Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
38 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Laurence Cheng, MD, PhD
Data sourced from clinicaltrials.gov
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