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

Primary Purpose

Atopic Dermatitis (Eczema)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARQ-151 cream 0.15%
ARQ-151 cream 0.05%
Sponsored by
Arcutis Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis (Eczema)

Eligibility Criteria

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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), 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).
  3. Clinical diagnosis of active atopic dermatitis for at least 3 months (2 weeks for Cohort 8).
  4. EASI Score ≥5.
  5. vIGA-AD score of 'Mild' ('2') or 'Moderate ('3').
  6. 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 .
  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.
  13. Subjects with prior exposure to ARQ-151
  14. Subjects 3 to <12 months old who were premature at birth
  15. Subject is nursing and subject's mother requires high dose systemic steroids

Sites / Locations

  • Arcutis Clinical Site 07
  • Arcutis Clinical Site 11
  • Arcutis Clinical Site 02
  • Arcutis Clinical Site 05
  • Arcutis Clinical Site 13
  • Arcutis Clinical Site 01
  • Arcutis Clinical Site 06
  • Arcutis Clinical Site 03
  • Arcutis Clinical Site 10
  • Arcutis Clinical Site 12

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARQ-151 cream 0.15% or 0.05%

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite
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
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)
Number of participants with adverse events during treatment will be assessed.

Secondary Outcome Measures

Eczema Area and Severity Index (EASI) Total Score Change and Percent Change in Total Score
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)
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
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
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
Change from baseline in BSA involvement at each study visit.
Worse Itch Numerical Rating Score (WI-NRS) Pruritis Score Change
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
≥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").

Full Information

First Posted
November 3, 2019
Last Updated
July 21, 2023
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04156191
Brief Title
Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
Official Title
An Open Label, Phase 1, Pharmacokinetics, Maximal Usage Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcutis Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis (Eczema)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARQ-151 cream 0.15% or 0.05%
Arm Type
Experimental
Arm Description
Open-label study of 0.15% or 0.05% active concentration
Intervention Type
Drug
Intervention Name(s)
ARQ-151 cream 0.15%
Intervention Description
ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days
Intervention Type
Drug
Intervention Name(s)
ARQ-151 cream 0.05%
Intervention Description
ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite
Description
Maximum observed plasma concentration of drug in plasma
Time Frame
4 weeks
Title
Area under the plasma concentration-time curve within a dosing interval (AUC) for roflumilast and its N-oxide metabolite
Description
The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.
Time Frame
4 weeks
Title
Treatment Emergent Adverse Events (TEAE)
Description
Number of participants with adverse events during treatment will be assessed.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI) Total Score Change and Percent Change in Total Score
Description
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.
Time Frame
Baseline, Week 2, and Week 4
Title
Eczema Area and Severity Index Score 100%, 90%, 75%, and 50% Improvement (EASI100, EASI90, EASI75, and EASI50)
Description
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.
Time Frame
Baseline, Week 2, and Week 4
Title
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
Description
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).
Time Frame
Baseline, Week 2, Week 4
Title
Change from baseline in vIGA-AD score at each study visit
Description
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).
Time Frame
Baseline, Week 2, Week 4
Title
Body Surface Area (BSA) Involvement Change
Description
Change from baseline in BSA involvement at each study visit.
Time Frame
Baseline, Week 2, Week 4
Title
Worse Itch Numerical Rating Score (WI-NRS) Pruritis Score Change
Description
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").
Time Frame
Baseline, Week 2, Week 4
Title
WI-NRS Pruritus Score Improvement
Description
≥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").
Time Frame
Baseline, Week 2, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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, 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. Exclusion Criteria: 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 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. Subjects with prior exposure to ARQ-151 Subjects 3 to <12 months old who were premature at birth Subject is nursing and subject's mother requires high dose systemic steroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Berk, MD
Organizational Affiliation
Arcutis Biotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arcutis Clinical Site 07
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Arcutis Clinical Site 11
City
Rancho Santa Margarita
State/Province
California
ZIP/Postal Code
92688
Country
United States
Facility Name
Arcutis Clinical Site 02
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Arcutis Clinical Site 05
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Arcutis Clinical Site 13
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Arcutis Clinical Site 01
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Arcutis Clinical Site 06
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Arcutis Clinical Site 03
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Arcutis Clinical Site 10
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Arcutis Clinical Site 12
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

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

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