Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: ARQ-151 cream 0.3%
Intervention description: ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in
      pediatric subjects (ages 6 to 11 years old) with plaque psoriasis:
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by
             the subject, as required by local laws.

          -  Males or females, 6 to 11 years old (inclusive).

          -  Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined
             by the Investigator or through subject interview. Stable disease for the past 3 weeks.

          -  Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas
             involving at least 2% of BSA (excluding the scalp, palms, and soles).

          -  An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at
             Baseline.

          -  Subject has adequate venous access for PK sampling in areas not involved by plaque
             psoriasis and not being treated with ARQ-151 (e.g., back of the hands).

          -  Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at
             Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). In
             addition, sexually active FOCBP must agree to use at least one form of highly
             effective contraception throughout the duration of the trial and for one week after
             application of the last dose.

          -  Females of non-childbearing potential must be pre-menarchal.

          -  In good health as judged by the Investigator, based on medical history, physical
             examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values,
             and urinalysis.

          -  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 with any serious medical or psychiatric condition or clinically significant
             laboratory, ECG, vital signs, or physical examination abnormality that would prevent
             study participation or place the subject at significant risk, as judged by the
             Investigator.

          -  Planned initiation or changes to concomitant medication that could, in the opinion of
             the Investigator, affect psoriasis vulgaris

          -  Current diagnosis of non-plaque form of psoriasis (e.g., guttate,
             erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis).
             Current diagnosis of drug-induced psoriasis.

          -  Subjects with any condition on the treatment area which, in the opinion of the
             Investigator, could confound efficacy measurements.

          -  Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for
             2 weeks prior to Baseline/Day 1and during the study period.

          -  Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors
             for 2 weeks prior to Baseline/Day 1 and during the study period.

          -  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.

          -  Subjects who cannot discontinue specific systemic therapies and/or topical therapies
             prior to the Baseline/Day 1 and during the study period according to the protocol.

          -  Subjects with any infection requiring oral or intravenous administration of
             antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1.

          -  Subjects with a CDI-2 (parent report) raw score >20 at Screening/Baseline