What is the mechanism of action of this treatment?

Common asthma treatments work through various mechanisms to control inflammation and bronchoconstriction. Inhaled corticosteroids (ICS) reduce airway inflammation, decreasing the frequency and severity of asthma attacks. Long-acting beta-agonists (LABAs) relax the muscles around the airways, making breathing easier. Leukotriene receptor antagonists block chemicals that cause inflammation and bronchoconstriction. Biologics, such as mepolizumab and dupilumab, target specific pathways in the immune system to reduce inflammation in severe asthma cases. CCR4 antagonists like RPT193 are being studied for their potential to block the recruitment of inflammatory cells to the airways, offering a new approach to managing asthma. These treatments are crucial for asthma patients as they help maintain better control over symptoms, reduce exacerbations, and improve overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for moderate-to-severe asthma, including biologics like anti-interleukin agents (anti-IL-13, anti-IL-4, anti-IL-5), dupilumab, and mepolizumab, often have side effects such as injection site reactions, headache, and increased risk of infections. Inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) can cause oral thrush, hoarseness, and, less commonly, systemic effects like adrenal suppression. Anti-interleukin agents may also lead to increased adverse events compared to placebo, such as nasopharyngitis and upper respiratory tract infections.

What prior FDA approvals exist?

The FDA has approved several biologics for the treatment of asthma, particularly targeting severe and eosinophilic phenotypes. Dupilumab, which inhibits IL-4Rα, is approved for severe asthma with an eosinophilic phenotype or oral corticosteroid dependence. Other biologics include mepolizumab, reslizumab, and benralizumab, which target IL-5 or its receptor to reduce eosinophilic inflammation. These treatments are similar to the investigational CCR4 antagonist RPT193, as they aim to modulate immune pathways involved in severe asthma.

What other types of research exist?

Promising novel alternatives to RPT193 for asthma treatment in 2024 include biologics such as dupilumab (IL-4/IL-13 inhibitor), tezepelumab (TSLP inhibitor), and anti-IL-5 agents like mepolizumab and benralizumab. Small molecule inhibitors like JAK inhibitors (e.g., tofacitinib) and PDE4 inhibitors (e.g., BI 1015550) are also being explored for their potential benefits in asthma management.

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Monoclonal Antibodies

RPT193 for Severe Asthma

Phase 2

Waitlist Available

Research Sponsored by RAPT Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Physician diagnosis of asthma for ≥6 months

* Pre-bronchodilator FEV1 of \>40% and \<80%

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Summary

This trial is testing a new medication called RPT193 in people with moderate-to-severe asthma who are not fully controlled by their current treatments. The goal is to see if RPT193 can help reduce symptoms or improve asthma control.

Who is the study for?

This trial is for adults with moderate to severe T2-high asthma who are not fully controlled by medium or high doses of inhaled corticosteroids and long-acting beta 2 agonists. Participants should meet other specific health criteria not listed here.

What is being tested?

The study tests RPT193 against a placebo in a randomized, double-blind setup where neither the participants nor the researchers know who receives which treatment until after the results are collected.

What are the potential side effects?

Potential side effects of RPT193 aren't specified here, but common asthma medication side effects include throat irritation, headache, rapid heartbeat, and tremors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with a Loss of Asthma Control event as defined by criteria listed

Secondary study objectives

Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RPT193 400 mgExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RPT193

2019

Completed Phase 1

~110

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common asthma treatments work through various mechanisms to control inflammation and bronchoconstriction. Inhaled corticosteroids (ICS) reduce airway inflammation, decreasing the frequency and severity of asthma attacks. Long-acting beta-agonists (LABAs) relax the muscles around the airways, making breathing easier. Leukotriene receptor antagonists block chemicals that cause inflammation and bronchoconstriction. Biologics, such as mepolizumab and dupilumab, target specific pathways in the immune system to reduce inflammation in severe asthma cases. CCR4 antagonists like RPT193 are being studied for their potential to block the recruitment of inflammatory cells to the airways, offering a new approach to managing asthma. These treatments are crucial for asthma patients as they help maintain better control over symptoms, reduce exacerbations, and improve overall quality of life.