Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema

NCT04156191 | Completed Phase 1 FDA Drug

• 1 other identifier: ARQ-151-105
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 10

Brief Summary

This is a research study where all subjects will receive study medication to understand how the body processes the study medication, and to determine the PK, safety and efficacy of ARQ-151 cream 0.15% or 0.05% in adolescent and pediatric subjects with mild to moderate AD. At entry, subjects in Cohorts 1-3 will have 1.5-35% Body Surface Area involvement (excluding the scalp, palms, soles) and mild or moderate atopic dermatitis (AD) based on vIGA-AD. Cohort 2 and Cohort 3 will be performed in parallel and may commence after results are available from ARQ-151-212, a Phase 2 study evaluating ARQ-151 cream 0.05% and 0.15% administered once a day for 4 weeks in adolescents and adults with mild to moderate AD affecting 1.5% to 35% BSA. For the maximal usage PK study (Cohorts 4-8), subjects will have BSA involvement (excluding the scalp, palms, soles) of ≥ 35% in subjects 3 months old to 11 years old (inclusive) or ≥25% in subjects 12 to \<17 years old with mild or moderate AD . Seven groups will be evaluated, including:

• Cohort 1: ARQ-151 cream 0.15% in adolescents (12-17 years old; inclusive)
• Cohort 2: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)
• Cohort 3: ARQ-151 cream 0.15% in children 2-5 years old (inclusive; will be performed in parallel with Cohort 2)
• Cohort 4: ARQ-151 cream 0.15% in adolescents 12 to \<17 years old
• Cohort 5: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)
• Cohort 6: ARQ-151 cream 0.15% in children 2-5 years old (inclusive)
• Cohort 7: ARQ-151 cream 0.05% in children 2-5 years old (inclusive)
• Cohort 8: ARQ-151 cream 0.05% in children 3 months old to less than 2 years old Subjects will apply ARQ-151 cream 0.15% or 0.05% once a day for 28 days to all AD affected areas and any newly appearing AD lesions that arise during the study, except on the scalp.

Conditions

Atopic Dermatitis (Eczema)

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite

  Maximum observed plasma concentration of drug in plasma

  4 weeks

• Area under the plasma concentration-time curve within a dosing interval (AUC) for roflumilast and its N-oxide metabolite

  The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.

  4 weeks

• Treatment Emergent Adverse Events (TEAE)

  Number of participants with adverse events during treatment will be assessed.

  4 weeks

Secondary Outcomes (7)

• Eczema Area and Severity Index (EASI) Total Score Change and Percent Change in Total Score

  Baseline, Week 2, and Week 4

• Eczema Area and Severity Index Score 100%, 90%, 75%, and 50% Improvement (EASI100, EASI90, EASI75, and EASI50)

  Baseline, Week 2, and Week 4

• Achievement of a Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 'clear' or 'almost clear' at each study visit, or 'clear' or 'almost clear' with a 2-point improvement from baseline at each study visit

  Baseline, Week 2, Week 4

• Change from baseline in vIGA-AD score at each study visit

  Baseline, Week 2, Week 4

• Body Surface Area (BSA) Involvement Change

  Baseline, Week 2, Week 4

Study Arms (1)

ARQ-151 cream 0.15% or 0.05%

EXPERIMENTAL

Open-label study of 0.15% or 0.05% active concentration

Drug: ARQ-151 cream 0.15%; Drug: ARQ-151 cream 0.05%

Interventions

ARQ-151 cream 0.15% DRUG

ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days

ARQ-151 cream 0.15% or 0.05%

ARQ-151 cream 0.05% DRUG

ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days

ARQ-151 cream 0.15% or 0.05%

Eligibility Criteria

• Age: 3 Months - 17 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, 12-17 years old (inclusive; Cohort 1), or 6-11 years old (inclusive; Cohort 2), or 2-5 years old (inclusive; Cohort 3), and in the maximal usage PK study subjects aged 12 to \<17 years old (Cohort 4), 6 to 11 years old (Cohort 5), 2-5 years old (Cohort 6 and Cohort 7), or 3 months to less than 2 years old (Cohort 8).
• Clinical diagnosis of active atopic dermatitis for at least 3 months (2 weeks for Cohort 8).
• EASI Score ≥5.
• vIGA-AD score of 'Mild' ('2') or 'Moderate ('3').
• Has AD involvement of 1.5 to 35% BSA (Cohorts 1-3) or ≥25% BSA (Cohorts 4-7), all excluding the scalp, palms, soles; or for Cohort 8 ≥35% BSA excluding the scalp, perioral, and below wrists/ankles .
• Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial.
• In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

You may not qualify if:

• Subjects with any serious medical or psychiatric condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
• Subjects with unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
• Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors.
• 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/Visit 2 and during the study.
• Subjects who cannot discontinue systemic and/or topical therapies.
• Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
• Subjects with actively infected AD or any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents
• Known or suspected:
• severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
• history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
• hypersensitivity to component(s) of the investigational product
• history of severe depression, suicidal ideation, Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Subjects (12 to 17 years old, inclusive) with modified PHQ-A score ≥10 at Screening or Baseline visits.
• Subjects (6 to 11 years old, inclusive) with a CDI-2 (parent report) raw score \>20 at Screening/Baseline

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (10)

Arcutis Clinical Site 07

Birmingham, Alabama, 35244, United States

Location

Arcutis Clinical Site 11

Rancho Santa Margarita, California, 92688, United States

Location

Arcutis Clinical Site 02

Coral Gables, Florida, 33146, United States

Location

Arcutis Clinical Site 05

Hialeah, Florida, 33016, United States

Location

Arcutis Clinical Site 13

Miami, Florida, 33137, United States

Location

Arcutis Clinical Site 01

Mt. Pleasant, South Carolina, 29464, United States

Location

Arcutis Clinical Site 06

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 03

Orem, Utah, 84058, United States

Location

Arcutis Clinical Site 10

West Jordan, Utah, 84088, United States

Location

Arcutis Clinical Site 12

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 7, 2019
• Study Start: December 23, 2019
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

US (10)