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
Fountain Valley, California
25
mi
from 91732
Fountain Valley, CA
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Anderson, South Carolina
2008
mi
from 91732
Anderson, SC
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Anniston, Alabama
1838
mi
from 91732
Anniston, AL
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Atlanta, Georgia 30322
1922
mi
from 91732
Atlanta, GA
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Austin, Texas
1212
mi
from 91732
Austin, TX
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Bardstown, Kentucky
1829
mi
from 91732
Bardstown, KY
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Berlin, New Jersey
2388
mi
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Berlin, NJ
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Birmingham, Alabama 35211
1785
mi
from 91732
Birmingham, AL
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Boston, Massachusetts
2578
mi
from 91732
Boston, MA
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Cerritos, California
15
mi
from 91732
Cerritos, CA
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Chattanooga, Tennessee
1853
mi
from 91732
Chattanooga, TN
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Chicago, Illinois 60612
1728
mi
from 91732
Chicago, IL
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Denver, Colorado
818
mi
from 91732
Denver, CO
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Draper, Utah
559
mi
from 91732
Draper, UT
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Encinitas, California
82
mi
from 91732
Encinitas, CA
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Forest Hills, New York
2440
mi
from 91732
Forest Hills, NY
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Glendale, Arizona
336
mi
from 91732
Glendale, AZ
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High Point, North Carolina 27262
1997
mi
from 91732
High Point, NC
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Hoover, Alabama
1786
mi
from 91732
Hoover, AL
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Houston, Texas 77004
1358
mi
from 91732
Houston, TX
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16003 Florida Avenue
Jacksonville, Florida 32209
2112
mi
from 91732
Jacksonville, FL
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Johnston, Rhode Island
?
mi
from 91732
Johnston, RI
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Las Vegas, Nevada
217
mi
from 91732
Las Vegas, NV
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Los Angeles, California
13
mi
from 91732
Los Angeles, CA
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Louisville, Kentucky 40202
1812
mi
from 91732
Louisville, KY
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Miami, Florida 33136
2322
mi
from 91732
Miami, FL
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New Albany, Indiana
1809
mi
from 91732
New Albany, IN
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Norfolk, Virginia
2337
mi
from 91732
Norfolk, VA
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North Hollywood, California
22
mi
from 91732
North Hollywood, CA
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Oceanside, California
70
mi
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Oceanside, CA
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Oklahoma City, Oklahoma
1165
mi
from 91732
Oklahoma City, OK
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Pflugerville, Texas
1215
mi
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Pflugerville, TX
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Pinellas Park, Florida
2125
mi
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Pinellas Park, FL
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Plano, Texas
1227
mi
from 91732
Plano, TX
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Providence, Rhode Island
2562
mi
from 91732
Providence, RI
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Richmond, Virginia 23298
2267
mi
from 91732
Richmond, VA
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Rochester, New York
2245
mi
from 91732
Rochester, NY
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Saint Joseph, Missouri
1334
mi
from 91732
Saint Joseph, MO
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San Antonio, Texas
1188
mi
from 91732
San Antonio, TX
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San Diego, California 92103
106
mi
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San Diego, CA
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San Francisco, California
41
mi
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San Francisco, CA
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Santa Monica, California
27
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Santa Monica, CA
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Savannah, Georgia
2129
mi
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Savannah, GA
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Shelby, North Carolina
2062
mi
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Shelby, NC
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Spartanburg, South Carolina
2043
mi
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Spartanburg, SC
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Tampa, Florida
2136
mi
from 91732
Tampa, FL
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Warren, Michigan
1968
mi
from 91732
Warren, MI
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