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ACTIVE NOT RECRUITING
NCT05732402
PHASE1/PHASE2

An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases

Sponsor: Alpine Immune Sciences, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis - LN), or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) 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. Participants with IgAN and pMN may also receive povetacicept for an additional 52 weeks, if eligible.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2023-03-15

Completion Date

2028-03-02

Last Updated

2025-10-14

Healthy Volunteers

No

Interventions

DRUG

Povetacicept

Administered by subcutaneous injection every 4 weeks

Locations (30)

Investigational Site (523)

Phoenix, Arizona, United States

Investigational Site (501)

Phoenix, Arizona, United States

Investigational Site (524)

Tucson, Arizona, United States

Investigational Site (506)

Valencia, California, United States

Investigational Site (513)

Arvada, Colorado, United States

Investigational Site (512)

Orlando, Florida, United States

Investigational Site (525)

Tamarac, Florida, United States

Investigational Site (502)

Lawrenceville, Georgia, United States

The Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Investigational Site (503)

Boston, Massachusetts, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Investigational Site (509)

Newark, New Jersey, United States

Investigational Site (511)

Albany, New York, United States

Investigational Site (508)

Brooklyn, New York, United States

Investigational Site (518)

Bethlehem, Pennsylvania, United States

Investigational Site (118)

Colleyville, Texas, United States

Investigational Site (516)

Houston, Texas, United States

Investigational Site (526)

Irving, Texas, United States

Investigational Site (519)

Concord, New South Wales, Australia

Investigational Site (515)

Saint Albans, Victoria, Australia

Investigational Site (102)

Nedlands, Western Australia, Australia

Investigational Site (191)

Caguas, Puerto Rico

Investigational Site (507)

Cheonan, Chungcheongnam-do, South Korea

Investigational Site (505)

Anyang-si, Gyeonggi-do, South Korea

Investigational Site (504)

Goyang-si, Gyeonggi-do, South Korea

Investigational Site (510)

Guri-si, Gyeonggi-do, South Korea

Investigational Site (125)

Seoul, Gyeonggi-do, South Korea

Investigational Site (520)

Seoul, Gyeonggi-do, South Korea

Investigational Site (521)

Seoul, Gyeonggi-do, South Korea

Investigational Site (116)

Suwon, Gyeonggi-do, South Korea