Benign Hematology

A Phase 1b, Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects with Autoimmune Cytopenias (RUBY-4)

Brief Summary: 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. 

Key Eligibility Criteria:

• Immune Thrombocytopenia (ITP):
  • Documented persistent or chronic primary ITP of at least 12 weeks duration from diagnosis to Cycle 1 Day 1
  • History of failure or relapse to at least 2 treatment regimens for ITP
• Warm Autoimmune Hemolytic Anemia (wAIHA):
  • Diagnosis of primary wAIHA of at least 12 weeks duration documented with a current or prior positive direct antiglobulin test (DAT) for anti-IgG (±C3d)
  • Documented history of anemia with hemoglobin ≤10 g/dL
• Cold Agglutinin Disease (CAD):
  • Diagnosis of primary CAD of at least 12 weeks duration 
  • Documented history of anemia with hemoglobin ≤10 g/dL
• Secondary AIHA, CAD, or ITP excluded