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An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases
The goal of this clinical study is to assess 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, patients 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.
Conditions:
🦠 Lupus Nephritis 🦠 Immunoglobulin A Nephropathy 🦠 Membranous Nephropathy 🦠 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
🗓️ Study Start (Actual) 15 March 2023
🗓️ Primary Completion (Estimated) January 2026
✅ Study Completion (Estimated) January 2026
👥 Enrollment (Estimated) 56
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Phoenix, Arizona, United States
📍 Phoenix, Arizona, United States
📍 Tucson, Arizona, United States
📍 Valencia, California, United States
📍 Arvada, Colorado, United States
📍 Orlando, Florida, United States
📍 Tamarac, Florida, United States
📍 Lawrenceville, Georgia, United States
📍 Boston, Massachusetts, United States
📍 Newark, New Jersey, United States
📍 Albany, New York, United States
📍 Brooklyn, New York, United States
📍 Bethlehem, Pennsylvania, United States
📍 Colleyville, Texas, United States
📍 Houston, Texas, United States
📍 Irving, Texas, United States
📍 Concord, New South Wales, Australia
📍 Saint Albans, Victoria, Australia
📍 Nedlands, Western Australia, Australia
📍 Cheonan, Chungcheongnam-do, Korea, Republic of
📍 Anyang-si, Gyeonggi-do, Korea, Republic of
📍 Goyang-si, Gyeonggi-do, Korea, Republic of
📍 Guri-si, Gyeonggi-do, Korea, Republic of
📍 Seoul, Gyeonggi-do, Korea, Republic of
📍 Seoul, Gyeonggi-do, Korea, Republic of
📍 Seoul, Gyeonggi-do, Korea, Republic of
📍 Suwon-si, Gyeonggi-do, Korea, Republic of
📍 Caguas, Puerto Rico
More locations available...

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 8 February 2023
  • First Submitted that Met QC Criteria 8 February 2023
  • First Posted 17 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2024
  • Last Update Posted 19 July 2024
  • Last Verified July 2024
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