Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-I)

  • STATUS
    Recruiting
  • End date
    Nov 14, 2022
  • participants needed
    650
  • sponsor
    Arcutis Biotherapeutics, Inc.
Updated on 14 March 2022

Summary

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.

Details
Condition Atopic Dermatitis Eczema
Treatment ARQ-151 Active, ARQ-151 Vehicle
Clinical Study IdentifierNCT04773587
SponsorArcutis Biotherapeutics, Inc.
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws
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 in the province of Québec in Canada
Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at 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 or barrier method of contraception throughout the trial
In good health as judged by the Investigator
Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator

Exclusion Criteria

Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
Has unstable AD or any consistent requirement for high potency topical steroids
Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding
Previous treatment with ARQ-151
Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening
Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation
Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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