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3-[(3R)-3-[1-[5-Chloro-4-[[(1R)-1-(2,4-Dichlorophenyl)Ethyl]Amino]-6-Methylpyrimidin-2-Yl]Azetidin-3-Yl]Piperidin-1-Yl]-1-Methylcyclobutane-1-Carboxylic Acid

This article explores the ongoing clinical trials of RPT193, a promising new drug for treating moderate-to-severe T2-high asthma in adults. The study aims to assess the efficacy and safety of RPT193 in patients whose asthma is partially controlled by standard inhaled corticosteroids and long-acting beta-2 agonists. We’ll delve into the trial’s objectives, eligibility criteria, and potential impact on asthma management.

Table of Contents

What is RPT193?

RPT193 is a new medication being studied for the treatment of moderate-to-severe asthma. It is currently in Phase 2 clinical trials, which means it is being tested to determine its effectiveness and safety in patients[1]. The full name of this drug is quite complex: 3-[(3R)-3-[1-[5-CHLORO-4-[[(1R)-1-(2,4-DICHLOROPHENYL)ETHYL]AMINO]-6-METHYLPYRIMIDIN-2-YL]AZETIDIN-3-YL]PIPERIDIN-1-YL]-1-METHYLCYCLOBUTANE-1-CARBOXYLIC ACID. However, for simplicity, it’s referred to as RPT193.

How Does RPT193 Work?

RPT193 is designed to help patients with a specific type of asthma called T2-high asthma. This type of asthma involves inflammation in the airways driven by a particular group of immune cells. While the exact mechanism isn’t fully explained in the trial information, RPT193 is likely targeting this inflammatory process to help control asthma symptoms[1].

Target Patient Group

This medication is being studied for adults aged 18 to 75 who have:

  • Moderate-to-severe asthma: This means their asthma is not well-controlled despite using current treatments.
  • T2-high asthma: This is determined by having either a high level of certain white blood cells (eosinophils) or high levels of nitric oxide in exhaled breath.
  • Asthma that is only partially controlled by their current medications, which include inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA)[1].

Clinical Trial Details

The ongoing clinical trial is designed to evaluate how well RPT193 works compared to a placebo (a dummy treatment with no active ingredients). Here are some key points about the trial:

  • It lasts for 14 weeks of treatment, followed by 6 weeks of follow-up.
  • Participants take either 400 mg of RPT193 or a placebo daily as oral tablets.
  • The main goal is to see if RPT193 can prevent loss of asthma control better than the placebo[1].

Potential Benefits

The researchers are hoping to see several improvements in patients taking RPT193:

  • Better lung function, measured by a test called FEV1 (forced expiratory volume in 1 second).
  • Improved asthma control, measured by questionnaires.
  • Less need for rescue inhalers.
  • Reduced inflammation in the airways, measured by a test called FeNO (fractional exhaled nitric oxide)[1].

Safety Considerations

As with any new medication, safety is a top priority. The trial is carefully monitoring for any side effects. Some important safety considerations include:

  • Women who are pregnant, breastfeeding, or planning to become pregnant cannot participate in the trial.
  • People with certain other medical conditions, such as severe heart or kidney problems, are not eligible for the trial.
  • Participants need to meet specific criteria for lung function and overall health to be included in the study[1].

Conclusion

RPT193 represents a potential new treatment option for people with moderate-to-severe asthma that isn’t well-controlled by current medications. If successful, it could offer a new way to manage this challenging condition. However, it’s important to remember that the drug is still in the testing phase, and more research is needed to fully understand its effectiveness and safety[1].

Aspect Details
Drug Name RPT193
Condition Moderate-to-severe T2-high asthma
Study Phase Phase 2
Main Objective Evaluate effect on loss of asthma control compared to placebo
Treatment Duration 14 weeks
Dosage 400 mg daily, oral tablets
Key Eligibility Criteria Adults 18-75, asthma diagnosis ≥6 months, partially controlled on ICS/LABA
Primary Endpoint Proportion of subjects experiencing loss of asthma control
Key Secondary Endpoints Safety, time to loss of control, changes in lung function and asthma control

FAQ

  • What is RPT193 and what is it being studied for? RPT193 is a new drug being studied for the treatment of moderate-to-severe T2-high asthma in adults. It's being evaluated for its effectiveness and safety in patients whose asthma is not fully controlled by standard inhaled corticosteroids and long-acting beta-2 agonists.
  • What is the main goal of this clinical trial? The main goal is to evaluate how 400 mg of RPT193 compares to a placebo in preventing loss of asthma control (LOAC) over a 14-week period in adults with partially controlled T2-high asthma who are already using inhaled corticosteroids and long-acting beta-2 agonists.
  • Who is eligible to participate in this trial? Eligible participants are adults aged 18-75 with a diagnosis of asthma for at least 6 months, partially controlled on medium or high-dose inhaled corticosteroids with long-acting beta-2 agonists. They must have certain lung function criteria and evidence of T2-high asthma inflammation.
  • How is the drug administered in this trial? RPT193 is administered as oral tablets taken daily for 14 weeks. Participants are randomly assigned to receive either RPT193 or a placebo, and the study is double-blinded, meaning neither the participants nor the researchers know who is receiving the actual drug.
  • What are the key outcomes being measured in this trial? The primary outcome is the proportion of participants who experience a loss of asthma control. Secondary outcomes include the frequency of side effects, time to loss of asthma control, changes in lung function (FEV1), asthma control questionnaire scores, and changes in other measures like peak expiratory flow and use of rescue inhalers.

Ongoing Clinical Trials on 3-[(3R)-3-[1-[5-Chloro-4-[[(1R)-1-(2,4-Dichlorophenyl)Ethyl]Amino]-6-Methylpyrimidin-2-Yl]Azetidin-3-Yl]Piperidin-1-Yl]-1-Methylcyclobutane-1-Carboxylic Acid

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

    Not recruiting

    2 1 1
    Investigated drugs:
    Bulgaria Czechia Poland

Glossary

  • T2-high asthma: A type of asthma characterized by high levels of type 2 inflammation, often associated with allergic responses and elevated levels of certain immune cells or markers.
  • Inhaled corticosteroids (ICS): Anti-inflammatory medications inhaled directly into the lungs to reduce airway inflammation in asthma.
  • Long-acting beta-2 agonists (LABA): Medications that help relax and open the airways, providing long-lasting relief of asthma symptoms.
  • FEV1 (Forced Expiratory Volume in 1 second): A measure of lung function that represents the amount of air a person can forcefully exhale in one second.
  • Peak Expiratory Flow (PEF): The maximum rate at which a person can exhale during a short, forceful breath.
  • Loss of Asthma Control (LOAC): A worsening of asthma symptoms or lung function that indicates the current treatment is not effectively managing the condition.
  • Fractional exhaled nitric oxide (FeNO): A measure of airway inflammation, often elevated in people with asthma.
  • Placebo: An inactive substance that looks like the real drug but has no therapeutic effect, used as a control in clinical trials.
  • Double-blind study: A study design where neither the participants nor the researchers know who is receiving the actual drug and who is receiving the placebo.

References

  1. http://clinicaltrials.eu/trial/study-on-rpt193-for-adults-with-moderate-to-severe-asthma-partially-controlled-by-inhaled-corticosteroids-and-long-acting-beta-2-agonists/