Actively Recruiting

Phase 1
Age: 2Years - 12Years
All Genders
NCT07340216

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

Led by Arcutis Biotherapeutics, Inc. · Updated on 2026-01-14

16

Participants Needed

5

Research Sites

59 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 2 to under 12 years at Day 1
  • Clinical diagnosis of psoriasis vulgaris for at least 2 months at Screening
  • Scalp psoriasis with at least moderate severity on Investigator Global Assessment at Day 1
  • Body psoriasis with at least mild severity on Investigator Global Assessment at Day 1
  • Scalp psoriasis involving 10% or more of total scalp at Day 1
  • Body psoriasis involving at least 3% body surface area (BSA) at Day 1
Not Eligible

You will not qualify if you...

  • Unable to stop medications and treatments before Day 1 (first application of study drug)
  • Current diagnosis of non-plaque psoriasis or drug-induced psoriasis
  • Significant active infection or infection requiring antibiotics, antifungal, or antiviral treatment within 7 days prior to Day 1
  • Skin conditions other than psoriasis vulgaris interfering with study evaluations
  • Unable to stop strong CYP3A4 inhibitors for 2 weeks before Day 1 and during study
  • History of severe kidney problems, moderate to severe liver disorders, or chronic infections like hepatitis B, hepatitis C, or HIV
  • Family members of the study staff or sponsor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Arcutis Clinical Study Site 106

Bryant, Arkansas, United States, 72022

Actively Recruiting

2

Arcutis Clinical Study Site 107

Miami Lakes, Florida, United States, 33014

Actively Recruiting

3

Arcutis Clinical Study Site 108

Meridian, Idaho, United States, 83646

Actively Recruiting

4

Arcutis Clinical Study Site 105

West Lafayette, Indiana, United States, 47906

Actively Recruiting

5

Arcutis Clinical Study Site 104

Arlington, Texas, United States, 76011

Actively Recruiting

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Research Team

A

Arcutis Biotherapeutics

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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