A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY, WITH A SAFETY AND DOSE CONFIRMATION RUN-IN PERIOD, TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA (SAPHIARE)
This study is looking into a new medicine, Obexelimab, for a blood condition called Warm Autoimmune Hemolytic Anemia (wAIHA). In this condition, the body's immune system attacks its own red blood cells. The main goals are to find out if Obexelimab is safe and if it helps improve the number of red blood cells in patients. Participants will be given either the new medicine or a dummy treatment (placebo) by injection under the skin. We will compare these two groups to understand if Obexelimab works better and is well-tolerated. This research aims to find better ways to treat wAIHA and improve patients' health.
At a glance
What is this study about?
This research study is about a condition called Warm Autoimmune Hemolytic Anemia, often shortened to wAIHA. In wAIHA, your own body's defence system, called the immune system, mistakenly attacks and destroys your red blood cells. Red blood cells are very important because they carry oxygen around your body. When they are destroyed too quickly, it can lead to anaemia, making you feel very tired and unwell. We're testing a new medication called Obexelimab to see if it can help stop this attack on red blood cells.
The study is designed to be very careful and fair. Some patients will receive the new medicine, Obexelimab, while others will receive a 'placebo'. A placebo looks just like the real medicine but contains no active ingredients – it's like a dummy treatment. This allows us to compare the effects of the new medicine against what happens without it. We're especially interested in whether Obexelimab can safely increase your red blood cell count and how you feel overall.
This is a 'Phase 3' study, which means it's one of the final steps in testing a new medicine before it might be considered for wider use. It involves many participants and doctors across different locations. The information we gather will be crucial in understanding if Obexelimab could be a helpful new treatment option for people living with wAIHA.
Key takeaways
- The study is for people with Warm Autoimmune Hemolytic Anemia.
- It's testing a new medicine called Obexelimab.
- Participants will receive either the new medicine or a dummy treatment.
- The main goals are to check safety and how well the medicine improves red blood cell levels.
- Participation involves regular clinic visits and injections under the skin.
- The study lasts for several months, with monitoring for up to 24 weeks.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women can take part.
Beyond age and sex, specific medical details will be checked by the study doctors to make sure the trial is right for you. They will need to ensure that your particular health situation matches the requirements of the study to keep you safe and ensure the study results are clear.
You should discuss with your doctor if this study could be suitable for you, as they will have access to all the detailed criteria.
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 Warm Autoimmune Hemolytic Anemia (wAIHA)?
- Are you able to attend regular clinic appointments?
- Are you willing to receive injections under the skin?
What does participation involve?
If you decide to take part in this study, you will first go through a check-up period to make sure you are suitable. During this time, you might receive the actual study drug to see how your body reacts to it.
After this initial period, you will be randomly assigned to receive either the new medicine, Obexelimab, or a placebo (a dummy treatment). Both are given as injections under the skin. You won't know which one you are receiving, nor will your study doctor, which helps keep the study fair. You will have regular visits to the clinic where doctors and nurses will monitor your health, take blood samples, and ask about how you are feeling. These visits will help us understand if the medicine is working and if there are any side effects. The study aims to look at your progress over several months, with careful monitoring until week 24 (about 6 months) and potentially longer for follow-up.
Potential risks and benefits
Locations (3)
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Common questions
What is Warm Autoimmune Hemolytic Anemia?
It's a condition where your body's immune system attacks and destroys its own red blood cells, which carry oxygen. This can lead to anaemia.
What is Obexelimab?
It's a new medicine being tested in this study to see if it can help stop the immune system from attacking red blood cells.
What does 'placebo-controlled' mean?
It means some participants will receive the new medicine, and others will receive a dummy treatment that looks the same but has no active ingredients. This helps us see if the medicine is actually working.
How will the medicine be given?
It will be given as an injection under the skin.
How long will I be in the study?
The main part of the study involves monitoring you up to Week 24 (about 6 months), with potential for longer follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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