Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)



Status:Recruiting
Conditions:Allergy, Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:March 15, 2018
End Date:September 2020
Contact:Menlo Study Director
Email:nularis3@menlotx.com
Phone:650-486-1416

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An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus

Study of the long term safety of serlopitant for the treatment of pruritus in adults.


Inclusion Criteria:

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

- Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.

- Female subjects of childbearing potential must be willing to practice highly effective
contraception until 5 weeks after last dose of study drug.

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

Exclusion Criteria:

- Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous
malignancies).

- Any known major psychiatric diagnosis, such as major depressive disorder, bipolar
disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol
use disorder, which may confound the assessment of serlopitant safety or efficacy, or
interfere with the subject's ability to comply with protocol-mandated activities,
within 3 years prior to enrollment.

- Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease,
or history of thyroid malignancy; or the prescense of any medical condition or
disability, that could interfere with the assessment of safety in this study or
compromise the safety of the subject.

- Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever
is longer) or expected participation in another clinical study involving an
investigational product or device during the subject's participation in this study.

- Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant,
fosaprepitant, rolapitant) within 4 weeks.

- Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.

- Currently pregnant or breastfeeding or planning to become pregnant during the study.
We found this trial at
41
sites
Detroit, Michigan 48202
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Ann Arbor, Michigan 48103
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Austin, Texas
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Aventura, Florida 33180
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Bellaire, Texas 77401
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Bexley, Ohio 43209
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Brooklyn, New York 11215
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Bryant, Arkansas 72022
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Buffalo, New York 14215
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Cleveland, Ohio 44142
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Coral Gables, Florida 33134
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Dallas, Texas 75216
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Dublin, Ohio 43016
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761 New Jersey 33
East Windsor, New Jersey 08520
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East Windsor, NJ
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Fremont, California 94538
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Fridley, Minnesota 55432
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Fridley, MN
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Glenn Dale, Maryland 20769
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Graz,
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Henderson, Nevada 89052
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High Point, North Carolina 27262
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Houston, Texas 77004
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Johnston, Rhode Island
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Johnston, RI
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Knoxville, Tennessee 37317
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Louisville, Kentucky 40202
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New Orleans, Louisiana 70112
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New York, New York 10029
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Newnan, Georgia 30263
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North Hollywood, California
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North Miami Beach, Florida 33162
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Omaha, Nebraska 68144
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Orange Park, Florida 32073
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Pflugerville, Texas
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Pittsburgh, Pennsylvania 15212
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Richmond, Virginia 23298
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Saint Joseph, Missouri
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San Antonio, Texas
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San Diego, California 92103
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Santa Ana, California 92701
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Santa Ana, CA
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Spartanburg, South Carolina
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Tulsa, Oklahoma 74136
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Webster, Texas 77598
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Webster, TX
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