Psoriasis Clinical Trial
Official title:
An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus
Verified date | May 2021 |
Source | Vyne Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
Status | Terminated |
Enrollment | 558 |
Est. completion date | June 17, 2020 |
Est. primary completion date | April 8, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Austria | Study Site 649 | Graz | |
Austria | Study Site 648 | Linz | |
Austria | Study Site 650 | Vienna | |
Germany | Study Site 623 | Bad Bentheim | |
Germany | Study Site 607 | Berlin | |
Germany | Study Site 641 | Berlin | |
Germany | Study Site 600 | Bielefeld | |
Germany | Study Site 617 | Bochum | |
Germany | Study Site 608 | Bonn | |
Germany | Study Site 642 | Buxtehude | |
Germany | Study Site 606 | Dresden | |
Germany | Study Site 621 | Erlangen | |
Germany | Study Site 602 | Frankfurt am main | |
Germany | Study Site 639 | Hamburg | |
Germany | Study Site 605 | Heidelberg | |
Germany | Study Site 611 | Leipzig | |
Germany | Study Site 620 | Mahlow | |
Germany | Study Site 614 | Mainz | |
Germany | Study Site 601 | Münster | |
Germany | Study Site 618 | Osnabrück | |
Germany | Study Site 615 | Selters | |
Germany | Study Site 643 | Stuttgart | |
Poland | Study Site 636 | Bydgoszcz | |
Poland | Study Site 628 | Iwonicz-Zdrój | |
Poland | Study Site 624 | Kraków | |
Poland | Study Site 633 | Kraków | |
Poland | Study Site 635 | Kraków | |
Poland | Study Site 629 | Lódz | |
Poland | Study Site 631 | Olsztyn | |
Poland | Study Site 625 | Osielsko | |
Poland | Study Site 644 | Poznan | |
Poland | Study Site 645 | Poznan | |
Poland | Study Site 634 | Rzeszów | |
Poland | Study Site 638 | Szczecin | |
Poland | Study Site 632 | Torun | |
Poland | Study Site 627 | Warszawa | |
Poland | Study Site 630 | Wroclaw | |
Poland | Study Site 637 | Wroclaw | |
Poland | Study Site 647 | Wroclaw | |
United States | Study Site 506 | Ann Arbor | Michigan |
United States | Study Site 365 | Austin | Texas |
United States | Study Site 501 | Aventura | Florida |
United States | Study Site 520 | Bellaire | Texas |
United States | Study Site 516 | Bexley | Ohio |
United States | Study Site 504 | Birmingham | Alabama |
United States | Study Site 507 | Brooklyn | New York |
United States | Study Site 508 | Buffalo | New York |
United States | Study Site 509 | Cleveland | Ohio |
United States | Study Site 210 | Coral Gables | Florida |
United States | Study Site 502 | Dallas | Texas |
United States | Study Site 515 | Detroit | Michigan |
United States | Study Site 524 | Dublin | Ohio |
United States | Study Site 201 | East Windsor | New Jersey |
United States | Study Site 534 | Fort Lauderdale | Florida |
United States | Study Site 204 | Fremont | California |
United States | Study Site 525 | Glenn Dale | Maryland |
United States | Study Site 526 | Henderson | Nevada |
United States | Study Site 341 | High Point | North Carolina |
United States | Study Site 224 | Houston | Texas |
United States | Study Site 345 | Johnston | Rhode Island |
United States | Study Site 511 | Knoxville | Tennessee |
United States | Study Site 228 | Louisville | Kentucky |
United States | Study Site 531 | Miami | Florida |
United States | Study Site 532 | Morgantown | West Virginia |
United States | Study Site 527 | New Orleans | Louisiana |
United States | Study Site 500 | New York | New York |
United States | Study Site 517 | New York | New York |
United States | Study Site 510 | Newnan | Georgia |
United States | Study Site 383 | North Hollywood | California |
United States | Study Site 222 | North Miami Beach | Florida |
United States | Study Site 227 | Omaha | Nebraska |
United States | Study Site 359 | Pflugerville | Texas |
United States | Study Site 523 | Philadelphia | Pennsylvania |
United States | Study Site 522 | Pittsburgh | Pennsylvania |
United States | Study Site 336 | Richmond | Virginia |
United States | Study Site 371 | Saint Joseph | Missouri |
United States | Study Site 528 | Saint Louis | Missouri |
United States | Study Site 356 | San Diego | California |
United States | Study Site 514 | Santa Ana | California |
United States | Study Site 388 | Skokie | Illinois |
United States | Study Site 343 | Spartanburg | South Carolina |
United States | Study Site 806 | Spokane | Washington |
United States | Study Site 112 | Tulsa | Oklahoma |
United States | Study Site 529 | Verona | New Jersey |
United States | Study Site 226 | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
Vyne Therapeutics Inc. |
United States, Austria, Germany, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Treatment-emergent Adverse Events | Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. | 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. |
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