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

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ClinicalTrials.gov Identifier: NCT02975206
Recruitment Status : Completed
First Posted : November 29, 2016
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Menlo Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Pruritus Atopic Dermatitis Drug: Serlopitant High Dose Drug: Placebo Oral Tablet Drug: Serlopitant Low Dose Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Experimental: Serlopitant High Dose
serlopitant tablets - high dose
Drug: Serlopitant High Dose
serlopitant tablets - high dose

Experimental: Serlopitant Low Dose
serlopitant tablets - low dose
Drug: Serlopitant Low Dose
serlopitant tablets - low dose

Placebo Comparator: Placebo Oral Tablet
matching placebo tablets
Drug: Placebo Oral Tablet
placebo tablet




Primary Outcome Measures :
  1. Change in WI-NRS From Baseline to Week 6 [ Time Frame: 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 :
  1. WI-NRS 4-point Responder Rate at Week 6 [ Time Frame: 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.

  2. Change in Quality of Life (ItchyQoL) From Baseline to Week 6 [ Time Frame: 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.



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975206


  Show 52 Study Locations
Sponsors and Collaborators
Menlo Therapeutics Inc.
Investigators
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Study Director: Mary Spellman, MD Menlo Therapeutics Inc.
  Study Documents (Full-Text)

Documents provided by Menlo Therapeutics Inc.:
Study Protocol  [PDF] November 21, 2017
Statistical Analysis Plan  [PDF] February 7, 2018


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Responsible Party: Menlo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02975206     History of Changes
Other Study ID Numbers: MTI-103
First Posted: November 29, 2016    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms
Serlopitant
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs