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
Rochester, New York
334
mi
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Rochester, NY
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Anderson, South Carolina
826
mi
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Anderson, SC
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Anniston, Alabama
999
mi
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Anniston, AL
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Atlanta, Georgia 30322
929
mi
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Atlanta, GA
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Austin, Texas
1691
mi
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Austin, TX
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Bardstown, Kentucky
820
mi
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Bardstown, KY
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Berlin, New Jersey
267
mi
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Berlin, NJ
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Birmingham, Alabama 35211
1048
mi
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Birmingham, AL
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Boston, Massachusetts
2
mi
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Boston, MA
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Cerritos, California
2585
mi
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Cerritos, CA
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Chattanooga, Tennessee
915
mi
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Chattanooga, TN
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Chicago, Illinois 60612
847
mi
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Chicago, IL
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Denver, Colorado
1762
mi
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Denver, CO
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Draper, Utah
2094
mi
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Draper, UT
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Encinitas, California
2572
mi
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Encinitas, CA
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Forest Hills, New York
182
mi
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Forest Hills, NY
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Fountain Valley, California
2584
mi
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Fountain Valley, CA
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Glendale, Arizona
2295
mi
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Glendale, AZ
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High Point, North Carolina 27262
775
mi
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High Point, NC
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Hoover, Alabama
1053
mi
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Hoover, AL
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Houston, Texas 77004
1603
mi
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Houston, TX
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16003 Florida Avenue
Jacksonville, Florida 32209
1035
mi
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Jacksonville, FL
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Johnston, Rhode Island
?
mi
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Johnston, RI
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Las Vegas, Nevada
2366
mi
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Las Vegas, NV
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Los Angeles, California
2588
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Los Angeles, CA
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Louisville, Kentucky 40202
821
mi
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Louisville, KY
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Miami, Florida 33136
1256
mi
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Miami, FL
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New Albany, Indiana
823
mi
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New Albany, IN
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Norfolk, Virginia
470
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Norfolk, VA
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North Hollywood, California
2591
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North Hollywood, CA
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Oceanside, California
2571
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Oceanside, CA
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Oklahoma City, Oklahoma
1490
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Oklahoma City, OK
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Pflugerville, Texas
1678
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Pflugerville, TX
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Pinellas Park, Florida
1195
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Pinellas Park, FL
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Plano, Texas
1533
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Plano, TX
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Providence, Rhode Island
40
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Providence, RI
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Richmond, Virginia 23298
472
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Richmond, VA
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Saint Joseph, Missouri
1245
mi
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Saint Joseph, MO
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San Antonio, Texas
1763
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San Antonio, TX
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San Diego, California 92103
2576
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San Diego, CA
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San Francisco, California
2596
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San Francisco, CA
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Santa Monica, California
2602
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Santa Monica, CA
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Savannah, Georgia
896
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Savannah, GA
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Shelby, North Carolina
743
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Shelby, NC
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Spartanburg, South Carolina
775
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Spartanburg, SC
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Tampa, Florida
1182
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Tampa, FL
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Warren, Michigan
607
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Warren, MI
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