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

Lupus Nephritis Clinical Trial

— RUBY-3  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732402
• Other study ID #: AIS-D03
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 15, 2023
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Alpine Immune Sciences, Inc.
• Contact: Sarah Murphy
• Phone: 919-786-8898
• Email: sarah.murphy[@]iconplc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Glomerulonephritis, IGA
• Glomerulonephritis, Membranous
• Immunoglobulin A Nephropathy
• Kidney Diseases
• Lupus Nephritis
• Membranous Nephropathy
• Nephritis
• Vasculitis

Intervention

Drug:
• povetacicept
Administered by subcutaneous injection every 4 weeks
• povetacicept
Administered by subcutaneous injection every 4 weeks

Locations

Country	Name	City	State
Australia	Investigational Site (519)	Concord	New South Wales
Australia	Investigational Site (102)	Nedlands	Western Australia
Australia	Investigational Site (515)	Saint Albans	Victoria
Korea, Republic of	Investigational Site (505)	Anyang-si	Gyeonggi-do
Korea, Republic of	Investigational Site (507)	Cheonan	Chungcheongnam-do
Korea, Republic of	Investigational Site (504)	Goyang-si	Gyeonggi-do
Korea, Republic of	Investigational Site (510)	Guri-si	Gyeonggi-do
Korea, Republic of	Investigational Site (125)	Seoul	Gyeonggi-do
Korea, Republic of	Investigational Site (520)	Seoul	Gyeonggi-do
Korea, Republic of	Investigational Site (521)	Seoul	Gyeonggi-do
Korea, Republic of	Investigational Site (116)	Suwon-si	Gyeonggi-do
United States	Investigational Site (511)	Albany	New York
United States	Investigational Site (513)	Arvada	Colorado
United States	Investigational Site (518)	Bethlehem	Pennsylvania
United States	Investigational Site (503)	Boston	Massachusetts
United States	Investigational Site (508)	Brooklyn	New York
United States	Investigational Site (516)	Houston	Texas
United States	Investigational Site (502)	Lawrenceville	Georgia
United States	Investigational Site (509)	Newark	New Jersey
United States	Investigational Site (512)	Orlando	Florida
United States	Investigational Site (501)	Phoenix	Arizona
United States	Investigational Site (523)	Phoenix	Arizona
United States	Investigational Site (524)	Tucson	Arizona
United States	Investigational Site (506)	Valencia	California

Sponsors (1)

Lead Sponsor	Collaborator
Alpine Immune Sciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Type, incidence, severity, and seriousness of AEs	Study Day 1 through 90 days after last dose of study drug