Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
Study Purpose
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03540160 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Menlo Therapeutics Inc. |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Austria, Germany, Poland, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pruritus, Prurigo Nodularis, Atopic Dermatitis, Psoriasis |
Arms
Experimental: Experimental: 5 mg Serlopitant Tablets
Serlopitant Tablets
Interventions
Drug: - 5 mg Serlopitant Tablets
Serlopitant Tablets
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Study Site 504
Birmingham, Alabama, 35233
Status
Withdrawn
Address
Study Site 221
Bryant, Arkansas, 72022
Status
Recruiting
Address
Study Site 204
Fremont, California, 94538
Status
Recruiting
Address
Study Site 383
North Hollywood, California, 91606
Status
Recruiting
Address
Study Site 356
San Diego, California, 92108
Status
Recruiting
Address
Study Site 514
Santa Ana, California, 92701
Status
Recruiting
Address
Study Site 501
Aventura, Florida, 33180
Status
Recruiting
Address
Study Site 210
Coral Gables, Florida, 33134
Status
Recruiting
Address
Study Site 534
Fort Lauderdale, Florida, 33316
Status
Recruiting
Address
Study Site 531
Miami, Florida, 33155
Status
Recruiting
Address
Study Site 222
North Miami Beach, Florida, 33162
Status
Withdrawn
Address
Study Site 519
Orange Park, Florida, 32073
Status
Recruiting
Address
Study Site 510
Newnan, Georgia, 30263
Status
Recruiting
Address
Study Site 388
Skokie, Illinois, 60077
Status
Recruiting
Address
Study Site 228
Louisville, Kentucky, 40202
Status
Recruiting
Address
Study Site 527
New Orleans, Louisiana, 70115
Status
Recruiting
Address
Study Site 525
Glenn Dale, Maryland, 20769
Status
Recruiting
Address
Study Site 506
Ann Arbor, Michigan, 48103
Status
Recruiting
Address
Study Site 515
Detroit, Michigan, 48202
Status
Withdrawn
Address
Study Site 209
Fridley, Minnesota, 55432
Status
Recruiting
Address
Study Site 371
Saint Joseph, Missouri, 64506
Status
Recruiting
Address
Study Site 528
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Study Site 227
Omaha, Nebraska, 68144
Status
Recruiting
Address
Study Site 526
Henderson, Nevada, 89052
Status
Recruiting
Address
Study Site 201
East Windsor, New Jersey, 08520
Status
Recruiting
Address
Study Site 529
Verona, New Jersey, 07044-2946
Status
Recruiting
Address
Study Site 507
Brooklyn, New York, 11203
Status
Recruiting
Address
Study Site 508
Buffalo, New York, 14221
Status
Recruiting
Address
Study Site 500
New York, New York, 10025
Status
Recruiting
Address
Study Site 517
New York, New York, 10075
Status
Withdrawn
Address
Study Site 503
New York, New York, 10155
Status
Recruiting
Address
Study Site 341
High Point, North Carolina, 27262
Status
Recruiting
Address
Study Site 516
Bexley, Ohio, 43209
Status
Recruiting
Address
Study Site 509
Cleveland, Ohio, 44106
Status
Recruiting
Address
Study Site 524
Dublin, Ohio, 43016
Status
Recruiting
Address
Study Site 112
Tulsa, Oklahoma, 74136
Status
Recruiting
Address
Study Site 523
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Study Site 522
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Study Site 345
Johnston, Rhode Island, 02919
Status
Recruiting
Address
Study Site 343
Spartanburg, South Carolina, 29303
Status
Recruiting
Address
Study Site 511
Knoxville, Tennessee, 37317
Status
Recruiting
Address
Study Site 365
Austin, Texas, 78745
Status
Recruiting
Address
Study Site 520
Bellaire, Texas, 77401
Status
Recruiting
Address
Study Site 502
Dallas, Texas, 75231
Status
Recruiting
Address
Study Site 224
Houston, Texas, 77004
Status
Recruiting
Address
Study Site 359
Pflugerville, Texas, 78660
Status
Withdrawn
Address
Study Site 361
San Antonio, Texas, 78213
Status
Recruiting
Address
Study Site 226
Webster, Texas, 77598
Status
Recruiting
Address
Study Site 336
Richmond, Virginia, 23220
Status
Recruiting
Address
Study Site 806
Spokane, Washington, 99202
Status
Recruiting
Address
Study Site 532
Morgantown, West Virginia, 26505
International Sites
Status
Recruiting
Address
Study Site 649
Graz, , 8036
Status
Recruiting
Address
Study Site 648
Linz, , 4020
Status
Recruiting
Address
Study Site 650
Vienna, , 1130
Status
Recruiting
Address
Study Site 623
Bad Bentheim, , 48455
Status
Recruiting
Address
Study Site 607
Berlin, , 10117
Status
Recruiting
Address
Study Site 641
Berlin, , 10783
Status
Recruiting
Address
Study Site 600
Bielefeld, , 33647
Status
Recruiting
Address
Study Site 617
Bochum, , 44793
Status
Recruiting
Address
Study Site 608
Bonn, , 53127
Status
Recruiting
Address
Study Site 642
Buxtehude, , 21614
Status
Recruiting
Address
Study Site 606
Dresden, , 01307
Status
Recruiting
Address
Study Site 621
Erlangen, , 91054
Status
Recruiting
Address
Study Site 602
Frankfurt am main, , 60590
Status
Recruiting
Address
Study Site 639
Hamburg, , 22391
Status
Recruiting
Address
Study Site 605
Heidelberg, , 69115
Status
Recruiting
Address
Study Site 611
Leipzig, , 04103
Status
Recruiting
Address
Study Site 620
Mahlow, , 15831
Status
Recruiting
Address
Study Site 614
Mainz, , 55131
Status
Recruiting
Address
Study Site 601
Münster, , 48149
Status
Recruiting
Address
Study Site 618
Osnabrück, , 49074
Status
Recruiting
Address
Study Site 615
Selters, , 56242
Status
Recruiting
Address
Study Site 643
Stuttgart, , 70178
Status
Recruiting
Address
Study Site 636
Bydgoszcz, , 85-065
Status
Recruiting
Address
Study Site 628
Iwonicz-Zdrój, , 38-440
Status
Recruiting
Address
Study Site 633
Kraków, , 30-033
Status
Recruiting
Address
Study Site 624
Kraków, , 31-070
Status
Recruiting
Address
Study Site 635
Kraków, , 31-209
Status
Recruiting
Address
Study Site 631
Olsztyn, , 10-900
Status
Recruiting
Address
Study Site 625
Osielsko, , 86-031
Status
Recruiting
Address
Study Site 645
Poznań, , 60-214
Status
Recruiting
Address
Study Site 644
Poznań, , 60-848
Status
Recruiting
Address
Study Site 634
Rzeszów, , 35-055
Status
Recruiting
Address
Study Site 638
Szczecin, , 70-332
Status
Recruiting
Address
Study Site 632
Toruń, , 87-100
Status
Recruiting
Address
Study Site 627
Warszawa, , 02-758
Status
Recruiting
Address
Study Site 637
Wrocław, , 50-566
Status
Recruiting
Address
Study Site 630
Wrocław, , 53-301
Status
Recruiting
Address
Study Site 647
Wrocław, , 53-658
Status
Recruiting
Address
Study Site 629
Łódź, , 90-436
