Psoriasis Clinical Trial
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
Summary
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
Eligibility Criteria
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.
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There are 85 Locations for this study
Birmingham Alabama, 35233, United States
Fremont California, 94538, United States
North Hollywood California, 91606, United States
San Diego California, 92108, United States
Santa Ana California, 92701, United States
Aventura Florida, 33180, United States
Coral Gables Florida, 33134, United States
Fort Lauderdale Florida, 33316, United States
Miami Florida, 33155, United States
North Miami Beach Florida, 33162, United States
Newnan Georgia, 30263, United States
Skokie Illinois, 60077, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70115, United States
Glenn Dale Maryland, 20769, United States
Ann Arbor Michigan, 48103, United States
Detroit Michigan, 48202, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68144, United States
Henderson Nevada, 89052, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Brooklyn New York, 11203, United States
Buffalo New York, 14221, United States
New York New York, 10025, United States
New York New York, 10075, United States
High Point North Carolina, 27262, United States
Bexley Ohio, 43209, United States
Cleveland Ohio, 44106, United States
Dublin Ohio, 43016, United States
Tulsa Oklahoma, 74136, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Johnston Rhode Island, 02919, United States
Spartanburg South Carolina, 29303, United States
Knoxville Tennessee, 37317, United States
Austin Texas, 78745, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75231, United States
Houston Texas, 77004, United States
Pflugerville Texas, 78660, United States
Webster Texas, 77598, United States
Richmond Virginia, 23220, United States
Spokane Washington, 99202, United States
Morgantown West Virginia, 26505, United States
Graz , 8036, Austria
Linz , 4020, Austria
Vienna , 1130, Austria
Bad Bentheim , 48455, Germany
Berlin , 10117, Germany
Berlin , 10783, Germany
Bielefeld , 33647, Germany
Bochum , 44793, Germany
Bonn , 53127, Germany
Buxtehude , 21614, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Frankfurt am main , 60590, Germany
Hamburg , 22391, Germany
Heidelberg , 69115, Germany
Leipzig , 04103, Germany
Mahlow , 15831, Germany
Mainz , 55131, Germany
Münster , 48149, Germany
Osnabrück , 49074, Germany
Selters , 56242, Germany
Stuttgart , 70178, Germany
Bydgoszcz , 85-06, Poland
Iwonicz-Zdrój , 38-44, Poland
Kraków , 30-03, Poland
Kraków , 31-07, Poland
Kraków , 31-20, Poland
Olsztyn , 10-90, Poland
Osielsko , 86-03, Poland
Poznań , 60-21, Poland
Poznań , 60-84, Poland
Rzeszów , 35-05, Poland
Szczecin , 70-33, Poland
Toruń , 87-10, Poland
Warszawa , 02-75, Poland
Wrocław , 50-56, Poland
Wrocław , 53-30, Poland
Wrocław , 53-65, Poland
Åódź , 90-43, Poland
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