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

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

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

Study Overview

• Status: Terminated
• Conditions: Psoriasis; Pruritus; Atopic Dermatitis; Prurigo Nodularis
• Intervention / Treatment: Drug: 5 mg Serlopitant Tablets

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Study Site 649
  • Linz, Austria, 4020
    • Study Site 648
  • Vienna, Austria, 1130
    • Study Site 650
• Germany
  • Bad Bentheim, Germany, 48455
    • Study Site 623
  • Berlin, Germany, 10117
    • Study Site 607
  • Berlin, Germany, 10783
    • Study Site 641
  • Bielefeld, Germany, 33647
    • Study Site 600
  • Bochum, Germany, 44793
    • Study Site 617
  • Bonn, Germany, 53127
    • Study Site 608
  • Buxtehude, Germany, 21614
    • Study Site 642
  • Dresden, Germany, 01307
    • Study Site 606
  • Erlangen, Germany, 91054
    • Study Site 621
  • Frankfurt am main, Germany, 60590
    • Study Site 602
  • Hamburg, Germany, 22391
    • Study Site 639
  • Heidelberg, Germany, 69115
    • Study Site 605
  • Leipzig, Germany, 04103
    • Study Site 611
  • Mahlow, Germany, 15831
    • Study Site 620
  • Mainz, Germany, 55131
    • Study Site 614
  • Münster, Germany, 48149
    • Study Site 601
  • Osnabrück, Germany, 49074
    • Study Site 618
  • Selters, Germany, 56242
    • Study Site 615
  • Stuttgart, Germany, 70178
    • Study Site 643
• Poland
  • Bydgoszcz, Poland, 85-065
    • Study Site 636
  • Iwonicz-Zdrój, Poland, 38-440
    • Study Site 628
  • Kraków, Poland, 30-033
    • Study Site 633
  • Kraków, Poland, 31-070
    • Study Site 624
  • Kraków, Poland, 31-209
    • Study Site 635
  • Olsztyn, Poland, 10-900
    • Study Site 631
  • Osielsko, Poland, 86-031
    • Study Site 625
  • Poznań, Poland, 60-214
    • Study Site 645
  • Poznań, Poland, 60-848
    • Study Site 644
  • Rzeszów, Poland, 35-055
    • Study Site 634
  • Szczecin, Poland, 70-332
    • Study Site 638
  • Toruń, Poland, 87-100
    • Study Site 632
  • Warszawa, Poland, 02-758
    • Study Site 627
  • Wrocław, Poland, 50-566
    • Study Site 637
  • Wrocław, Poland, 53-301
    • Study Site 630
  • Wrocław, Poland, 53-658
    • Study Site 647
  • Łódź, Poland, 90-436
    • Study Site 629
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Study Site 504
  • California
    • Fremont, California, United States, 94538
      • Study Site 204
    • North Hollywood, California, United States, 91606
      • Study Site 383
    • San Diego, California, United States, 92108
      • Study Site 356
    • Santa Ana, California, United States, 92701
      • Study Site 514
  • Florida
    • Aventura, Florida, United States, 33180
      • Study Site 501
    • Coral Gables, Florida, United States, 33134
      • Study Site 210
    • Fort Lauderdale, Florida, United States, 33316
      • Study Site 534
    • Miami, Florida, United States, 33155
      • Study Site 531
    • North Miami Beach, Florida, United States, 33162
      • Study Site 222
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Study Site 510
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Study Site 388
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Study Site 228
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Study Site 527
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Study Site 525
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Study Site 506
    • Detroit, Michigan, United States, 48202
      • Study Site 515
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Study Site 371
    • Saint Louis, Missouri, United States, 63110
      • Study Site 528
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Study Site 227
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Study Site 526
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Study Site 201
    • Verona, New Jersey, United States, 07044-2946
      • Study Site 529
  • New York
    • Brooklyn, New York, United States, 11203
      • Study Site 507
    • Buffalo, New York, United States, 14221
      • Study Site 508
    • New York, New York, United States, 10025
      • Study Site 500
    • New York, New York, United States, 10075
      • Study Site 517
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Study Site 341
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Study Site 516
    • Cleveland, Ohio, United States, 44106
      • Study Site 509
    • Dublin, Ohio, United States, 43016
      • Study Site 524
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Study site 112
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Study Site 523
    • Pittsburgh, Pennsylvania, United States, 15213
      • Study Site 522
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Study Site 345
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Study Site 343
  • Tennessee
    • Knoxville, Tennessee, United States, 37317
      • Study Site 511
  • Texas
    • Austin, Texas, United States, 78745
      • Study Site 365
    • Bellaire, Texas, United States, 77401
      • Study Site 520
    • Dallas, Texas, United States, 75231
      • Study Site 502
    • Houston, Texas, United States, 77004
      • Study Site 224
    • Pflugerville, Texas, United States, 78660
      • Study Site 359
    • Webster, Texas, United States, 77598
      • Study Site 226
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Study Site 336
  • Washington
    • Spokane, Washington, United States, 99202
      • Study Site 806
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Study Site 532

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 5 mg Serlopitant Tablets; Serlopitant Tablets	Drug: 5 mg Serlopitant Tablets; Serlopitant Tablets; Other Names: VPD-737

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): April 8, 2020
• Study Completion (Actual): June 17, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: May 26, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Manifestations; Psoriasis; Dermatitis; Pruritus; Prurigo; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurokinin-1 Receptor Antagonists; Serlopitant
• Other Study ID Numbers: MTI-107; 2017-004211-40 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No