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

Vyne Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Pruritus

Treatments: Drug: Serlopitant High Dose; Drug: Serlopitant Low Dose; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02975206

MTI-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 484 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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484 participants in 3 patient groups, including a placebo group

Serlopitant High Dose

Experimental group

Description:

serlopitant tablets - high dose

Treatment:

Drug: Serlopitant High Dose

Serlopitant Low Dose

Experimental group

Description:

serlopitant tablets - low dose

Treatment:

Drug: Serlopitant Low Dose

Placebo Oral Tablet

Placebo Comparator group

Description:

matching placebo tablets

Treatment:

Drug: Placebo Oral Tablet