An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases.

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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, or lupus-related kidney disease (lupus nephritis) 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 study treatment extension period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alpine Immune Sciences, Inc.

Criteria

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

• UPCR ≥0.5 g/g

2. pMN

• Less than 50% reduction of proteinuria in the last 24 weeks while on angiotensin converting enzyme inhibitor (ACEis)/angiotensin II receptor blockers (ARBs)

• UPCR ≥3.5 g/g

• Positive anti-PLA2R1 antibodies or anti-THSD7A antibodies

3. LN

• UPCR ≥1 g/g, with additional criteria per protocol

• Positive anti-dsDNA

• Positive anti-nuclear antibody

3. On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1

4. Receiving stable dose(s) of standard-of-care medications and no prohibited concomitant medications per protocol

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