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

You may be able to join if

• Indication-specific Criteria a. Immune Thrombocytopenia (ITP) * Documented persistent or chronic primary ITP of at least 12 weeks duration * History of failure or relapse to at least 2 treatment regimens for ITP * A documented history of response to IVIg or steroids * History of exposure to a TPO-RA unless otherwise contraindicated or unavailable * Documented history of platelets <30 × 10^9/L b. 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 * At least one of the following: (i) haptoglobin LLN (iii) lactate dehydrogenase >ULN * History of failure or relapse to at least 2 treatment regimens for wAIHA c. Cold Agglutinin Disease (CAD) * Diagnosis of primary CAD of at least 12 weeks duration with all of the following: (i) chronic hemolysis (ii) polyspecific DAT positive (iii) monospecific DAT strongly positive for C3d (iv) cold agglutinin titer ≥64 at 4°C (v) IgG DAT ≤1+ (vi) no overt malignant disease * Documented history of anemia with hemoglobin ≤10 g/dL * Evidence of hemolysis: (i) indirect bilirubin>ULN and (ii) lactate dehydrogenase >ULN or haptoglobin
• (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations
• Indication-specific Criteria for Warm Autoimmune Hemolytic Anemia (wAIHA) and Cold Agglutinin Disease (CAD): Documentation of folic acid and vitamin B12 within normal ranges