What side effects are associated with this type of intervention?

Common treatments for Autoimmune Hemolytic Anemia (AIHA) include monoclonal antibodies like rituximab, which target B cells. Known side effects of rituximab include infusion reactions, which can be severe during the first cycle, especially in patients with high white blood cell counts. Other side effects may include infections, serum-sickness-like reactions, and in rare cases, progressive multifocal leukoencephalopathy (PML). These side effects are important considerations when evaluating the safety and efficacy of similar treatments like Ianalumab.

What prior FDA approvals exist?

The FDA has approved several treatments for Autoimmune Hemolytic Anemia (AIHA), though specific approvals for monoclonal antibodies targeting B cells like Ianalumab are limited. Rituximab, another monoclonal antibody that targets CD20 on B cells, has been used off-label for AIHA and has shown efficacy in clinical practice. Rituximab is primarily approved for conditions such as non-Hodgkin's lymphoma and chronic lymphocytic leukemia but has been widely adopted for various autoimmune diseases, including AIHA. Other treatments for AIHA typically include corticosteroids, immunosuppressive agents, and splenectomy, but these are not monoclonal antibodies targeting B cells.

What other types of research exist?

Promising novel alternatives to Ianalumab for Autoimmune Hemolytic Anemia patients in 2024 could include Rituximab, which is a well-established monoclonal antibody targeting CD20 on B cells, and newer agents like Ofatumumab and Obinutuzumab, which also target CD20 with potentially different efficacy and safety profiles. Additionally, therapies targeting other pathways involved in AIHA, such as complement inhibitors (e.g., Eculizumab), may also be considered.

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Monoclonal Antibodies

Ianalumab for Autoimmune Hemolytic Anemia (VAYHIA Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Patients must be 18 years and older at the time of signing consent

Hemoglobin concentration at screening <10 g/dL, associated with presence of symptoms related to anemia

Must not have

Presence of other forms of AIHA (cold or intermediate forms), Evans Syndrome or other cytopenias

Live or live-attenuated vaccination within 4 weeks before randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to end of study (up to 39 months after randomization of last patient)

Awards & highlights

Pivotal Trial

Summary

This trial is testing ianalumab, a new medication, in patients with warm autoimmune hemolytic anemia who haven't responded to other treatments. The goal is to see if ianalumab can help increase and maintain their hemoglobin levels.

Who is the study for?

This trial is for adults with warm autoimmune hemolytic anemia (wAIHA) who haven't had success with at least one previous treatment. They should have symptoms related to anemia and a hemoglobin level below 10 g/dL. Participants must not have changed their supportive care dose in the last four weeks.

What is being tested?

The study is testing Ianalumab against a placebo in patients with wAIHA who didn't respond well to past treatments. The goal is to see if Ianalumab is more effective and safe compared to not receiving the active drug.

What are the potential side effects?

While specific side effects of Ianalumab are not listed, common ones may include reactions at the injection site, increased risk of infections, potential liver issues, or other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My hemoglobin is below 10 g/dL and I feel tired or weak.

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My hemoglobin levels are between 5 and 10 g/dL, and I feel symptoms of anemia.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a type of anemia or low blood cell counts not caused by iron deficiency.

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I have not received a live vaccine in the last 4 weeks.

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I do not have any current infections needing treatment, including COVID-19.

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I have had my spleen removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to end of study (up to 39 months after randomization of last patient)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to end of study (up to 39 months after randomization of last patient)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to end of study (up to 39 months after randomization of last patient) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Binary variable indicating whether a patient achieves a durable response

Secondary study objectives

Change from baseline in immunoglobulin levels

Change from baseline in the 8 domain scores and in the summary scores (PCS, MCS) of SF-36 questionnaire

Change from baseline in the T-score of PROMIS Fatigue-13a questionnaire

+17 more

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: Ianalumab low doseExperimental Treatment1 Intervention

Participants will receive low dose ianalumab intravenously

Group II: Ianalumab high doseExperimental Treatment1 Intervention

Participants will receive high dose ianalumab intravenously

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo intravenously

0 / 8Eligibility criteria met

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

Common treatments for Autoimmune Hemolytic Anemia (AIHA) include corticosteroids, immunosuppressive drugs, and monoclonal antibodies. Corticosteroids, such as prednisone, work by reducing inflammation and suppressing the immune system's attack on red blood cells. Immunosuppressive drugs like cyclophosphamide inhibit the proliferation of immune cells that target red blood cells. Monoclonal antibodies, such as rituximab and ianalumab, target B cells, which are responsible for producing the antibodies that attack red blood cells. These treatments are crucial for AIHA patients as they help to reduce the destruction of red blood cells, alleviate symptoms, and improve overall quality of life by modulating the immune response.