Active — Not RecruitingPhase 3

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

Italy, Poland, Spain134 participantsStarted 2023-09-25

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

Safety and Dose Confirmation Run-in Period (SRP)

Timeframe: 24 weeks

Randomized Control Period (RCP)

Timeframe: 24 weeks

NCT IDNCT05786573

SponsorZenas BioPharma (USA), LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.