Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin



Status:Recruiting
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 120
Updated:2/21/2019
Start Date:January 22, 2019
End Date:April 2020
Contact:Menlo Study Director
Email:capstone@menlotx.com
Phone:650-486-1416

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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and
Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin


Inclusion:

- Male or female, age 18 years or older at consent.

- The subject must have ongoing chronic pruritus

- The subject's pruritus is assessed by the investigator to be of unknown origin at
baseline.

- Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the
Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to
Baseline visit indicating an appropriate pruritus level for the study.

- The pruritus must have been unresponsive to prior treatment with emollients.

- The subject's pruritus must be present on multiple segments of the body

- Willing and able to complete daily eDiary entries within a consistent timeframe for
the duration of the study

- All females who are of childbearing potential must be willing to practice highly
effective contraception and not be pregnant or nursing

- Willing to comply with study visits and study related requirements including providing
written informed consent.

- Adequate cognitive and physical ability, in the investigator's opinion, to comply with
study visits and study related requirements including providing written informed
consent

Exclusion

- Prior treatment with any NK1-receptor antagonists

- Known dermatologic or systemic condition(s), other than dry skin, that is considered
by the investigator to be the primary cause of current pruritus.

- Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules,
or history of thyroid malignancy.

- Use of an excluded therapy within 3 weeks prior to randomization

- Treatment with any investigational therapy within 3 weeks prior to randomization.

- Serum creatinine, total bilirubin, alanine aminotransferase or aspartate
aminotransferase > 2.5 times the upper limit of normal during screening.

- History of malignancy within 3 years prior to randomization, with the (actinic
keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of
skin).

- Any known major psychiatric diagnosis that would impact the subject's ability to
complete the study

- Suicidal ideation within 3 years prior to randomization, or any history of suicide
attempt.

- Known use of recreational drugs.

- Documented history of parasitic infection, including skin parasites such as scabies,
within 12 weeks prior to randomization.

- Presence of clinically significant dementia, intellectual impairment, or any medical
condition or disability that, in the investigator's opinion, could interfere with the
assessment of safety or efficacy in this trial or compromise the safety of the
subject.

- History of hypersensitivity to serlopitant or any of its components.

- Planned or anticipated major surgical procedure or other activity that would interfere
with the subject's ability to comply with protocol-mandated assessments (e.g. extended
international travel) during the subject's participation in the study.
We found this trial at
27
sites
Indianapolis, Indiana 46290
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Indianapolis, IN
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Aventura, Florida 33180
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Aventura, FL
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Brighton, Massachusetts 02135
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Brighton, MA
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Bronx, New York 10458
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Bronx, NY
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Denver, Colorado
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Denver, CO
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Dublin, Ohio 43016
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Dublin, OH
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Fremont, California 94538
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Fremont, CA
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High Point, North Carolina 27262
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High Point, NC
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Hot Springs, Arkansas 72022
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Hot Springs, AR
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16003 Florida Avenue
Jacksonville, Florida 32209
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Jacksonville, FL
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Johnston, Rhode Island
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Johnston, RI
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Las Vegas, Nevada
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Las Vegas, NV
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Los Angeles, California
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Los Angeles, CA
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Miami, Florida 33136
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Miami, FL
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Morristown, New Jersey 07960
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Morristown, NJ
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Nashville, Tennessee 37215
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Nashville, TN
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Norfolk, Virginia
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Norfolk, VA
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330 Changebridge Road
Ocean Township, New Jersey 07712
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Ocean Township, NJ
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Pflugerville, Texas
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Pflugerville, TX
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Raleigh, North Carolina 27612
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Raleigh, NC
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Saint Joseph, Missouri
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Saint Joseph, MO
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San Antonio, Texas
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San Antonio, TX
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Savannah, Georgia
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Savannah, GA
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Spokane, Washington 99202
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Spokane, WA
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Walla Walla, Washington 09362
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Walla Walla, WA
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Warwick, Rhode Island 02886
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Warwick, RI
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West Palm Beach, Florida 33406
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West Palm Beach, FL
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