Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
NCT ID: NCT03546816
Last Updated: 2021-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
285 participants
INTERVENTIONAL
2018-05-02
2020-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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5 mg Serlopitant Tablets
5mg Serlopitant Tablets
Serlopitant Tablets
Matching Placebo Tablets
Placebo Tablets
Placebo Tablets
Interventions
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5mg Serlopitant Tablets
Serlopitant Tablets
Placebo Tablets
Placebo Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prurigo nodularis (PN), with at least ten nodules on at least two different body surface areas.
3. Idiopathic PN, or an identified pruritic condition associated with the PN with persistent pruritus despite at least 6 weeks of optimized and stable treatment of the underlying condition.
4. The worst pruritus is identified as within the areas of the PN lesions, with a Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to Baseline visit indicating an appropriate pruritus level for the study.
5. Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
6. Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study.
7. Willing and able to comply with study visits and study related requirements including providing written informed consent.
Exclusion Criteria
2. Active pruritic skin disease, other than PN, within 6 months (with the exception of acute dermatoses such as contact dermatitis, sunburn, viral exanthem, which have been resolved for longer than 4 weeks).
3. Treatment with any of the following therapies within 4 weeks.
1. Other neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant).
2. Systemic or topical immunosuppressive/immunomodulatory therapies.
3. Systemic therapies with recognized anti-pruritic properties.
4. Strong cytochrome-P 3A4 inhibitors.
5. Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn.
4. Treatment with topical anti-pruritic therapies within 2 weeks.
5. Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer.
6. Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives, whichever is longer.
7. Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase \> 2.5 times the upper limit of normal during screening.
8. Untreated or inadequately treated thyroid adrenal, or pituitary nodules or disease, or history of thyroid malignancy.
9. Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
10. Relevant major psychiatric diagnosis in the past 3 years, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
11. Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks.
12. Any medical condition or disability that could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject.
13. History of hypersensitivity to serlopitant or any of its components.
14. Currently pregnant or breastfeeding or planning to become pregnant during the study.
15. Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments during participation in the study.
18 Years
ALL
No
Sponsors
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Vyne Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Study Site 504
Birmingham, Alabama, United States
Study Site 533
Rogers, Arkansas, United States
Study Site 204
Fremont, California, United States
Study Site 383
North Hollywood, California, United States
Study Site 356
San Diego, 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 534
Fort Lauderdale, Florida, United States
Study Site 531
Miami, Florida, United States
Study Site 530
Miami, 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 228
Louisville, Kentucky, United States
Study Site 527
New Orleans, Louisiana, United States
Study Site 525
Glenn Dale, Maryland, United States
Study Site 379
Boston, Massachusetts, United States
Study Site 506
Ann Arbor, Michigan, United States
Study Site 515
Detroit, Michigan, United States
Study Site 371
Saint Joseph, Missouri, United States
Study Site 528
St Louis, Missouri, United States
Study Site 227
Omaha, Nebraska, United States
Study Site 526
Henderson, Nevada, United States
Study Site 201
East Windsor, New Jersey, United States
Study Site 529
Verona, New Jersey, United States
Study Site 507
Brooklyn, New York, United States
Study Site 508
Buffalo, New York, United States
Study Site 500
New York, New York, United States
Study Site 517
New York, New York, 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 524
Dublin, Ohio, United States
Study Site 112
Tulsa, Oklahoma, United States
Study Site 523
Philadelphia, Pennsylvania, United States
Study Site 522
Pittsburgh, Pennsylvania, United States
Study Site 345
Johnston, Rhode Island, United States
Study Site 511
Knoxville, Tennessee, United States
Study Site 805
Nashville, Tennessee, United States
Study Site 365
Austin, Texas, United States
Study Site 520
Bellaire, Texas, United States
Study Site 502
Dallas, Texas, United States
Study Site 224
Houston, Texas, United States
Study Site 359
Pflugerville, Texas, United States
Study Site 361
San Antonio, Texas, United States
Study Site 226
Webster, Texas, United States
Study Site 806
Spokane, Washington, United States
Study Site 532
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MTI-105
Identifier Type: -
Identifier Source: org_study_id
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