An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis

Study Overview
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Brief Summary
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Phase 2 study of RPT193 in adults with atopic dermatitis

Detailed Description
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Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis

Official Title
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A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: RPT193
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RPT193 400 mg<br>RPT193 400 mg oral tablet administered daily for 16 weeks | Drug: RPT193<br>* RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17<br>|
| Experimental: RPT193 200 mg<br>RPT193 200 mg oral tablet administered daily for 16 weeks | Drug: RPT193<br>* RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17<br>|
| Experimental: RPT193 50 mg<br>RPT193 50 mg oral tablet administered daily for 16 weeks | Drug: RPT193<br>* RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17<br>|
| Placebo Comparator: Placebo<br>Matching placebo oral tablet administered daily for 16 weeks | Other: Placebo<br>* Nonactive placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy | % change in Eczema Area Severity Index (EASI) | 16 weeks | 
| Safety as measured by adverse events | Incidence of treatment-emergent adverse events | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis