Clinical trial NCT04773600: Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
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: 683
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 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). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.


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: vIGA-AD Success at Week 2
timeFrame: Week 2
measure: vIGA-AD Success at Week 1
timeFrame: Week 1
measure: Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4
timeFrame: Week 4
measure: Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4
timeFrame: Week 2
measure: Achievement of a 4-point Reduction at Week 1 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4
timeFrame: Week 1
measure: Achievement of ≥75% Decrease From Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75)
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 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: Birmingham
country: United States
facility: Arcutis Clinical Site 31
state: Alabama
city: Fort Smith
country: United States
facility: Arcutis Clinical Site 51
state: Arkansas
city: Inglewood
country: United States
facility: Arcutis Clinical Site 46
state: California
city: San Diego
country: United States
facility: Arcutis Clinical Site 19
state: California
city: San Diego
country: United States
facility: Arcutis Clinical Site 36
state: California
city: Santa Monica
country: United States
facility: Arcutis Clinical Site 13
state: California
city: Centennial
country: United States
facility: Arcutis Clinical Site 54
state: Colorado
city: Boca Raton
country: United States
facility: Arcutis Clinical Site 55
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 30
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Clinical Site 37
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 58
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 41
state: Florida
city: Sanford
country: United States
facility: Arcutis Clinical Site 11
state: Florida
city: West Palm Beach
country: United States
facility: Arcutis Clinical Site 57
state: Florida
city: Boise
country: United States
facility: Arcutis Clinical Site 62
state: Idaho
city: Plainfield
country: United States
facility: Clinical Site 04
state: Indiana
city: Louisville
country: United States
facility: Arcutis Clinical Site 43
state: Kentucky
city: Baton Rouge
country: United States
facility: Arcutis Clinical Site 63
state: Louisiana
city: Lake Charles
country: United States
facility: Arcutis Clinical Site 42
state: Louisiana
city: Mandeville
country: United States
facility: Arcutis Clinical Site 38
state: Louisiana
city: Metairie
country: United States
facility: Arcutis Clinical Site 06
state: Louisiana
city: Rockville
country: United States
facility: Arcutis Clinical Site 34
state: Maryland
city: Clinton Township
country: United States
facility: Arcutis Clinical Site 29
state: Michigan
city: Fort Gratiot
country: United States
facility: Arcutis Clinical Site 21
state: Michigan
city: Troy
country: United States
facility: Arcutis Clinical Site 61
state: Michigan
city: Saint Joseph
country: United States
facility: Arcutis Clinical Site 245
state: Missouri
city: New York
country: United States
facility: Arcutis Clinical Site 53
state: New York
city: Rochester
country: United States
facility: Arcutis Clinical Site 39
state: New York
city: Stony Brook
country: United States
facility: Arcutis Clinical Site 33
state: New York
city: High Point
country: United States
facility: Arcutis Clinical Site 01
state: North Carolina
city: Hershey
country: United States
facility: Arcutis Clinical Site 24
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Arcutis Clinical Site 07
state: Pennsylvania
city: Charleston
country: United States
facility: Arcutis Clinical Site 35
state: South Carolina
city: Charleston
country: United States
facility: Arcutis Clinical Site 18
state: South Carolina
city: North Charleston
country: United States
facility: Arcutis Clinical Site 15
state: South Carolina
city: Austin
country: United States
facility: Clinical Site 05
state: Texas
city: College Station
country: United States
facility: Arcutis Clinical Site 03
state: Texas
city: Frisco
country: United States
facility: Arcutis Clinical Site 59
state: Texas
city: Grapevine
country: United States
facility: Arcutis Clinical Site 250
state: Texas
city: Pflugerville
country: United States
facility: Arcutis Clinical Site 52
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 02
state: Texas
city: Orem
country: United States
facility: Arcutis Clinical Site 32
state: Utah
city: Burke
country: United States
facility: Arcutis Clinical Site 22
state: Virginia
city: Norfolk
country: United States
facility: Arcutis Clinical Site 17
state: Virginia
city: Calgary
country: Canada
facility: Arcutis Clinical Site 12
state: Alberta
city: Surrey
country: Canada
facility: Arcutis Clinical Site 09
state: British Columbia
city: Winnipeg
country: Canada
facility: Arcutis Clinical Site 26
state: Manitoba
city: Ajax
country: Canada
facility: Arcutis Clinical Site 20
state: Ontario
city: London
country: Canada
facility: Arcutis Clinical Site 23
state: Ontario
city: Toronto
country: Canada
facility: Arcutis Clinical Site 25
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Clinical Site 16
state: Ontario
city: Drummondville
country: Canada
facility: Arcutis Clinical Site 08
state: Quebec
city: Québec
country: Canada
facility: Arcutis Clinical Site 27
state: Quebec
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: