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

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 6 to 11 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 6 Years - 11 Years
Gender All
More Inclusion & Exclusion 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

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.

NCT04655313
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 Recruiting
Countries 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 503, Mountain Brook, Alabama

Status

Recruiting

Address

Arcutis Clinical Site 503

Mountain Brook, Alabama, 35223

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006 #5

Arcutis Clinical Site 504, Scottsdale, Arizona

Status

Recruiting

Address

Arcutis Clinical Site 504

Scottsdale, Arizona, 85255

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006 #5

Arcutis Clinical Site 509, Fountain Valley, California

Status

Recruiting

Address

Arcutis Clinical Site 509

Fountain Valley, California, 92708

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 508, Los Angeles, California

Status

Recruiting

Address

Arcutis Clinical Site 508

Los Angeles, California, 90057

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 511, Rancho Santa Margarita, California

Status

Recruiting

Address

Arcutis Clinical Site 511

Rancho Santa Margarita, California, 92688

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 510, Boca Raton, Florida

Status

Recruiting

Address

Arcutis Clinical Site 510

Boca Raton, Florida, 33428

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 502, Coral Gables, Florida

Status

Recruiting

Address

Arcutis Clinical Site 502

Coral Gables, Florida, 33146

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006 #5

Arcutis Clinical Site 513, Delray Beach, Florida

Status

Recruiting

Address

Arcutis Clinical Site 513

Delray Beach, Florida, 33484

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 501, Hialeah, Florida

Status

Recruiting

Address

Arcutis Clinical Site 501

Hialeah, Florida, 33016

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006 #5

Arcutis Clinical Site 507, Miami, Florida

Status

Recruiting

Address

Arcutis Clinical Site 507

Miami, Florida, 33155

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 506, Arlington, Texas

Status

Recruiting

Address

Arcutis Clinical Site 506

Arlington, Texas, 76001

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 519, Frisco, Texas

Status

Recruiting

Address

Arcutis Clinical Site 519

Frisco, Texas, 75034

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

Arcutis Clinical Site 505, Houston, Texas

Status

Recruiting

Address

Arcutis Clinical Site 505

Houston, Texas, 77030

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

International Sites

Arcutis Clinical Site 530, Santo Domingo, Dominican Republic

Status

Recruiting

Address

Arcutis Clinical Site 530

Santo Domingo, ,

Site Contact

Arcutis Study Inquiry

studyinquiry@arcutis.com

805-418-5006

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