ARQ-154 (roflumilast) foam 0.3% for children with scalp and body psoriasis: maximal-use safety and blood levels
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 trial will test whether ARQ-154 foam 0.3% applied to the scalp and body of children aged 2 to 11 produces measurable blood levels and is safe and tolerable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Arcutis Biotherapeutics, Inc. Industry-sponsored |
| Locations | 5 sites (Bryant, Arkansas and 4 other locations) |
| Trial ID | NCT07340216 on ClinicalTrials.gov |
What this trial studies
This is an open-label, single-arm, maximal-use pharmacokinetic and safety study of topical ARQ-154 foam 0.3% in pediatric participants with scalp and body plaque psoriasis. Eligible children will apply the foam under defined maximal-use conditions and have blood samples taken to characterize systemic exposure and plasma pharmacokinetics. Safety and tolerability will be monitored through adverse event reporting, physical exams, and laboratory tests. The study focuses on participants with at least moderate scalp disease and at least mild body involvement to capture higher-use scenarios.
Who should consider this trial
Good fit: Children aged 2 to under 12 years with a clinical diagnosis of plaque psoriasis, at least moderate scalp involvement and at least mild body involvement who can stop prohibited medications and attend study visits are ideal candidates.
Not a fit: Patients with non-plaque or drug-induced psoriasis, recent significant infections, or those who cannot discontinue other psoriasis treatments are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could establish a known systemic exposure and safety profile that supports safe topical use of ARQ-154 foam in young children with scalp and body psoriasis.
How similar studies have performed: Topical roflumilast formulations have shown promising safety and efficacy signals in adult psoriasis studies, but maximal-use pediatric pharmacokinetic data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bryant, Arkansas and 4 other locations
- Arcutis Clinical Study Site 106 — Bryant, Arkansas, United States (Recruiting)
- Arcutis Clinical Study Site 107 — Miami Lakes, Florida, United States (Recruiting)
- Arcutis Clinical Study Site 108 — Meridian, Idaho, United States (Recruiting)
- Arcutis Clinical Study Site 105 — West Lafayette, Indiana, United States (Recruiting)
- Arcutis Clinical Study Site 104 — Arlington, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Arcutis Biotherapeutics
- Email: studyinquiry@arcutis.com
- Phone: 844-692-6729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.