Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

Arcutis Biotherapeutics, Inc.652 enrolled

Overview

This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

652

Conditions

Atopic Dermatitis Eczema

Interventions

Roflumilast Cream 0.05%DRUG

Roflumilast cream for topical application.

Vehicle CreamDRUG

Vehicle cream matched to roflumilast cream for topical application.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent by parent(s) or legal guardian as required by local laws. 2. Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1). 3. Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening. 4. In good health as judged by the Investigator. 5. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Exclusion Criteria: 1. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator 2. Has unstable AD or any consistent requirement for high potency topical steroids. 3. Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study. 4. Previous treatment with ARQ-151. 5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. 6. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled (in other studies of ARQ-151) subjects living in the same house.

Locations (76)

Outcomes

Primary Outcomes

Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4

The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.

Time frame: Week 4

Secondary Outcomes

Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD

The percentage of participants with vIGA-AD success at Week 4 who had 'moderate' vIGA-AD score (vIGA score of 3) at baseline is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline in participants with moderate vIGA-AD baseline.

Time frame: Week 4

Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA

The percentage of participants with a moderate baseline vIGA-AD score who achieved EASI-75 is presented. EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head {10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Time frame: Week 4

Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear'

The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 4 is presented. The vIGA is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.

Data from ClinicalTrials.gov

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Arcutis Clinical Site 56

Birmingham, Alabama, United States

Arcutis Clinical Site 14

Birmingham, Alabama, United States

Arcutis Clinical Site 69

Montgomery, Alabama, United States

Arcutis Clinical Site 68

Gilbert, Arizona, United States

Arcutis Clinical Site 26

Scottsdale, Arizona, United States

Arcutis Clinical Site 50

Bryant, Arkansas, United States

Arcutis Clinical Site 59

Fort Smith, Arkansas, United States

Arcutis Clinical Site 71

Little Rock, Arkansas, United States

Arcutis Clinical Site 09

Inglewood, California, United States

Arcutis Clinical Site 45

Rancho Santa Margarita, California, United States

...and 66 more locations