Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
- Conditions
- Atopic Dermatitis Eczema
- Interventions
- Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
- Registration Number
- NCT04804605
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1220
- 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.
- 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.)
- 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.
- 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.
- 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).
- 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.
- Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
- Subjects that use any Excluded Medications and Treatments.
- 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.
- Subjects with known genetic dermatological conditions that overlap with AD.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
- Primary Outcome Measures
Name Time Method 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 24 or 52 weeks AEs and SAEs
- Secondary Outcome Measures
Name Time Method Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment 24 or 52 weeks 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).
vIGA-AD success 24 or 52 weeks Defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline
WI-NRS score over time 24 or 52 weeks WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
EASI score over time 24 or 52 weeks 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.
Trial Locations
- Locations (92)
Arcutis Clinical Site 69
🇺🇸Beverly Hills, California, United States
Arcutis Clinical Site 93
🇺🇸Clarksville, Indiana, United States
Arcutis Clinical Site 88
🇺🇸Clarkston, Michigan, United States
Arcutis Clinical Site 59
🇺🇸Coral Gables, Florida, United States
Arcutis Clinical Site 82
🇺🇸Rochester, New York, United States
Arcutis Clinical Site 123
🇺🇸Centennial, Colorado, United States
Arcutis Clinical Site 114
🇺🇸West Lafayette, Indiana, United States
Clinical Site 04
🇺🇸Jacksonville, Florida, United States
Arcutis Clinical Site 130
🇺🇸Thousand Oaks, California, United States
Arcutis Clinical Site 15
🇺🇸Largo, Florida, United States
Arcutis Clinical Site 138
🇺🇸Wellington, Florida, United States
Arcutis Clinical Site 76
🇺🇸Rockville, Maryland, United States
Arcutis Clinical Site 47
🇺🇸Sandy Springs, Georgia, United States
Arcutis Clinical Site 52
🇨🇦London, Ontario, Canada
Arcutis Clinical Site 31
🇺🇸Santa Monica, California, United States
Arcutis Clinical Site 45
🇨🇦Montréal, Quebec, Canada
Arcutis Clinical Site 46
🇨🇦Montréal, Ontario, Canada
Arcutis Clinical Site 21
🇺🇸College Station, Texas, United States
Arcutis Clinical Site 53
🇺🇸Hershey, Pennsylvania, United States
Arcutis Clinical Site 51
🇺🇸Burke, Virginia, United States
Arcutis Clinical Site 101
🇺🇸Johnston, Rhode Island, United States
Arcutis Clinical Site 84
🇺🇸Bellaire, Texas, United States
Arcutis Clinical Site 74
🇺🇸Orem, Utah, United States
Clinical Site 46
🇨🇦Mississauga, Ontario, Canada
Clinical Site 09
🇨🇦Windsor, Ontario, Canada
Clinical Site 23
🇺🇸Austin, Texas, United States
Arcutis Clinical Site 126
🇺🇸Frisco, Texas, United States
Arcutis Clinical Site 56
🇨🇦Montréal, Quebec, Canada
Arcutis Clinical Site 39
🇨🇦Waterloo, Ontario, Canada
Arcutis Clinical Site 40
🇺🇸Norfolk, Virginia, United States
Arcutis Clinical Site 26
🇨🇦Drummondville, Quebec, Canada
Arcutis Clinical Site 81
🇺🇸Inglewood, California, United States
Arcutis Clinical Site 72
🇺🇸Coral Gables, Florida, United States
Arcutis Clinical Site 29
🇺🇸Sanford, Florida, United States
