RecruitingPhase IIInterventional

A trial to test tocilizumab, an anti-inflammatory medication, in understanding how controlling the whole body's inflammation can prevent inflammation damage to the brain following head injury

This research is investigating if an anti-inflammatory medicine, tocilizumab, can help patients who have suffered a serious head injury and are in intensive care. Too much inflammation in the brain after an injury is believed to slow down recovery. Tocilizumab is already used for other inflammatory conditions. This study is an important first step to see if the medicine can reduce brain inflammation and if we can detect its effects through blood tests. If successful, it could lead to a larger study to confirm if it truly improves recovery for head injury patients. Taking part would involve receiving either the study medicine or standard care, and then being monitored for six months.

At a glance

Status

Recruiting

Phase

Phase II

Enrolment target

Start

01 Mar 2026

Estimated completion

31 Dec 2028

Traumatic brain injury

What is this study about?

When someone has a serious head injury, their body often reacts by causing a lot of inflammation, especially in the brain. Scientists believe that this inflammation can make it harder for the brain to heal and for the person to recover properly. This study aims to find out if giving an anti-inflammatory medicine called tocilizumab could help with this problem.

Tocilizumab is a medicine that's already used to treat other conditions where inflammation is a big issue, like rheumatoid arthritis. More recently, it's also been used to help people with severe COVID-19. Because this is the first time researchers are looking at using tocilizumab for head injuries, the main goal of this study is to see if it actually reduces inflammation in the brain and if doctors can spot these changes through blood tests. This step is crucial before they can move on to a bigger study to see if it directly improves how well people recover from a head injury.

There isn't currently a specific medicine that directly treats a head injury, so doctors focus on keeping the body working as normally as possible. If this study shows promising results, it could open the door to new ways of helping people recover better after a head injury.

Key takeaways

This study is testing an anti-inflammatory medicine (tocilizumab) for severe head injuries.
It aims to see if the medicine reduces brain inflammation and can be detected in blood.
Tocilizumab is already used for other inflammatory conditions.
Patients in intensive care with a specific brain drain are eligible.
Participants will be followed for 6 months; some may receive placebo.
Information from this study could help future head injury patients.

Who may be eligible?

This study is for adults aged 18 or over who have had a serious head injury that means they need to be treated in intensive care. They must also have a special drain in place that measures brain activity and inflammation.

There are also some things that would mean someone cannot take part. For example, if they have a severe, active infection, a history of being very allergic to tocilizumab, or if they are pregnant or breastfeeding. Patients who are already taking certain strong immune-suppressing medicines or have very low blood counts (like blood platelets or certain white blood cells) would also not be able to join.

Also, if their injury happened too long ago for them to receive the study medicine within 48 hours, or if they have other medical conditions that would make taking part unsafe, they would be excluded. Doctors will carefully check all these points to make sure the study is safe for everyone involved.

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 had a serious head injury and are currently in intensive care?
Do you have a special drain in your brain to measure things like inflammation?
Do you have any serious active infections?
Are you pregnant or breastfeeding?
Do you have severe allergies to certain medicines?

Answer every question to see your result.

What does participation involve?

If you are able to join the study, you would be involved in one of two groups, called 'work packages'. In one group (Work Package 1), 10 participants will receive either a single dose of tocilizumab or the usual care given to head injury patients. In the other group (Work Package 2), 50 participants will be randomly chosen to receive either a single dose of tocilizumab or a 'placebo' (a salt-water solution that looks like the medicine but has no active drug), alongside their usual care.

The first 14 people in Work Package 2 will know whether they are getting the study medicine, but for the next 36 people, neither the patient nor the doctors will know who is getting which treatment until after the study, which helps make the results fairer. After receiving the treatment, all participants will be followed up by the study team for 6 months to see how they are doing.

During your time in the study, you will have regular blood tests, often taken at the same time as other routine blood tests. There might be some extra visits, but the team has tried to keep these to a minimum. There's a chance that during these checks, doctors might find something new about your health that you didn't know about. If this happens, they will discuss it with you and your GP.

Potential risks and benefits

There is no guarantee that taking part in this study will directly benefit you. The main aim is to understand more about head injuries and how tocilizumab might affect inflammation in the brain, which could help future patients. Like all medicines, tocilizumab can cause side effects. The most common ones include infections (like colds), headaches, high blood pressure, and changes in liver blood tests. Because head injury patients in intensive care are already at higher risk of infections, and tocilizumab can affect the immune system, the study will carefully monitor for infections. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

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

Addenbrookes Hospital
City only
Cambridge, England

Common questions

What is tocilizumab?

It's a medicine used to reduce inflammation in the body. It’s already used for conditions like rheumatoid arthritis and severe COVID-19.

Will I definitely get the active medicine?

Depending on which group you're in, you might receive the study medicine (tocilizumab) or a placebo (inactive salt-water solution), or just standard care. It's often decided by chance.

How long will I be involved in the study?

If you take part, you will be followed up for 6 months after receiving the study treatment.

What happens if I don't want to continue?

You can choose to leave the study at any time, and this will not affect the medical care you receive.

Who is paying for this research?

The study is funded by the Medical Research Council in the UK.

How to find out more

Study Team

cuh.neurosciencecctu@nhs.net +44 (0)1223 348498 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.