An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)
- Conditions
- Autoimmune Cytopenias (warm autoimmune hemolytic anemia [wAIHA], cold agglutinin disease [CAD], immune thrombocytopenia [ITP])MedDRA version: 20.0Level: LLTClassification code: 10068863Term: Cold agglutinin disease Class: 10005329MedDRA version: 23.0Level: PTClassification code: 10083842Term: Immune thrombocytopenia Class: 100000004851MedDRA version: 25.0Level: LLTClassification code: 10087092Term: Warm autoimmune hemolytic anemia Class: 100000004848Therapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2023-507067-19-00
- Lead Sponsor
- Alpine Immune Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 126
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of povetacicept in subjects with autoimmune cytopenias.;Secondary Objective: To assess the efficacy of povetacicept in subjects with autoimmune cytopenias., To assess the PK of povetacicept in subjects with autoimmune cytopenias., To assess the incidence of anti-drug antibodies (ADA) against povetacicept in subjects with autoimmune cytopenias.;Primary end point(s): Type, incidence, severity, and seriousness of AEs.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Assessment of efficacy, PK, and ADA