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

Study acronym: RUBY-3
StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary and study completion dates: Jan 31, 2026 to Mar 2, 2028
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 121 words
    • Secondary endpoints: 12 to 21
    v19
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 296 to confirmed 72
    • Site details revised at 30 of 30 sites
    v18
  3. Study sites: 28 to 30v17
  4. Enrollment target: 56 to 296v16 Show 7 more changesShow less
    • Primary endpoint revised
    • Primary and study completion dates: Jan 2026 to Jan 31, 2026
    • Interventions: povetacicept (Drug), povetacicept (Drug) to Povetacicept (Drug)
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints expanded, about 148 words
    • Study arms: 2 to 1
    • Study title shortened, about 1 word
  5. Study sites: 31 to 28v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 30 to 31v14
  2. Study sites: 29 to 30v13
  3. Study sites: 24 to 29v12
  4. Eligibility criteria shortened, about 12 wordsv11
  5. Study sites: 22 to 24v10
  6. Enrollment target: 42 to 56
    • Eligibility criteria shortened, about 8 words
    v9
  7. Site details revised at 1 of 22 sitesv8
  8. Site details revised at 2 of 22 sitesv7
  9. Site details revised at 2 of 22 sitesv6
  10. Study sites: 14 to 22v5
  11. Phase: Phase 1 to Phase 1/2
    • Study sites: 6 to 14
    • Eligibility criteria expanded, about 132 words
    v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Mar 2023 to Mar 15, 2023
    v3
  13. Study title revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05732402
Lead Sponsor Alpine Immune Sciences, Inc.
Conditions
(from sponsor)		 Lupus Nephritis, Immunoglobulin A Nephropathy, Membranous Nephropathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Related terms Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Churg-Strauss Syndrome, Glomerulonephritis, IGA, Glomerulonephritis, Membranous, Granulomatosis with Polyangiitis, Lupus Nephritis, Microscopic Polyangiitis
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov