Clinical trial NCT04804605: Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Official title: A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% 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: 2021-03-18
Enrollment: 1220
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 52 weeks by subjects with atopic dermatitis (eczema).

Detailed description: This is an open-label study in which ARQ-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).

Eligibility criteria: Inclusion Criteria:

1. For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.
2. Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
3. Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.
4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. 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. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
2. Subjects that use any Excluded Medications and Treatments.
3. Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
4. Subjects with known genetic dermatological conditions that overlap with AD.
5. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house.

Primary outcomes:
measure: To assess long-term safety in a multicenter, open-label, single-arm, 52-week study in subjects with atopic dermatitis treated with ARQ-151 cream: AEs and SAEs
timeFrame: 24 or 52 weeks
Secondary outcomes:
measure: Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment
timeFrame: 24 or 52 weeks
measure: vIGA-AD success
timeFrame: 24 or 52 weeks
measure: WI-NRS score over time
timeFrame: 24 or 52 weeks
measure: EASI score over time
timeFrame: 24 or 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Arcutis Clinical Site 112
state: Alabama
city: Birmingham
country: United States
facility: Arcutis Clinical Site 73
state: Alabama
city: Scottsdale
country: United States
facility: Arcutis Clinical Site 63
state: Arizona
city: Bryant
country: United States
facility: Arcutis Clinical Site 106
state: Arkansas
city: Fort Smith
country: United States
facility: Arcutis Clinical Site 116
state: Arkansas
city: Beverly Hills
country: United States
facility: Arcutis Clinical Site 69
state: California
city: Inglewood
country: United States
facility: Arcutis Clinical Site 81
state: California
city: San Francisco
country: United States
facility: Clinical Site 08
state: California
city: Santa Monica
country: United States
facility: Arcutis Clinical Site 31
state: California
city: Thousand Oaks
country: United States
facility: Arcutis Clinical Site 130
state: California
city: Centennial
country: United States
facility: Arcutis Clinical Site 123
state: Colorado
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 59
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Clinical Site 72
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Clinical Site 79
state: Florida
city: Hollywood
country: United States
facility: Arcutis Clinical Site 103
state: Florida
city: Jacksonville
country: United States
facility: Clinical Site 04
state: Florida
city: Largo
country: United States
facility: Arcutis Clinical Site 15
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 67
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 95
state: Florida
city: Miami
country: United States
facility: Arcutis Clinical Site 68
state: Florida
city: Sanford
country: United States
facility: Arcutis Clinical Site 29
state: Florida
city: Tampa
country: United States
facility: Clinical Site 01
state: Florida
city: Wellington
country: United States
facility: Arcutis Clinical Site 138
state: Florida
city: Sandy Springs
country: United States
facility: Arcutis Clinical Site 47
state: Georgia
city: Boise
country: United States
facility: Arcutis Clinical Site 145
state: Idaho
city: Rolling Meadows
country: United States
facility: Arcutis Clinical Site 13
state: Illinois
city: Clarksville
country: United States
facility: Arcutis Clinical Site 93
state: Indiana
city: Plainfield
country: United States
facility: Clinical Site 22
state: Indiana
city: West Lafayette
country: United States
facility: Arcutis Clinical Site 114
state: Indiana
city: Louisville
country: United States
facility: Clinical Site 03
state: Kentucky
city: Covington
country: United States
facility: Arcutis Clinical Site 80
state: Louisiana
city: Lake Charles
country: United States
facility: Arcutis Clinical Site 85
state: Louisiana
city: Metairie
country: United States
facility: Arcutis Clinical Site 24
state: Louisiana
city: Rockville
country: United States
facility: Arcutis Clinical Site 76
state: Maryland
city: Bay City
country: United States
facility: Arcutis Clinical Site 94
state: Michigan
city: Clarkston
country: United States
facility: Arcutis Clinical Site 88
