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
16003 Florida Avenue
Jacksonville, Florida 32209
677
mi
from 43215
Jacksonville, FL
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Anderson, South Carolina
377
mi
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Anderson, SC
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Anniston, Alabama
462
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Anniston, AL
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Atlanta, Georgia 30322
432
mi
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Atlanta, GA
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Austin, Texas
1065
mi
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Austin, TX
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Bardstown, Kentucky
198
mi
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Bardstown, KY
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Berlin, New Jersey
429
mi
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Berlin, NJ
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Birmingham, Alabama 35211
491
mi
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Birmingham, AL
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Boston, Massachusetts
643
mi
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Boston, MA
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Cerritos, California
1967
mi
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Cerritos, CA
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Chattanooga, Tennessee
362
mi
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Chattanooga, TN
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Chicago, Illinois 60612
274
mi
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Chicago, IL
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Denver, Colorado
1161
mi
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Denver, CO
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Draper, Utah
1514
mi
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Draper, UT
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Encinitas, California
1949
mi
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Encinitas, CA
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Forest Hills, New York
485
mi
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Forest Hills, NY
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Fountain Valley, California
1966
mi
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Fountain Valley, CA
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Glendale, Arizona
1665
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Glendale, AZ
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High Point, North Carolina 27262
303
mi
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High Point, NC
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Hoover, Alabama
499
mi
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Hoover, AL
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Houston, Texas 77004
993
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Houston, TX
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Johnston, Rhode Island
?
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Johnston, RI
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Las Vegas, Nevada
1756
mi
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Las Vegas, NV
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Los Angeles, California
1972
mi
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Los Angeles, CA
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Louisville, Kentucky 40202
188
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Louisville, KY
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Miami, Florida 33136
993
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Miami, FL
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New Albany, Indiana
189
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New Albany, IN
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Norfolk, Virginia
423
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Norfolk, VA
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North Hollywood, California
1975
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North Hollywood, CA
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Oceanside, California
1949
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Oceanside, CA
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Oklahoma City, Oklahoma
849
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Oklahoma City, OK
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Pflugerville, Texas
1052
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Pflugerville, TX
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Pinellas Park, Florida
837
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Pinellas Park, FL
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Plano, Texas
896
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Plano, TX
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Providence, Rhode Island
619
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Providence, RI
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Richmond, Virginia 23298
342
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Richmond, VA
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Rochester, New York
355
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Rochester, NY
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Saint Joseph, Missouri
626
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Saint Joseph, MO
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San Antonio, Texas
1138
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San Antonio, TX
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San Diego, California 92103
1951
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San Diego, CA
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San Francisco, California
1982
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San Francisco, CA
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Santa Monica, California
1986
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Santa Monica, CA
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Savannah, Georgia
555
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Savannah, GA
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Shelby, North Carolina
332
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Shelby, NC
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Spartanburg, South Carolina
351
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Spartanburg, SC
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Tampa, Florida
830
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Tampa, FL
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Warren, Michigan
173
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Warren, MI
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