Clinical trial NCT03841331: Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Keywords: Pruritus
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin


Eligibility criteria: Inclusion:

* Male or female, age 18 years or older at consent.
* The subject must have ongoing chronic pruritus
* The subject's pruritus is assessed by the investigator to be of unknown origin at baseline.
* 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.
* The pruritus must have been unresponsive to prior treatment with emollients.
* The subject's pruritus must be present on multiple segments of the body
* Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study
* All females who are of childbearing potential must be willing to practice highly effective contraception and not be pregnant or nursing
* Willing to comply with study visits and study related requirements including providing written informed consent.
* Adequate cognitive and physical ability, in the investigator's opinion, to comply with study visits and study related requirements including providing written informed consent

Exclusion

* Prior treatment with any NK1-receptor antagonists
* Known dermatologic or systemic condition(s), other than dry skin, that is considered by the investigator to be the primary cause of current pruritus.
* Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy.
* Use of an excluded therapy within 3 weeks prior to randomization
* Treatment with any investigational therapy within 3 weeks prior to randomization.
* Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase \> 2.5 times the upper limit of normal during screening.
* History of malignancy within 3 years prior to randomization, with the (actinic keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of skin).
* Any known major psychiatric diagnosis that would impact the subject's ability to complete the study
* Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt.
* Known use of recreational drugs.
* Documented history of parasitic infection, including skin parasites such as scabies, within 12 weeks prior to randomization.
* Presence of clinically significant dementia, intellectual impairment, or any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
* History of hypersensitivity to serlopitant or any of its components.
* Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject's participation in the study.

Primary outcomes:
measure: Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10
timeFrame: At Week 10
measure: WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
timeFrame: At Weeks 2, 4, 6, and 8
measure: WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
timeFrame: At Weeks 2, 4, 6, 8, and 10
measure: Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
timeFrame: At Weeks 2, 4, 6, 8, and 10
measure: Change From Baseline in Daily WI-NRS Scores Through Week 2
timeFrame: Through 2 weeks
measure: Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
timeFrame: At Weeks 2, 4, 6, and 10
Secondary outcomes:
measure: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
measure: Plasma Concentrations of Serlopitant and Metabolites
timeFrame: At Week 10
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Study Site 221
state: Arkansas
city: Bakersfield
country: United States
facility: Study Site 823
state: California
city: Fremont
country: United States
facility: Study Site 204
state: California
city: Los Angeles
country: United States
facility: Study Site 803
state: California
city: Centennial
country: United States
facility: Study Site 820
state: Colorado
city: Denver
country: United States
facility: Study Site 804
state: Colorado
city: Aventura
country: United States
facility: Study Site 811
state: Florida
city: Jacksonville
country: United States
facility: Study Site 801
state: Florida
city: Miami
country: United States
facility: Study Site 807
state: Florida
city: Miami
country: United States
facility: Study Site 331
state: Florida
city: Sarasota
country: United States
facility: Study Site 824
state: Florida
city: West Palm Beach
country: United States
facility: Study Site 818
state: Florida
city: Savannah
country: United States
facility: Study Site 349
state: Georgia
city: Indianapolis
country: United States
facility: Study Site 814
state: Indiana
city: Brighton
country: United States
facility: Study Site 808
state: Massachusetts
city: Rolla
country: United States
facility: Study Site 822
state: Missouri
city: Saint Joseph
country: United States
facility: Study Site 371
state: Missouri
city: Saint Louis
country: United States
facility: Study Site 817
state: Missouri
city: Bellevue
country: United States
facility: Study Site 821
state: Nebraska
city: Las Vegas
country: United States
facility: Study Site 813
state: Nevada
city: Las Vegas
country: United States
facility: Study Site 387
state: Nevada
city: Morristown
country: United States
facility: Study Site 816
state: New Jersey
city: Ocean Township
country: United States
facility: Study Site 121
state: New Jersey
city: Bronx
country: United States
facility: Study Site 802
state: New York
city: Brooklyn
country: United States
facility: Study Site 507
state: New York
city: High Point
country: United States
facility: Study Site 341
state: North Carolina
city: Raleigh
country: United States
facility: Study Site 810
state: North Carolina
city: Dublin
country: United States
facility: Study Site 524
state: Ohio
city: Portland
country: United States
facility: Study Site 116
state: Oregon
city: Pittsburgh
country: United States
facility: Study Site 522
state: Pennsylvania
city: Johnston
country: United States
facility: Study Site 345
state: Rhode Island
city: Warwick
country: United States
facility: Study Site 815
state: Rhode Island
city: Nashville
country: United States
facility: Study Site 805
state: Tennessee
city: Austin
country: United States
facility: Study Site 365
state: Texas
city: Dallas
country: United States
facility: Study Site 120
state: Texas
city: Fort Worth
country: United States
facility: Study Site 819
state: Texas
city: Pflugerville
country: United States
facility: Study Site 359
state: Texas
city: San Antonio
country: United States
facility: Study Site 809
state: Texas
city: Norfolk
country: United States
facility: Study Site 217
state: Virginia
city: Spokane
country: United States
facility: Study Site 806
state: Washington
city: Walla Walla
country: United States
facility: Study Site 812
state: Washington
Study officials:
References: