Asthma
Conditions
Keywords
asthma
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.
Interventions
DRUGRPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
OTHERPlacebo
placebo
Sponsors
RAPT Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Bulgaria, Czechia, Poland, United States
Contacts
STUDY_DIRECTORLaurence Cheng, MD, PhD
RAPT Therapeutics, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 58 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment Bulgaria | 2 participants |
| Region of Enrollment Czechia | 2 participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 6 / 19 | 3 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
None listed