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An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Sponsor: Alpine Immune Sciences, Inc.
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
Conditions
Interventions
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