Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

Psoriasis Clinical Trial

Official title:

An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03540160
• Other study ID #: MTI-107
• Secondary ID: 2017-004211-40
• Status: Terminated
• Phase: Phase 3
• Start date: March 15, 2018
• Est. completion date: June 17, 2020

Study information

• Verified date: May 2021
• Source: Vyne Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of the long term safety of serlopitant for the treatment of pruritus in adults.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Prurigo
• Prurigo Nodularis
• Pruritus
• Psoriasis

Intervention

Drug:
• 5 mg Serlopitant Tablets
Serlopitant Tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Poland, 

Outcome

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.