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

Launched by ALPINE IMMUNE SCIENCES, INC. · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called povetacicept for adults with certain blood disorders known as autoimmune cytopenias, which include immune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease. The main goal is to see if povetacicept is safe and can help improve these conditions. Participants in the study will receive povetacicept approximately every four weeks for six months, with an option to continue treatment for an additional six months if desired.

To be eligible for this trial, participants must have been diagnosed with one of the targeted conditions for at least 12 weeks and have previously tried at least two other treatments without success. Key requirements include having low platelet counts for immune thrombocytopenia or low hemoglobin levels for the other conditions. Participants will be monitored closely during the study to ensure their safety. It’s important to note that individuals with certain other medical conditions or recent treatments may not qualify for this trial. Overall, this study aims to explore a potential new option for patients struggling with these challenging blood disorders.

Gender

ALL

Eligibility criteria

• 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.