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An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases (RUBY-3)

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ClinicalTrials.gov Identifier: NCT05732402
Recruitment Status : Recruiting
First Posted : February 17, 2023
Last Update Posted : May 17, 2024
Sponsor:
Information provided by (Responsible Party):
Alpine Immune Sciences, Inc.

Brief Summary:

The goal of this clinical study is to evaluate multiple dose levels of povetacicept (ALPN-303) 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.


Condition or disease Intervention/treatment Phase
Lupus Nephritis Immunoglobulin A Nephropathy Membranous Nephropathy Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Drug: povetacicept Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026


Arm Intervention/treatment
Experimental: povetacicept 80mg Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Name: ALPN-303

Experimental: povetacicept 240mg Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Name: ALPN-303




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Study Day 1 through 90 days after last dose of study drug ]
    Type, incidence, severity, and seriousness of AEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. IgAN

      • Biopsy-confirmed diagnosis ≤10 years prior to the start of screening AND Screening UPCR ≥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.

    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.
  3. 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 mL/min/1.73m2 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-BAFF/APRIL therapies within protocol specified timeframes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05732402


Contacts
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Contact: Sarah Murphy 919-786-8898 sarah.murphy@iconplc.com

Locations
Show Show 29 study locations
Sponsors and Collaborators
Alpine Immune Sciences, Inc.
Investigators
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Study Director: Jiahua Li, M.D. Alpine Immune Sciences, Inc.
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Responsible Party: Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier: NCT05732402    
Other Study ID Numbers: AIS-D03
First Posted: February 17, 2023    Key Record Dates
Last Update Posted: May 17, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpine Immune Sciences, Inc.:
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:
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Kidney Diseases
Nephritis
Lupus Nephritis
Glomerulonephritis, Membranous
Glomerulonephritis, IGA
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Vascular Diseases
Cardiovascular Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Systemic Vasculitis
Skin Diseases, Vascular
Skin Diseases