Trials / Completed
CompletedNCT02975206
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 484 (actual)
- Sponsor
- Vyne Therapeutics Inc. · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Serlopitant High Dose | serlopitant tablets - high dose |
| DRUG | Placebo Oral Tablet | placebo tablet |
| DRUG | Serlopitant Low Dose | serlopitant tablets - low dose |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-01-16
- Completion
- 2018-02-23
- First posted
- 2016-11-29
- Last updated
- 2021-05-20
- Results posted
- 2019-03-05
Locations
52 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02975206. Inclusion in this directory is not an endorsement.