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 sites126 target enrollmentNovember 30, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Autoimmune Cytopenias (warm autoimmune hemolytic anemia [wAIHA], cold agglutinin disease [CAD], immune thrombocytopenia [ITP])
Sponsor: Alpine Immune Sciences Inc.
Enrollment: 126
Status: Recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

November 30, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Alpine Immune Sciences Inc.

•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.