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

NCT07340216 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ARQ-154-127
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

Brief Summary

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%.

Conditions

Psoriasis

Keywords

Scalp and Body Psoriasis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

ARQ-154 Foam 0.3%

EXPERIMENTAL

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%

Interventions

ARQ-154 Foam 0.3% DRUG

ARQ-154 Foam 0.3%

ARQ-154 Foam 0.3%

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (5)

Arcutis Clinical Study Site 106

Bryant, Arkansas, 72022, United States

RECRUITING

Arcutis Clinical Study Site 107

Miami Lakes, Florida, 33014, United States

RECRUITING

Arcutis Clinical Study Site 108

Meridian, Idaho, 83646, United States

RECRUITING

Arcutis Clinical Study Site 105

West Lafayette, Indiana, 47906, United States

RECRUITING

Arcutis Clinical Study Site 104

Arlington, Texas, 76011, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Arcutis Biotherapeutics

CONTACT

844-692-6729; studyinquiry@arcutis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 14, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (5)