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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
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
Time frame: 14 weeks
Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 20 weeks
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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
Sonce Medical Research
Miami, Florida, United States
Coral Research Clinical Corp
Miami, Florida, United States
San Marcos Research Clinic
Miami Lakes, 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
...and 19 more locations