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

Phase 3

Terminated

• Conditions: Pruritus; Prurigo Nodularis; Atopic Dermatitis; Psoriasis
• Interventions: Drug: 5 mg Serlopitant Tablets

• Registration Number: NCT03540160
• Lead Sponsor: Vyne Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-05-26
• Study First Posted: 2018-05-30
• Primary Completion: 2020-04-08
• Study Completion: 2020-06-17
• Results First Submitted: 2020-10-28
• Results First Submitted QC: 2020-11-26
• Results First Posted: 2020-11-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 558

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: 5 mg Serlopitant Tablets	5 mg Serlopitant Tablets	Serlopitant Tablets

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment-emergent Adverse Events	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.	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.

Trial Locations

Locations (85)

Study Site 201; 🇺🇸 East Windsor, New Jersey, United States

Study Site 523; 🇺🇸 Philadelphia, Pennsylvania, United States

Study Site 502; 🇺🇸 Dallas, Texas, United States

Study Site 224; 🇺🇸 Houston, Texas, United States

Study Site 531; 🇺🇸 Miami, Florida, United States

Study Site 617; 🇩🇪 Bochum, Germany

Study Site 620; 🇩🇪 Mahlow, Germany

Study Site 601; 🇩🇪 Münster, Germany

Study Site 615; 🇩🇪 Selters, Germany

Study Site 630; 🇵🇱 Wrocław, Poland

Study Site 204; 🇺🇸 Fremont, California, United States

Study Site 383; 🇺🇸 North Hollywood, California, United States

Study Site 514; 🇺🇸 Santa Ana, California, United States

Study Site 501; 🇺🇸 Aventura, Florida, United States

Study Site 210; 🇺🇸 Coral Gables, Florida, United States

Study Site 222; 🇺🇸 North Miami Beach, Florida, United States

Study Site 510; 🇺🇸 Newnan, Georgia, United States

Study Site 388; 🇺🇸 Skokie, Illinois, United States

Study Site 525; 🇺🇸 Glenn Dale, Maryland, United States

Study Site 528; 🇺🇸 Saint Louis, Missouri, United States

Study Site 500; 🇺🇸 New York, New York, United States

Study Site 529; 🇺🇸 Verona, New Jersey, United States

Study Site 508; 🇺🇸 Buffalo, New York, United States

Study Site 507; 🇺🇸 Brooklyn, New York, United States

Study Site 517; 🇺🇸 New York, New York, United States

Study Site 524; 🇺🇸 Dublin, Ohio, United States

Study Site 341; 🇺🇸 High Point, North Carolina, United States

Study Site 516; 🇺🇸 Bexley, Ohio, United States

Study Site 509; 🇺🇸 Cleveland, Ohio, United States

Study Site 112; 🇺🇸 Tulsa, Oklahoma, United States

Study Site 345; 🇺🇸 Johnston, Rhode Island, United States

Study Site 522; 🇺🇸 Pittsburgh, Pennsylvania, United States

Study Site 343; 🇺🇸 Spartanburg, South Carolina, United States

Study Site 511; 🇺🇸 Knoxville, Tennessee, United States

Study Site 520; 🇺🇸 Bellaire, Texas, United States

Study Site 359; 🇺🇸 Pflugerville, Texas, United States

Study Site 226; 🇺🇸 Webster, Texas, United States

Study Site 532; 🇺🇸 Morgantown, West Virginia, United States

Study Site 806; 🇺🇸 Spokane, Washington, United States

Study Site 649; 🇦🇹 Graz, Austria

Study Site 648; 🇦🇹 Linz, Austria

Study Site 623; 🇩🇪 Bad Bentheim, Germany

Study Site 650; 🇦🇹 Vienna, Austria

Study Site 607; 🇩🇪 Berlin, Germany

Study Site 641; 🇩🇪 Berlin, Germany

Study Site 600; 🇩🇪 Bielefeld, Germany

Study Site 642; 🇩🇪 Buxtehude, Germany

Study Site 608; 🇩🇪 Bonn, Germany

Study Site 606; 🇩🇪 Dresden, Germany

Study Site 602; 🇩🇪 Frankfurt am main, Germany

Study Site 621; 🇩🇪 Erlangen, Germany

Study Site 639; 🇩🇪 Hamburg, Germany

Study Site 611; 🇩🇪 Leipzig, Germany

Study Site 605; 🇩🇪 Heidelberg, Germany

Study Site 614; 🇩🇪 Mainz, Germany

Study Site 618; 🇩🇪 Osnabrück, Germany

Study Site 643; 🇩🇪 Stuttgart, Germany

Study Site 624; 🇵🇱 Kraków, Poland

Study Site 636; 🇵🇱 Bydgoszcz, Poland

Study Site 628; 🇵🇱 Iwonicz-Zdrój, Poland

Study Site 633; 🇵🇱 Kraków, Poland

Study Site 635; 🇵🇱 Kraków, Poland

Study Site 625; 🇵🇱 Osielsko, Poland

Study Site 631; 🇵🇱 Olsztyn, Poland

Study Site 634; 🇵🇱 Rzeszów, Poland

Study Site 645; 🇵🇱 Poznań, Poland

Study Site 632; 🇵🇱 Toruń, Poland

Study Site 638; 🇵🇱 Szczecin, Poland

Study Site 644; 🇵🇱 Poznań, Poland

Study Site 637; 🇵🇱 Wrocław, Poland

Study Site 627; 🇵🇱 Warszawa, Poland

Study Site 647; 🇵🇱 Wrocław, Poland

Study Site 629; 🇵🇱 Łódź, Poland

Study Site 534; 🇺🇸 Fort Lauderdale, Florida, United States

Study Site 526; 🇺🇸 Henderson, Nevada, United States

Study Site 371; 🇺🇸 Saint Joseph, Missouri, United States

Study Site 228; 🇺🇸 Louisville, Kentucky, United States

Study Site 515; 🇺🇸 Detroit, Michigan, United States

Study Site 504; 🇺🇸 Birmingham, Alabama, United States

Study Site 356; 🇺🇸 San Diego, California, United States

Study Site 527; 🇺🇸 New Orleans, Louisiana, United States

Study Site 365; 🇺🇸 Austin, Texas, United States

Study Site 506; 🇺🇸 Ann Arbor, Michigan, United States

Study Site 227; 🇺🇸 Omaha, Nebraska, United States

Study Site 336; 🇺🇸 Richmond, Virginia, United States