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

Last updated: March 5, 2025
Sponsor: Alpine Immune Sciences, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Collagen Vascular Diseases

Vascular Diseases

Kidney Disease

Treatment

povetacicept

Povetacicept

Clinical Study ID

NCT05732402
AIS-D03
  • Ages > 18
  • All Genders

Study 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 .

Eligibility Criteria

Inclusion

Key Inclusion Criteria Summary:

  1. Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) 2.

Indication-specific criteria:

a. 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.

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.

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,

  • Positive anti-dsDNA at screening

  • On stable background immunosuppression ≥ 8 weeks prior to Day 1

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.

  1. On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1

Key Exclusion Criteria Summary:

  1. Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease

  2. eGFR <30 (milliliter per minute per square meter (mL/min/1.73m^2) or rapidly progressive glomerulonephritis

  3. Recent serious or ongoing infection; risk or history of serious infection

  4. Receipt of B cell depleting therapies or anti-BAFFand/or APRIL therapies within protocol specified timeframes

Study Design

Total Participants: 296
Treatment Group(s): 2
Primary Treatment: povetacicept
Phase: 1/2
Study Start date:
March 15, 2023
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Investigational Site (519)

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Investigational Site (515)

    Saint Albans, Victoria 3021
    Australia

    Active - Recruiting

  • Investigational Site (102)

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Investigational Site (434)

    Vienna, 1090
    Austria

    Site Not Available

  • Investigational Site (507)

    Cheonan, Chungcheongnam-do 31151
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (505)

    Anyang-si, Gyeonggi-do 14068
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (504)

    Goyang-si, Gyeonggi-do 10444
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (510)

    Guri-si, Gyeonggi-do 11923
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (125)

    Seoul, Gyeonggi-do 03080
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (520)

    Seoul, Gyeonggi-do 03181
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (521)

    Seoul, Gyeonggi-do 05278
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (116)

    Suwon-si, Gyeonggi-do 16499
    Korea, Republic of

    Active - Recruiting

  • Investigational Site (437)

    Trondheim, Trondelag 7030
    Norway

    Site Not Available

  • Investigational Site (433)

    Sarpsborg, 47014
    Norway

    Site Not Available

  • Investigational Site (191)

    Caguas, 00725
    Puerto Rico

    Active - Recruiting

  • Investigational Site (436)

    Barcelona, Community Of Catalonia 08003
    Spain

    Site Not Available

  • Investigational Site (439)

    London, England E1 1BB
    United Kingdom

    Site Not Available

  • Investigational Site (501)

    Phoenix, Arizona 85302
    United States

    Active - Recruiting

  • Investigational Site (523)

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Investigational Site (524)

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Investigational Site (506)

    Valencia, California 91335
    United States

    Active - Recruiting

  • Investigational Site (513)

    Arvada, Colorado 80002
    United States

    Active - Recruiting

  • Investigational Site (512)

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Investigational Site (525)

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Investigational Site (502)

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Investigational Site (503)

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Investigational Site (509)

    Newark, New Jersey 07103
    United States

    Active - Recruiting

  • Investigational Site (511)

    Albany, New York 12209
    United States

    Active - Recruiting

  • Investigational Site (508)

    Brooklyn, New York 11203
    United States

    Active - Recruiting

  • Investigational Site (518)

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • Investigational Site (118)

    Colleyville, Texas 76034
    United States

    Active - Recruiting

  • Investigational Site (516)

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Investigational Site (526)

    Irving, Texas 75061
    United States

    Active - Recruiting

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