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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    10
  • sponsor
    Arcutis Biotherapeutics, Inc.
Updated on 31 July 2021
psoriasis vulgaris
plaque psoriasis

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:

Details
Condition Psoriasis, Psoriasis and Psoriatic Disorders, Plaque Psoriasis
Treatment ARQ-151 Cream 0.3%
Clinical Study IdentifierNCT04746911
SponsorArcutis Biotherapeutics, Inc.
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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
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