A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
This study is a test of a new medicine called KT-621 for adults who have moderate to severe eosinophilic asthma that isn't well controlled. Eosinophilic asthma is a type of asthma where a particular white blood cell, called an eosinophil, plays a big role. The main goals are to find out if KT-621 helps to improve asthma symptoms, to check if it's safe to use, and to understand how the body handles the medicine. Participants will either receive KT-621 or a dummy medicine (called a placebo). This is a 'Phase 2' study, meaning we are still in the early stages of testing the medicine.
At a glance
What is this study about?
This study is looking for volunteers with a specific type of asthma called eosinophilic asthma, which is moderate to severe and not currently well-controlled. Eosinophilic asthma involves a higher-than-normal level of certain white blood cells called eosinophils, which can cause inflammation in the airways and make asthma symptoms worse. Even with current treatments, some people still struggle with their symptoms, and this study hopes to find a new way to help.
The new medicine being tested is called KT-621, and it's given as a tablet by mouth. We want to understand several important things about it. Firstly, we want to see if it can effectively reduce asthma symptoms, prevent flare-ups, and improve overall lung function. Secondly, patient safety is always the top priority, so we will carefully monitor any side effects or unwanted reactions to KT-621. Finally, we'll study how the medicine is absorbed, distributed, and processed by the body.
This is a 'Phase 2' study, which means it's an important step in the journey of developing new medicines. It helps us get a clearer picture of whether KT-621 could be a helpful treatment option for people with eosinophilic asthma in the future. Participants will be closely monitored by a medical team throughout the study.
Key takeaways
- This study is testing a new oral medicine (KT-621) for moderate to severe eosinophilic asthma.
- It's a Phase 2 study, focusing on safety, effectiveness, and how the medicine works in the body.
- You might receive KT-621 or a placebo (dummy pill).
- Regular clinic visits, tests, and symptom tracking are required.
- You must be between 18 and 75, have specific asthma symptoms, and be on stable current asthma medicines.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with asthma for at least a year. Your asthma should be classed as moderate to severe and specifically be the 'eosinophilic' type, which means you have high levels of certain white blood cells called eosinophils. You should also be taking regular asthma medication that includes an inhaled steroid and a long-acting reliever, and your medication doses should have been stable for some time.
There are also some medical checks needed, such as showing that your lung function (measured by a test called FEV1) is within a certain range and that your airways respond to a short-acting reliever medicine. You should also have had at least one asthma flare-up in the past year that needed stronger treatment like steroid tablets or an urgent medical visit.
This study is not suitable for you if you have other serious lung conditions that are not asthma. You'll need to be able to attend all study visits and follow the treatment plan. If you are a woman who could become pregnant, you'll need to agree to use effective contraception during the study.
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 between 18 and 75 years old?
- Have you been diagnosed with asthma for at least one year?
- Are you currently taking a stable dose of inhaled steroids and a long-acting reliever for your asthma?
- Have you had at least one serious asthma flare-up in the last year needing stronger medicine or urgent care?
- Do you have high levels of eosinophils (a type of white blood cell) related to your asthma?
- Are you able to attend all required study visits and follow the study instructions?
What does participation involve?
If you decide to take part, you'll be given either the new medicine, KT-621, or a 'placebo' (a dummy pill with no active medicine) – you won't know which one you are receiving. Both are given by mouth. You'll have regular visits to the study clinic, where doctors and nurses will carry out various checks including physical exams, blood tests, breathing tests, and asking questions about your asthma symptoms. You'll also be asked to complete an electronic diary about your symptoms.
The study will involve several visits over a period of time, and it's important you can attend all of them. You'll be closely monitored throughout the study to track your asthma and any effects of the medicine. The total duration of your involvement in the study will be explained to you by the study team.
Potential risks and benefits
Locations (27)
- Kymera Investigative SiteVerified postcodeLong Beach, United States· Recruiting
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- Kymera Investigative SiteVerified postcodeToledo, United States· Recruiting
Common questions
What is eosinophilic asthma?
It's a type of asthma where a higher number of specific white blood cells (eosinophils) cause inflammation in your airways and make your asthma worse.
What is a placebo?
A placebo is a dummy pill that looks like the study medicine but contains no active ingredients. It helps us fairly compare the new medicine's effects.
How long will the study last?
The exact duration of the study for each participant will be explained by the study team, but it involves several visits over a period of time.
Will I still take my regular asthma medicine?
Yes, you must be on a stable dose of your regular inhaled steroid and long-acting reliever medication before and during the study.
Can I leave the study if I change my mind?
Yes, you have the right to withdraw from the study at any time, for any reason, without consequences for your medical care.
How to find out more
Kymera Medical Director
Always speak to your GP or specialist before deciding to take part in a study.
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