A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

• Status: Not yet recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zenas BioPharma (USA), LLC

Criteria

Inclusion Criteria:

1. Males and females, ≥ 18 years of age

2. Clinically diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA.

3. Diagnosis of primary or secondary wAIHA documented by a positive direct antiglobulin test specific for anti-IgG or anti-IgA.

4. Failed at least 1 prior wAIHA treatment regimen.

5. At least one sign or symptom of anemia as assessed by the investigator at screening.

6. Other inclusion criteria apply.

Exclusion Criteria:

1. Have cold antibody AIHA, cold agglutinin syndrome, mixed type (i.e., warm, and cold) AIHA, or paroxysmal cold hemoglobinuria.

2. Have any other associated cause of hereditary or acquired hemolytic anemia.

3. For the RCP only, patients with secondary wAIHA not due to autoimmune disorders, including LPDs.

4. Received a transfusion within 2 weeks prior to randomization.

5. Use of B cell-depleting, B cell-targeted, or other biologic immunomodulatory agents within the 6 months prior to randomization.

6. Received IV Ig or epoetin alfa within 6 weeks prior to randomization.

7. Receiving more than 2 concomitant medications for the treatment of wAIHA.

8. Other exclusion criteria apply.