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Study on RPT193 for Adults with Moderate-to-Severe Asthma Partially Controlled by Inhaled Corticosteroids and Long-Acting Beta 2 Agonists

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment for adults with moderate-to-severe asthma, specifically a type known as T2-high asthma. This type of asthma is characterized by certain immune responses in the body. The study will evaluate a medication called RPT193, which is taken as a tablet. Participants in the study will either receive RPT193 or a placebo, which is a tablet without active ingredients. The purpose of the study is to assess how well RPT193 works in preventing the worsening of asthma symptoms in people who are already using inhaled corticosteroids and long-acting beta 2 agonists, which are common treatments for asthma.

During the study, participants will take RPT193 or a placebo for a period of 14 weeks. The study will monitor how the treatment affects asthma control, including any changes in breathing tests and the need for additional asthma medication. Participants will have regular check-ups to track their progress and any side effects they might experience. The study aims to provide more information on the safety and effectiveness of RPT193 as a potential new treatment option for asthma.

In addition to RPT193, the study involves other medications commonly used for asthma, such as Fluticasone Propionate, Salmeterol, and Salbutamol Sulfate. These medications are typically administered through inhalers and are part of the standard treatment for asthma. The study will help determine if adding RPT193 to these existing treatments can offer better control of asthma symptoms. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the treatment's impact.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will begin by taking a medication called RPT193. This is administered in the form of a tablet.
The dosage for RPT193 is 400 mg, and it is taken orally.
Step 2
Initial treatment phase
Participants will continue their existing inhaled corticosteroid and long-acting beta 2 agonist therapy. This includes medications such as Flixotide and Seretide Diskus, which are administered via inhalation.
The inhalation medications are used to help manage asthma symptoms and are taken as prescribed by the healthcare provider.
Step 3
Monitoring and assessment
Throughout the 14-week study period, participants will be monitored for any changes in asthma control. This includes tracking the frequency of reliever inhaler use and any asthma exacerbations.
Participants will have regular assessments to measure lung function, including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).
Step 4
Completion of treatment
At the end of the 14-week period, participants will complete their course of RPT193 and continue with their regular asthma management plan as advised by their healthcare provider.
Final assessments will be conducted to evaluate the overall effect of the treatment on asthma control and lung function.

Who can join the trial?

15 criteria

Must be a male or female adult aged between 18 and 75 years old.
Women who can have children must have a negative pregnancy test before starting the study and at the beginning of the study.
Women who can have children and are sexually active must agree to use a very effective birth control method from at least 4 weeks before starting the study until at least 30 days after the last dose of the study medication. These methods include hormonal birth control, devices placed inside the uterus, a partner who has had a vasectomy, or using two barrier methods like a condom with a cervical cap.
Women must agree not to undergo egg retrieval during the study and for 30 days after the last dose of the study medication.
Men who are sexually active must agree to use one of the highly effective birth control methods from the start of the study until at least 90 days after the last dose of the study medication. If their female partner uses hormonal birth control, she should start at least 4 weeks before the study and continue until at least 90 days after the last dose.
Men must agree not to donate sperm during the study and for 90 days after the last dose of the study medication.
Must be willing to participate and able to give informed consent before any study-related procedures.
Must have been diagnosed with **asthma** for at least 6 months according to GINA guidelines.
Must have a **body mass index (BMI)** of at least 18 kg/m². BMI is a measure of body fat based on height and weight.
Must have a **pre-bronchodilator FEV1** (a measure of lung function) between 40% and 80% at the screening visit and between 40% and 85% at the start of the study. FEV1 is the amount of air you can forcefully exhale in one second.
Must show evidence of reversible airway obstruction, which means the lungs can improve after using medication. This is shown by a 12% and 200 mL increase in FEV1 after using an inhaler or having a history of such improvement within the last year.
Must have a history of either using a systemic corticosteroid (a type of medication) for at least 3 days or being hospitalized or visiting the emergency room for worsening asthma in the past year.
Must be on medium- or high-dose inhaled corticosteroid therapy combined with a long-acting beta 2 agonist, with a stable dose for 8 weeks before the study and at the start of the study.
Must have a questionnaire score between 1.5 and 3.5 at screening and between 1.25 and 3.5 at the start of the study.
Must have an **absolute eosinophil count** of at least 300/µL within the last 6 months or a **FeNO** (a measure of airway inflammation) of at least 25 parts per billion at screening.

Who cannot join the trial?

7 criteria

Patients who do not have a diagnosis of **asthma**.
Patients who are not adults. This means individuals who are not yet 18 years old.
Patients who do not have **T2-high partially controlled asthma**. This is a type of asthma that is not fully managed even with medication.
Patients who are not currently using **inhaled corticosteroids (ICS)**. These are medications that help reduce inflammation in the airways.
Patients who are not using **long-acting beta 2 agonists (LABA)**. These are medications that help relax muscles in the airways to improve breathing.
Patients who are not able to follow the study procedures for 14 weeks.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

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Diagnostic-consultative center “Aleksandrovska” EOOD
Sofia, Bulgaria
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Diagnostics And Consultation Center Convex Ltd.
Sofia, Bulgaria
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MUDr. Jaroslav Mares - ordinace pro TBC a respiracní nemoci
Strakonice, Czechia

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Investigated drugs

RPT193 is an investigational medication being studied for its potential to help adults with moderate-to-severe asthma. This medication is being tested to see if it can improve asthma control in patients who are already using inhaled corticosteroids and long-acting beta 2 agonists. The goal is to determine if RPT193 can reduce the frequency or severity of asthma symptoms over a period of 14 weeks.

What is already known about the treatment

RPT193 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating moderate-to-severe asthma. It is specifically targeted at adults whose asthma is partially controlled with inhaled corticosteroids and long-acting beta 2 agonists. RPT193 works by modulating immune responses at the molecular level, aiming to reduce inflammation and improve asthma control. It is classified as an investigational drug, and its use is primarily within the context of clinical research.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The condition can vary in severity and may be triggered by allergens, exercise, cold air, or stress. Asthma progresses through episodes or attacks, where symptoms worsen and may require medical intervention. Over time, if not managed properly, asthma can lead to persistent airway changes and reduced lung function. The condition is often managed with medications to control inflammation and relieve symptoms.