Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma
- Registration Number
- NCT05935332
- Lead Sponsor
- RAPT Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RPT193 400 mg RPT193 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of participants with a Loss of Asthma Control event as defined by criteria listed 14 weeks ≥ 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 Outcome Measures
Name Time Method Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0 20 weeks Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Trial Locations
- Locations (29)
Allergy and Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
Bensch Clinical Research LLC
🇺🇸Stockton, California, United States
Allianz Research Institute
🇺🇸Westminster, California, United States
Allianz Research Institute CO
🇺🇸Aurora, Colorado, United States
San Marcos Research Clinic
🇺🇸Miami Lakes, Florida, United States
Sonce Medical Research
🇺🇸Miami, Florida, United States
Coral Research Clinical Corp
🇺🇸Miami, Florida, United States
Clinical Research Trials of Florida
🇺🇸Tampa, Florida, United States
OK Clinical Research LLC
🇺🇸Edmond, Oklahoma, United States
Velocity Clinical Research Grants Pass
🇺🇸Grants Pass, Oregon, United States
Scroll for more (19 remaining)Allergy and Asthma Associates of Santa Clara Valley Research Center🇺🇸San Jose, California, United States