Clinical trial NCT04746911: Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Plaque Psoriasis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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:


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma pharmacokinetic (PK) profile of ARQ-151 cream 0.3% and its major N-oxide metabolite
timeFrame: Week 4
measure: Incidence of adverse events
timeFrame: Week 4
measure: Incidence of application site reactions
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain Brook
country: United States
facility: Arcutis Clinical Site 603
state: Alabama
city: Scottsdale
country: United States
facility: Arcutis Clinical Site 604
state: Arizona
city: Fountain Valley
country: United States
facility: Arcutis Clinical Site 609
state: California
city: Los Angeles
country: United States
facility: Arcutis Clinical Site 618
state: California
city: Los Angeles
country: United States
facility: Arcutis Clinical Site 608
state: California
city: Rancho Santa Margarita
country: United States
facility: Arcutis Clinical Site 611
state: California
city: Boca Raton
country: United States
facility: Arcutis Clinical Site 610
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 602
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Clinical Site 613
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Study Site 628
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 607
state: Florida
city: West Lafayette
country: United States
facility: Arcutis Clinical Site 627
state: Indiana
city: Arlington
country: United States
facility: Arcutis Clinical Site 606
state: Texas
city: Frisco
country: United States
facility: Arcutis Clinical Site 619
state: Texas
city: Frisco
country: United States
facility: Arcutis Clinical Study Site 619
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 605
state: Texas
city: Toronto
country: Canada
facility: Arcutis Clinical Site 621
state: Ontario
city: Santo Domingo
country: Dominican Republic
facility: Arcutis Clinical Site 630
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: