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
Brooklyn, New York 11215
2186
mi
from 91732
Brooklyn, NY
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Ann Arbor, Michigan 48103
1931
mi
from 91732
Ann Arbor, MI
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Austin, Texas
1212
mi
from 91732
Austin, TX
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Aventura, Florida 33180
2320
mi
from 91732
Aventura, FL
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Bellaire, Texas 77401
1354
mi
from 91732
Bellaire, TX
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Bexley, Ohio 43209
1964
mi
from 91732
Bexley, OH
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Bryant, Arkansas 72022
1493
mi
from 91732
Bryant, AR
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Buffalo, New York 14215
2180
mi
from 91732
Buffalo, NY
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Cleveland, Ohio 44142
2032
mi
from 91732
Cleveland, OH
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Coral Gables, Florida 33134
2319
mi
from 91732
Coral Gables, FL
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Dallas, Texas 75216
1223
mi
from 91732
Dallas, TX
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Detroit, Michigan 48202
1966
mi
from 91732
Detroit, MI
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Dublin, Ohio 43016
1954
mi
from 91732
Dublin, OH
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761 New Jersey 33
East Windsor, New Jersey 08520
2406
mi
from 91732
East Windsor, NJ
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Fremont, California 94538
327
mi
from 91732
Fremont, CA
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Fridley, Minnesota 55432
1512
mi
from 91732
Fridley, MN
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Glenn Dale, Maryland 20769
2292
mi
from 91732
Glenn Dale, MD
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?
mi
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Graz,
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Henderson, Nevada 89052
218
mi
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Henderson, NV
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High Point, North Carolina 27262
1997
mi
from 91732
High Point, NC
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Houston, Texas 77004
1358
mi
from 91732
Houston, TX
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Johnston, Rhode Island
?
mi
from 91732
Johnston, RI
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Knoxville, Tennessee 37317
1923
mi
from 91732
Knoxville, TN
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Louisville, Kentucky 40202
1812
mi
from 91732
Louisville, KY
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New Orleans, Louisiana 70112
1655
mi
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New Orleans, LA
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New York, New York 10029
2435
mi
from 91732
New York, NY
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Newnan, Georgia 30263
1900
mi
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Newnan, GA
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North Hollywood, California
22
mi
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North Hollywood, CA
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North Miami Beach, Florida 33162
2319
mi
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North Miami Beach, FL
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Omaha, Nebraska 68144
1301
mi
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Omaha, NE
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Orange Park, Florida 32073
2130
mi
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Orange Park, FL
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Pflugerville, Texas
1215
mi
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Pflugerville, TX
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Pittsburgh, Pennsylvania 15212
2119
mi
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Pittsburgh, PA
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Richmond, Virginia 23298
2267
mi
from 91732
Richmond, VA
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Saint Joseph, Missouri
1334
mi
from 91732
Saint Joseph, MO
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San Antonio, Texas
1188
mi
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San Antonio, TX
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San Diego, California 92103
106
mi
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San Diego, CA
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Santa Ana, California 92701
78
mi
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Santa Ana, CA
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Spartanburg, South Carolina
2043
mi
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Spartanburg, SC
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Tulsa, Oklahoma 74136
1250
mi
from 91732
Tulsa, OK
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Webster, Texas 77598
1377
mi
from 91732
Webster, TX
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