Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
- Conditions
- PruritusAtopic Dermatitis
- Interventions
- Registration Number
- NCT02975206
- Lead Sponsor
- Vyne Therapeutics Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 484
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Oral Tablet Placebo Oral Tablet matching placebo tablets Serlopitant High Dose Serlopitant High Dose serlopitant tablets - high dose Serlopitant Low Dose Serlopitant Low Dose serlopitant tablets - low dose
- Primary Outcome Measures
Name Time Method Change in WI-NRS From Baseline to Week 6 Week 6 compared to Baseline Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.
- Secondary Outcome Measures
Name Time Method Change in Quality of Life (ItchyQoL) From Baseline to Week 6 Week 6 compared to Baseline ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.
WI-NRS 4-point Responder Rate at Week 6 Week 6 compared to Baseline Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.
Trial Locations
- Locations (52)
Study Site 364
🇺🇸Glendale, Arizona, United States
Study Site 352
🇺🇸Berlin, New Jersey, United States
Study Site 366
🇺🇸Fountain Valley, California, United States
Study Site 379
🇺🇸Boston, Massachusetts, United States
Study Site 382
🇺🇸Anderson, South Carolina, United States
Study Site 335
🇺🇸Houston, Texas, United States
Study Site 365
🇺🇸Austin, Texas, United States
Study Site 336
🇺🇸Richmond, Virginia, United States
Study Site 380
🇺🇸Bardstown, Kentucky, United States
Study Site 369
🇺🇸Atlanta, Georgia, United States
Study Site 349
🇺🇸Savannah, Georgia, United States
Study Site 332
🇺🇸Anniston, Alabama, United States
Study Site 341
🇺🇸High Point, North Carolina, United States
Study Site 386
🇺🇸Encinitas, California, United States
Study Site 383
🇺🇸North Hollywood, California, United States
Study Site 371
🇺🇸Saint Joseph, Missouri, United States
Study Site 357
🇺🇸Chattanooga, Tennessee, United States
Study Site 381
🇺🇸Chicago, Illinois, United States
Study Site 353
🇺🇸Pinellas Park, Florida, United States
Study Site 360
🇺🇸New Albany, Indiana, United States
Study Site 375
🇺🇸Forest Hills, New York, United States
Study Site 350
🇺🇸Warren, Michigan, United States
Study Site 343
🇺🇸Spartanburg, South Carolina, United States
Study Site 345
🇺🇸Johnston, Rhode Island, United States
Study Site 367
🇺🇸Richmond, Virginia, United States
Study Site 348
🇺🇸Miami, Florida, United States
Study Site 378
🇺🇸Miami, Florida, United States
Study Site 387
🇺🇸Las Vegas, Nevada, United States
Study Site 356
🇺🇸San Diego, California, United States
Study Site 337
🇺🇸Oklahoma City, Oklahoma, United States
Study Site 347
🇺🇸San Diego, California, United States
Study Site 340
🇺🇸Hoover, Alabama, United States
Study Site 334
🇺🇸Cerritos, California, United States
Study Site 338
🇺🇸Los Angeles, California, United States
Study Site 333
🇺🇸San Francisco, California, United States
Study Site 376
🇺🇸Santa Monica, California, United States
Study Site 370
🇺🇸Jacksonville, Florida, United States
Study Site 331
🇺🇸Miami, Florida, United States
Study Site 373
🇺🇸Rochester, New York, United States
Study Site 355
🇺🇸Shelby, North Carolina, United States
Study Site 359
🇺🇸Pflugerville, Texas, United States
Study Site 351
🇺🇸Draper, Utah, United States
Study Site 342
🇺🇸Norfolk, Virginia, United States
Study Site 374
🇺🇸Oceanside, California, United States
Study Site 362
🇺🇸Providence, Rhode Island, United States
Study Site 361
🇺🇸San Antonio, Texas, United States
Study Site 339
🇺🇸Plano, Texas, United States
Study Site 368
🇺🇸Tampa, Florida, United States
Study Site 344
🇺🇸Louisville, Kentucky, United States
Study Site 363
🇺🇸Birmingham, Alabama, United States
Study Site 358
🇺🇸Denver, Colorado, United States
Study Site 377
🇺🇸Tampa, Florida, United States