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
Dublin, Ohio 43016
806
mi
from
Dublin, OH
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Ann Arbor, Michigan 48103
806
mi
from
Ann Arbor, MI
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Austin, Texas
517
mi
from
Austin, TX
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Aventura, Florida 33180
1315
mi
from
Aventura, FL
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Bellaire, Texas 77401
572
mi
from
Bellaire, TX
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Bexley, Ohio 43209
814
mi
from
Bexley, OH
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Brooklyn, New York 11215
1056
mi
from
Brooklyn, NY
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Bryant, Arkansas 72022
368
mi
from
Bryant, AR
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Buffalo, New York 14215
1056
mi
from
Buffalo, NY
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Cleveland, Ohio 44142
894
mi
from
Cleveland, OH
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Coral Gables, Florida 33134
1320
mi
from
Coral Gables, FL
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Dallas, Texas 75216
347
mi
from
Dallas, TX
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Detroit, Michigan 48202
841
mi
from
Detroit, MI
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761 New Jersey 33
East Windsor, New Jersey 08520
1257
mi
from
East Windsor, NJ
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Fremont, California 94538
1318
mi
from
Fremont, CA
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Fridley, Minnesota 55432
558
mi
from
Fridley, MN
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Glenn Dale, Maryland 20769
1138
mi
from
Glenn Dale, MD
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?
mi
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Graz,
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Henderson, Nevada 89052
954
mi
from
Henderson, NV
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High Point, North Carolina 27262
853
mi
from
High Point, NC
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Houston, Texas 77004
572
mi
from
Houston, TX
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Johnston, Rhode Island
?
mi
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Johnston, RI
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Knoxville, Tennessee 37317
777
mi
from
Knoxville, TN
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Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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New Orleans, Louisiana 70112
697
mi
from
New Orleans, LA
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New York, New York 10029
1290
mi
from
New York, NY
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Newnan, Georgia 30263
790
mi
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Newnan, GA
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North Hollywood, California
1173
mi
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North Hollywood, CA
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North Miami Beach, Florida 33162
1315
mi
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North Miami Beach, FL
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Omaha, Nebraska 68144
261
mi
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Omaha, NE
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Orange Park, Florida 32073
1059
mi
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Orange Park, FL
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Pflugerville, Texas
505
mi
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Pflugerville, TX
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Pittsburgh, Pennsylvania 15212
971
mi
from
Pittsburgh, PA
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Richmond, Virginia 23298
1111
mi
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Richmond, VA
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Saint Joseph, Missouri
212
mi
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Saint Joseph, MO
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San Antonio, Texas
576
mi
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San Antonio, TX
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San Diego, California 92103
1142
mi
from
San Diego, CA
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Santa Ana, California 92701
1220
mi
from
Santa Ana, CA
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Spartanburg, South Carolina
903
mi
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Spartanburg, SC
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Tulsa, Oklahoma 74136
149
mi
from
Tulsa, OK
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Webster, Texas 77598
588
mi
from
Webster, TX
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