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BEYOND: BION-1301 in Adults With IgA Nephropathy
NCT05852938Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jul 2023
- Primary completion
- Aug 2027
- Countries
- 23
- Sponsor
- Novartis
- Modality
- Monoclonal Antibodies
- Drugs
- zigakibart
- Conditions
- IgA nephropathy (IgAN)
01
Overview
Phase 3, randomised, double-blind trial in IgA nephropathy (IgAN) comparing BION-1301 with Placebo (2 arms). Primary endpoint: Change from baseline in eGFR at 104 weeks. Started Jul 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
BION-1301
BION-1301 600mg subcutaneous administration every 2 weeks for 104 weeks
Placebo
Placebo subcutaneous administration every 2 weeks for 104 weeks
03
Who it enrols
Adults with biopsy-proven IgA Nephropathy, eGFR >= 30 mL/min/1.73m^2, significant proteinuria despite stable maximally tolerated ACEi/ARB therapy.
04
Endpoints
Primary
Change from baseline in eGFR
Secondary
Change in proteinuria (natural log UPCR)
Annualized rate of change in eGFR
Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)
Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)
Percent Change in Proteinuria and Total Urine Protein
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