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

Phase 2

Completed

Interventions: Drug: Placebo Oral Tablet
Drug: Serlopitant High Dose
Drug: Serlopitant Low Dose

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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo Oral Tablet	Placebo Oral Tablet	matching placebo tablets
Serlopitant High Dose	Serlopitant High Dose	serlopitant tablets - high dose
Serlopitant Low Dose	Serlopitant Low Dose	serlopitant tablets - low dose

Primary Outcome Measures

Name	Time	Method
Change in WI-NRS From Baseline to Week 6	Week 6 compared to Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life (ItchyQoL) From Baseline to Week 6	Week 6 compared to Baseline	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.
WI-NRS 4-point Responder Rate at Week 6	Week 6 compared to Baseline	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.

Locations (52): Study Site 332
🇺🇸
Anniston, Alabama, United States
Study Site 363
🇺🇸
Birmingham, Alabama, United States
Study Site 340
🇺🇸
Hoover, Alabama, United States
Study Site 364
🇺🇸
Glendale, Arizona, United States
Study Site 334
🇺🇸
Cerritos, California, United States
Study Site 386
🇺🇸
Encinitas, California, United States
Study Site 366
🇺🇸
Fountain Valley, California, United States
Study Site 338
🇺🇸
Los Angeles, California, United States
Study Site 383
🇺🇸
North Hollywood, California, United States
Study Site 374
🇺🇸
Oceanside, California, United States
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Study Site 332
🇺🇸Anniston, Alabama, United States