Pharmacokinetics, Safety, and Efficacy of ARQ-151 Once a Day in Adolescents and Children With Mild to Moderate Eczema

Overview

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 safety and efficacy of ARQ-151 cream 0.15% in adolescent and pediatric subjects with mild to moderate AD. At entry, subjects 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. Three 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 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.

Full Title of Study: “An Open Label, Phase 1, Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: ARQ-151 cream 0.15%
    • Open-label study of 0.15% active concentration

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite subjects
    • Time Frame: 4 weeks
    • Maximum observed plasma concentration of drug in plasma
  • Area under the plasma concentration-time curve within a dosing interval (AUC) for roflumilast and its N-oxide metabolite
    • Time Frame: 4 weeks
    • The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.
  • Treatment Emergent Adverse Events (TEAE)
    • Time Frame: 4 weeks
    • Number of participants with adverse events during treatment will be assessed.

Secondary Measures

  • Eczema Area and Severity Index (EASI) Total Score Change and Percent Change in Total Score
    • Time Frame: Baseline, Week 2, and Week 4
    • Change in EASI Total Score at weeks 2 and 4 and percent change from baseline in EASI Total Score at weeks 2 and 4. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
  • Eczema Area and Severity Index Score 100%, 90%, 75%, and 50% Improvement (EASI100, EASI90, EASI75, and EASI50)
    • Time Frame: Baseline, Week 2, and Week 4
    • Proportion of patients with a 100%, 90%, 75%, and 50% or greater improvement in Eczema Area and Severity Index (EASI100, EASI90, EASI75, and EASI50) score from baseline to each study visit. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
  • 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
    • Time Frame: Baseline, Week 2, Week 4
    • The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
  • Change from baseline in vIGA-AD score at each study visit
    • Time Frame: Baseline, Week 2, Week 4
    • The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
  • Body Surface Area (BSA) Involvement Change
    • Time Frame: Baseline, Week 2, Week 4
    • Change from baseline in BSA involvement at each study visit.
  • Worse Itch Numerical Rating Score (WI-NRS) Pruritis Score Change
    • Time Frame: Baseline, Week 2, Week 4
    • Change from baseline in WI-NRS pruritus score at each study visit. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from ’0 to 10′ (“no itch” to “worst imaginable itch”).
  • WI-NRS Pruritus Score Improvement
    • Time Frame: Baseline, Week 2, Week 4
    • ≥4-point improvement from Baseline in WI-NRS pruritus score at each study visit. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from ’0 to 10′ (“no itch” to “worst imaginable itch”).

Participating in This Clinical Trial

Inclusion Criteria

1. Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subject, as required by local laws.

2. 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).

3. Clinical diagnosis of active atopic dermatitis for at least 3 months.

4. EASI Score >5.

5. vIGA-AD score of 'Mild' ('2') or 'Moderate ('3').

6. Has AD involvement of 1.5-35% BSA (excluding the scalp, palms, soles)

7. 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.

8. In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

Exclusion Criteria

1. 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.

2. Subjects with unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.

3. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors.

4. 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.

5. Subjects who cannot discontinue systemic and/or topical therapies.

6. 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.

7. Subjects with actively infected AD or any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents

8. Known or suspected:

1. severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)

2. history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))

3. hypersensitivity to component(s) of the investigational product

4. history of severe depression, suicidal ideation, Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current

9. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

10. Subjects (12 to 17 years old, inclusive) with modified PHQ-A score ≥10 at Screening or Baseline visits.

11. Subjects (6 to 11 years old, inclusive) with a CDI-2 (parent report) raw score >20 at Screening/Baseline

12. Subjects with a history of a major surgery within 4 weeks prior to Baseline/Visit 1 or subjects who have a major surgery planned during the study.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Arcutis, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Berk, MD, Study Director, Arcutis, Inc.
  • Overall Contact(s)
    • Arcutis Study Inquiry, 805 418 5006, studyinquiry@arcutis.com

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