A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
This study is looking at a new treatment called itolizumab for people who develop a condition called acute graft versus host disease, often known as aGVHD. This can happen after a stem cell transplant when the new immune cells mistakenly attack the patient's body. Researchers want to see if itolizumab, when given alongside standard steroid treatments, can help more people improve. It's a 'Phase 3' study, which means it's one of the final steps to see if the medicine is safe and effective before it could be widely used. Participants will receive either itolizumab or a dummy medicine called a placebo, plus their usual steroid treatment. Doctors will check how many people have a significant improvement by day 29 of the study.
At a glance
What is this study about?
This study is about a health problem called acute Graft Versus Host Disease (aGVHD). This can happen in some people after they've had a stem cell transplant, which is often used to treat serious blood cancers. During a stem cell transplant, you receive healthy new blood-forming cells from a donor. Sometimes, these new donor cells can realise they are in a 'new' body and start to attack the patient's own body, seeing it as foreign. This attack is what we call Graft Versus Host Disease, and it can affect different parts of the body like the skin, gut, and liver. 'Acute' means it happens soon after the transplant.
The purpose of this study is to test a new medicine called itolizumab. It's hoped that itolizumab, when given together with the usual steroid medicines that doctors prescribe for aGVHD, might help people get better more effectively than steroids alone. Steroids are the standard first treatment, but they don't work for everyone, and they can have side effects.
This is a 'Phase 3' study, which means it's a large and important step in checking if a new medicine works well and is safe before it can be made available more widely. The study will mainly look at how many people show a significant improvement in their aGVHD by day 29 of taking the study medicine.
Key takeaways
- Tests a new medicine, itolizumab, for acute Graft Versus Host Disease (aGVHD).
- Compares itolizumab with a dummy medicine (placebo) alongside standard steroids.
- Aims to see how many people show a significant improvement by Day 29.
- Open to adults aged 18 and over, both men and women.
- Participation is voluntary and you can withdraw at any time.
Who may be eligible?
To join this study, people need to be at least 18 years old. There's no upper age limit, so older adults can also take part. Both men and women are welcome to participate.
The study is specifically for individuals who have been diagnosed with acute Graft Versus Host Disease (aGVHD) and are just starting treatment for it. The doctors running the study will carefully check everyone to make sure they meet all the specific health requirements needed to take part safely. It's important that participants are able to take the study medication and attend appointments as required.
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 acute Graft Versus Host Disease (aGVHD)?
- Are you just beginning treatment for your aGVHD?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two groups: one group will receive the new medicine, itolizumab, and the other will receive a 'placebo', which looks exactly like the study medicine but doesn't contain any active drug. Everyone in the study will also receive the standard steroid treatment for their aGVHD. This ensures we can fairly compare if itolizumab makes a difference. Neither you nor your doctor will know whether you are receiving itolizumab or the placebo, which helps make the study results as fair as possible.
You will have regular visits to the hospital or clinic so the study doctors can monitor your health and how your aGVHD is responding to treatment. These visits will involve physical examinations, blood tests, and other checks to see if the treatment is working and to look for any side effects. The study will specifically check your response on Day 29. The total duration of your participation, including follow-up visits after the main treatment period, will be explained in detail by the study team.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
- —UnverifiedPortugal
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedItaly
Common questions
What is acute Graft Versus Host Disease (aGVHD)?
aGVHD is a common complication after a stem cell transplant, where new immune cells from the donor attack the patient's body.
What is the new medicine being tested?
The new medicine is called itolizumab. It's being tested to see if it improves aGVHD symptoms.
Will I definitely get the new medicine?
No, you have an equal chance of receiving either the new medicine or a dummy medicine (placebo), in addition to your usual steroid treatment.
How long will the study observe me?
The main measurement of how well the treatment is working will be checked by Day 29 of the study, though you'll be monitored for longer.
Can I leave the study if I want to?
Yes, you are free to stop participating in the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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