Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02975206
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2016-11-22
Brief Title:
Study of the Efficacy Safety and Tolerability of Serlopitant for Pruritus Itch in Atopic Dermatitis
Sponsor:
Vyne Therapeutics Inc
Organization:
Vyne Therapeutics Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATOMIK
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 111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None