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NCT02975206 Clinical Trial

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— ATOMIK  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02975206
Other study ID # MTI-103
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2016
Est. completion date February 23, 2018

Study information
Verified date May 2021
Source Vyne Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

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 information / eligibility
Status Completed
Enrollment 484
Est. completion date February 23, 2018
Est. primary completion date January 16, 2018
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Serlopitant High Dose
serlopitant tablets - high dose
• Placebo Oral Tablet
placebo tablet
• Serlopitant Low Dose
serlopitant tablets - low dose

Locations
Country Name City State
United States Study Site 382 Anderson South Carolina
United States Study Site 332 Anniston Alabama
United States Study Site 369 Atlanta Georgia
United States Study Site 365 Austin Texas
United States Study Site 380 Bardstown Kentucky
United States Study Site 352 Berlin New Jersey
United States Study Site 363 Birmingham Alabama
United States Study Site 379 Boston Massachusetts
United States Study Site 334 Cerritos California
United States Study Site 357 Chattanooga Tennessee
United States Study Site 381 Chicago Illinois
United States Study Site 358 Denver Colorado
United States Study Site 351 Draper Utah
United States Study Site 386 Encinitas California
United States Study Site 375 Forest Hills New York
United States Study Site 366 Fountain Valley California
United States Study Site 364 Glendale Arizona
United States Study Site 341 High Point North Carolina
United States Study Site 340 Hoover Alabama
United States Study Site 335 Houston Texas
United States Study Site 370 Jacksonville Florida
United States Study Site 345 Johnston Rhode Island
United States Study Site 387 Las Vegas Nevada
United States Study Site 338 Los Angeles California
United States Study Site 344 Louisville Kentucky
United States Study Site 331 Miami Florida
United States Study Site 348 Miami Florida
United States Study Site 378 Miami Florida
United States Study Site 360 New Albany Indiana
United States Study Site 342 Norfolk Virginia
United States Study Site 383 North Hollywood California
United States Study Site 374 Oceanside California
United States Study Site 337 Oklahoma City Oklahoma
United States Study Site 359 Pflugerville Texas
United States Study Site 353 Pinellas Park Florida
United States Study Site 339 Plano Texas
United States Study Site 362 Providence Rhode Island
United States Study Site 336 Richmond Virginia
United States Study Site 367 Richmond Virginia
United States Study Site 373 Rochester New York
United States Study Site 371 Saint Joseph Missouri
United States Study Site 361 San Antonio Texas
United States Study Site 347 San Diego California
United States Study Site 356 San Diego California
United States Study Site 333 San Francisco California
United States Study Site 376 Santa Monica California
United States Study Site 349 Savannah Georgia
United States Study Site 355 Shelby North Carolina
United States Study Site 343 Spartanburg South Carolina
United States Study Site 368 Tampa Florida
United States Study Site 377 Tampa Florida
United States Study Site 350 Warren Michigan

Sponsors (1)
Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in WI-NRS From Baseline to Week 6 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. Week 6 compared to Baseline
Secondary WI-NRS 4-point Responder Rate at Week 6 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. Week 6 compared to Baseline
Secondary Change in Quality of Life (ItchyQoL) From Baseline to Week 6 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. Week 6 compared to Baseline
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