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
Berlin, New Jersey
1237
mi
from
Berlin, NJ
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Anderson, South Carolina
874
mi
from
Anderson, SC
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Anniston, Alabama
728
mi
from
Anniston, AL
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Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
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Austin, Texas
517
mi
from
Austin, TX
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Bardstown, Kentucky
674
mi
from
Bardstown, KY
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Birmingham, Alabama 35211
683
mi
from
Birmingham, AL
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Boston, Massachusetts
1444
mi
from
Boston, MA
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Cerritos, California
1163
mi
from
Cerritos, CA
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Chattanooga, Tennessee
719
mi
from
Chattanooga, TN
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Chicago, Illinois 60612
609
mi
from
Chicago, IL
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Denver, Colorado
409
mi
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Denver, CO
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Draper, Utah
775
mi
from
Draper, UT
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Encinitas, California
1141
mi
from
Encinitas, CA
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Forest Hills, New York
1294
mi
from
Forest Hills, NY
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Fountain Valley, California
1160
mi
from
Fountain Valley, CA
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Glendale, Arizona
856
mi
from
Glendale, AZ
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High Point, North Carolina 27262
853
mi
from
High Point, NC
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Hoover, Alabama
687
mi
from
Hoover, AL
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Houston, Texas 77004
572
mi
from
Houston, TX
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16003 Florida Avenue
Jacksonville, Florida 32209
1043
mi
from
Jacksonville, FL
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Johnston, Rhode Island
?
mi
from
Johnston, RI
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Las Vegas, Nevada
960
mi
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Las Vegas, NV
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Los Angeles, California
1168
mi
from
Los Angeles, CA
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Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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Miami, Florida 33136
1321
mi
from
Miami, FL
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New Albany, Indiana
653
mi
from
New Albany, IN
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Norfolk, Virginia
1182
mi
from
Norfolk, VA
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North Hollywood, California
1173
mi
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North Hollywood, CA
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Oceanside, California
1142
mi
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Oceanside, CA
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Oklahoma City, Oklahoma
158
mi
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Oklahoma City, OK
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Pflugerville, Texas
505
mi
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Pflugerville, TX
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Pinellas Park, Florida
1111
mi
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Pinellas Park, FL
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Plano, Texas
332
mi
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Plano, TX
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Providence, Rhode Island
1424
mi
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Providence, RI
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Richmond, Virginia 23298
1111
mi
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Richmond, VA
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Rochester, New York
1122
mi
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Rochester, NY
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Saint Joseph, Missouri
212
mi
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Saint Joseph, MO
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San Antonio, Texas
576
mi
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San Antonio, TX
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San Diego, California 92103
1142
mi
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San Diego, CA
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San Francisco, California
1181
mi
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San Francisco, CA
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Santa Monica, California
1182
mi
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Santa Monica, CA
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Savannah, Georgia
1023
mi
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Savannah, GA
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Shelby, North Carolina
918
mi
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Shelby, NC
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Spartanburg, South Carolina
903
mi
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Spartanburg, SC
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Tampa, Florida
1117
mi
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Tampa, FL
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Warren, Michigan
845
mi
from
Warren, MI
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