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

NCT ID: NCT04655313

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2022-01-12

Brief 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:

Conditions

Psoriasis; Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARQ-151 cream 0.3%

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

Group Type: EXPERIMENTAL

ARQ-151 cream 0.3%

Intervention Type: DRUG

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

Interventions

ARQ-151 cream 0.3%

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

Intervention Type: DRUG

Other Intervention Names

Topical roflumilast

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Berk, MD

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics, Inc.

Locations

Arcutis Clinical Site 503

Mountain Brook, Alabama, United States

Arcutis Clinical Site 504

Scottsdale, Arizona, United States

Arcutis Clinical Site 509

Fountain Valley, California, United States

Arcutis Site 518

Los Angeles, California, United States

Arcutis Clinical Site 508

Los Angeles, California, United States

Arcutis Clinical Site 511

Rancho Santa Margarita, California, United States

Arcutis Clinical Site 510

Boca Raton, Florida, United States

Arcutis Clinical Site 502

Coral Gables, Florida, United States

Arcutis Clinical Site 513

Delray Beach, Florida, United States

Arcutis Clinical Site 501

Hialeah, Florida, United States

Arcutis Clinical Site 507

Miami, Florida, United States

Arcutis Clinical Site 527

West Lafayette, Indiana, United States

Arcutis Clinical Site 506

Arlington, Texas, United States

Arcutis Clinical Site 519

Frisco, Texas, United States

Arcutis Clinical Site 505

Houston, Texas, United States

Arcutis Clinical Site 521

Toronto, Ontario, Canada

Arcutis Clinical Site 530

Santo Domingo, , Dominican Republic

Countries

United States; Canada; Dominican Republic

References

Hebert AA, Guide SV, Groysman V, Gonzalez ME, Blanco D, Laquer V, Seal MS, Thurston A, Krupa D, Snyder S, Burnett P, Chu DH, Berk DR, Higham RC. Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years. Pediatr Dermatol. 2025 Aug 27. doi: 10.1111/pde.70013. Online ahead of print.

Reference Type: DERIVED

PMID: 40862624 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARQ-151-215

Identifier Type: -

Identifier Source: org_study_id