Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 2 to 5 Years Old) With Plaque Psoriasis

This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:

Study Overview

• Status: Completed
• Conditions: Psoriasis; Plaque Psoriasis
• Intervention / Treatment: Drug: ARQ-151 cream 0.3%

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Arcutis Clinical Site 621
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Arcutis Clinical Site 630
• United States
  • Alabama
    • Mountain Brook, Alabama, United States, 35223
      • Arcutis Clinical Site 603
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Arcutis Clinical Site 604
  • California
    • Fountain Valley, California, United States, 92708
      • Arcutis Clinical Site 609
    • Los Angeles, California, United States, 90017
      • Arcutis Clinical Site 618
    • Los Angeles, California, United States, 90057
      • Arcutis Clinical Site 608
    • Rancho Santa Margarita, California, United States, 92688
      • Arcutis Clinical Site 611
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Arcutis Clinical Site 610
    • Coral Gables, Florida, United States, 33146
      • Arcutis Clinical Site 602
    • Delray Beach, Florida, United States, 33484
      • Arcutis Clinical Site 613
    • Miami, Florida, United States, 33125
      • Arcutis Clinical Study Site 628
    • Miami, Florida, United States, 33155
      • Arcutis Clinical Site 607
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Arcutis Clinical Site 627
  • Texas
    • Arlington, Texas, United States, 76001
      • Arcutis Clinical Site 606
    • Frisco, Texas, United States, 75034
      • Arcutis Clinical Site 619
    • Frisco, Texas, United States, 75034
      • Arcutis Clinical Study Site 619
    • Houston, Texas, United States, 77030
      • Arcutis Clinical Site 605

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent of parent(s) or legal guardian.
• Males or females, 2 to 5 years old (inclusive).
• Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks.
• Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles).
• An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline.
• Subject has adequate venous access for PK sampling in areas not involved by plaque psoriasis and not being treated with ARQ-151 (e.g., back of the hands).
• In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs and hematology values.
• Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and Visit Schedule, according to the judgment of the Investigator.

Exclusion Criteria:

• Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
• Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris
• Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
• Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period.
• Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Baseline/Day 1 and during the study period.
• Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
• Subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the Baseline/Day 1 and during the study period according to the protocol.
• Subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1.

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-151 cream 0.3%; Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks	Drug: ARQ-151 cream 0.3%; ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks; Other Names: Topical roflumilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma pharmacokinetic (PK) profile of ARQ-151 cream 0.3% and its major N-oxide metabolite	Plasma levels of circulating roflumilast and its major N-oxide metabolite	Week 4
Incidence of adverse events	Number of participants with adverse events during treatment will be assessed	Week 4
Incidence of application site reactions	Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed	Week 4

Collaborators and Investigators

• Sponsor: Arcutis Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: ARQ-151-216

Drug and device information, study documents

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