NCT05852938

A Study of Zigakibart in Adults With IgA Nephropathy

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Detailed description

Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m\^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301, Novartis FUB523, or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to \< 30 mL/min/1.73 m\^2. The exploratory cohort will be randomized using the same schema as the primary cohort. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on eGFR as measured by the change from Baseline in eGFR. Following completion of the 104-week treatment period, subjects may be eligible to enroll in an open-label extension (OLE) study to receive open-label treatment with BION-1301 under a separate protocol. Subjects who do not enroll in the OLE will enter the protocol-specified 24-week safety follow-up period. To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.

Conditions

• IgA Nephropathy
• Immunoglobulin A Nephropathy

Interventions

Type	Name	Description
DRUG	BION-1301	BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.
DRUG	Placebo	Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.

Timeline

• Start date: 2023-07-06
• Primary completion: 2027-08-10
• Completion: 2028-01-25
• First posted: 2023-05-10
• Last updated: 2026-04-01

Locations

200 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Croatia, Czechia, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study