Clinical trial NCT04845620: Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
Official title: A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% 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: 2021-04-15
Enrollment: 652
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

Detailed description: This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.

Eligibility criteria: 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.

Primary outcomes:
measure: IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4.
timeFrame: Week 4
Secondary outcomes:
measure: In subjects with vIGA-AD score of 'Moderate' at randomization, IGA Success at Week 4
timeFrame: Week 4
measure: In subjects with vIGA-AD score of 'Moderate' at randomization, achievement of at least 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4
timeFrame: Week 4
measure: In subjects with vIGA-AD score of 'Moderate' at randomization, vIGA-AD score of 'clear' or 'almost clear' at Week 4
timeFrame: Week 4
measure: vIGA-AD success at Week 2
timeFrame: Week 2
measure: vIGA-AD of 'clear' or 'almost 'clear' at Week 2
timeFrame: Week 2
measure: vIGA-AD success at Week 1
timeFrame: Week 1
measure: vIGA-AD of 'clear' or 'almost 'clear' at Week 1
timeFrame: Week 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Arcutis Clinical Site 56
state: Alabama
city: Birmingham
country: United States
facility: Arcutis Clinical Site 14
state: Alabama
city: Montgomery
country: United States
facility: Arcutis Clinical Site 69
state: Alabama
city: Gilbert
country: United States
facility: Arcutis Clinical Site 68
state: Arizona
city: Scottsdale
country: United States
facility: Arcutis Clinical Site 26
state: Arizona
city: Bryant
country: United States
facility: Arcutis Clinical Site 50
state: Arkansas
city: Fort Smith
country: United States
facility: Arcutis Clinical Site 59
state: Arkansas
city: Little Rock
country: United States
facility: Arcutis Clinical Site 71
state: Arkansas
city: Inglewood
country: United States
facility: Arcutis Clinical Site 09
state: California
city: Rancho Santa Margarita
country: United States
facility: Arcutis Clinical Site 45
state: California
city: San Diego
country: United States
facility: Arcutis Clinical Site 30
state: California
city: Thousand Oaks
country: United States
facility: Arcutis Clinical Site 70
state: California
city: Boca Raton
country: United States
facility: Arcutis Clinical Site 48
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 33
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 12
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Clinical Site 11
state: Florida
city: Largo
country: United States
facility: Arcutis Clinical Site 28
state: Florida
city: Miami Lakes
country: United States
facility: Arcutis Clinical Site 10
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 79
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 43
state: Florida
city: North Miami Beach
country: United States
facility: Arcutis Clinical Site 35
state: Florida
city: Wellington
country: United States
facility: Arcutis Clinical Site 75
state: Florida
city: Sandy Springs
country: United States
facility: Arcutis Clinical Site 20
state: Georgia
city: Boise
country: United States
facility: Arcutis Clinical Site 82
state: Idaho
city: Chicago
country: United States
facility: Arcutis Clinical Site 60
state: Illinois
city: Rolling Meadows
country: United States
facility: Arcutis Clinical Site 07
state: Illinois
city: Clarksville
country: United States
facility: Arcutis Clinical Site 42
state: Indiana
city: Plainfield
country: United States
facility: Arcutis Clinical Site 21
state: Indiana
city: West Lafayette
country: United States
facility: Arcutis Clinical Site 57
state: Indiana
city: Louisville
country: United States
facility: Arcutis Clinical Site 22
state: Kentucky
city: Louisville
country: United States
facility: Arcutis Clinical Site 46
state: Kentucky
city: Baton Rouge
country: United States
facility: Arcutis Clinical Site 84
state: Louisiana
city: Lake Charles
country: United States
facility: Arcutis Clinical Site 34
state: Louisiana
city: Metairie
country: United States
facility: Arcutis Clinical Site 51
state: Louisiana
city: Metairie
country: United States
facility: Arcutis Clinical Site 40
state: Louisiana
city: Columbia
country: United States
facility: Arcutis Clinical Site 77
state: Maryland
city: Rockville
country: United States
facility: Arcutis Clinical Site 13
state: Maryland
city: Rockville
country: United States
facility: Arcutis Clinical Site 15
state: Maryland
city: Auburn Hills
country: United States
facility: Arcutis Clinical Site 53
state: Michigan
city: Bay City
country: United States
facility: Arcutis Clinical Site 41
state: Michigan
city: Clarkston
country: United States
facility: Arcutis Clinical Site 36
state: Michigan
city: Troy
country: United States
facility: Arcutis Clinical Site 72
state: Michigan
city: New Brighton
country: United States
facility: Arcutis Clinical Site 05
state: Minnesota
city: Saint Joseph
country: United States
facility: Arcutis Clinical Site 47
state: Missouri
city: Reno
country: United States
facility: Arcutis Clinical Site 16
state: Nevada
city: Lebanon
country: United States
facility: Arcutis Clinical Site 55
state: New Hampshire
city: Brooklyn
country: United States
facility: Arcutis Clinical Site 54
state: New York
city: New York
country: United States
facility: Arcutis Clinical Site 44
state: New York
city: Rochester
country: United States
facility: Arcutis Clinical Site 32
state: New York
city: Cincinnati
country: United States
facility: Arcutis Clinical Site 58
state: Ohio
city: Mason
country: United States
facility: Arcutis Clinical Site 81
state: Ohio
city: Gresham
country: United States
facility: Arcutis Clinical Site 01
state: Oregon
city: Portland
country: United States
facility: Arcutis Clinical Site 52
state: Oregon
city: Portland
country: United States
facility: Arcutis Clinical Site 63
state: Oregon
city: Bethlehem
country: United States
facility: Arcutis Clinical Site 65
state: Pennsylvania
city: Hershey
country: United States
facility: Arcutis Clinical Site 31
state: Pennsylvania
city: Newtown Square
country: United States
facility: Arcutis Clinical Site 24
state: Pennsylvania
city: Charleston
country: United States
facility: Arcutis Clinical Site 62
state: South Carolina
city: Summerville
country: United States
facility: Arcutis Clinical Site 39
state: South Carolina
city: Austin
country: United States
facility: Arcutis Clinical Site 08
state: Texas
city: Bellaire
country: United States
facility: Arcutis Clinical Site 27
state: Texas
city: Fort Worth
country: United States
facility: Arcutis Clinical Site 74
state: Texas
city: Frisco
country: United States
facility: Arcutis Clinical Site 66
state: Texas
city: Grapevine
country: United States
facility: Arcutis Clinical Site 61
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 04
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 02
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 18
state: Texas
city: South Jordan
country: United States
facility: Arcutis Clinical Site 03
state: Utah
city: Burke
country: United States
facility: Arcutis Clinical Site 06
state: Virginia
city: Charlottesville
country: United States
facility: Arcutis Clinical Site 76
state: Virginia
city: Spokane
country: United States
facility: Arcutis Clinical Site 25
state: Washington
city: Calgary
country: Canada
facility: Arcutis Clinical Site 29
state: Alberta
city: Winnipeg
country: Canada
facility: Arcutis Clinical Site 64
state: Manitoba
city: Burlington
country: Canada
facility: Arcutis Clinical Site 73
state: Ontario
city: Markham
country: Canada
facility: Arcutis Clinical Site 36
state: Ontario
city: Saskatoon
country: Canada
facility: Arcutis Clinical Site 78
state: Saskatchewan
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: