Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Last updated: September 13, 2024
Sponsor: Arcutis Biotherapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Dermatitis, Atopic

Allergies & Asthma

Rash

Treatment

Vehicle Cream

ARQ-151 Active

ARQ-151 Vehicle

Clinical Study ID

NCT04773587
ARQ-151-311
  • Ages > 6
  • All Genders

Study Summary

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants legally competent to sign and give informed consent and, ifappropriate, assent as required by local laws.

  2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located inthe province of Québec in Canada.

  3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), asdetermined by the Investigator. Stable disease for the past 4 weeks with nosignificant flares in atopic dermatitis before screening.

  4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy testat Screening and a negative urine pregnancy test at Baseline/Day 1. In addition,sexually active FOCBP must agree to use at least one form of a highly effective orbarrier method of contraception throughout the trial.

  5. In good health as judged by the Investigator.

  6. Subjects considered reliable and capable of adhering to the Protocol and visitschedule, according to the judgment of the Investigator.

Exclusion

Exclusion Criteria:

  1. Subjects with any serious medical condition or clinically significant abnormalitythat would prevent study participation or place the subject at significant risk, asjudged by the Investigator

  2. Has unstable AD or any consistent requirement for high potency topical steroids.

  3. Subjects who are unwilling to refrain from prolonged sun exposure and from using atanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior toBaseline/Day 1 and during the study.

  4. Females who are pregnant, wishing to become pregnant during the study, or arebreast-feeding.

  5. Previous treatment with ARQ-151.

  6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior toScreening.

  7. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand thelocal language(s). Subjects who are unable to communicate, read or understand thelocal language, or who display another condition, which in the Investigator'sopinion, makes them unsuitable for clinical study participation.

  8. Subjects who are family members of the clinical study site, clinical study staff, orsponsor, or family members of enrolled subjects living in the same house.

Study Design

Total Participants: 654
Treatment Group(s): 4
Primary Treatment: Vehicle Cream
Phase: 3
Study Start date:
January 27, 2021
Estimated Completion Date:
August 30, 2022

Connect with a study center

  • Arcutis Clinical Site 41

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Arcutis Clinical Site 29

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Arcutis Clinical Site 11

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Clinical Site 25

    Mississauga, Ontario L5H 1G9
    Canada

    Site Not Available

  • Arcutis Clinical Site 32

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Arcutis Clinical Site 09

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Arcutis Clinical Site 24

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Arcutis Clinical Site 57

    Montgomery, Alabama 36117
    United States

    Site Not Available

  • Arcutis Clinical Site 34

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Arcutis Clinical Site 58

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • Arcutis Clinical Site 40

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Arcutis Clinical Site 06

    Encinitas, California 92024
    United States

    Site Not Available

  • Arcutis Clinical Site 52

    Los Angeles, California 90056
    United States

    Site Not Available

  • Arcutis Clinical Site 05

    San Diego, California 92123
    United States

    Site Not Available

  • Arcutis Clinical Site 08

    San Francisco, California 94132
    United States

    Site Not Available

  • Arcutis Clinical Site 62

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Arcutis Clinical Site 30

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Arcutis Clinical Site 04

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Arcutis Clinical Site 15

    Largo, Florida 33770
    United States

    Site Not Available

  • Arcutis Clinical Site 39

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Arcutis Clinical Site 38

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Arcutis Clinical Site 01

    Tampa, Florida 33613
    United States

    Site Not Available

  • Arcutis Clinical Site 61

    Wellington, Florida 33449
    United States

    Site Not Available

  • Arcutis Clinical Site 26

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Arcutis Clinical Site 13

    Rolling Meadows, Illinois 33770
    United States

    Site Not Available

  • Arcutis Clinical Site 48

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Arcutis Clinical Site 02

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Arcutis Clinical Site 03

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Arcutis Clinical Site 36

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Arcutis Clinical Site 55

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Arcutis Clinical Site 54

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Arcutis Clinical Site 46

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Arcutis Clinical Site 37

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Arcutis Clinical Site 10

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Arcutis Clinical Site 33

    Reno, Nevada 89509
    United States

    Site Not Available

  • Arcutis Clinical Site 42

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Arcutis Clinical Site 17

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Arcutis Clinical Site 14

    Portland, Oregon 97239
    United States

    Site Not Available

  • Arcutis Clinical Site 16

    Portland, Oregon 97223
    United States

    Site Not Available

  • Arcutis Clinical Site 35

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • Arcutis Clinical Site 101

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Arcutis Clinical Site 31

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Arcutis Clinical Site 19

    Arlington, Texas 76011
    United States

    Site Not Available

  • Arcutis Clinical Site 43

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Arcutis Clinical Site 20

    Houston, Texas 77056
    United States

    Site Not Available

  • Arcutis Clinical Site 27

    Houston, Texas 77030
    United States

    Site Not Available

  • Arcutis Clinical Site 28

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Arcutis Clinical Site 21

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Arcutis Clinical Site 12

    Spokane, Washington 99202
    United States

    Site Not Available

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