Not recruitingRare disease

Study on Povetacicept for Patients with Autoimmune Cytopenias (wAIHA, CAD, ITP)

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying autoimmune cytopenias, which are conditions where the immune system mistakenly attacks and destroys blood cells. The specific types of autoimmune cytopenias being studied include warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), and immune thrombocytopenia (ITP). The treatment being tested in this study is called Povetacicept Injection, also known by its code name ALPN-303. This medication is given as a solution for injection under the skin.

The purpose of the study is to evaluate the safety and tolerability of Povetacicept in individuals with these autoimmune conditions. Participants in the study will receive Povetacicept and will be monitored to assess how their bodies respond to the treatment. The study will look at various factors, including any side effects that may occur and how the medication affects the participants' health over time.

Throughout the study, participants will receive regular check-ups and assessments to ensure their well-being and to gather information on the effectiveness of the treatment. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered. This trial aims to provide valuable insights into the potential benefits and risks of using Povetacicept for treating autoimmune cytopenias.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status related to autoimmune cytopenias such as warm autoimmune hemolytic anemia, cold agglutinin disease, or immune thrombocytopenia.
Step 2
Treatment initiation
The treatment involves receiving povetacicept, which is administered as a subcutaneous injection. This means the medication is injected under the skin.
The dosage and frequency of the injections are determined by the study protocol and are designed to evaluate the safety and tolerability of the medication.
Step 3
Ongoing monitoring
Throughout the study, regular monitoring is conducted to assess the effects of the treatment. This includes checking for any side effects, measuring the effectiveness of the medication, and conducting blood tests to monitor health indicators.
The primary focus is on the type, incidence, severity, and seriousness of any adverse effects experienced during the trial.
Step 4
Efficacy assessment
The study also evaluates the efficacy of povetacicept in managing symptoms of autoimmune cytopenias. This involves assessing improvements in blood counts and other relevant health markers.
Step 5
Study completion
The study is expected to conclude by July 30, 2026. At the end of the study, a final assessment is conducted to summarize the findings related to the safety and efficacy of the treatment.

Who can join the trial?

18 criteria

Participants must have one of the following conditions: Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (wAIHA), or Cold Agglutinin Disease (CAD).
For Immune Thrombocytopenia (ITP):
- Must have had ITP for at least 12 weeks.
- Must have tried at least two treatments for ITP that did not work or the condition came back.
- Must have tried a treatment called TPO-RA unless it was not safe or available.
- Must have a history of low platelets, which are cells that help stop bleeding, with a count less than 30.
- For Warm Autoimmune Hemolytic Anemia (wAIHA):
  - Must have had wAIHA for at least 12 weeks, confirmed by a positive test for certain antibodies.
  - Must have a history of low hemoglobin, which is a part of red blood cells, with a level of 9 or less.
  - Must have at least one of the following: low haptoglobin (a protein) or high lactate dehydrogenase (an enzyme).
  - Must have tried at least two treatments for wAIHA that did not work or the condition came back.
  - For Cold Agglutinin Disease (CAD):
    
    Must have had CAD for at least 12 weeks with ongoing breakdown of red blood cells.
    Must have positive tests for certain antibodies and a cold agglutinin titer of 64 or more at 4°C.
    Must not have any obvious cancer.
    Must have a history of low hemoglobin, with a level of 9 or less.
    Must have at least one of the following: low haptoglobin or high lactate dehydrogenase.
    Must have tried at least one treatment for CAD that did not work or the condition came back.
    If taking standard medications for these conditions, the doses must be stable for a certain period as specified in the study.
    Both males and females can participate.
    Participants must be within the age range specified by the study.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent major surgery.
Patients who are currently participating in another clinical trial.
Patients with a history of severe allergic reactions.
Patients who have an active infection that requires treatment.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain medications that might affect the study results.
Patients with a history of cancer, except for certain types of skin cancer.
Patients with uncontrolled high blood pressure or diabetes.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero-Universitaria Maggiore Della Carita
Verified
Novara, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Verified
Milan, Italy
Sykehuset Oestfold HF Kalnes
Responsive
Graalum, Norway

Trial locations

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Investigated drugs

Povetacicept is a medication being studied for its potential to treat autoimmune cytopenias, which are conditions where the immune system mistakenly attacks and destroys blood cells. The trial aims to assess how safe and well-tolerated this medication is in patients, as well as to understand how it behaves in the body and its effects on the disease.

Povetacicept

What is already known about the treatment

Povetacicept – Povetacicept is administered through an injection, typically under the skin. It is currently being studied in clinical trials to determine its safety and effectiveness for treating autoimmune cytopenias, which include conditions like warm autoimmune hemolytic anemia, cold agglutinin disease, and immune thrombocytopenia. The medication works by modulating the immune system to reduce the abnormal destruction of blood cells. It is classified as an immunomodulatory agent, aiming to balance the immune response in these specific blood disorders.

Investigated diseases

Warm Autoimmune Hemolytic Anemia (wAIHA)
This is a condition where the immune system mistakenly attacks and destroys red blood cells at body temperature. It leads to a decrease in red blood cells, causing symptoms like fatigue, shortness of breath, and pale skin. The destruction of red blood cells can occur rapidly or gradually, affecting the severity of symptoms. Over time, the body may try to compensate by producing more red blood cells, but this may not be sufficient to meet the body's needs.
Cold Agglutinin Disease (CAD)
This is a rare autoimmune disorder where the immune system attacks red blood cells at cold temperatures. It causes the red blood cells to clump together, leading to their destruction. Symptoms often include fatigue, weakness, and a bluish discoloration of the skin in cold environments. The disease can lead to anemia and other complications if the destruction of red blood cells is significant.
Immune Thrombocytopenia (ITP)
This is a disorder characterized by a low platelet count due to the immune system attacking and destroying platelets. Platelets are essential for blood clotting, so a deficiency can lead to easy bruising, bleeding gums, and prolonged bleeding from cuts. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more significant bleeding issues. The progression of the disease can be unpredictable, with periods of remission and relapse.