Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Roflumilast Cream 0.05%; Roflumilast Cream 0.15%; Vehicle Cream
Intervention description: Roflumilast 0.05% cream for topical application; Roflumilast 0.15% cream for topical application; Inactive vehicle cream matched to roflumilast cream for topical application.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of
      roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days
      by adolescents and adults with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants legally competent to sign and give informed consent or, in the case of
             adolescents, assent with consent of a parent(s) or legal guardian, as required by
             local laws.

          2. Males and females ages 12 years and older (inclusive) at the time of consent.

          3. Clinical diagnosis of active atopic dermatitis for at least 6 months.

          4. BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.

          5. vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild'
             ('2') or 'moderate ('3') at Baseline.

          6. EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.

          7. Females of childbearing potential must have a negative serum pregnancy test at
             Screening and, if sexually active, agree to use birth control throughout the trial.

          8. In good health as judged by the Investigator, based on medical history, physical
             examination, and clinical tests.

        Exclusion Criteria:

          1. Subjects with any serious medical condition or clinically significant physical
             examination or test abnormality that would prevent study participation or place the
             subject at significant risk.

          2. Evidence of skin conditions other than AD (atopic dermatitis) that would interfere
             with evaluation of the effect of the study medication.

          3. Pregnant or lactating women or women planning to become pregnant during the study.

          4. Known allergies to excipients in ARQ-151 cream.

          5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or
             inhibitors .

          6. Subjects who are unwilling to refrain from using a tanning bed as well as outdoor
             tanning or excessive sun exposure.

          7. Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies
             for the treatment of AD.

          8. Known or suspected:

               -  severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B
                  or C)

               -  history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human
                  immunodeficiency virus (HIV))

               -  within last 5 years, a history of severe depression, suicidal ideation

          9. Previous treatment with ARQ-151.

         10. Subjects with a history of chronic alcohol or drug abuse in past 6 months.

         11. Current or a history of cancer within 5 years with the exception of fully excised skin
             basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the
             cervix.

         12. Subjects with active infection that requires oral or intravenous administration of
             antibiotics, antifungal or antiviral agents.

         13. Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a
             major surgery planned during the study.

         14. Subjects with any condition which makes them unsuitable for clinical study
             participation or are family members of the clinical study site, clinical study staff,
             sponsor, or family members of enrolled subjects.