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

NCT04655313 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ARQ-151-215
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 17

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

Outcome Measures

Primary Outcomes (4)

• Plasma Concentration of ARQ-151 Cream 0.3%

  Plasma levels of circulating roflumilast were determined at 2 points in the study.

  Predose on Days 14 and 28

• Plasma Concentration of the Roflumilast Major N-oxide Metabolite

  Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study.

  Predose on Days 14 and 28

• Number of Participants With ≥1 Adverse Event (AE)

  The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

  Up to 28 days

• Number of Participants With Application Site Reactions

  The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product.

  Baseline (Day 1), Day 7, and Day 14

Study Arms (1)

ARQ-151 cream 0.3%

EXPERIMENTAL

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

Drug: ARQ-151 cream 0.3%

Interventions

ARQ-151 cream 0.3% DRUG

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

Also known as: Topical roflumilast

ARQ-151 cream 0.3%

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (17)

Arcutis Clinical Site 503

Mountain Brook, Alabama, 35223, United States

Location

Arcutis Clinical Site 504

Scottsdale, Arizona, 85255, United States

Location

Arcutis Clinical Site 509

Fountain Valley, California, 92708, United States

Location

Arcutis Site 518

Los Angeles, California, 90017, United States

Location

Arcutis Clinical Site 508

Los Angeles, California, 90057, United States

Location

Arcutis Clinical Site 511

Rancho Santa Margarita, California, 92688, United States

Location

Arcutis Clinical Site 510

Boca Raton, Florida, 33428, United States

Location

Arcutis Clinical Site 502

Coral Gables, Florida, 33146, United States

Location

Arcutis Clinical Site 513

Delray Beach, Florida, 33484, United States

Location

Arcutis Clinical Site 501

Hialeah, Florida, 33016, United States

Location

Arcutis Clinical Site 507

Miami, Florida, 33155, United States

Location

Arcutis Clinical Site 527

West Lafayette, Indiana, 47906, United States

Location

Arcutis Clinical Site 506

Arlington, Texas, 76001, United States

Location

Arcutis Clinical Site 519

Frisco, Texas, 75034, United States

Location

Arcutis Clinical Site 505

Houston, Texas, 77030, United States

Location

Arcutis Clinical Site 521

Toronto, Ontario, MG5-1X8, Canada

Location

Arcutis Clinical Site 530

Santo Domingo, Dominican Republic

Location

Related Publications (1)

• 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.

  PMID: 40862624 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: November 30, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-11

Locations

CA (1); DO (1); US (15)