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%.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: ARQ-154 Foam 0.3%

Detailed Description

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%

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Arcutis Clinical Study Site 106
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Arcutis Clinical Study Site 107
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Arcutis Clinical Study Site 108
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Arcutis Clinical Study Site 105
  • Texas
    • Arlington, Texas, United States, 76011
      • Arcutis Clinical Study Site 104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARQ-154 Foam 0.3%; ARQ-154 foam 0.3% will be applied QD. Treatment duration will be up to 6 weeks, including 2 weeks under maximal usage conditions, followed by an optional 4 weeks under non-maximal usage conditions.	Drug: ARQ-154 Foam 0.3%; ARQ-154 Foam 0.3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Roflumilast and Roflumilast N-Oxide from plasma	Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration.	2 Weeks
Participant incidence of adverse events	Number of participants with adverse events during treatment will be assessed	6 Weeks
Incidence of application site reactions	Number of participants that experience an application site skin reaction by investigator assessment and participant assessment will be assessed	6 Weeks
The incidence of changes from Baseline in the total Children's Depression Inventory 2 (CDI-2)score.	The CDI-2 is an assessment instrument used to evaluate the severity of depressive symptoms in children.	6 Weeks

Collaborators and Investigators

• Sponsor: Arcutis Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Scalp and Body Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: ARQ-154-127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No