Psoriasis Clinical Trial

Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)

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:

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT04655313

Recruitment Status:

Completed

Sponsor:

Arcutis Biotherapeutics, Inc.

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There are 16 Locations for this study

See Locations Near You

Arcutis Clinical Site 503
Mountain Brook Alabama, 35223, United States
Arcutis Clinical Site 504
Scottsdale Arizona, 85255, United States
Arcutis Clinical Site 509
Fountain Valley California, 92708, United States
Arcutis Site 518
Los Angeles California, 90017, United States
Arcutis Clinical Site 508
Los Angeles California, 90057, United States
Arcutis Clinical Site 511
Rancho Santa Margarita California, 92688, United States
Arcutis Clinical Site 510
Boca Raton Florida, 33428, United States
Arcutis Clinical Site 502
Coral Gables Florida, 33146, United States
Arcutis Clinical Site 513
Delray Beach Florida, 33484, United States
Arcutis Clinical Site 501
Hialeah Florida, 33016, United States
Arcutis Clinical Site 507
Miami Florida, 33155, United States
Arcutis Clinical Site 527
West Lafayette Indiana, 47906, United States
Arcutis Clinical Site 506
Arlington Texas, 76001, United States
Arcutis Clinical Site 519
Frisco Texas, 75034, United States
Arcutis Clinical Site 505
Houston Texas, 77030, United States
Arcutis Clinical Site 521
Toronto Ontario, MG5-1, Canada
Arcutis Clinical Site 530
Santo Domingo , , Dominican Republic

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT04655313

Recruitment Status:

Completed

Sponsor:


Arcutis Biotherapeutics, Inc.

How clear is this clinincal trial information?

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