Arcutis Clinical Site 13
🇺🇸Rolling Meadows, Illinois, United States
Arcutis Clinical Site 58
🇺🇸Clinton Township, Michigan, United States
Arcutis Clinical Site 71
🇺🇸East Windsor, New Jersey, United States
Arcutis Clinical Site 96
🇺🇸Kew Gardens, New York, United States
Arcutis Clinical Site 17
🇺🇸Gresham, Oregon, United States
Arcutis Clinical Site 118
🇺🇸Grapevine, Texas, United States
Arcutis Clinical Site 109
🇺🇸Katy, Texas, United States
Arcutis Clinical Site 50
🇨🇦Fredericton, New Brunswick, Canada
Arcutis Clinical Site 43
🇨🇦Ajax, Ontario, Canada
Arcutis Clinical Site 95
🇺🇸Miami, Florida, United States
Arcutis Clinical Site 68
🇺🇸Miami, Florida, United States
Arcutis Clinical Site 79
🇺🇸Delray Beach, Florida, United States
Arcutis Clinical Site 67
🇺🇸Miami, Florida, United States
Clinical Site 10
🇺🇸New Brighton, Minnesota, United States
Clinical Site 33
🇺🇸North Charleston, South Carolina, United States
Arcutis Clinical Site 35
🇺🇸Houston, Texas, United States
Clinical Site 11
🇨🇦Markham, Ontario, Canada
Arcutis Clinical Site 48
🇺🇸Houston, Texas, United States
Arcutis Clinical Site 54
🇨🇦Toronto, Ontario, Canada
Arcutis Clinical Site 36
🇺🇸West Jordan, Utah, United States
Arcutis Clinical Site 133
🇺🇸Kenosha, Wisconsin, United States
Clinical Site 08
🇺🇸San Francisco, California, United States
Clinical Site 20
🇺🇸San Antonio, Texas, United States
Arcutis Clinical Site 49
🇺🇸San Antonio, Texas, United States
Arcutis Clinical Site 55
🇨🇦Winnipeg, Manitoba, Canada
Arcutis Clinical Site 106
🇺🇸Bryant, Arkansas, United States
Arcutis Clinical Site 145
🇺🇸Boise, Idaho, United States
Arcutis Clinical Site 80
🇺🇸Covington, Louisiana, United States
Arcutis Clinical Site 60
🇺🇸Murfreesboro, Tennessee, United States
Arcutis Clinical Site 63
🇺🇸Scottsdale, Arizona, United States
Arcutis Clinical Site 85
🇺🇸Lake Charles, Louisiana, United States
Arcutis Clinical Site 24
🇺🇸Metairie, Louisiana, United States
Arcutis Clinical Site 116
🇺🇸Fort Smith, Arkansas, United States
Arcutis Clinical Site 62
🇺🇸Reno, Nevada, United States
Arcutis Clinical Site 70
🇨🇦Calgary, Alberta, Canada
Arcutis Clinical Site 27
🇨🇦Surrey, British Columbia, Canada
Arcutis Clinical Site 91
🇺🇸Summerville, South Carolina, United States
Arcutis Clinical Site 66
🇺🇸Detroit, Michigan, United States
Arcutis Clinical Site 112
🇺🇸Birmingham, Alabama, United States
Arcutis Clinical Site 73
🇺🇸Birmingham, Alabama, United States
Arcutis Clinical Site 108
🇺🇸Portland, Oregon, United States
Arcutis Clinical Site 16
🇺🇸Portland, Oregon, United States
Arcutis Clinical Site 14
🇺🇸Portland, Oregon, United States
Arcutis Clinical Site 61
🇨🇦Peterborough, Ontario, Canada
Arcutis Clinical Site 102
🇺🇸Saint Joseph, Missouri, United States
Arcutis Clinical Site 103
🇺🇸Hollywood, Florida, United States
Clinical Site 22
🇺🇸Plainfield, Indiana, United States
Arcutis Clinical Site 94
🇺🇸Bay City, Michigan, United States
Arcutis Clinical Site 132
🇺🇸Troy, Michigan, United States
Arcutis Clinical Site 19
🇺🇸High Point, North Carolina, United States
Arcutis Clinical Site 64
🇺🇸Newtown Square, Pennsylvania, United States
Arcutis Clinical Site 25
🇺🇸Pittsburgh, Pennsylvania, United States
Arcutis Clinical Site 34
🇺🇸Arlington, Texas, United States
Arcutis Clinical Site 12
🇺🇸Spokane, Washington, United States
Clinical Site 01
🇺🇸Tampa, Florida, United States
Clinical Site 03
🇺🇸Louisville, Kentucky, United States
Arcutis Clinical Site 77
🇺🇸Charleston, South Carolina, United States
Arcutis Clinical Site 41
🇺🇸Charleston, South Carolina, United States