ACTIVE_NOT_RECRUITING

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

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Conditions

Lupus NephritisImmunoglobulin A NephropathyMembranous NephropathyAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisIgA nephropathyglomerulonephritis, IgABerger diseaselupus glomerulonephritidesprimary membranous nephropathyglomerulonephritis, membranousPLA2RTHSD7AALPN-303povetaciceptRUBY-3RUBY3Gd-IgA1GdIgA1anti-neutrophil cytoplasmic antibody associated vasculitisANCA VasculitisAAVMicroscopic polyangiitisGranulomatosis with polyangiitisEosinophilic granulomatosis with polyangiitisWegener's granulomatosisChurg-Strauss DiseaseMyeloperoxidase (MPO)Proteinase 3 (PR3)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases (RUBY-3)

Quick Facts

Study Start:2023-03-15
Study Completion:2028-03-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05732402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Investigational Site (523)
Phoenix, Arizona, 85016
United States
Investigational Site (501)
Phoenix, Arizona, 85302
United States
Investigational Site (524)
Tucson, Arizona, 85712
United States
Investigational Site (506)
Valencia, California, 91335
United States
Investigational Site (513)
Arvada, Colorado, 80002
United States
Investigational Site (512)
Orlando, Florida, 32806
United States
Investigational Site (525)
Tamarac, Florida, 33321
United States
Investigational Site (502)
Lawrenceville, Georgia, 30046
United States
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
United States
Investigational Site (503)
Boston, Massachusetts, 02115
United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
United States
Investigational Site (509)
Newark, New Jersey, 07103
United States
Investigational Site (511)
Albany, New York, 12209
United States
Investigational Site (508)
Brooklyn, New York, 11203
United States
Investigational Site (518)
Bethlehem, Pennsylvania, 18017
United States
Investigational Site (118)
Colleyville, Texas, 76034
United States
Investigational Site (516)
Houston, Texas, 77054
United States
Investigational Site (526)
Irving, Texas, 75061
United States

Collaborators and Investigators

Sponsor: Alpine Immune Sciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15
Study Completion Date2028-03-02

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2028-03-02

Terms related to this study

Keywords Provided by Researchers

  • IgA nephropathy
  • glomerulonephritis, IgA
  • Immunoglobulin A nephropathy
  • Berger disease
  • lupus nephritis
  • lupus glomerulonephritides
  • primary membranous nephropathy
  • membranous nephropathy
  • glomerulonephritis, membranous
  • PLA2R
  • THSD7A
  • ALPN-303
  • povetacicept
  • RUBY-3
  • RUBY3
  • Gd-IgA1
  • GdIgA1
  • anti-neutrophil cytoplasmic antibody associated vasculitis
  • ANCA Vasculitis
  • AAV
  • Microscopic polyangiitis
  • Granulomatosis with polyangiitis
  • Eosinophilic granulomatosis with polyangiitis
  • Wegener's granulomatosis
  • Churg-Strauss Disease
  • Myeloperoxidase (MPO)
  • Proteinase 3 (PR3)

Additional Relevant MeSH Terms

  • Lupus Nephritis
  • Immunoglobulin A Nephropathy
  • Membranous Nephropathy
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis