Open Actively Recruiting
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
- 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.
- Other inclusion criteria apply.
- 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.
- Other exclusion criteria apply.
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- UCLA Westwood