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Active (not recruiting) Phase 1/2 NCT05757570

An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias

Phase 1/2 – combined early trial
Conditions: Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Warm Autoimmune Hemolytic Anemia Cold Agglutinin Disease

Sponsor: Alpine Immune Sciences, Inc.

trial.available_in: БГ
Overview
The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.
Who can participate
Key Inclusion Criteria: 1. Indication-specific Criteria 1. Immune Thrombocytopenia (ITP) * Documented persistent or chronic primary ITP of at least 12 weeks duration from diagnosis to Cycle 1 Day 1 * 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 2. 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 \< lower limit of normal (LLN) (ii) indirect bilirubin \> upper limit of normal (ULN) (iii) lactate dehydrogenase\>ULN * History of failure or relapse to at least 2 treatment regimens for wAIHA 3. 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 during screening: (i) indirect bilirubin \>ULN and (ii) lactate dehydrogenase\>ULN or haptoglobin \<LLN * History of failure or relapse to at least 1 treatment regimen for CAD 2. (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations Key Exclusion Criteria: 1. Secondary AIHA, CAD, or ITP 2. Treatment with any of the following within the noted period prior to study entry 1. rituximab: \<12 weeks 2. IVIg: \<4 weeks 3. sutimlimab, any use after initiation of screening is exclusionary 4. plasmapheresis, plasma exchange, or double-filtration plasmapheresis: \<8 weeks 5. transfusions with blood, blood products or other rescue medications: \<2 weeks 6. splenectomy: \<12 weeks 7. 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 3. Recent serious or ongoing infection; risk or history of serious infection Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 9
Australia (1)
Investigational Site (410)
Box Hill
Canada (1)
Investigational Site (406)
Greenfield Park
Germany (1)
Investigational Site (438)
Essen
Italy (1)
Investigational Site (432)
Meldola
Norway (1)
Investigational Site (433)
Grålum
Spain (1)
Investigational Site (436)
Barcelona
Turkey (1)
Investigational Site (415)
Ankara
United Kingdom (1)
Investigational Site (442)
Leeds
United States (1)
Investigational Site (230)
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.07.2023
Completion date
01.07.2026
Registry ID
NCT05757570
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.