Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Arcutis Biotherapeutics, Inc.654 enrolled

Overview

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

654

Conditions

Atopic Dermatitis Eczema

Interventions

Roflumilast Cream 0.15%DRUG

Roflumilast Cream 0.15% - Active

Vehicle CreamDRUG

Cream - Vehicle

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. 2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada. 3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening. 4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. 5. In good health as judged by the Investigator. 6. 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 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. 4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 5. Previous treatment with ARQ-151. 6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening. 7. 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. 8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.

Locations (49)

Outcomes

Primary Outcomes

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

The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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), with higher scores indicative of greater symptom severity.

Time frame: Week 4

Secondary Outcomes

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

The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame: Week 4

Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

Time frame: Week 4

Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

Data from ClinicalTrials.gov

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Arcutis Clinical Site 57

Montgomery, Alabama, United States

Arcutis Clinical Site 34

Scottsdale, Arizona, United States

Arcutis Clinical Site 58

Little Rock, Arkansas, United States

Arcutis Clinical Site 40

Beverly Hills, California, United States

Arcutis Clinical Site 06

Encinitas, California, United States

Arcutis Clinical Site 52

Los Angeles, California, United States

Arcutis Clinical Site 05

San Diego, California, United States

Arcutis Clinical Site 08

San Francisco, California, United States

Arcutis Clinical Site 62

Thousand Oaks, California, United States

Arcutis Clinical Site 30

Coral Gables, Florida, United States

...and 39 more locations

The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

Time frame: Week 1

Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4

The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ≥75% reduction from the baseline EASI score. 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: Week 4

Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4

The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame: Week 4

Achievement of vIGA-AD Success at Week 2

The percentage of participants achieving "success" on the VIGA-AD at Week 2 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame: Week 2

Achievement of vIGA-AD Success at Week 1

The percentage of participants achieving "success" on the VIGA-AD at Week 1 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame: Week 1

Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2

Time frame: Week 2

Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1

Time frame: Week 1