Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 study to evaluate the efficacy and safety of RPT193 in adults with moderate-to-severe T2-high asthma who are partially controlled on inhaled corticosteroid and long-acting beta 2 agonist therapy

This research is looking at a new medication called RPT193 for adults who have asthma that's considered moderate to severe and isn't completely managed by their current inhalers (like steroid and long-acting bronchodilator inhalers). It’s a ‘Phase 2’ study, which means scientists are checking if the new medicine works and if it's safe to use. They will look at how often people have asthma flare-ups and how well their lungs are working. The goal is to see if RPT193 could help people better manage their asthma symptoms and reduce the need for extra medications or hospital visits. This study hopes to find out if RPT193 could be a useful new treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rapt Therapeutics Inc.

Enrolment target

Start

09 Oct 2023

Asthma

What is this study about?

This study is about a new medicine called RPT193, and it's for adults in the UK who have asthma. Specifically, it's for those whose asthma is described as 'moderate to severe' and isn't fully controlled even though they're regularly using their usual inhalers, like those containing steroids and long-acting bronchodilators.

The main aim of this research is to see if RPT193 can help stop asthma flare-ups and improve breathing. Researchers will be carefully checking how often participants experience things like a big drop in their peak flow (a measure of breathing function), needing extra puffs of their reliever inhaler, or having to go to hospital because of their asthma. They will also be looking closely at any side effects to make sure the medicine is safe. This type of study, called a Phase 2 trial, is a middle step in testing new medicines to see if they are promising enough to continue with further research.

By taking part, individuals could help doctors understand if RPT193 could be a new and effective treatment option for asthma. The information gathered from this study will be used to decide if RPT193 should be tested in larger groups of people, ultimately helping more patients in the future who struggle to control their asthma with current treatments.

Key takeaways

Tests a new medicine (RPT193) for moderate to severe asthma.
Aims to improve asthma control and reduce flare-ups.
Checks how effective and safe the new medicine is.
Participants will receive close medical monitoring.
Requires regular clinic visits and lung function tests.
Participation helps future asthma treatments.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. Both men and women are welcome to take part.

You would also need to have asthma that is considered 'moderate to severe' and that isn't fully controlled with your current asthma medications, specifically inhaled steroid and long-acting bronchodilator inhalers.

There might be other health conditions or medications that would mean you couldn't join the study, but the study team would discuss all of these details with you.

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 asthma that is considered moderate to severe?
Is your asthma not fully controlled by your current steroid and long-acting bronchodilator inhalers?
Are you able to attend regular clinic appointments for the study?
Are you currently living in the UK where this study is taking place?

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. If you do, the study would involve taking the new medicine, RPT193, or a comparison medicine (which might be a different asthma inhaler or a tablet without active substance, also known as a placebo). You would continue to use your current asthma inhalers as directed by the study team, which could include medications like Flixotide, Seretide, or Ventolin.

Throughout the study, you would have several visits to the clinic where the research team will monitor your asthma. They will check your breathing using lung function tests (like FEV1 and PEF), ask you questions about your asthma symptoms, and monitor for any side effects. You might also need to use your reliever inhaler a certain way and keep a diary of your symptoms. Some visits might involve a test called FeNO, which measures a gas in your breath to check airway inflammation. The study will likely last for several weeks or months, with follow-up appointments after you stop taking the study medication to make sure you are well.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of joining this study is that the new medicine, RPT193, might help improve your asthma control and reduce your symptoms. You would also receive close medical attention and monitoring from the study team. However, there's no guarantee the new medicine will work for you, or that you'll receive the active drug. Potential risks include experiencing side effects from the study medication, which the research team would explain in detail. You might also need to attend clinic visits regularly, which could take up some of your time. It’s very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Czechia
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is RPT193?

RPT193 is a new medicine being tested to see if it can help adults with moderate to severe asthma.

What kind of asthma is this study for?

This study is for adults whose asthma is moderate to severe and isn't fully controlled by their regular inhalers.

Will I still use my regular asthma inhalers?

Yes, you would continue to use your usual asthma inhalers as instructed by the study team while participating.

What is a 'Phase 2' study?

A Phase 2 study is a mid-stage research trial that checks if a new medicine works and is safe for people.

What is a 'placebo'?

A placebo is a tablet without any active medicine in it, used for comparison to see the true effect of the new drug.