What side effects are associated with this type of intervention?

Common treatments for Autoimmune Hemolytic Anemia (AIHA) include corticosteroids, immunosuppressive drugs, and monoclonal antibodies like rituximab. Side effects of corticosteroids can include weight gain, hypertension, and increased risk of infections. Immunosuppressive drugs such as cyclophosphamide may cause bone marrow suppression, increased infection risk, and gastrointestinal issues. Monoclonal antibodies like rituximab can lead to infusion reactions, including fever, chills, and allergic reactions, as well as increased susceptibility to infections. Obexelimab, a monoclonal antibody targeting CD19 and FcγRIIb, is being studied for its efficacy and safety, with potential side effects likely similar to those of other monoclonal antibodies, including infusion reactions and immunosuppression.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments of Autoimmune Hemolytic Anemia (AIHA) that are directly comparable to obexelimab. However, treatments for AIHA often involve immunosuppressive therapies and monoclonal antibodies that target B cells. Rituximab, an anti-CD20 monoclonal antibody, has been used off-label for AIHA due to its ability to deplete B cells and reduce autoantibody production. Other treatments may include corticosteroids and immunosuppressive agents like cyclophosphamide. Obexelimab, which targets CD19 and FcγRIIb, represents a novel approach by specifically inhibiting B cell activity and reducing autoantibody production.

What other types of research exist?

Promising, novel alternatives to Obexelimab for Autoimmune Hemolytic Anemia (AIHA) patients include therapies such as Rituximab (a monoclonal antibody targeting CD20 to deplete B cells) and newer agents like Sutimlimab (a monoclonal antibody that inhibits the classical complement pathway by targeting C1s). These treatments are designed to reduce the production of autoantibodies and mitigate hemolysis, offering potential benefits for AIHA patients.

← Back to Search

Monoclonal Antibodies

Obexelimab for Autoimmune Hemolytic Anemia

Phase 3

Recruiting

Research Sponsored by Zenas BioPharma (USA), LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests obexelimab, an injectable medication, in patients with Warm Autoimmune Hemolytic Anemia who haven't responded to other treatments. It aims to manage the immune system's attack on red blood cells.

Who is the study for?

Adults diagnosed with Warm Autoimmune Hemolytic Anemia (wAIHA) who have tried at least one treatment without success can join. They must show symptoms of anemia and have had wAIHA for over three months. People can't join if they've had recent blood transfusions, used certain immune therapies in the past six months, or are on more than two wAIHA medications.

What is being tested?

The trial is testing Obexelimab's effectiveness and safety against a placebo in treating wAIHA. Participants will be randomly assigned to receive either Obexelimab or a placebo to compare outcomes between the two groups.

What are the potential side effects?

Potential side effects of Obexelimab may include reactions at the injection site, increased risk of infections, headaches, nausea, and possible immune system-related issues. The exact side effects will be monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Randomized Control Period (RCP)

Safety and Dose Confirmation Run-in Period (SRP)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Safety and Dose Confirmation Run-in Period (SRP): ObexelimabExperimental Treatment1 Intervention

Obexelimab will be administered as an SC injection for 24 weeks.

Group II: Randomized Control Period (RCP): ObexelimabExperimental Treatment1 Intervention

Obexelimab will be administered as an SC injection for 24 weeks.

Group III: Randomized Control Period (RCP): PlaceboPlacebo Group1 Intervention

Placebo will be administered as an SC injection for 24 weeks

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Autoimmune Hemolytic Anemia (AIHA) include corticosteroids, immunosuppressive agents, and monoclonal antibodies. Corticosteroids, such as prednisone, work by broadly suppressing the immune system, reducing inflammation, and decreasing the production of autoantibodies that target red blood cells. Immunosuppressive agents like cyclophosphamide further inhibit the immune response by targeting rapidly dividing cells, including those of the immune system. Monoclonal antibodies, such as rituximab, target specific proteins on B cells (e.g., CD20) to deplete these cells and reduce autoantibody production. Obexelimab, a monoclonal antibody under investigation, targets CD19 and FcγRIIb to inhibit B cell activity and reduce autoantibody production. These mechanisms are crucial for AIHA patients as they directly address the underlying autoimmune process, helping to prevent the destruction of red blood cells and manage the disease more effectively.