Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Last updated: June 13, 2025
Sponsor: Arcutis Biotherapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatitis, Atopic

Allergy

Atopic Dermatitis

Treatment

ARQ-151 cream 0.05%

Clinical Study ID

NCT06998056
ARQ-151-218
  • Ages 3-2
  • All Genders

Study Summary

This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Informed consent of a parent(s) or legal guardian(s), as required by local laws.

  2. Males and females, ages 3 months to <2 years old at Day 1.

  3. Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month durationprior to or at the screening visit.

  4. Has AD involvement of ≥3% BSA at Day1.

  5. In good health as judged by the Investigator

  6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable ofadhering to the Protocol and visit schedule, according to the judgment of theInvestigator.

Exclusion

Exclusion Criteria:

  1. Subjects with any serious medical condition, clinically significant vital signs, orphysical examination abnormality that would prevent study participation or place thesubject at significant risk, as judged by the Investigator.

  2. Subjects who have unstable AD or any consistent requirement for high potency topicalsteroids to manage AD signs or symptoms.

  3. Subjects previously treated with ARQ-151

  4. Subjects currently undergoing allergy testing or food challenges, or plan to do soduring the study.

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

  6. Subjects who are family members of the clinical study staff or sponsor.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: ARQ-151 cream 0.05%
Phase: 2
Study Start date:
June 09, 2025
Estimated Completion Date:
June 30, 2026

Study Description

This study is an open label safety study in which ARQ-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Connect with a study center

  • Arcutis Clinical Study Site 203

    Winnipeg, Manitoba R3J0S9
    Canada

    Active - Recruiting

  • Arcutis Clinical Study Site 216

    Waterloo, Ontario N2J1C4
    Canada

    Active - Recruiting

  • Arcutis Clinical Study Site 225

    Saskatoon, Saskatchewan S7K2C1
    Canada

    Active - Recruiting

  • Arcutis Clinical Study Site 208

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 221

    Bryant, Arkansas 72022
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 209

    Rancho Santa Margarita, California 92688
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 207

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 213

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 219

    West Lafayette, Indiana 47906
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 12

    Minneapolis, Minnesota 55112
    United States

    Site Not Available

  • Arcutis Clinical Study Site 212

    Minneapolis, Minnesota 55112
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 211

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 220

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Arcutis Clinical Study Site 224

    Fort Worth, Texas 76244
    United States

    Active - Recruiting

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