state: Michigan
city: Clinton Township
country: United States
facility: Arcutis Clinical Site 58
state: Michigan
city: Detroit
country: United States
facility: Arcutis Clinical Site 66
state: Michigan
city: Troy
country: United States
facility: Arcutis Clinical Site 132
state: Michigan
city: New Brighton
country: United States
facility: Clinical Site 10
state: Minnesota
city: Saint Joseph
country: United States
facility: Arcutis Clinical Site 102
state: Missouri
city: Reno
country: United States
facility: Arcutis Clinical Site 62
state: Nevada
city: East Windsor
country: United States
facility: Arcutis Clinical Site 71
state: New Jersey
city: Kew Gardens
country: United States
facility: Arcutis Clinical Site 96
state: New York
city: Rochester
country: United States
facility: Arcutis Clinical Site 82
state: New York
city: High Point
country: United States
facility: Arcutis Clinical Site 19
state: North Carolina
city: Gresham
country: United States
facility: Arcutis Clinical Site 17
state: Oregon
city: Portland
country: United States
facility: Arcutis Clinical Site 108
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: Hershey
country: United States
facility: Arcutis Clinical Site 53
state: Pennsylvania
city: Newtown Square
country: United States
facility: Arcutis Clinical Site 64
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Arcutis Clinical Site 25
state: Pennsylvania
city: Johnston
country: United States
facility: Arcutis Clinical Site 101
state: Rhode Island
city: Charleston
country: United States
facility: Arcutis Clinical Site 77
state: South Carolina
city: Charleston
country: United States
facility: Arcutis Clinical Site 41
state: South Carolina
city: North Charleston
country: United States
facility: Clinical Site 33
state: South Carolina
city: Summerville
country: United States
facility: Arcutis Clinical Site 91
state: South Carolina
city: Murfreesboro
country: United States
facility: Arcutis Clinical Site 60
state: Tennessee
city: Arlington
country: United States
facility: Arcutis Clinical Site 34
state: Texas
city: Austin
country: United States
facility: Clinical Site 23
state: Texas
city: Bellaire
country: United States
facility: Arcutis Clinical Site 84
state: Texas
city: College Station
country: United States
facility: Arcutis Clinical Site 21
state: Texas
city: Frisco
country: United States
facility: Arcutis Clinical Site 126
state: Texas
city: Grapevine
country: United States
facility: Arcutis Clinical Site 118
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 48
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 35
state: Texas
city: Katy
country: United States
facility: Arcutis Clinical Site 109
state: Texas
city: San Antonio
country: United States
facility: Clinical Site 20
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 49
state: Texas
city: Orem
country: United States
facility: Arcutis Clinical Site 74
state: Utah
city: West Jordan
country: United States
facility: Arcutis Clinical Site 36
state: Utah
city: Burke
country: United States
facility: Arcutis Clinical Site 51
state: Virginia
city: Norfolk
country: United States
facility: Arcutis Clinical Site 40
state: Virginia
city: Spokane
country: United States
facility: Arcutis Clinical Site 12
state: Washington
city: Kenosha
country: United States
facility: Arcutis Clinical Site 133
state: Wisconsin
city: Calgary
country: Canada
facility: Arcutis Clinical Site 70
state: Alberta
city: Surrey
country: Canada
facility: Arcutis Clinical Site 27
state: British Columbia
city: Winnipeg
country: Canada
facility: Arcutis Clinical Site 55
state: Manitoba
city: Fredericton
country: Canada
facility: Arcutis Clinical Site 50
state: New Brunswick
city: Ajax
country: Canada
facility: Arcutis Clinical Site 43
state: Ontario
city: London
country: Canada
facility: Arcutis Clinical Site 52
state: Ontario
city: Markham
country: Canada
facility: Clinical Site 11
state: Ontario
city: Mississauga
country: Canada
facility: Clinical Site 46
state: Ontario
city: Montréal
country: Canada
facility: Arcutis Clinical Site 46
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Clinical Site 61
state: Ontario
city: Toronto
country: Canada
facility: Arcutis Clinical Site 54
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Clinical Site 39
state: Ontario
city: Windsor
country: Canada
facility: Clinical Site 09
state: Ontario
city: Drummondville
country: Canada
facility: Arcutis Clinical Site 26
state: Quebec
city: Montréal
country: Canada
facility: Arcutis Clinical Site 45
state: Quebec
city: Montréal
country: Canada
facility: Arcutis Clinical Site 56
state: Quebec
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: