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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746911
• Other study ID #: ARQ-151-216
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: March 2023
• Source: Arcutis Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• ARQ-151 cream 0.3%
ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks

Locations

Country	Name	City	State
Canada	Arcutis Clinical Site 621	Toronto	Ontario
Dominican Republic	Arcutis Clinical Site 630	Santo Domingo
United States	Arcutis Clinical Site 606	Arlington	Texas
United States	Arcutis Clinical Site 610	Boca Raton	Florida
United States	Arcutis Clinical Site 602	Coral Gables	Florida
United States	Arcutis Clinical Site 613	Delray Beach	Florida
United States	Arcutis Clinical Site 609	Fountain Valley	California
United States	Arcutis Clinical Site 619	Frisco	Texas
United States	Arcutis Clinical Study Site 619	Frisco	Texas
United States	Arcutis Clinical Site 605	Houston	Texas
United States	Arcutis Clinical Site 608	Los Angeles	California
United States	Arcutis Clinical Site 618	Los Angeles	California
United States	Arcutis Clinical Site 607	Miami	Florida
United States	Arcutis Clinical Study Site 628	Miami	Florida
United States	Arcutis Clinical Site 603	Mountain Brook	Alabama
United States	Arcutis Clinical Site 611	Rancho Santa Margarita	California
United States	Arcutis Clinical Site 604	Scottsdale	Arizona
United States	Arcutis Clinical Site 627	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Arcutis Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of adverse events	Number of participants with adverse events during treatment will be assessed	Week 4
Primary	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