Clinical trial NCT04773587: Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Official title: A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis Eczema
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 654
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores
timeFrame: Week 4
measure: 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
timeFrame: Week 4
measure: 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
timeFrame: Week 2
measure: 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
timeFrame: Week 1
measure: Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4
timeFrame: Week 4
measure: Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4
timeFrame: Week 4
measure: Achievement of vIGA-AD Success at Week 2
timeFrame: Week 2
measure: Achievement of vIGA-AD Success at Week 1
timeFrame: Week 1
measure: Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2
timeFrame: Week 2
measure: Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1
timeFrame: Week 1
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Arcutis Clinical Site 57
state: Alabama
city: Scottsdale
country: United States
facility: Arcutis Clinical Site 34
state: Arizona
city: Little Rock
country: United States
facility: Arcutis Clinical Site 58
state: Arkansas
city: Beverly Hills
country: United States
facility: Arcutis Clinical Site 40
state: California
city: Encinitas
country: United States
facility: Arcutis Clinical Site 06
state: California
city: Los Angeles
country: United States
facility: Arcutis Clinical Site 52
state: California
city: San Diego
country: United States
facility: Arcutis Clinical Site 05
state: California
city: San Francisco
country: United States
facility: Arcutis Clinical Site 08
state: California
city: Thousand Oaks
country: United States
facility: Arcutis Clinical Site 62
state: California
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 30
state: Florida
city: Jacksonville
country: United States
facility: Arcutis Clinical Site 04
state: Florida
city: Largo
country: United States
facility: Arcutis Clinical Site 15
state: Florida
city: Miami Lakes
country: United States
facility: Arcutis Clinical Site 39
state: Florida
city: North Miami Beach
country: United States
facility: Arcutis Clinical Site 38
state: Florida
city: Tampa
country: United States
facility: Arcutis Clinical Site 01
state: Florida
city: Wellington
country: United States
facility: Arcutis Clinical Site 61
state: Florida
city: Sandy Springs
country: United States
facility: Arcutis Clinical Site 26
state: Georgia
city: Rolling Meadows
country: United States
facility: Arcutis Clinical Site 13
state: Illinois
city: Clarksville
country: United States
facility: Arcutis Clinical Site 48
state: Indiana
city: Indianapolis
country: United States
facility: Arcutis Clinical Site 02
state: Indiana
city: Louisville
country: United States
facility: Arcutis Clinical Site 03
state: Kentucky
city: Rockville
country: United States
facility: Arcutis Clinical Site 36
state: Maryland
city: Auburn Hills
country: United States
facility: Arcutis Clinical Site 55
state: Michigan
city: Bay City
country: United States
facility: Arcutis Clinical Site 54
state: Michigan
city: Clarkston
country: United States
facility: Arcutis Clinical Site 46
state: Michigan
city: Detroit
country: United States
facility: Arcutis Clinical Site 37
state: Michigan
city: New Brighton
country: United States
facility: Arcutis Clinical Site 10
state: Minnesota
city: Reno
country: United States
facility: Arcutis Clinical Site 33
state: Nevada
city: East Windsor
country: United States
facility: Arcutis Clinical Site 42
state: New Jersey
city: Gresham
country: United States
facility: Arcutis Clinical Site 17
state: Oregon
city: Portland
country: United States
facility: Arcutis Clinical Site 16
state: Oregon
city: Portland
country: United States
facility: Arcutis Clinical Site 14
state: Oregon
city: Newtown Square
country: United States
facility: Arcutis Clinical Site 35
state: Pennsylvania
city: Johnston
country: United States
facility: Arcutis Clinical Site 101
state: Rhode Island
city: Murfreesboro
country: United States
facility: Arcutis Clinical Site 31
state: Tennessee
city: Arlington
country: United States
facility: Arcutis Clinical Site 19
state: Texas
city: Bellaire
country: United States
facility: Arcutis Clinical Site 43
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 27
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 20
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 28
state: Texas
city: South Jordan
country: United States
facility: Arcutis Clinical Site 21
state: Utah
city: Spokane
country: United States
facility: Arcutis Clinical Site 12
state: Washington
city: Calgary
country: Canada
facility: Arcutis Clinical Site 41
state: Alberta
city: Fredericton
country: Canada
facility: Arcutis Clinical Site 29
state: New Brunswick
city: Markham
country: Canada
facility: Arcutis Clinical Site 11
state: Ontario
city: Mississauga
country: Canada
facility: Clinical Site 25
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Clinical Site 32
state: Ontario
city: Windsor
country: Canada
facility: Arcutis Clinical Site 09
state: Ontario
city: Montréal
country: Canada
facility: Arcutis Clinical Site 24
state: Quebec
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: