AuthorisedTherapeutic exploratory (Phase II)Interventional

AN OUTPATIENT, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, CROSS-OVER STUDY OF THE EFFICACY OF ARS-2 IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA

This study is looking into a new nasal spray treatment called ARS-2 for people who suffer from chronic spontaneous urticaria, also known as chronic hives. This is a condition where people get itchy red welts on their skin without a clear trigger. The study wants to find out if this new nasal spray can quickly make the itching and hives better during a flare-up. Researchers will compare it to a dummy spray (placebo) to see if it really works. They'll also be checking how quickly symptoms go away, if they come back within a day, and if there are any side effects. People over 18, both men and women, with chronic hives can join. It's an important step in finding better ways to manage this often uncomfortable condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ars Pharmaceuticals IRL Limited

Enrolment target

Start

27 Aug 2025

Chronic Spontaneous Urticaria (CSU)

What is this study about?

Imagine you get itchy red bumps all over your skin, sometimes with swelling, and it happens often without a clear reason. This is called Chronic Spontaneous Urticaria (CSU), or just chronic hives. It can be really uncomfortable and impact your daily life. This study is testing a new kind of treatment for these flare-ups: a nasal spray called ARS-2.

The main goal of this study is to see if this nasal spray can quickly make your itching and hives better when you have a flare-up. To do this fairly, some participants will get the actual ARS-2 nasal spray, while others will get a 'dummy' spray (called a placebo) that looks and feels the same but has no medicine. Later, the groups will switch so everyone gets a chance to try the ARS-2 spray. This helps researchers truly understand if the active medicine is what's making a difference.

Researchers will be carefully tracking how your symptoms change, such as how much your itchiness and hives improve, and how quickly. They'll also be watching to see if your symptoms come back within 24 hours and if any new problems (side effects) happen. This type of study, called a Phase II study, helps us learn if a new treatment is safe and effective enough to be studied more widely in the future.

Key takeaways

Tests a new nasal spray (ARS-2) for chronic hives.
Compares the spray to a dummy treatment (placebo).
Aims to see if it quickly reduces itching and hives.
Open to adults aged 18 and over with chronic hives.
You might switch between the real and dummy spray during the study.
Helps find better ways to manage chronic hives.

Who may be eligible?

This study is looking for adults who experience chronic spontaneous urticaria, also known as chronic hives. You must be at least 18 years old to take part.

Both men and women are welcome to join the study. The researchers want to include a wide range of people to make sure the results apply to many different individuals with chronic hives.

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 get chronic spontaneous urticaria (chronic hives)?
Are you experiencing regular flare-ups of hives?
Are you willing to use a nasal spray as part of a study?
Are you able to regularly track your symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your journey would involve several steps. You'd be asked to use either the active nasal spray (ARS-2) or a dummy nasal spray during your hive flare-ups. This is a "cross-over" study, meaning that at some point, you would switch from one type of spray to the other. You'll keep track of your symptoms, like how itchy you are and how many hives you have, using a special system. Researchers will also be looking at how quickly your symptoms improve and if they come back within 24 hours. They will also monitor for any side effects and might ask you to take photos of any swelling to track changes. The total duration of your involvement in the study will be explained in detail by the study team, but it will involve a series of assessments and using the nasal spray as directed during your flare-ups.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits. You could receive a new treatment that might help your chronic hives, and you'll be closely monitored by medical professionals. However, there are also potential risks, such as experiencing side effects from the nasal spray, or the treatment might not work for you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your 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
Germany

Common questions

What are 'chronic spontaneous urticaria'?

These are itchy red bumps (hives) or swelling on your skin that appear regularly for six weeks or more, and there's no clear cause.

What does 'randomized, double-blinded, placebo-controlled, cross-over' mean?

It means you're randomly assigned to get either the real spray or a dummy spray, neither you nor the doctors know which it is, and then you'll switch roles later. This helps get fair results.

What is a 'Phase II' study?

It's an early stage of testing a new medicine. It checks if the treatment is safe and if it works well enough to be studied in a larger group.

Will I know if I'm getting the real medicine or the dummy spray?

No, during the study, neither you nor the doctors will know. This is to make results unbiased. However, at some point, everyone will get the active spray.

What if my symptoms get worse during the study?

You'll be closely monitored by the study team. They will instruct you on what to do if your symptoms worsen and how to contact them for help.