← Back to all trials
Active Not Recruiting
NCT05757570
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias
Conditions: Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: Alpine Immune Sciences, Inc.
Location: Investigational Site (230) Los Angeles California
Summary
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.
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 \ 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 \
Source: ClinicalTrials.gov (NCT05757570). StuddyBuddy aggregates publicly available trial information.