N=9 | Not yet recruiting | Sponsor: Novartis Pharma AG

New P1/2 trial • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Novartis will present new data from 33 abstracts across its Cardiovascular, Renal, and Metabolic (CRM) disease portfolio at the upcoming American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas and American Heart Association’s (AHA) Scientific Sessions 2025 in New Orleans, Louisiana, advancing scientific insight into these critical disease areas (Novartis Press Release)

Clinical data • Autosomal Dominant Polycystic Kidney Disease • Cardiovascular • Chronic Kidney Disease • IgA Nephropathy

SHIFT: A Kidney Biopsy Study in Adults with IgAN Treated with Zigakibart (KIDNEY WEEK 2025) - "Key secondary endpoints: CFB in MEST-C score, CD68+, C3c staining, proteinuria, hematuria, eGFR, Gd-IgA, IgA, IgG, IgM levels, safety, tolerability, and pharmacokinetics. The SHIFT study aims to demonstrate the disease-modifying effect of zigakibart while characterizing the time course of changes in clinical and laboratory markers of kidney disease during a two-year treatment period."

Biopsy • Clinical • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease • CD68

BEYONDx: A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Zigakibart in Adults with Primary IgaN (KIDNEY WEEK 2025) - P3 | "Figure. BEYONDx study design"

Clinical • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Nephrology • Renal Disease

Long-Term Stabilization of Kidney Function Regardless of Baseline eGFR and Urine Protein-to-Creatinine Ratio (UPCR) in Patients with IgAN: Subgroup Analyses from the Phase 1/2 Trial of Zigakibart (KIDNEY WEEK 2025) - P1/2 | "A similar trend was observed in pts stratified by BL UPCR through Wk100 ( Fig.B ). Conclusion Sustained eGFR stabilization was observed over 100 wks of zigakibart treatment, demonstrating efficacy irrespective of disease severity."

Clinical • P1/2 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy. (clinicaltrials.gov) - P3 | N=223 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

SHIFT: A Study to Assess the Effects of Zigakibart on IgA Nephropathy. (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2 trial • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

BEYOND: A Study of Zigakibart in Adults With IgA Nephropathy (clinicaltrials.gov) - P3 | N=350 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Glomerulonephritis • IgA Nephropathy • Renal Disease

Results from ongoing trials and other highlights (Novartis Press Release) - P1/2 | N=103 | NCT04684745 | Sponsor: Novartis Pharmaceuticals | "Updated results from the Phase I/II study for zigakibart in IgAN showed a robust and clinically meaningful reduction in proteinuria of 60.4% from baseline and eGFR stabilization over 100 weeks of treatment. To date, this is the longest duration of treatment reported for an anti-APRIL agent, demonstrating long-term safety and efficacy. Data presented at ERA. The Phase III BEYOND trial is ongoing with anticipated readout in 2026."

P1/2 data • P3 data • IgA Nephropathy

Changes in proteinuria and kidney function in subgroups of patients with IgAN defined by baseline Gd-IgA1 levels in a Phase 1/2 study of zigakibart (ERA 2025) - P1/2 | "Following 76 weeks of zigakibart treatment patients achieved 74.4% mean percent reduction of Gd-IgA1. Zigakibart provides clinically meaningful treatment benefits in terms of proteinuria reduction and eGFR stabilisation in patients with IgAN, independent of their baseline Gd-IgA1 levels."

Clinical • P1/2 data • Glomerulonephritis • IgA Nephropathy • Inflammation • Lupus Nephritis • Renal Disease

Sustained long term efficacy and safety of zigakibart over 100 weeks in patients with IgAN (ERA 2025) - P1/2, P3 | "Zigakibart was well tolerated and led to robust, clinically meaningful reductions in proteinuria and eGFR stabilisation in patients, which were sustained up to 100 weeks of treatment. To date, this is the longest duration of treatment reported for an anti-APRIL agent, demonstrating long-term efficacy and safety. Clinically meaningful proteinuria remission rates were maintained for the duration of treatment and sustained eGFR stabilisation was observed independent of the proteinuria remission status."

Clinical • Late-breaking abstract • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Inflammation • Lupus Nephritis

Zigakibart-treated patients with IgAN achieved high rates of proteinuria remission and stable eGFR over 76 weeks in a Phase 1/2 study (ERA 2025) - P1/2 | "Following 76 weeks of zigakibart treatment, 29% and 45% of patients achieved UPE reductions below stringent thresholds of <300 and <500 mg/24 h, demonstrating robust, clinically meaningful proteinuria remission. Sustained eGFR stabilisation was observed independent of the achieved UPE remission thresholds. Taken together, these findings support the disease- modifying effect of zigakibart in IgAN."

Clinical • P1/2 data • Glomerulonephritis • IgA Nephropathy • Inflammation • Lupus Nephritis • Renal Disease

Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. (PubMed, Kidney Int) - P1/2, P3 | "Overall, zigakibart demonstrated robust pharmacological activity, and clinical evidence shows an acceptable safety profile with clinically meaningful proteinuria reduction and sustained estimated glomerular filtration rate stabilization in patients with IgAN, providing a potentially disease-modifying approach for the treatment of IgAN. The effects of zigakibart on proteinuria and long-term kidney function in adults with IgAN are being evaluated in the ongoing Phase 3 BEYOND study (NCT05852938)."

Journal • P1/2 data • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease • TNFSF13

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy(The BEYOND Study) (ChiCTR) - P3 | N=292 | Recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

New P3 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease