Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis

An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis

This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.

ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis.

The goal of the study is to:

• Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%.
• Assess the safety and tolerability of ARQ-154 foam 0.3%

Inclusion Criteria:

• Males and females, ages 2 years to < 12 years old at Day 1.
• Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator.
• Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day 1.
• An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day 1.
• Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day 1.
• Body psoriasis (non-scalp) involving at least 3% BSA on Day 1.

Exclusion Criteria:

• Participants who cannot discontinue medications and treatments prior to Day 1 (first application of IP).
• Current diagnosis of non-plaque forms of psoriasis. Current diagnosis of drug-induced psoriasis.
• Participants who have significant active systemic or localized infection or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days prior to Day 1.
• Participants with skin conditions other than psoriasis vulgaris that would interfere with evaluations of the effect of the study medication, as determined by the Investigator.
• Participants who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Day 1 and during the study period.
• A medical history of severe renal insufficiency, moderate to severe hepatic disorders (e.g., Child-Pugh B or C), or chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).
• Participants who are family members of the clinical study staff or sponsor.