What side effects are associated with this type of intervention?

Common treatments for Cold Agglutinin Disease (CAD) often involve immune modulation therapies such as rituximab, which targets CD20 on B cells. Side effects of rituximab can include infusion reactions, infections, and hematologic toxicities. Other immune modulators like corticosteroids may cause weight gain, hypertension, and increased risk of infections. The trial drug povetacicept, being studied for autoimmune cytopenias including CAD, aims to modulate the immune system, and its safety profile is still under evaluation.

What prior FDA approvals exist?

Cold Agglutinin Disease (CAD) is a rare autoimmune hemolytic anemia. The FDA has approved treatments such as rituximab, a monoclonal antibody targeting CD20 on B cells, which helps reduce the production of cold agglutinins. Another treatment is sutimlimab, which inhibits the classical complement pathway, thereby reducing hemolysis. These treatments modulate the immune system, similar to the investigational drug povetacicept, which is being studied for its potential benefits in autoimmune cytopenias, including CAD.

What other types of research exist?

Promising novel alternatives to povetacicept for Cold Agglutinin Disease patients include therapies such as rituximab, which targets CD20 on B cells, and sutimlimab, a monoclonal antibody that inhibits the classical complement pathway. Both have shown efficacy in treating CAD by reducing hemolysis and improving hemoglobin levels.

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Immunomodulator

Povetacicept for Autoimmune Hemolytic Anemia (RUBY-4 Trial)

Q: What is the mechanism of action of this treatment?

Cold Agglutinin Disease (CAD) treatments often focus on immune modulation to reduce the immune system's attack on red blood cells. Therapies like rituximab target B-cells to decrease the production of harmful antibodies responsible for red blood cell destruction. This approach is crucial for CAD patients as it helps manage symptoms and prevent severe anemia, thereby improving their quality of life.

Phase 1 & 2

Recruiting

Research Sponsored by Alpine Immune Sciences, Inc.

Eligibility Criteria Checklist

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

Must have

For Warm Autoimmune Hemolytic Anemia (wAIHA): Diagnosis of primary wAIHA of at least 12 weeks duration documented with a current or prior positive direct antiglobulin test (DAT) for anti-IgG (±C3d), Documented history of anemia with hemoglobin ≤9 g/dL, At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >ULN (iii) lactate dehydrogenase>ULN, History of failure or relapse to at least 2 treatment regimens for wAIHA

Be older than 18 years old

Must not have

Transfusions with blood, blood products or other rescue medications: <2 weeks prior to study entry

Treatment with plasmapheresis, plasma exchange, or double-filtration plasmapheresis: <8 weeks prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called povetacicept in adults with certain blood disorders where the immune system attacks their own blood cells. The goal is to see if povetacicept is safe and can help improve these conditions. Participants will receive the medication regularly for several months, with an option to extend the treatment for additional months.

Who is the study for?

Adults with autoimmune cytopenias like immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease can join. They must have tried at least one or two treatments before without success. Participants should not have had certain recent treatments (like plasmapheresis), a splenectomy, or blood transfusions shortly before the trial starts.

What is being tested?

The study is testing povetacicept to see if it's safe and effective for treating autoimmune cytopenias. Participants will receive doses every four weeks for six months, with a chance to continue in a six-month extension period of the treatment.

What are the potential side effects?

Possible side effects are not detailed here but typically could include reactions at the injection site, increased risk of infections due to immune system suppression, fatigue, headaches, and potential impacts on liver function.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with wAIHA for over 12 weeks, have low hemoglobin, and treatments haven't worked.

Exclusion Criteria

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

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I haven't had any blood transfusions or similar treatments in the last 2 weeks.

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I haven't had plasmapheresis or similar treatments in the last 8 weeks.

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I have a condition where my immune system attacks my blood cells.

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I have not had a serious infection recently or ongoing.

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I haven't taken sutimlimab or similar drugs in the last 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Povetacicept Dose AExperimental Treatment1 Intervention

Based on the findings of Part 1, one or two dose levels may be assessed in Part 2; if two dose levels are assessed participants will be randomized to receive one of the two dose levels of Povetacicept

Group II: Part 1: Povetacicept 240mgExperimental Treatment1 Intervention

Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept

0 / 6Eligibility 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

Cold Agglutinin Disease (CAD) treatments often focus on immune modulation to reduce the immune system's attack on red blood cells. Therapies like rituximab target B-cells to decrease the production of harmful antibodies responsible for red blood cell destruction. This approach is crucial for CAD patients as it helps manage symptoms and prevent severe anemia, thereby improving their quality of life.