Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-OLE)

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    1500
  • sponsor
    Arcutis Biotherapeutics, Inc.
Updated on 4 October 2022

Summary

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 52 weeks by subjects with atopic dermatitis (eczema).

Description

This is an open-label study in which ARQ-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).

Details
Condition Atopic Dermatitis Eczema
Treatment ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Clinical Study IdentifierNCT04804605
SponsorArcutis Biotherapeutics, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws
Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study
Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. 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
Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator

Exclusion Criteria

Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study
Subjects that use any Excluded Medications and Treatments
Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements
Subjects with known genetic dermatological conditions that overlap with AD
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding
Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), 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 (subjects enrolled in other studies of ARQ-151 cream) 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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