Clinical trial NCT03540160: Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
Official title: An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pruritus
Prurigo Nodularis
Atopic Dermatitis
Psoriasis
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Subjects With Treatment-emergent Adverse Events
timeFrame: From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Study Site 504
state: Alabama
city: Fremont
country: United States
facility: Study Site 204
state: California
city: North Hollywood
country: United States
facility: Study Site 383
state: California
city: San Diego
country: United States
facility: Study Site 356
state: California
city: Santa Ana
country: United States
facility: Study Site 514
state: California
city: Aventura
country: United States
facility: Study Site 501
state: Florida
city: Coral Gables
country: United States
facility: Study Site 210
state: Florida
city: Fort Lauderdale
country: United States
facility: Study Site 534
state: Florida
city: Miami
country: United States
facility: Study Site 531
state: Florida
city: North Miami Beach
country: United States
facility: Study Site 222
state: Florida
city: Newnan
country: United States
facility: Study Site 510
state: Georgia
city: Skokie
country: United States
facility: Study Site 388
state: Illinois
city: Louisville
country: United States
facility: Study Site 228
state: Kentucky
city: New Orleans
country: United States
facility: Study Site 527
state: Louisiana
city: Glenn Dale
country: United States
facility: Study Site 525
state: Maryland
city: Ann Arbor
country: United States
facility: Study Site 506
state: Michigan
city: Detroit
country: United States
facility: Study Site 515
state: Michigan
city: Saint Joseph
country: United States
facility: Study Site 371
state: Missouri
city: Saint Louis
country: United States
facility: Study Site 528
state: Missouri
city: Omaha
country: United States
facility: Study Site 227
state: Nebraska
city: Henderson
country: United States
facility: Study Site 526
state: Nevada
city: East Windsor
country: United States
facility: Study Site 201
state: New Jersey
city: Verona
country: United States
facility: Study Site 529
state: New Jersey
city: Brooklyn
country: United States
facility: Study Site 507
state: New York
city: Buffalo
country: United States
facility: Study Site 508
state: New York
city: New York
country: United States
facility: Study Site 500
state: New York
city: New York
country: United States
facility: Study Site 517
state: New York
city: High Point
country: United States
facility: Study Site 341
state: North Carolina
city: Bexley
country: United States
facility: Study Site 516
state: Ohio
city: Cleveland
country: United States
facility: Study Site 509
state: Ohio
city: Dublin
country: United States
facility: Study Site 524
state: Ohio
city: Tulsa
country: United States
facility: Study Site 112
state: Oklahoma
city: Philadelphia
country: United States
facility: Study Site 523
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Study Site 522
state: Pennsylvania
city: Johnston
country: United States
facility: Study Site 345
state: Rhode Island
city: Spartanburg
country: United States
facility: Study Site 343
state: South Carolina
city: Knoxville
country: United States
facility: Study Site 511
state: Tennessee
city: Austin
country: United States
facility: Study Site 365
state: Texas
city: Bellaire
country: United States
facility: Study Site 520
state: Texas
city: Dallas
country: United States
facility: Study Site 502
state: Texas
city: Houston
country: United States
facility: Study Site 224
state: Texas
city: Pflugerville
country: United States
facility: Study Site 359
state: Texas
city: Webster
country: United States
facility: Study Site 226
state: Texas
city: Richmond
country: United States
facility: Study Site 336
state: Virginia
city: Spokane
country: United States
facility: Study Site 806
state: Washington
city: Morgantown
country: United States
facility: Study Site 532
state: West Virginia
city: Graz
country: Austria
facility: Study Site 649
city: Linz
country: Austria
facility: Study Site 648
city: Vienna
country: Austria
facility: Study Site 650
city: Bad Bentheim
country: Germany
facility: Study Site 623
city: Berlin
country: Germany
facility: Study Site 607
city: Berlin
country: Germany
facility: Study Site 641
city: Bielefeld
country: Germany
facility: Study Site 600
city: Bochum
country: Germany
facility: Study Site 617
city: Bonn
country: Germany
facility: Study Site 608
city: Buxtehude
country: Germany
facility: Study Site 642
city: Dresden
country: Germany
facility: Study Site 606
city: Erlangen
country: Germany
facility: Study Site 621
city: Frankfurt am main
country: Germany
facility: Study Site 602
city: Hamburg
country: Germany
facility: Study Site 639
city: Heidelberg
country: Germany
facility: Study Site 605
city: Leipzig
country: Germany
facility: Study Site 611
city: Mahlow
country: Germany
facility: Study Site 620
city: Mainz
country: Germany
facility: Study Site 614
city: Münster
country: Germany
facility: Study Site 601
city: Osnabrück
country: Germany
facility: Study Site 618
city: Selters
country: Germany
facility: Study Site 615
city: Stuttgart
country: Germany
facility: Study Site 643
city: Bydgoszcz
country: Poland
facility: Study Site 636
city: Iwonicz-Zdrój
country: Poland
facility: Study Site 628
city: Kraków
country: Poland
facility: Study Site 633
city: Kraków
country: Poland
facility: Study Site 624
city: Kraków
country: Poland
facility: Study Site 635
city: Olsztyn
country: Poland
facility: Study Site 631
city: Osielsko
country: Poland
facility: Study Site 625
city: Poznań
country: Poland
facility: Study Site 645
city: Poznań
country: Poland
facility: Study Site 644
city: Rzeszów
country: Poland
facility: Study Site 634
city: Szczecin
country: Poland
facility: Study Site 638
city: Toruń
country: Poland
facility: Study Site 632
city: Warszawa
country: Poland
facility: Study Site 627
city: Wrocław
country: Poland
facility: Study Site 637
city: Wrocław
country: Poland
facility: Study Site 630
city: Wrocław
country: Poland
facility: Study Site 647
city: Łódź
country: Poland
facility: Study Site 629
Study officials:
References: