An Open-label Study of Povetacicept (ALPN-303) in Subjects With Autoimmune Cytopenias (RUBY-4)
Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Warm Autoimmune Hemolytic Anemia
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease, Autoimmune Cytopenia, Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura, Hemolytic Anemia, RUBY4, RUBY-4, Povetacicept, ALPN-303, ALPN303, Autoimmune Hemolytic Anemia, ITP, wAIHA, AIHA, CAD
Eligibility Criteria
Summary of Key Inclusion Criteria: Indication-specific Criteria Immune Thrombocytopenia (ITP) Documented primary ITP of at least 12 weeks duration History of failure or relapse to at least 2 treatment regimens for ITP History of exposure to a TPO-RA unless otherwise contraindicated or unavailable Documented history of platelets <30 × 10^9/L 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 ≤9 g/dL At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >ULN (iii) lactate dehydrogenase>ULN History of failure or relapse to at least 2 treatment regimens for wAIHA 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 ≤9 g/dL At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >ULN (iii) lactate dehydrogenase>ULN History of failure or relapse to at least 2 treatment regimens for CAD (All indications) If receiving standard-of-care medications, doses must be stable for protocol-specified durations Summary of Key Exclusion Criteria: Secondary AIHA, CAD, or ITP Treatment with any of the following within the noted period prior to study entry rituximab: 12 weeks IVIG, sutimlimab, other marketed biologic therapeutics: 8 weeks plasmapheresis, plasma exchange, or double-filtration plasmapheresis: 8 weeks transfusions with blood, blood products or other rescue medications: 2 weeks splenectomy: 12 weeks other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization by the applicable national health authority: 5 half-lives and requires agreement of the Medical Monitor Recent serious or ongoing infection; risk or history of serious infection
Sites / Locations
- Investigational Site (230)Recruiting
- Investigational Site (401)Recruiting
- Investigational Site (419)Recruiting
- Investigational Site (219)Recruiting
- Investigational Site (402)Recruiting
- Investigational Site (409)Recruiting
- Investigational Site (407)Recruiting
- Investigational Site (403)Recruiting
- Investigational Site (415)Recruiting
Arms of the Study
Arm 1
Experimental
povetacicept 240mg