Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects with Autoimmune Cytopenias (RUBY-4) - AIS-D04

Alpine Immune Sciences Inc.0 个研究点目标入组 126 人开始时间: 2023年11月30日最近更新: 2024年8月21日

适应症

试验速览

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•Indication-specific Criteria a. 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 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 =9 g/dL * At least one of the following: (i) haptoglobin ULN (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 =9 g/dL * At least one of the following: (i) haptoglobin ULN (iii) lactate dehydrogenase >ULN * History of failure or relapse to at least 1 treatment regimen for CAD, (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations

•Secondary AIHA, CAD, or ITP, Treatment with any of the following within the noted period prior to study entry a. rituximab: <12 weeks b. IVIg: <4 weeks c. sutimlimab, other marketed biologic therapeutics: <8 weeks d. plasmapheresis, plasma exchange, or double-filtration plasmapheresis: <8 weeks e. transfusions with blood, blood products or other rescue medications: 2 weeks f. splenectomy: <12 weeks g. other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization or approved 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.

发起方

Alpine Immune Sciences Inc.