Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma

Study Overview
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Brief Summary
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Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).

Detailed Description
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Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA). After a screening period subjects will receive standardized, inhaled therapy during a run-in period. Subjects will be randomized to receive RPT193 or placebo through Week 14. All enrolled subjects will receive background inhaled therapy with ICS and LABA.

Official Title
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A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 in Adults With Moderate-to-severe T2-high Asthma Who Are Partially Controlled on Inhaled Corticosteroid and Long-acting Beta 2 Agonist Therapy

Conditions
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Asthma

Intervention / Treatment
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* Drug: RPT193
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of asthma for ≥6 months Pre-bronchodilator FEV1 of >40% and <80% History of treatment with corticosteroid or hospitalization for worsening asthma Medium- or high-dose inhaled corticosteroid use Exclusion Criteria: History of smoking/vaping History of severe COVID Serious and/or uncontrolled pulmonary, cardiac, immune system conditions Requires systemic oral or IV corticosteroids in the month prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RPT193 400 mg<br> | Drug: RPT193<br>* RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a Loss of Asthma Control event as defined by criteria listed | ≥ 30% reduction in peak expiratory flow; ≥ 6 additional inhalations of short-acting beta 2 agonist; increase by factor of 4 or more of inhaled corticosteroids; and/or evidence of a severe asthma exacerbation | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0 | Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma