Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial): a multicentre, randomized, open-label, non-inferiority trial.

This study, called EXOTIC, is for adults who suffer from chronic spontaneous urticaria, which is a medical term for hives that keep coming back without a clear reason. Many people with this condition are treated with a medicine called Xolair (omalizumab). The main aim of this study is to find out if patients can take their Xolair injections less frequently than usual and still keep their hives under control just as effectively. Researchers will compare two groups: one receiving Xolair on a standard schedule, and another receiving it at longer intervals. By doing this, the study hopes to see if it's possible to reduce the number of injections a person needs while still ensuring their hives are well-managed. This could make treatment more convenient for patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Bispebjerg Hospital

Enrolment target

Start

24 Nov 2023

Chronic spontaneous urticaria

What is this study about?

This study, known as the EXOTIC trial, is investigating a common condition called chronic spontaneous urticaria. This is a type of long-lasting hives that appear on the skin without an obvious cause, and it can be very uncomfortable and disruptive to daily life. A widely used treatment for this condition is a medicine called Xolair, which is given as an injection.

The main purpose of this research is to see if patients who are currently taking Xolair can take their doses less often than they do now, without their hives getting worse. Currently, Xolair is given on a regular schedule, and this study wants to find out if it's possible to extend the time between injections while still keeping the hives under good control. This is important because fewer injections could mean more convenience for patients and potentially reduce treatment burden.

To figure this out, the study will involve different groups of people with chronic spontaneous urticaria who are already using Xolair. Some will continue with their usual injection schedule, while others will have longer gaps between their doses. By carefully comparing how well their hives are controlled in both groups over time, the researchers hope to understand if a longer interval between injections is just as effective as the standard approach. The results could help doctors and patients decide on the best and most convenient way to manage this condition.

Key takeaways

The study explores if Xolair can be given less often for ongoing hives.
It aims to make treatment more convenient without losing effectiveness.
You must be an adult with chronic spontaneous urticaria to participate.
Participation involves receiving Xolair and regular health check-ups.
The study could help find better ways to manage chronic hives.
You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of all adult ages can take part.

The study welcomes both men and women, as well as people of all genders. The key is that you must be living with chronic spontaneous urticaria, which means you have ongoing hives that appear without a clear reason.

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 chronic spontaneous urticaria (ongoing hives)?
Are you able to attend study visits regularly?
Are you willing to receive Xolair injections as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of the treatment groups (either the usual Xolair schedule or a longer interval schedule). You'll receive Xolair injections throughout the study. Your hives will be regularly checked, likely through questionnaires about your symptoms, to see how well the treatment is working. This will probably involve several visits to a clinic over a period of time, where doctors and nurses will monitor your health and how you're responding to the medication. The total duration of your involvement will be clearly explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from careful monitoring of your condition by medical professionals throughout the study. If the new dosing schedule proves effective, it could lead to more convenient treatment options in the future. However, there's always a chance the new schedule might not control your hives as well, or you might experience side effects from the medication, even though Xolair is a well-known treatment. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is chronic spontaneous urticaria?

It's a medical term for hives (itchy red welts on the skin) that keep appearing for weeks or months without a clear cause.

What is Xolair?

Xolair is a medicine given by injection that is used to treat chronic spontaneous urticaria and some other conditions.

What does 'extending treatment intervals' mean?

It means taking the medicine injection less often, so there's a longer time between each dose.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, meaning both you and the study doctors will know which treatment schedule you are on.

What does 'non-inferiority' mean for this study?

It means the study aims to show that the new, less frequent dosing schedule is just as good, or almost as good, as the standard schedule in controlling hives.