An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases (RUBY-3)

Description

The goal of this clinical study is to evaluate multiple dose levels of povetacicept (ALPN-303) in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, lupus-related kidney disease (lupus nephritis). or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period.

Trial Eligibility

Key Inclusion Criteria Summary: 1. Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) 2. Indication-specific criteria: 1. IgAN * Biopsy-confirmed diagnosis ≤10 years prior to the start of screening AND Screening UPCR ≥0.5 g/g. * No background immunosuppression therapies. 2. pMN * A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR ≥1 g/g * Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks. * No background immunosuppression therapies except for optional calcineurin inhibitors. LN * A Biopsy-confirmed diagnosis of active, proliferative Class III, IV, (with or without Class V) LN ≤6 months prior to the start of screening AND * Screening UPCR ≥1 g/g, * Positive anti-dsDNA at screening * On stable background immunosuppression ≥ 8 weeks prior to Day 1 AAV * Past diagnosis of renal AAV, defined as either of the following: * History of renal biopsy consistent with renal AAV. * History of clinically diagnosed renal AAV. * Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening. * At least 4 weeks since initiation of AAV induction therapy, if applicable. 3. On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1 Key Exclusion Criteria Summary: 1. Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease 2. eGFR \<30 mL/min/1.73m2 or rapidly progressive glomerulonephritis 3. Recent serious or ongoing infection; risk or history of serious infection 4. Receipt of B cell depleting therapies or anti-BAFF/APRIL therapies within protocol specified timeframes

Study Info

Interventions

Locations Recruiting

Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.