An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular 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 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: 2025-02
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Povetacicept	Povetacicept	Participants will receive Povetacicept for 24 weeks with the possibility of participating in treatment extensions through 104 weeks of treatment.

Primary Outcome Measures

Name	Time	Method
Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug

Secondary Outcome Measures

Name	Time	Method
Time Required for Povetacicept To Reach Half its Concentration (t1/2)	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Change from Baseline in Peripheral Blood Lymphocytes and Subsets	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Change from Baseline Over Time In Circulating Levels Of anti-dsDNA in LN; galactose deficient IgA1 (Gd-IgA1); anti-PLA2R1 or anti THSD7A in pMN and anti-PR3 or anti-MPO in Anti-neutrophil Cytoplasmic Antibody Associated Vasculitis (AAV)	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE).	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Change From Baseline Over Time In Complement Components (C3, C4, CH50)	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Immunological Remission	At 12, 24, 36, 48, and 52 Weeks
Change from Baseline at Week 24 in UPCR(Urine protein/creatinine ratio) (based on assessment of 24-hour urine)	Baseline and at Week 24
Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)	Baseline and at Week 24
Renal Response	At Week 24
Remission of Vasculitis (Birmingham Vasculitis Activity Score (BVAS = 0)) (for AAV cohorts only)	At Week 24
Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept	Study Day 1 Through 24 Weeks After Last Dose Of Study Drug

Trial Locations

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; 🇺🇸 Saint Louis, Missouri, United States

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

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

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

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

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

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

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