Not yet recruitingPHASE2INTERVENTIONAL

Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)

This research is investigating a severe drug allergy called DRESS syndrome. It's a rare condition where your body has a strong, harmful reaction to a medicine, affecting several organs. Currently, treatment mainly involves steroids, which don't always work well or can have side effects. This study aims to see if adding a new drug, benralizumab (Fasenra), to the standard steroid treatment can help people with DRESS syndrome. Benralizumab targets specific immune cells called eosinophils, which are often increased in DRESS. The hope is this new combination could help you recover quicker and shorten the time you need to spend in the hospital. It's a carefully planned study comparing the new treatment with just standard care in a fair way.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University Hospital, Lille

Enrolment target

Start

06 Jan 2027

Estimated completion

01 Sep 2029

DRESS Syndrome

What is this study about?

Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS syndrome, is a very serious and unusual reaction that some people have to certain medications. It can affect many different organs in your body, not just your skin. At the moment, doctors aren't completely sure why DRESS syndrome happens, but they think that certain immune cells, called eosinophils, might play a big role. Many people with DRESS syndrome have a higher number of these eosinophil cells in their blood or body tissues.

Currently, the main treatment for DRESS syndrome is medicines called corticosteroids (often just called steroids). While these can be helpful, they don't always work for everyone, or they might cause side effects that are difficult to manage. This study is looking for a new and better way to treat DRESS syndrome. They are testing a specific drug called benralizumab (you might know it as Fasenra), which is already used for other conditions where eosinophils are a problem, like some types of asthma.

The main goal of this research is to see if adding benralizumab to the usual steroid treatment can help you recover from DRESS syndrome more quickly. If it works, it could mean a shorter hospital stay for patients. The study is very carefully designed: it's 'double-blind,' meaning neither you nor your doctor will know if you're getting the new drug or a dummy treatment (a 'placebo'), and people are chosen randomly for each group. This helps ensure the results are fair and reliable.

Key takeaways

This study is testing a new treatment for a rare and severe drug reaction called DRESS syndrome.
The new treatment, benralizumab, targets specific immune cells called eosinophils, which are often high in DRESS syndrome.
The goal is to see if benralizumab, added to standard care, can help patients recover faster and reduce hospital stays.
Participation involves being randomly assigned to receive either standard care or standard care plus the study drug (or a placebo).
It's a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving.
You can withdraw from the study at any time without affecting your medical treatment.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over, who has recently been diagnosed with DRESS syndrome. Your doctor will use a special scoring system (called the REGIScar score) to confirm you have DRESS syndrome, based on how severe your symptoms are. You would also need to have a skin rash, a fever of 38°C or higher, and at least one of your organs affected in a way consistent with DRESS syndrome. This could include swollen glands, changes in your liver or kidney test results, or breathing difficulties. You would also need to have higher than normal levels of eosinophil cells in your blood.

Crucially, you must be willing to give written agreement (called informed consent) to take part in the study. You also need to have social insurance. If you are under 18, unfortunately, you wouldn't be able to join this particular study.

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 recently been diagnosed with DRESS syndrome by a doctor?
Do you have a rash, a fever, and at least one organ affected by DRESS syndrome (like liver, kidney, or breathing issues)?
Do your blood tests show higher than normal levels of eosinophils?
Are you able to give written permission to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups. One group will receive the standard treatment for DRESS syndrome (steroids, either as tablets or creams, depending on your needs). The other group will receive the standard steroid treatment plus the study drug, benralizumab, which will be given as an injection. There's also a chance you could receive a dummy injection (placebo) instead of benralizumab, so neither you nor your doctor would know which you are getting.

Throughout the study, you would undergo regular assessments, which will likely include blood tests, physical examinations, and questions about your symptoms. These visits are to monitor how you are responding to treatment and to check for any side effects. The total duration of your participation, including follow-up, would be determined by the study protocol, but the aim of the treatment is to speed up recovery and potentially reduce your hospital stay.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study could be that the new treatment, benralizumab, helps you recover from DRESS syndrome faster and potentially shortens your hospital stay compared to standard care alone. However, there's no guarantee the treatment will work for you, and it's possible you might experience side effects from the study drug, or from receiving regular injections. The doctors overseeing the study will closely monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Delphine STAUMONT-SALLE
Verified postcode
Lille, France

Common questions

What is DRESS syndrome?

DRESS syndrome is a very serious and rare reaction to certain medicines that can affect your skin and several organs in your body.

What is benralizumab (Fasenra)?

Benralizumab is an existing medicine used for some other conditions, like certain types of asthma, that aims to reduce specific immune cells called eosinophils.

Will I know if I'm getting the new drug or standard care?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're getting benralizumab or a dummy treatment (placebo) alongside your usual steroids.

What are eosinophils, and why are they important in this study?

Eosinophils are a type of immune cell. In DRESS syndrome, these cells are often found in higher numbers, and this study believes reducing them might help with recovery.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Delphine STAUMONT-SALLE, Professor, MD

drc@chu-lille.fr +33320444145 Official trial record

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