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Clinical Trials in the USA / NCT05732402
Active, not recruiting Phase 1/2

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

NCT05732402 · tracked via the Priya Life Science USA tracker
Sponsor
Alpine Immune Sciences, Inc.
Phase
Phase 1/2
Started
2023-03-15
Last updated
2025-10-14

Condition(s) studied

Lupus NephritisImmunoglobulin A NephropathyMembranous NephropathyAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Investigational drug(s) / intervention(s)

Povetacicept

Povetacicept: Administered by subcutaneous injection every 4 weeks

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria Summary: Part A: * Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) * On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1 * Indication-specific criteria: 1. IgAN * Biopsy-confirmed diagnosis less than or equal to (≤)10 years prior to the start of screening AND Screening UPCR greater than or equal to (≥)0.5 g/g. * No background immunosuppression therapies. 2. pMN * A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR ≥1 g/g * Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks. * No background immunosuppression therapies except for optional calcineurin inhibitors. 3. LN * A Biopsy-confirmed diagnosis of active, proliferative Class III, IV, (with or without Class V) LN ≤6 months prior to the start of screening AND Screening UPCR ≥1 g/g, * Anti-dsDNA at screening. Anti-dsDNA testing is required but the result need not be positive. * On stable background immunosuppression ≥ 8 weeks prior to Day 1 4. AAV * Past diagnosis of renal AAV, defined as either of the following: * History of renal biopsy consistent with renal AAV. * History of clinically diagnosed renal AAV. * Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening. * At least 4 weeks since initiation of AAV induction therapy, if applicable. Part B: * Participants meet at least 1 of the following criteria: * Completed investigational product (IP) treatment and 24 weeks of follow-up in Part A, or * Had IP interruption(s) in Part A, but did not permanently discontinue IP, and completed study visits up to the last scheduled visit of the follow-up period of Part A. Key Exclusion Criteria Summary: Part A: * Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease * eGFR \<30 milliliter per minute per square meter (mL/min/1.73m\^2) or rapidly progressive glomerulonephritis * Recent serious or ongoing infection; risk or history of serious infection * Receipt of B cell depleting therapies or anti-BAFF and/or APRIL therapies within protocol specified timeframes Part B: * History of poor compliance with IP and/or procedures in Part A, as deemed by the investigator or Sponsor * History of any AEs or clinical conditions during Part A or emerging thereafter that may pose a safety concern for participation in Part B as deemed by investigator or Sponsor. Other protocol defined Inclusion/Exclusion criteria will apply

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Investigational Site (523) Phoenix Arizona
Investigational Site (501) Phoenix Arizona
Investigational Site (524) Tucson Arizona
Investigational Site (506) Valencia California
Investigational Site (513) Arvada Colorado
Investigational Site (512) Orlando Florida
Investigational Site (525) Tamarac Florida
Investigational Site (502) Lawrenceville Georgia
The Johns Hopkins University School of Medicine Baltimore Maryland
Investigational Site (503) Boston Massachusetts
Washington University School of Medicine in St. Louis St Louis Missouri
Investigational Site (509) Newark New Jersey
Investigational Site (511) Albany New York
Investigational Site (508) Brooklyn New York
Investigational Site (518) Bethlehem Pennsylvania
Investigational Site (118) Colleyville Texas
Investigational Site (516) Houston Texas
Investigational Site (526) Irving Texas
Investigational Site (519) Concord New South Wales
Investigational Site (515) Saint Albans Victoria
Investigational Site (102) Nedlands Western Australia
Investigational Site (191) Caguas Puerto Rico
Investigational Site (507) Cheonan Chungcheongnam-do
Investigational Site (505) Anyang-si Gyeonggi-do
Investigational Site (504) Goyang-si Gyeonggi-do
Investigational Site (510) Guri-si Gyeonggi-do
Investigational Site (125) Seoul Gyeonggi-do
Investigational Site (520) Seoul Gyeonggi-do
Investigational Site (521) Seoul Gyeonggi-do
Investigational Site (116) Suwon Gyeonggi-do

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05732402 on ClinicalTrials.gov ↗ ← All trials in the USA