Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Study Overview
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Brief Summary
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Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Detailed Description
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This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.

Official Title
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A Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Pruritus In Adults And Adolescents With A History Of Atopic Dermatitis

Conditions
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Pruritus, Atopic Dermatitis

Intervention / Treatment
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* Drug: Serlopitant High Dose
* Drug: Placebo Oral Tablet
* Drug: Serlopitant Low Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 13 years or older Pruritus prior to and during the initial screening period Diagnosis of atopic dermatitis Judged to be in good health in the investigator's opinion Exclusion Criteria: Prior treatment with study drug or similar drug Pruritus due to another reason besides atopic dermatitis Presence of any medical condition or disability that could interfere with study History of hypersensitivity to serlopitant or any of its components Currently pregnant or male partner of pregnant female Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding

Ages Eligible for Study
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Minimum Age: 13 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serlopitant High Dose<br>serlopitant tablets - high dose | Drug: Serlopitant High Dose<br>* serlopitant tablets - high dose<br>|
| Experimental: Serlopitant Low Dose<br>serlopitant tablets - low dose | Drug: Serlopitant Low Dose<br>* serlopitant tablets - low dose<br>|
| Placebo Comparator: Placebo Oral Tablet<br>matching placebo tablets | Drug: Placebo Oral Tablet<br>* placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WI-NRS From Baseline to Week 6 | Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline. | Week 6 compared to Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WI-NRS 4-point Responder Rate at Week 6 | Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline. | Week 6 compared to Baseline | 
| Change in Quality of Life (ItchyQoL) From Baseline to Week 6 | ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5. | Week 6 compared to Baseline |