Clinical trial NCT03546816: Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pruritus
Prurigo Nodularis
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis


Eligibility criteria: Inclusion Criteria (Subjects must meet the following criteria to be randomized into the study:

1. Male or female, age 18 years or older at consent.
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 (Subjects who meet any of the following criteria are not eligible for participation in the study):

1. Prior treatment with serlopitant.
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.

Primary outcomes:
measure: Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
timeFrame: At Week 10
Secondary outcomes:
measure: Percent of Subjects With WI-NRS 4-point Responder at Week 4
timeFrame: At Week 4
measure: Percent of Subjects With WI-NRS 4-point Responder at Week 2
timeFrame: At Week 2
measure: Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
timeFrame: At Weeks 2, 4, 6, and 10
measure: Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10
timeFrame: At Weeks 2, 4, and 10
measure: Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
timeFrame: At Weeks 2, 4, and 10
measure: Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10
timeFrame: At Weeks 2, 4, and 10
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
timeFrame: At Week 10
measure: Change From Baseline in DLQI Question 1 to Week 10
timeFrame: At Week 10
measure: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
timeFrame: 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Study Site 504
state: Alabama
city: Rogers
country: United States
facility: Study Site 533
state: Arkansas
city: Fremont
country: United States
facility: Study Site 204
state: California
city: North Hollywood
country: United States
facility: Study Site 383
state: California
city: San Diego
country: United States
facility: Study Site 356
state: California
city: Santa Ana
country: United States
facility: Study Site 514
state: California
city: Aventura
country: United States
facility: Study Site 501
state: Florida
city: Coral Gables
country: United States
facility: Study Site 210
state: Florida
city: Fort Lauderdale
country: United States
facility: Study Site 534
state: Florida
city: Miami
country: United States
facility: Study Site 531
state: Florida
city: Miami
country: United States
facility: Study Site 530
state: Florida
city: North Miami Beach
country: United States
facility: Study Site 222
state: Florida
city: Newnan
country: United States
facility: Study Site 510
state: Georgia
city: Skokie
country: United States
facility: Study Site 388
state: Illinois
city: Louisville
country: United States
facility: Study Site 228
state: Kentucky
city: New Orleans
country: United States
facility: Study Site 527
state: Louisiana
city: Glenn Dale
country: United States
facility: Study Site 525
state: Maryland
city: Boston
country: United States
facility: Study Site 379
state: Massachusetts
city: Ann Arbor
country: United States
facility: Study Site 506
state: Michigan
city: Detroit
country: United States
facility: Study Site 515
state: Michigan
city: Saint Joseph
country: United States
facility: Study Site 371
state: Missouri
city: Saint Louis
country: United States
facility: Study Site 528
state: Missouri
city: Omaha
country: United States
facility: Study Site 227
state: Nebraska
city: Henderson
country: United States
facility: Study Site 526
state: Nevada
city: East Windsor
country: United States
facility: Study Site 201
state: New Jersey
city: Verona
country: United States
facility: Study Site 529
state: New Jersey
city: Brooklyn
country: United States
facility: Study Site 507
state: New York
city: Buffalo
country: United States
facility: Study Site 508
state: New York
city: New York
country: United States
facility: Study Site 500
state: New York
city: New York
country: United States
facility: Study Site 517
state: New York
city: High Point
country: United States
facility: Study Site 341
state: North Carolina
city: Bexley
country: United States
facility: Study Site 516
state: Ohio
city: Cleveland
country: United States
facility: Study Site 509
state: Ohio
city: Dublin
country: United States
facility: Study Site 524
state: Ohio
city: Tulsa
country: United States
facility: Study Site 112
state: Oklahoma
city: Philadelphia
country: United States
facility: Study Site 523
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Study Site 522
state: Pennsylvania
city: Johnston
country: United States
facility: Study Site 345
state: Rhode Island
city: Knoxville
country: United States
facility: Study Site 511
state: Tennessee
city: Nashville
country: United States
facility: Study Site 805
state: Tennessee
city: Austin
country: United States
facility: Study Site 365
state: Texas
city: Bellaire
country: United States
facility: Study Site 520
state: Texas
city: Dallas
country: United States
facility: Study Site 502
state: Texas
city: Houston
country: United States
facility: Study Site 224
state: Texas
city: Pflugerville
country: United States
facility: Study Site 359
state: Texas
city: San Antonio
country: United States
facility: Study Site 361
state: Texas
city: Webster
country: United States
facility: Study Site 226
state: Texas
city: Spokane
country: United States
facility: Study Site 806
state: Washington
city: Morgantown
country: United States
facility: Study Site 532
state: West Virginia
Study officials:
References: