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

NCT ID: NCT02975206

Last Updated: 2021-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-02-23

Brief Summary

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

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Detailed Description

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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

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Pruritus Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Serlopitant High Dose

serlopitant tablets - high dose

Group Type EXPERIMENTAL

Serlopitant High Dose

Intervention Type DRUG

serlopitant tablets - high dose

Serlopitant Low Dose

serlopitant tablets - low dose

Group Type EXPERIMENTAL

Serlopitant Low Dose

Intervention Type DRUG

serlopitant tablets - low dose

Placebo Oral Tablet

matching placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

placebo tablet

Interventions

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Serlopitant High Dose

serlopitant tablets - high dose

Intervention Type DRUG

Placebo Oral Tablet

placebo tablet

Intervention Type DRUG

Serlopitant Low Dose

serlopitant tablets - low dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Spellman, MD

Role: STUDY_DIRECTOR

Vyne Therapeutics Inc.

Locations

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Study Site 332

Anniston, Alabama, United States

Site Status

Study Site 363

Birmingham, Alabama, United States

Site Status

Study Site 340

Hoover, Alabama, United States

Site Status

Study Site 364

Glendale, Arizona, United States

Site Status

Study Site 334

Cerritos, California, United States

Site Status

Study Site 386

Encinitas, California, United States

Site Status

Study Site 366

Fountain Valley, California, United States

Site Status

Study Site 338

Los Angeles, California, United States

Site Status

Study Site 383

North Hollywood, California, United States

Site Status

Study Site 374

Oceanside, California, United States

Site Status

Study Site 347

San Diego, California, United States

Site Status

Study Site 356

San Diego, California, United States

Site Status

Study Site 333

San Francisco, California, United States

Site Status

Study Site 376

Santa Monica, California, United States

Site Status

Study Site 358

Denver, Colorado, United States

Site Status

Study Site 370

Jacksonville, Florida, United States

Site Status

Study Site 331

Miami, Florida, United States

Site Status

Study Site 348

Miami, Florida, United States

Site Status

Study Site 378

Miami, Florida, United States

Site Status

Study Site 353

Pinellas Park, Florida, United States

Site Status

Study Site 368

Tampa, Florida, United States

Site Status

Study Site 377

Tampa, Florida, United States

Site Status

Study Site 369

Atlanta, Georgia, United States

Site Status

Study Site 349

Savannah, Georgia, United States

Site Status

Study Site 381

Chicago, Illinois, United States

Site Status

Study Site 360

New Albany, Indiana, United States

Site Status

Study Site 380

Bardstown, Kentucky, United States

Site Status

Study Site 344

Louisville, Kentucky, United States

Site Status

Study Site 379

Boston, Massachusetts, United States

Site Status

Study Site 350

Warren, Michigan, United States

Site Status

Study Site 371

Saint Joseph, Missouri, United States

Site Status

Study Site 387

Las Vegas, Nevada, United States

Site Status

Study Site 352

Berlin, New Jersey, United States

Site Status

Study Site 375

Forest Hills, New York, United States

Site Status

Study Site 373

Rochester, New York, United States

Site Status

Study Site 341

High Point, North Carolina, United States

Site Status

Study Site 355

Shelby, North Carolina, United States

Site Status

Study Site 337

Oklahoma City, Oklahoma, United States

Site Status

Study Site 345

Johnston, Rhode Island, United States

Site Status

Study Site 362

Providence, Rhode Island, United States

Site Status

Study Site 382

Anderson, South Carolina, United States

Site Status

Study Site 343

Spartanburg, South Carolina, United States

Site Status

Study Site 357

Chattanooga, Tennessee, United States

Site Status

Study Site 365

Austin, Texas, United States

Site Status

Study Site 335

Houston, Texas, United States

Site Status

Study Site 359

Pflugerville, Texas, United States

Site Status

Study Site 339

Plano, Texas, United States

Site Status

Study Site 361

San Antonio, Texas, United States

Site Status

Study Site 351

Draper, Utah, United States

Site Status

Study Site 342

Norfolk, Virginia, United States

Site Status

Study Site 336

Richmond, Virginia, United States

Site Status

Study Site 367

Richmond, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MTI-103

Identifier Type: -

Identifier Source: org_study_id

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