Clinical trial NCT04655313: Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)
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 6 to 11 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: 2020-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
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 6 to 11 years old) with plaque psoriasis:


Eligibility criteria: Inclusion Criteria:

* Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subject, as required by local laws.
* Males or females, 6 to 11 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).
* Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the duration of the trial and for one week after application of the last dose.
* Females of non-childbearing potential must be pre-menarchal.
* In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.
* 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.
* Subjects with a CDI-2 (parent report) raw score \>20 at Screening/Baseline

Primary outcomes:
measure: Plasma Concentration of ARQ-151 Cream 0.3%
timeFrame: Predose on Days 14 and 28
measure: Plasma Concentration of the Roflumilast Major N-oxide Metabolite
timeFrame: Predose on Days 14 and 28
measure: Number of Participants With ≥1 Adverse Event (AE)
timeFrame: Up to 28 days
measure: Number of Participants With Application Site Reactions
timeFrame: Baseline (Day 1), Day 7, and Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain Brook
country: United States
facility: Arcutis Clinical Site 503
state: Alabama
city: Scottsdale
country: United States
facility: Arcutis Clinical Site 504
state: Arizona
city: Fountain Valley
country: United States
facility: Arcutis Clinical Site 509
state: California
city: Los Angeles
country: United States
facility: Arcutis Site 518
state: California
city: Los Angeles
country: United States
facility: Arcutis Clinical Site 508
state: California
city: Rancho Santa Margarita
country: United States
facility: Arcutis Clinical Site 511
state: California
city: Boca Raton
country: United States
facility: Arcutis Clinical Site 510
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 502
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Clinical Site 513
state: Florida
city: Hialeah
country: United States
facility: Arcutis Clinical Site 501
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 507
state: Florida
city: West Lafayette
country: United States
facility: Arcutis Clinical Site 527
state: Indiana
city: Arlington
country: United States
facility: Arcutis Clinical Site 506
state: Texas
city: Frisco
country: United States
facility: Arcutis Clinical Site 519
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 505
state: Texas
city: Toronto
country: Canada
facility: Arcutis Clinical Site 521
state: Ontario
city: Santo Domingo
country: Dominican Republic
facility: Arcutis Clinical Site 530
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: