Active not recruitingPHASE1, PHASE2INTERVENTIONAL

An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias

This research study is investigating a new medication called povetacicept for adults living with certain autoimmune blood conditions. These conditions include Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (wAIHA), and Cold Agglutinin Disease (CAD). These conditions all involve the immune system mistakenly attacking healthy blood cells. The main goal of this study is to find out if povetacicept is a safe treatment option and if it can help improve the health of people with these diseases. Participants will receive the study medicine roughly every four weeks for six months, with a possible six-month extension period. This type of study aims to gather important information that could lead to new ways to manage these conditions.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Alpine Immune Sciences, Inc.

Enrolment target

Start

03 Jul 2023

Estimated completion

01 Jul 2026

Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Warm Autoimmune Hemolytic Anemia Cold Agglutinin Disease

What is this study about?

This study is looking into a new medication called povetacicept for adults who have specific autoimmune blood conditions. Autoimmune conditions happen when your body's immune system, which is meant to fight off infections, mistakenly attacks your own healthy cells. In the case of Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (wAIHA), and Cold Agglutinin Disease (CAD), the immune system attacks different types of blood cells, leading to symptoms like tiredness, bruising, or feeling unwell.

The main aim of this research is to see if povetacicept is a safe treatment and if it can help improve these conditions. Researchers want to understand if it can reduce the immune system's attack on blood cells, potentially leading to better blood counts and fewer symptoms for patients. This study is an 'open-label' study, which means both you and your doctor will know if you are receiving the study medicine.

Finding new and effective treatments for these conditions is very important because current therapies don't always work for everyone, or they might have side effects. This study is an early-stage trial (Phase 1 and 2), meaning it's one of the first times the drug is being tested in humans to see how well it works and what doses might be helpful, as well as checking its safety. The information gathered will be crucial in deciding if povetacicept could become a widely available treatment in the future.

Key takeaways

This study is testing a new medicine, povetacicept, for certain autoimmune blood conditions.
It aims to see if the medicine is safe and if it helps people with Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, and Cold Agglutinin Disease.
Participants will receive the medicine every four weeks for six months, with a possible extension.
The study is for adults aged 18 and over who meet specific medical criteria.
It's an 'open-label' study, meaning everyone knows you're getting the study drug.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have one of the specific autoimmune blood conditions: Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (wAIHA), or Cold Agglutinin Disease (CAD). For each condition, there are certain requirements, such as how long you've had the condition and that previous treatments haven't worked well for you.

For example, if you have ITP, you would need to have had it for at least 12 weeks and have tried at least two other treatments without success. If you have wAIHA or CAD, similar rules apply about how long you've had the condition, certain blood test results, and having tried previous treatments.

There are also some reasons why you wouldn't be able to join. For instance, if your condition is caused by another illness (secondary), rather than being a primary autoimmune disease. Also, you couldn't join if you've recently had certain other treatments, such as rituximab, IVIg, or plasmapheresis, within a specific timeframe before the study starts.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (wAIHA), or Cold Agglutinin Disease (CAD)?
Have you had your condition for at least 12 weeks?
Have previous treatments for your condition not worked well for you?
Are you able to avoid certain specific treatments (like rituximab or IVIg) for a set time before joining the study?
Is your specific blood condition not caused by another underlying disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, povetacicept, as an infusion (given into a vein). This treatment will be given approximately every four weeks for an initial period of six months. Throughout this time, you'll have regular visits to the clinic for medical check-ups, blood tests, and to make sure you're feeling well and that the treatment is safe for you. After the first six months, you might have the option to continue receiving the study medicine for an additional six months, if your doctor and the research team think it's still beneficial. The total time you could be involved in the study, including the extension, would be one year.

Potential risks and benefits

Taking part in a clinical study means you might receive a new medicine that could potentially help improve your condition, especially if other treatments haven't worked for you. However, as with any new medicine, there might be side effects that no one knows about yet, or the medicine might not work for you. The study team will carefully monitor you for any potential risks or side effects throughout your participation. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (44)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Investigational Site (230)
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Los Angeles, United States
Investigational Site (401)
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Washington D.C., United States
Investigational Site (419)
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Cooper City, United States
Investigational Site (425)
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Miami, United States
Investigational Site (219)
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Iowa City, United States
Investigational Site (435)
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Columbia, United States
Investigational site (405)
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Lake Success, United States
Investigational Site (423)
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New Hyde Park, United States
Investigational Site (421)
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New York, United States
Investigational Site (404)
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New York, United States
Investigational Site (420)
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Shirley, United States
Investigational Site (422)
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The Bronx, United States

Common questions

What is an autoimmune condition?

An autoimmune condition is when your body's immune system, which normally fights off germs, mistakenly attacks your own healthy cells or tissues.

What does 'open-label' mean for this study?

Open-label means that both you and your study doctor will know that you are receiving the study medicine, povetacicept.

How often will I receive the study medicine?

You will receive the study medicine, povetacicept, as an infusion roughly every four weeks.

How long will I be in the study?

The main part of the study lasts for six months, with a possibility of extending your participation for another six months, making the total up to one year.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.