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Actively Recruiting
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
About
Brief Summary
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Males and females, ≥ 18 years of age
- Clinically diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA.
- Diagnosis of primary or secondary wAIHA documented by a positive direct antiglobulin test specific for anti-IgG or anti-IgA.
- Failed at least 1 prior wAIHA treatment regimen.
- At least one sign or symptom of anemia as assessed by the investigator at screening.
6. Other inclusion criteria apply.
Exclusion Criteria:
- Have cold antibody AIHA, cold agglutinin syndrome, mixed type (i.e., warm, and cold) AIHA, or paroxysmal cold hemoglobinuria.
- Have any other associated cause of hereditary or acquired hemolytic anemia.
- For the RCP only, patients with secondary wAIHA not due to autoimmune disorders, including LPDs.
- Received a transfusion within 2 weeks prior to randomization.
- Use of B cell-depleting, B cell-targeted, or other biologic immunomodulatory agents within the 6 months prior to randomization.
- Received IV Ig or epoetin alfa within 6 weeks prior to randomization.
- Receiving more than 2 concomitant medications for the treatment of wAIHA.
8. Other exclusion criteria apply.
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Study Stats
Protocol No.
23-000522
Category
Blood Disorders
Principal Investigator
Contact
Location
- UCLA Westwood