An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
- Conditions
- Lupus NephritisImmunoglobulin A NephropathyMembranous NephropathyAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Interventions
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
Not provided
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 Immunological Remission At 12, 24, 36, 48, and 52 Weeks 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 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
Scroll for more (20 remaining)Investigational Site (523)🇺🇸Phoenix, Arizona, United States