Clinical trial NCT02975206: Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Pruritus In Adults And Adolescents With A History Of Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Atopic Dermatitis
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 484
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
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 Pruritus (Itch) in Atopic Dermatitis

Detailed description: This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 13 years or older
* Pruritus prior to and during the initial screening period
* Diagnosis of atopic dermatitis
* Judged to be in good health in the investigator's opinion

Exclusion Criteria:

* Prior treatment with study drug or similar drug
* Pruritus due to another reason besides atopic dermatitis
* Presence of any medical condition or disability that could interfere with study
* History of hypersensitivity to serlopitant or any of its components
* Currently pregnant or male partner of pregnant female
* Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding

Primary outcomes:
measure: Change in WI-NRS From Baseline to Week 6
timeFrame: Week 6 compared to Baseline
Secondary outcomes:
measure: WI-NRS 4-point Responder Rate at Week 6
timeFrame: Week 6 compared to Baseline
measure: Change in Quality of Life (ItchyQoL) From Baseline to Week 6
timeFrame: Week 6 compared to Baseline
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Study Site 332
state: Alabama
city: Birmingham
country: United States
facility: Study Site 363
state: Alabama
city: Hoover
country: United States
facility: Study Site 340
state: Alabama
city: Glendale
country: United States
facility: Study Site 364
state: Arizona
city: Cerritos
country: United States
facility: Study Site 334
state: California
city: Encinitas
country: United States
facility: Study Site 386
state: California
city: Fountain Valley
country: United States
facility: Study Site 366
state: California
city: Los Angeles
country: United States
facility: Study Site 338
state: California
city: North Hollywood
country: United States
facility: Study Site 383
state: California
city: Oceanside
country: United States
facility: Study Site 374
state: California
city: San Diego
country: United States
facility: Study Site 347
state: California
city: San Diego
country: United States
facility: Study Site 356
state: California
city: San Francisco
country: United States
facility: Study Site 333
state: California
city: Santa Monica
country: United States
facility: Study Site 376
state: California
city: Denver
country: United States
facility: Study Site 358
state: Colorado
city: Jacksonville
country: United States
facility: Study Site 370
state: Florida
city: Miami
country: United States
facility: Study Site 331
state: Florida
city: Miami
country: United States
facility: Study Site 348
state: Florida
city: Miami
country: United States
facility: Study Site 378
state: Florida
city: Pinellas Park
country: United States
facility: Study Site 353
state: Florida
city: Tampa
country: United States
facility: Study Site 368
state: Florida
city: Tampa
country: United States
facility: Study Site 377
state: Florida
city: Atlanta
country: United States
facility: Study Site 369
state: Georgia
city: Savannah
country: United States
facility: Study Site 349
state: Georgia
city: Chicago
country: United States
facility: Study Site 381
state: Illinois
city: New Albany
country: United States
facility: Study Site 360
state: Indiana
city: Bardstown
country: United States
facility: Study Site 380
state: Kentucky
city: Louisville
country: United States
facility: Study Site 344
state: Kentucky
city: Boston
country: United States
facility: Study Site 379
state: Massachusetts
city: Warren
country: United States
facility: Study Site 350
state: Michigan
city: Saint Joseph
country: United States
facility: Study Site 371
state: Missouri
city: Las Vegas
country: United States
facility: Study Site 387
state: Nevada
city: Berlin
country: United States
facility: Study Site 352
state: New Jersey
city: Forest Hills
country: United States
facility: Study Site 375
state: New York
city: Rochester
country: United States
facility: Study Site 373
state: New York
city: High Point
country: United States
facility: Study Site 341
state: North Carolina
city: Shelby
country: United States
facility: Study Site 355
state: North Carolina
city: Oklahoma City
country: United States
facility: Study Site 337
state: Oklahoma
city: Johnston
country: United States
facility: Study Site 345
state: Rhode Island
city: Providence
country: United States
facility: Study Site 362
state: Rhode Island
city: Anderson
country: United States
facility: Study Site 382
state: South Carolina
city: Spartanburg
country: United States
facility: Study Site 343
state: South Carolina
city: Chattanooga
country: United States
facility: Study Site 357
state: Tennessee
city: Austin
country: United States
facility: Study Site 365
state: Texas
city: Houston
country: United States
facility: Study Site 335
state: Texas
city: Pflugerville
country: United States
facility: Study Site 359
state: Texas
city: Plano
country: United States
facility: Study Site 339
state: Texas
city: San Antonio
country: United States
facility: Study Site 361
state: Texas
city: Draper
country: United States
facility: Study Site 351
state: Utah
city: Norfolk
country: United States
facility: Study Site 342
state: Virginia
city: Richmond
country: United States
facility: Study Site 336
state: Virginia
city: Richmond
country: United States
facility: Study Site 367
state: Virginia
Study officials:
affiliation: Vyne Therapeutics Inc.
name: Mary Spellman, MD
role: STUDY_DIRECTOR
References: