Study of epinephrine nasal spray (ARS-2) for treating chronic spontaneous urticaria symptoms in adult patients

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What is this study about?

This study focuses on people with Chronic Spontaneous Urticaria (CSU), a condition that causes recurring itchy hives on the skin. The research evaluates a new nasal spray medication called ARS-2 containing epinephrine (also known as adrenaline) compared to a placebo nasal spray. The purpose is to determine how effectively the medication relieves itching and hives during acute flare-ups of the condition.

The study uses two different strengths of the nasal spray – 0.5 mg and 1 mg of epinephrine. Participants will receive both the active medication and placebo at different times during the study, allowing researchers to compare the effectiveness of each treatment. The medication is administered as a nasal spray, which means it is sprayed into the nose.

During the study, participants will use a smartphone application to record their symptoms and any side effects they experience. They will track how quickly their symptoms improve after using the spray and whether the symptoms return within 24 hours. The study will measure changes in both itching and hive severity, as well as monitor the safety of the treatment.

1 Initial assessment

You will be diagnosed with Chronic Spontaneous Urticaria (CSU), a condition that causes itching and hives.

Your vital signs will be checked, including blood pressure and heart rate, after 5 minutes of rest.

If you are female, a pregnancy test will be conducted.

2 Treatment preparation

You will receive a smartphone application to record your daily symptoms and any side effects.

You will need to track your symptoms daily using the Uniform Assessment System (UAS) for recording itch and hive severity.

You will also use a visual analog scale (VAS) to record any swelling symptoms.

3 Treatment phase

You will receive either epinephrine nasal spray (0.5 mg or 1 mg) or a placebo nasal spray.

The study follows a crossover design, meaning you will receive different treatments at different times.

You will use the nasal spray when experiencing moderate to severe symptoms.

You will continue your regular chronic treatment throughout the study period.

4 Monitoring period

You will record your symptoms and any changes after using the nasal spray.

The monitoring will include tracking how quickly your symptoms improve.

You will need to note if symptoms return within 24 hours of treatment.

Any side effects must be recorded in the smartphone application.

5 Study completion

The study will continue until September 2026.

Final assessments of your symptoms and overall response to treatment will be recorded.

Your participation will help evaluate the effectiveness of the nasal spray in treating acute CSU symptoms.

Who Can Join the Study?

Must be between 18 and 65 years old
Must have been diagnosed with Chronic Spontaneous Urticaria (CSU) and experience moderate to severe symptoms (itching and hives) approximately 1-2 times a month or every other month during the past year while on treatment
Must have been on daily treatment for at least 6 weeks
Must be willing to use a smartphone application to record study assessments and side effects
Must not have a history of significant high blood pressure or heart disease in the last 10 years (controlled high blood pressure without beta blockers is acceptable)
Must have stable vital signs at screening:
– Blood pressure: top number between 90-140
– Bottom number between 50-90
– Heart rate between 45-100 beats per minute
If female, must not be pregnant or breastfeeding and must have negative pregnancy tests during study visits
Must be able to communicate clearly with the study team and be able to read and complete questionnaires on the smartphone application
Must be willing and able to provide written informed consent to participate in the study

Who Cannot Join the Study?

Age below 18 or above 75 years old
Previous allergic reactions to any similar medications
Pregnant women or those planning pregnancy during the study period
Breastfeeding mothers
Current participation in other clinical trials
History of serious allergic reactions (anaphylaxis)
Presence of other skin conditions that could interfere with evaluating urticaria (hives)
Severe heart, liver, or kidney disease
Uncontrolled high blood pressure (hypertension)
Active infections requiring treatment
History of cancer in the past 5 years
Use of medications that could interfere with the study drug
Mental health conditions that could affect ability to follow study procedures
Drug or alcohol abuse within the past year
Any condition that, in the opinion of the study doctor, makes participation unsafe

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fnrojnwsvh Ilqwxwbrt Fmq Ttbaztalarkkj Mchatpaj Aoc Pjzvdvqddciy Itgr	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.07.2025

Trial locations

Investigated drugs:

Epinephrine

ARS-2 is an investigational medication being studied for the treatment of chronic spontaneous urticaria, a condition that causes recurring itchy hives on the skin. The medication is being tested to evaluate its effectiveness in reducing both itching sensations and the appearance of hives in patients with this condition.

Investigated diseases:

Chronic spontaneous urticaria

Chronic Spontaneous Urticaria (CSU) – A persistent skin condition characterized by the recurring appearance of itchy hives (wheals) and/or swelling (angioedema) that occur without any specific external trigger. The hives are temporary and typically last for less than 24 hours in any one spot, but new ones may continuously appear. The condition is considered chronic when it persists for six weeks or longer. Symptoms can appear anywhere on the body and may vary in intensity throughout the day. The condition can cause significant discomfort due to intense itching and burning sensations.

Trial ID:

2025-521930-27-00

Protocol code:

EPI-U02

NCT ID:

NCT06927999

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of epinephrine nasal spray (ARS-2) for treating chronic spontaneous urticaria symptoms in adult patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?