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

Phase 1

Recruiting

• Conditions: Lupus Nephritis; Immunoglobulin A Nephropathy; Membranous Nephropathy; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Interventions: Drug: povetacicept

• Registration Number: NCT05732402
• Lead Sponsor: Alpine Immune Sciences, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Study Start: 2023-03-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
povetacicept 80mg	povetacicept	-
povetacicept 240mg	povetacicept	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	Study Day 1 through 90 days after last dose of study drug	Type, incidence, severity, and seriousness of AEs

Trial Locations

Locations (28)

Investigational Site (523); 🇺🇸 Phoenix, Arizona, United States

Investigational Site (507); 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of

Investigational Site (524); 🇺🇸 Tucson, Arizona, United States

Investigational Site (502); 🇺🇸 Lawrenceville, Georgia, United States

Investigational Site (118); 🇺🇸 Colleyville, Texas, United States

Investigational Site (519); 🇦🇺 Concord, New South Wales, Australia

Investigational Site (102); 🇦🇺 Nedlands, Western Australia, Australia

Investigational Site (512); 🇺🇸 Orlando, Florida, United States

Investigational Site (515); 🇦🇺 Saint Albans, Victoria, Australia

Investigational Site (504); 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Investigational Site (501); 🇺🇸 Phoenix, Arizona, United States

Investigational Site (506); 🇺🇸 Valencia, California, United States

Investigational Site (511); 🇺🇸 Albany, New York, United States

Investigational Site (526); 🇺🇸 Irving, Texas, United States

Investigational Site (191); 🇵🇷 Caguas, Puerto Rico

Investigational Site (509); 🇺🇸 Newark, New Jersey, United States

Investigational Site (510); 🇰🇷 Guri-si, Gyeonggi-do, Korea, Republic of

Investigational Site (125); 🇰🇷 Seoul, Gyeonggi-do, Korea, Republic of

Investigational Site (516); 🇺🇸 Houston, Texas, United States

Investigational Site (503); 🇺🇸 Boston, Massachusetts, United States

Investigational Site (521); 🇰🇷 Seoul, Gyeonggi-do, Korea, Republic of

Investigational Site (505); 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of

Investigational Site (116); 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

Investigational Site (525); 🇺🇸 Tamarac, Florida, United States

Investigational Site (508); 🇺🇸 Brooklyn, New York, United States

Investigational Site (513); 🇺🇸 Arvada, Colorado, United States

Investigational Site (518); 🇺🇸 Bethlehem, Pennsylvania, United States

Investigational Site (520); 🇰🇷 Seoul, Gyeonggi-do, Korea, Republic of