Psoriasis Clinical Trial

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

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:

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT04746911

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 603
Mountain Brook Alabama, 35223, United States
Arcutis Clinical Site 604
Scottsdale Arizona, 85255, United States
Arcutis Clinical Site 609
Fountain Valley California, 92708, United States
Arcutis Clinical Site 618
Los Angeles California, 90017, United States
Arcutis Clinical Site 608
Los Angeles California, 90057, United States
Arcutis Clinical Site 611
Rancho Santa Margarita California, 92688, United States
Arcutis Clinical Site 610
Boca Raton Florida, 33428, United States
Arcutis Clinical Site 602
Coral Gables Florida, 33146, United States
Arcutis Clinical Site 613
Delray Beach Florida, 33484, United States
Arcutis Clinical Study Site 628
Miami Florida, 33125, United States
Arcutis Clinical Site 607
Miami Florida, 33155, United States
Arcutis Clinical Site 627
West Lafayette Indiana, 47906, United States
Arcutis Clinical Site 606
Arlington Texas, 76001, United States
Arcutis Clinical Site 619
Frisco Texas, 75034, United States
Arcutis Clinical Study Site 619
Frisco Texas, 75034, United States
Arcutis Clinical Site 605
Houston Texas, 77030, United States
Arcutis Clinical Site 621
Toronto Ontario, M5G 1, Canada
Arcutis Clinical Site 630
Santo Domingo , , Dominican Republic

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT04746911

Recruitment Status:

Completed

Sponsor:


Arcutis Biotherapeutics, Inc.

How clear is this clinincal trial information?

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