NCT04746911

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 2 to 5 years old) with plaque psoriasis:

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2

Geographic Reach
3 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

February 5, 2021

Last Update Submit

March 7, 2023

Conditions

PsoriasisPlaque Psoriasis

Outcome Measures

Primary Outcomes (3)

  • Plasma pharmacokinetic (PK) profile of ARQ-151 cream 0.3% and its major N-oxide metabolite

    Plasma levels of circulating roflumilast and its major N-oxide metabolite

    Week 4

  • Incidence of adverse events

    Number of participants with adverse events during treatment will be assessed

    Week 4

  • Incidence of application site reactions

    Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed

    Week 4

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

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Arcutis Clinical Site 603

Mountain Brook, Alabama, 35223, United States

Location

Arcutis Clinical Site 604

Scottsdale, Arizona, 85255, United States

Location

Arcutis Clinical Site 609

Fountain Valley, California, 92708, United States

Location

Arcutis Clinical Site 618

Los Angeles, California, 90017, United States

Location

Arcutis Clinical Site 608

Los Angeles, California, 90057, United States

Location

Arcutis Clinical Site 611

Rancho Santa Margarita, California, 92688, United States

Location

Arcutis Clinical Site 610

Boca Raton, Florida, 33428, United States

Location

Arcutis Clinical Site 602

Coral Gables, Florida, 33146, United States

Location

Arcutis Clinical Site 613

Delray Beach, Florida, 33484, United States

Location

Arcutis Clinical Study Site 628

Miami, Florida, 33125, United States

Location

Arcutis Clinical Site 607

Miami, Florida, 33155, United States

Location

Arcutis Clinical Site 627

West Lafayette, Indiana, 47906, United States

Location

Arcutis Clinical Site 606

Arlington, Texas, 76001, United States

Location

Arcutis Clinical Site 619

Frisco, Texas, 75034, United States

Location

Arcutis Clinical Study Site 619

Frisco, Texas, 75034, United States

Location

Arcutis Clinical Site 605

Houston, Texas, 77030, United States

Location

Arcutis Clinical Site 621

Toronto, Ontario, M5G 1X8, Canada

Location

Arcutis Clinical Site 630

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: 40862624DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Berk, MD

    Arcutis Biotherapeutics, Inc.

    STUDY DIRECTOR

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

February 5, 2021

First Posted

February 10, 2021

Study Start

March 1, 2021

Primary Completion

May 11, 2022

Study Completion

May 11, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

CA(1)DO(1)US(16)