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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 5 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04746911
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arcutis Biotherapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Berk, MD
Principal Investigator Affiliation Arcutis Biotherapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Canada, Dominican Republic, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Plaque Psoriasis
Arms & Interventions

Arms

Experimental: ARQ-151 cream 0.3%

Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks

Interventions

Drug: - ARQ-151 cream 0.3%

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arcutis Clinical Site 603, Mountain Brook, Alabama

Status

Address

Arcutis Clinical Site 603

Mountain Brook, Alabama, 35223

Arcutis Clinical Site 604, Scottsdale, Arizona

Status

Address

Arcutis Clinical Site 604

Scottsdale, Arizona, 85255

Arcutis Clinical Site 609, Fountain Valley, California

Status

Address

Arcutis Clinical Site 609

Fountain Valley, California, 92708

Arcutis Clinical Site 618, Los Angeles, California

Status

Address

Arcutis Clinical Site 618

Los Angeles, California, 90017

Arcutis Clinical Site 608, Los Angeles, California

Status

Address

Arcutis Clinical Site 608

Los Angeles, California, 90057

Arcutis Clinical Site 611, Rancho Santa Margarita, California

Status

Address

Arcutis Clinical Site 611

Rancho Santa Margarita, California, 92688

Arcutis Clinical Site 610, Boca Raton, Florida

Status

Address

Arcutis Clinical Site 610

Boca Raton, Florida, 33428

Arcutis Clinical Site 602, Coral Gables, Florida

Status

Address

Arcutis Clinical Site 602

Coral Gables, Florida, 33146

Arcutis Clinical Site 613, Delray Beach, Florida

Status

Address

Arcutis Clinical Site 613

Delray Beach, Florida, 33484

Arcutis Clinical Study Site 628, Miami, Florida

Status

Address

Arcutis Clinical Study Site 628

Miami, Florida, 33125

Arcutis Clinical Site 607, Miami, Florida

Status

Address

Arcutis Clinical Site 607

Miami, Florida, 33155

Arcutis Clinical Site 627, West Lafayette, Indiana

Status

Address

Arcutis Clinical Site 627

West Lafayette, Indiana, 47906

Arcutis Clinical Site 606, Arlington, Texas

Status

Address

Arcutis Clinical Site 606

Arlington, Texas, 76001

Arcutis Clinical Site 619, Frisco, Texas

Status

Address

Arcutis Clinical Site 619

Frisco, Texas, 75034

Arcutis Clinical Study Site 619, Frisco, Texas

Status

Address

Arcutis Clinical Study Site 619

Frisco, Texas, 75034

Arcutis Clinical Site 605, Houston, Texas

Status

Address

Arcutis Clinical Site 605

Houston, Texas, 77030

International Sites

Arcutis Clinical Site 621, Toronto, Ontario, Canada

Status

Address

Arcutis Clinical Site 621

Toronto, Ontario, M5G 1X8

Arcutis Clinical Site 630, Santo Domingo, Dominican Republic

Status

Address

Arcutis Clinical Site 630

Santo Domingo, ,

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