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

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

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).

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.

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