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An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias (RUBY-4)

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Sponsor changed: Alpine Immune Sciences, Inc. to Alpine Immune Sciences Inc, A Subsidiary of Vertex Trial completed · Interventions modified · Primary and study completion dates changed from estimate of Jul 2026 to Aug 12, 2026 · 1 morev17 Show 4 more changesShow less
    • Trial completed
    • Interventions modified
    • Primary and study completion dates changed from estimate of Jul 2026 to Aug 12, 2026
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Re-verified, no change to tracked fieldsv16
  3. Notable Primary and study completion dates: Nov 2027 to Jul 2026 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 126 to confirmed 30 · Site details revised at 44 of 44 sitesv15 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 126 to confirmed 30
    • Site details revised at 44 of 44 sites
  4. Minor Site details revised at 4 of 44 sitesv14
  5. Minor Study sites: 39 to 44v13
Show 11 earlier versionsHide 11 earlier versions
  1. Notable Primary endpoint revised Eligibility criteria expanded, about 25 words · Study title revised · Study arms: 3 to 2v12 Show 3 more changesShow less
    • Eligibility criteria expanded, about 25 words
    • Study title revised
    • Study arms: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study sites: 32 to 39v11
  3. Minor Study sites: 26 to 32v10
  4. Minor Study sites: 25 to 26v9
  5. Minor Study sites: 21 to 25v8
  6. Minor Study sites: 19 to 21v7
  7. Minor Study sites: 17 to 19v6
  8. Notable Phase: Phase 1 to Phase 1/2 Enrollment target: 42 to 126 · Study sites: 9 to 17 · Study arms: 1 to 3 · 2 morev5 Show 5 more changesShow less
    • Enrollment target: 42 to 126
    • Study sites: 9 to 17
    • Study arms: 1 to 3
    • Eligibility criteria expanded, about 5 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Minor Study sites: 5 to 9v4
  10. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of May 2023 to Jul 3, 2023 · Study title expanded, about 1 wordv3 Show 3 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of May 2023 to Jul 3, 2023
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Minor Study title revisedv2 See this version in full on ClinicalTrials.gov ↗
  1. Minor 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 povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease 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 study treatment extension period.
Trial Details
NCT Number NCT05757570
Lead Sponsor Alpine Immune Sciences Inc, A Subsidiary of Vertex
Conditions Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov