Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)

Study Overview
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Brief Summary
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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:

Official Title
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An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 6 to 11 Years Old) With Plaque Psoriasis

Conditions
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Psoriasis, Plaque Psoriasis

Intervention / Treatment
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* Drug: ARQ-151 cream 0.3%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARQ-151 cream 0.3%<br>Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks | Drug: ARQ-151 cream 0.3%<br>* ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks<br>* Other names: Topical roflumilast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of ARQ-151 Cream 0.3% | Plasma levels of circulating roflumilast were determined at 2 points in the study. | Predose on Days 14 and 28 | 
| Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study. | Predose on Days 14 and 28 | 
| Number of Participants With ≥1 Adverse Event (AE) | The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. | Up to 28 days | 
| Number of Participants With Application Site Reactions | The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product. | Baseline (Day 1), Day 7, and Day 14 |