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



Status:Completed
Conditions:Allergy, Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology
Healthy:No
Age Range:13 - Any
Updated:3/7/2019
Start Date:November 2016
End Date:February 23, 2018

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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

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

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.

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
We found this trial at
47
sites
Houston, Texas 77004
1892
mi
from 98109
Houston, TX
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Anderson, South Carolina
2227
mi
from 98109
Anderson, SC
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Anniston, Alabama
2117
mi
from 98109
Anniston, AL
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Atlanta, Georgia 30322
2179
mi
from 98109
Atlanta, GA
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Austin, Texas
1770
mi
from 98109
Austin, TX
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Bardstown, Kentucky
1968
mi
from 98109
Bardstown, KY
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Berlin, New Jersey
2389
mi
from 98109
Berlin, NJ
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Birmingham, Alabama 35211
2079
mi
from 98109
Birmingham, AL
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Boston, Massachusetts
2485
mi
from 98109
Boston, MA
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Cerritos, California
977
mi
from 98109
Cerritos, CA
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Chattanooga, Tennessee
2083
mi
from 98109
Chattanooga, TN
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Chicago, Illinois 60612
1733
mi
from 98109
Chicago, IL
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Denver, Colorado
1020
mi
from 98109
Denver, CO
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Draper, Utah
714
mi
from 98109
Draper, UT
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Encinitas, California
1042
mi
from 98109
Encinitas, CA
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Forest Hills, New York
2409
mi
from 98109
Forest Hills, NY
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Fountain Valley, California
988
mi
from 98109
Fountain Valley, CA
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Glendale, Arizona
1107
mi
from 98109
Glendale, AZ
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High Point, North Carolina 27262
2183
mi
from 98109
High Point, NC
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Hoover, Alabama
2084
mi
from 98109
Hoover, AL
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16003 Florida Avenue
Jacksonville, Florida 32209
2442
mi
from 98109
Jacksonville, FL
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Johnston, Rhode Island
?
mi
from 98109
Johnston, RI
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Las Vegas, Nevada
873
mi
from 98109
Las Vegas, NV
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Los Angeles, California
962
mi
from 98109
Los Angeles, CA
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Louisville, Kentucky 40202
1939
mi
from 98109
Louisville, KY
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Miami, Florida 33136
2731
mi
from 98109
Miami, FL
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New Albany, Indiana
1935
mi
from 98109
New Albany, IN
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Norfolk, Virginia
2430
mi
from 98109
Norfolk, VA
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North Hollywood, California
951
mi
from 98109
North Hollywood, CA
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Oceanside, California
1030
mi
from 98109
Oceanside, CA
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Oklahoma City, Oklahoma
1523
mi
from 98109
Oklahoma City, OK
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Pflugerville, Texas
1766
mi
from 98109
Pflugerville, TX
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Pinellas Park, Florida
2521
mi
from 98109
Pinellas Park, FL
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Plano, Texas
1673
mi
from 98109
Plano, TX
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Providence, Rhode Island
2485
mi
from 98109
Providence, RI
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Richmond, Virginia 23298
2350
mi
from 98109
Richmond, VA
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Rochester, New York
2161
mi
from 98109
Rochester, NY
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Saint Joseph, Missouri
1467
mi
from 98109
Saint Joseph, MO
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San Antonio, Texas
1787
mi
from 98109
San Antonio, TX
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San Diego, California 92103
1065
mi
from 98109
San Diego, CA
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San Francisco, California
934
mi
from 98109
San Francisco, CA
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Santa Monica, California
961
mi
from 98109
Santa Monica, CA
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Savannah, Georgia
2400
mi
from 98109
Savannah, GA
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Shelby, North Carolina
2246
mi
from 98109
Shelby, NC
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Spartanburg, South Carolina
2242
mi
from 98109
Spartanburg, SC
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Tampa, Florida
2527
mi
from 98109
Tampa, FL
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Warren, Michigan
1930
mi
from 98109
Warren, MI
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