Open-Label Extension Study of BION-1301 in IgA Nephropathy

Status Recruiting

Clinical Trial Summary

This is an open-label extension (OLE) study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of BION-1301 in adults with IgA nephropathy

Clinical Trial Description

This is a Phase 2, multicenter, open-label extension (OLE) study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. Patients who previously participated in Study ADU-CL-19 (NCT03945318) will receive open-label treatment with BION-1301 for up to approximately 2 years. Study participants will receive BION-1301 at the same dose, route, and dosing schedule as they received in ADU-CL-19. Dose, route, and/or dosing schedule may be changed during the OLE study based on a review by the Safety Review Team of all available PK, PD, and clinical activity data from previous and ongoing studies of BION-1301. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04684745
Study type	Interventional
Source	Chinook Therapeutics, Inc.
Contact	Chinook Therapeutics
Phone	(206) 485-7051
Email	clinicaltrials@chinooktx.com
Status	Recruiting
Phase	Phase 2
Start date	September 10, 2020
Completion date	November 2023

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