Atopic Dermatitis
Conditions
Keywords
atopic dermatitis
Brief summary
Phase 2 study of RPT193 in adults with atopic dermatitis
Detailed description
Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis
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
Nonactive placebo tablet
Sponsors
RAPT Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria * 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening * inadequate response to a ≥1 month treatment with topical medications * Atopic dermatitis covering ≥10% of the body surface area * EASI score ≥16 * Validated Investigator Global Assessment (VIGA) ≥3 * Use of emollient(s) at least 2x daily for 1 week prior to baseline * Negative coronavirus disease (COVID)-19 results at screening
Exclusion criteria
* Uncontrolled moderate-to-severe asthma * Uncontrolled diabetes * Stage III or IV cardiac failure * Severe renal condition * Major surgery within 8 weeks of screening * Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline * Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline * Received live or live-attenuated vaccine within 4 weeks of baseline * Prior receipt of RPT193
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD | 16 weeks | % change in Eczema Area Severity Index (EASI) from baseline at Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 16 weeks | To evaluate the safety and tolerability of RPT193 administered orally QD for 16 weeks |
Countries
Canada, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 43.3 years STANDARD_DEVIATION 16.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 65 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 114 Participants |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment United States | 54 participants |
| Sex: Female, Male Female | 125 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 57 | 0 / 57 | 0 / 56 |
| other Total, other adverse events | 12 / 59 | 7 / 57 | 5 / 57 | 4 / 56 |
| serious Total, serious adverse events | 2 / 59 | 0 / 57 | 1 / 57 | 0 / 56 |
Outcome results
None listed