Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial to investigate the effect of acalabrutinib on skin prick test wheal size in adults with grass pollen allergy

This trial is investigating a medicine called acalabrutinib for adults who suffer from grass pollen allergy. Grass pollen allergy can cause symptoms like sneezing, itchy eyes, and a runny nose, especially during certain times of the year. The main goal of this study is to see if taking acalabrutinib can make skin prick test reactions to grass pollen smaller. Skin prick tests are a common way to check for allergies. This is an early-stage study, which means researchers are mainly focusing on how the medicine works in the body and if it has any effects on allergic reactions. They hope to learn if this medicine could be a new way to help manage grass pollen allergy.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Alk-Abello A/S

Enrolment target

Start

19 Oct 2023

grass pollen allergy

What is this study about?

This research study is about a medicine called acalabrutinib and its potential to help people who have an allergy to grass pollen. If you have a grass pollen allergy, your body overreacts when it comes into contact with grass pollen, leading to symptoms like sneezing, watery eyes, and an itchy nose. This study is trying to understand if acalabrutinib can reduce how strongly your body reacts to grass pollen.

To find this out, the researchers will be performing skin prick tests on participants. These tests involve putting a tiny drop of grass pollen and a control solution on the skin, usually on the forearm, and then gently pricking the skin so the substance can enter just under the surface. If you're allergic, you'll develop a small, red, itchy bump called a 'wheal' at the site. The study aims to see if participants taking acalabrutinib have smaller wheals compared to what you might normally expect.

This is an early phase of research, sometimes called a Human Pharmacology (Phase I) study. This means it's one of the first times this specific medicine is being studied in people for this particular condition. The researchers want to carefully observe how the medicine affects the body and specifically if it has a measurable impact on allergic reactions to grass pollen.

Key takeaways

This study is testing a medicine called acalabrutinib for adults with grass pollen allergy.
The main aim is to see if the medicine reduces the size of skin prick test reactions.
It's an early-stage study to understand how the medicine affects allergic responses.
Participation involves clinic visits, taking the study medicine, and having skin prick tests.
Findings could help develop new ways to manage grass pollen allergy in the future.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There's no upper age limit for taking part in this specific trial.

Both men and women are welcome to participate. The study aims to include a diverse group of people to understand how the medicine works in different individuals.

To be considered for this study, you must have a confirmed grass pollen allergy. The medical team will check this, likely through your medical history and allergy tests.

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 a doctor-diagnosed grass pollen allergy?
Are you comfortable attending regular clinic visits?
Are you willing to have skin prick tests?
Are you able to take study medication as directed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. This might involve a medical check-up, blood tests, and confirming your grass pollen allergy. If you're eligible, you would then begin the study.

The study involves taking the medicine acalabrutinib for a set period. You would have regular visits to the clinic, where the study team would monitor your health, ask about any symptoms, and perform specific tests. These tests would include skin prick tests to measure your allergic reaction to grass pollen over time. There would also be blood tests to see how the medicine is affecting your body.

The total duration of the study, including all visits and follow-up, would be explained to you in detail before you agree to participate.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is contributing to medical knowledge that could one day help people with grass pollen allergy. While there's no guarantee the medicine will directly benefit you, you will receive close medical attention during the trial. Potential risks could include side effects from the study medicine, discomfort from blood tests or skin prick tests, or needing to attend several clinic visits. You will be given a full explanation of all known or possible risks before you decide to take part. Remember, you have the right to withdraw from 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
Germany

Common questions

What is acalabrutinib?

Acalabrutinib is a medicine that scientists are investigating to see if it can help with grass pollen allergy. It's usually used for different conditions, but this study is testing its effect on allergic reactions.

What is a skin prick test?

A skin prick test is a common way to check for allergies. A tiny drop of the allergen (like grass pollen) is placed on your skin, and then the skin is gently pricked. If you're allergic, a small, itchy bump will appear.

Why is this study only for adults?

Early-stage studies like this one often start with adults to carefully understand how a new treatment works in the body before considering younger age groups.

Will taking part cure my grass pollen allergy?

This study is designed to investigate if acalabrutinib can reduce allergic reactions, not necessarily to cure the allergy. The main goal is to gather information about the medicine's effects.

Do I have to pay to join the study?

No, you do not have to pay to participate in a clinical trial. All study-related medication, tests, and procedures are provided at no cost to you.