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A study to evaluate the effects of KT-621 in adults with moderate to severe eosinophilic asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Eosinophilic Asthma, a type of Asthma where the airways are inflamed due to high levels of eosinophils, which are a specific type of white blood cell. The condition being studied is specifically Uncontrolled Moderate to Severe Eosinophilic Asthma, meaning the symptoms are not well-managed by current standard treatments. The purpose of the study is to evaluate the efficacy of different doses of the experimental medication KT-621 compared to a placebo.

Participants in the study will take an oral tablet. Some will receive different doses of KT-621, while others will receive a placebo. To ensure the results are fair, the study is double blind, meaning neither the participants nor the researchers know which specific treatment is being administered at any given time. The study is organized into different groups that receive their assigned medication simultaneously to compare how well the drug works and to monitor its safety profile.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
After joining the study, one will be assigned to receive either the test medication, known as kt-621, or a placebo, which is an inactive substance that looks like the medicine but has no active ingredients.
The kt-621 is an oral tablet, meaning it is taken by mouth.
Step 2
Medication administration and monitoring
The medication is administered for a period of 12 weeks.
During this time, changes in fev1 will be measured. fev1 refers to the amount of air that can be forcibly exhaled in one second, which helps determine how well the lungs are working.
Measurements will include pre-bronchodilator fev1, which is the lung function measured before using a rescue inhaler, and post-bronchodilator fev1, which is the lung function measured after using a rescue inhaler.
The acq-5 score and aqlq(s) global score will be used to assess asthma control and how asthma affects daily life.
Safety will be monitored by tracking any treatment-emergent adverse events, which are any side effects or health changes that occur during the study.

Who can join the trial?

10 criteria

You must have a history of at least one asthma exacerbation, which is a sudden worsening of asthma symptoms, that required either systemic corticosteroids (steroid medicines taken by mouth, through a vein, or by injection) and/or a hospital stay or emergency room visit within the last 52 weeks.
Your absolute blood eosinophil count, which is a measurement of a specific type of white blood cell involved in allergic reactions, must be 0.30 x 10^9/L or higher.
You can be any gender, but you must use contraception (methods to prevent pregnancy) in accordance with local rules for clinical study participants.
You must be between 18 and 75 years old at the time of signing the consent form.
You must have been officially diagnosed with asthma for at least 52 weeks before the start of the study.
You must be taking a stable dose of a medium- to high-dose inhaled steroid combined with a LABA (a long-acting medication that helps keep airways open) for at least 12 weeks, without changing your dose or schedule in the 4 weeks before the study begins.
Your FEV1, which is a test that measures how much air you can forcefully exhale in one second, must be between 40% and 80% of the normal expected value for your age and size.
Your ACQ-5 score, which is a questionnaire used to measure how well your asthma is controlled, must be 1.5 or higher.
Your FeNO level, which is a test that measures the amount of nitric oxide in your breath to check for airway inflammation, must be 25 parts per billion (ppb) or higher.
You must show evidence of reversible airway obstruction, meaning your breathing improves after using a bronchodilator (a quick-relief medicine like albuterol that opens the airways).

Who cannot join the trial?

15 criteria

Having any serious lung disease other than asthma, such as COPD (a condition that makes it hard to breathe), bronchiectasis (damaged airways), pulmonary fibrosis (scarring of the lungs), cystic fibrosis (a genetic disease affecting mucus), lung cancer, or infections in the lungs.
Having conditions that cause high levels of eosinophils (a type of white blood cell involved in allergies and asthma) in the blood, such as Churg Strauss syndrome or hypereosinophilic syndrome.
Having any medical or mental health condition that, in the doctor's opinion, could make participation unsafe or prevent the study results from being accurate.
A history of using drugs or alcohol excessively within the last 2 years.
Current use of nicotine, including smoking tobacco, using vaping products, or electronic cigarettes. People who used to smoke must have stopped for at least 26 weeks.
Having any type of cancer within the last 5 years, unless it was a specific type of skin or cervix cancer that was completely removed by surgery.
Having a severe asthma flare-up in the 4 weeks before the study starts that required systemic corticosteroids (strong medicines like pills or injections used to reduce inflammation), a hospital visit, or emergency care.
Testing positive for HIV (a virus that attacks the immune system), Hepatitis B, Hepatitis C, or having an active or untreated tuberculosis (TB) infection.
Having abnormal blood results, such as low platelets (cells that help blood clot), low hemoglobin (a protein in red blood cells that carries oxygen), or low neutrophils (white blood cells that fight infection).
Having abnormal liver tests, such as high levels of AST or ALT (enzymes that indicate liver health) or high bilirubin (a yellow substance produced by the liver).
A known or suspected immunodeficiency disorder (a condition where the immune system is weak) or a history of frequent or severe infections.
A current or recent parasitic infection (an infection caused by tiny organisms like worms) or having traveled to areas where these infections are common in the last 3 months.
Having had major surgery in the 8 weeks before the study starts or planning to have any surgery during the study.
Having any current infection (like a chest or throat infection) that required antibiotics, antifungals (medicine for fungus), or antivirals (medicine for viruses) in the recent weeks.
Any other health condition that might make the study unsafe, such as uncontrolled diabetes, heart failure, high blood pressure, kidney disease requiring dialysis, or autoimmune diseases like lupus or rheumatoid arthritis.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Pneumocare
Namur, Belgium

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Investigated drugs

KT-621 is an experimental medicine taken as a pill by mouth. It is being studied to see if it can help improve symptoms and manage health in adults who have moderate to severe asthma caused by high levels of a specific type of white blood cell called eosinophils.

What is already known about the treatment

KT-621
This medication is an experimental drug administered as a tablet taken by mouth. It is currently being studied in clinical trials to determine its effectiveness and safety for treating adults with moderate to severe asthma characterized by high levels of eosinophils, which are a type of white blood cell. This substance belongs to a class of drugs designed to target specific immune system responses at a molecular level to reduce airway inflammation. As an investigational therapy, it is not yet widely available in medical practice.
Placebo
This is an inactive substance administered as an oral tablet that looks exactly like the study medication. It is used in clinical research as a control to help scientists determine if the actual test drug is producing real effects. The placebo contains no active medicinal ingredients and does not work to change the body's molecular processes or treat asthma symptoms.

Investigated diseases

Uncontrolled Moderate to Severe Eosinophilic Asthma - This is a type of chronic lung disease characterized by inflammation in the airways. It occurs when a specific type of white blood cell, called an eosinophil, builds up in the lungs. This buildup causes the airways to become swollen and narrow, making it difficult to breathe. The condition is considered uncontrolled when symptoms persist despite standard management. Over time, this ongoing inflammation can lead to frequent breathing difficulties and airway sensitivity.