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
Overview
- Phase
- Phase 2
- Intervention
- RPT193
- Conditions
- Asthma
- Sponsor
- RAPT Therapeutics, Inc.
- Enrollment
- 38
- Locations
- 29
- Primary Endpoint
- Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
- Status
- Terminated
- Last Updated
- last month
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
RPT193 400 mg
Intervention: RPT193
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
Time Frame: 14 weeks
Participants experiencing LOAC events; ≥ 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
Secondary Outcomes
- Change in FEV1 (L) of Week 14 Compared to Baseline(14 Weeks)
- Number of Participants With Non-serious Treatment-Emergent Adverse Events Experienced by ≥5% of Participants - Any TEAEs(14 weeks)