Active not recruitingPHASE3INTERVENTIONAL

A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

This research study is looking at a new drug called obexelimab for adults with Warm Autoimmune Hemolytic Anemia (wAIHA). This condition causes your body to wrongly attack its own red blood cells. We want to find out if obexelimab is effective in improving the condition and if it's safe to use. Participants will receive either obexelimab or a placebo (a dummy drug) at random, or they may receive obexelimab in an initial safety period. This study is for people who have already tried at least one other treatment for their wAIHA that didn't work well enough. Your participation could help us understand more about this potential new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Zenas BioPharma (USA), LLC

Enrolment target

134

Start

25 Sep 2023

Estimated completion

31 Aug 2026

Warm Autoimmune Hemolytic Anemia

What is this study about?

This study, called SApHiAre, is focused on finding new and better ways to treat Warm Autoimmune Hemolytic Anemia (wAIHA). This is a condition where your immune system mistakenly attacks and destroys your red blood cells, leading to anaemia. This can cause symptoms like tiredness, shortness of breath, and feeling weak. Many existing treatments work for some people, but others may find their condition doesn't improve enough, or they experience side effects.

The main goal of this study is to test a new medicine called obexelimab. We want to see how well it works in reducing the destruction of red blood cells and improving anaemia symptoms. We also want to understand if it's safe for people to use. This kind of research is really important because it helps us find new treatment options for conditions that currently have limited choices or where existing treatments aren't suitable for everyone.

Participants in the study will be carefully monitored throughout. By taking part, you could contribute valuable information that helps doctors understand if obexelimab could be a helpful treatment for people with wAIHA in the future. It's an opportunity to potentially try a new treatment while receiving close medical attention.

Key takeaways

This study tests a new medicine, obexelimab, for Warm Autoimmune Hemolytic Anemia (wAIHA).
It's for adults whose wAIHA hasn't fully responded to previous treatments.
Participants will receive either obexelimab or a placebo, or obexelimab in an initial safety phase.
Involves regular clinic visits and injections under the skin.
Total participation could last up to about 1 year and 7 months.
Contributes to understanding a potential new treatment for wAIHA.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older) with a confirmed diagnosis of Warm Autoimmune Hemolytic Anemia (wAIHA) that you've had for at least three months. Importantly, you must have already tried at least one other treatment for your wAIHA that didn't work well enough for you.

We're looking for individuals who have clear signs or symptoms of anaemia, such as your doctor has assessed. Your diagnosis of wAIHA must be based on specific blood tests that confirm your immune system is attacking your red blood cells in a particular way.

There are also reasons why you might not be able to join. For instance, if your anaemia is due to other types of autoimmune haemolytic conditions (like cold haemolytic anaemia), or if you've recently had a blood transfusion, or have used certain other medications that affect your immune system, you might not be eligible. The study also cannot accept patients with secondary wAIHA not related to autoimmune disorders.

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?
Do you have a diagnosis of Warm Autoimmune Hemolytic Anemia (wAIHA)?
Have you tried at least one other wAIHA treatment that didn't work well enough?
Do you have signs or symptoms of anaemia?
Have you *not* had a blood transfusion in the last 2 weeks?
Have you *not* recently taken certain strong immune-affecting medications?

Answer every question to see your result.

What does participation involve?

Taking part in this study involves several steps over a maximum of about 81 weeks (around 1 year and 7 months). First, there's a screening period of up to 4 weeks to check if you're suitable for the study. If you qualify, you'll then enter a main treatment period that could be either a 6-month safety period where everyone receives obexelimab, or a 6-month period where you'll be randomly assigned to receive either obexelimab or a placebo (a dummy injection).

During these periods, you'll receive the study medicine as injections under your skin. You'll need to visit the study site frequently, especially at the beginning (weekly for the first 5 weeks, then every two weeks). At these visits, doctors and nurses will carry out checks to see how the medicine is affecting you, both in terms of your wAIHA and your general health, and to ensure you're tolerating the treatment well. After the initial 6 months, you might have the opportunity to continue receiving obexelimab for up to another year in an open-label extension period. Finally, there will be an 8-week follow-up period after your last dose of the study medicine.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving a new investigational treatment that might help with your condition, and close medical supervision of your health. However, there are also potential risks, including side effects from the study medication, which may be unknown. The study medication or placebo may not be effective for your condition. As with any medical procedure, there's a small risk associated with blood draws and injections. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Verified postcode
Milan, Italy
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
Verified postcode
Gdansk, Poland
Hospital Universitario de Burgos
Verified postcode
Burgos, Spain
Hospital Universitario 12 de Octubre
Verified postcode
Madrid, Spain
National Cheng Kung University Hospital
Verified postcode
Tainan, Taiwan
Plymouth Hospitals NHS Trust
Verified postcode
Plymouth, United Kingdom
Kent and Canterbury Hospital
Verified postcode
Canterbury, United Kingdom

Common questions

What is Warm Autoimmune Hemolytic Anemia (wAIHA)?

wAIHA is a condition where your body's immune system mistakenly attacks and destroys its own red blood cells, leading to anaemia and symptoms like tiredness and shortness of breath.

What is obexelimab?

Obexelimab is an investigational new medicine being tested in this study to see if it can help treat wAIHA.

What is a placebo?

A placebo is an inactive substance or treatment that looks the same as the real medicine but contains no active drug. It's used to compare the effects of the actual medicine.

How long will I be in the study?

Including screening and follow-up, the maximum time you could be involved in the study is about 81 weeks, which is roughly 1 year and 7 months.

What if I want to leave the study early?

You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.