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])
- Registration Number
- 2023-507067-19-00
- Lead Sponsor
- Alpine Immune Sciences Inc.
- Brief Summary
To evaluate the safety and tolerability of povetacicept in subjects with autoimmune cytopenias.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Not specified
- Target Recruitment
- 30
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
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: any use after initiation of screening is exclusionary, 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type, incidence, severity, and seriousness of AEs. Type, incidence, severity, and seriousness of AEs.
- Secondary Outcome Measures
Name Time Method Assessment of efficacy, PK, and ADA Assessment of efficacy, PK, and ADA
Trial Locations
- Locations (44)
Investigational Site (230)
🇺🇸Los Angeles, California, United States
Investigational Site (401)
🇺🇸Washington, District of Columbia, United States
Investigational Site (419)
🇺🇸Cooper City, Florida, United States
Investigational Site (425)
🇺🇸Miami, Florida, United States
Investigational Site (219)
🇺🇸Iowa City, Iowa, United States
Investigational Site (435)
🇺🇸Columbia, Maryland, United States
Investigational Site (422)
🇺🇸Bronx, New York, United States
Investigational site (405)
🇺🇸Lake Success, New York, United States
Investigational Site (423)
🇺🇸New Hyde Park, New York, United States
Investigational Site (421)
🇺🇸New York, New York, United States
Scroll for more (34 remaining)Investigational Site (230)🇺🇸Los Angeles, California, United States