Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
- Conditions
- Atopic Dermatitis Eczema
- Interventions
- Drug: ARQ-151 ActiveDrug: ARQ-151 Vehicle
- Registration Number
- NCT04845620
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 652
- Informed consent by parent(s) or legal guardian as required by local laws.
- Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
- 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.
- In good health as judged by the Investigator.
- Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
- 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
- Has unstable AD or any consistent requirement for high potency topical steroids.
- Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
- Previous treatment with ARQ-151.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARQ-151 Cream 0.05% ARQ-151 Active Active comparator ARQ-151 Vehicle Cream ARQ-151 Vehicle Placebo comparator
- Primary Outcome Measures
Name Time Method IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4. Week 4 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).
- Secondary Outcome Measures
Name Time Method In subjects with vIGA-AD score of 'Moderate' at randomization, IGA Success at Week 4 Week 4 IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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).
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 Week 4 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.
In subjects with vIGA-AD score of 'Moderate' at randomization, vIGA-AD score of 'clear' or 'almost clear' at Week 4 Week 4 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 at Week 2 Week 2 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 of 'clear' or 'almost 'clear' at Week 2 Week 2 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 at Week 1 Week 1 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 of 'clear' or 'almost 'clear' at Week 1 Week 1 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).
Trial Locations
- Locations (75)
Arcutis Clinical Site 16
🇺🇸Reno, Nevada, United States
Arcutis Clinical Site 55
🇺🇸Lebanon, New Hampshire, United States
Arcutis Clinical Site 31
🇺🇸Hershey, Pennsylvania, United States
Arcutis Clinical Site 34
🇺🇸Lake Charles, Louisiana, United States
Arcutis Clinical Site 40
🇺🇸Metairie, Louisiana, United States
Arcutis Clinical Site 57
🇺🇸West Lafayette, Indiana, United States
Arcutis Clinical Site 06
🇺🇸Burke, Virginia, United States
Arcutis Clinical Site 21
🇺🇸Plainfield, Indiana, United States
Arcutis Clinical Site 08
🇺🇸Austin, Texas, United States
Arcutis Clinical Site 65
🇺🇸Bethlehem, Pennsylvania, United States
Arcutis Clinical Site 53
🇺🇸Auburn Hills, Michigan, United States
Arcutis Clinical Site 25
🇺🇸Spokane, Washington, United States
Arcutis Clinical Site 24
🇺🇸Newtown Square, Pennsylvania, United States
Arcutis Clinical Site 36
🇨🇦Markham, Ontario, Canada
Arcutis Clinical Site 32
🇺🇸Rochester, New York, United States
Arcutis Clinical Site 29
🇨🇦Calgary, Alberta, Canada
Arcutis Clinical Site 61
🇺🇸Grapevine, Texas, United States
Arcutis Clinical Site 03
🇺🇸South Jordan, Utah, United States
Arcutis Clinical Site 51
🇺🇸Metairie, Louisiana, United States
Arcutis Clinical Site 15
🇺🇸Rockville, Maryland, United States
Arcutis Clinical Site 41
🇺🇸Bay City, Michigan, United States
Arcutis Clinical Site 72
🇺🇸Troy, Michigan, United States
Arcutis Clinical Site 66
🇺🇸Frisco, Texas, United States
Arcutis Clinical Site 07
🇺🇸Rolling Meadows, Illinois, United States
Arcutis Clinical Site 81
🇺🇸Mason, Ohio, United States
Arcutis Clinical Site 05
🇺🇸New Brighton, Minnesota, United States
Arcutis Clinical Site 64
🇨🇦Winnipeg, Manitoba, Canada
Arcutis Clinical Site 01
🇺🇸Gresham, Oregon, United States
Arcutis Clinical Site 84
🇺🇸Baton Rouge, Louisiana, United States
Arcutis Clinical Site 77
🇺🇸Columbia, Maryland, United States
Arcutis Clinical Site 13
🇺🇸Rockville, Maryland, United States
Arcutis Clinical Site 79
🇺🇸Miami, Florida, United States
Arcutis Clinical Site 60
🇺🇸Chicago, Illinois, United States
Arcutis Clinical Site 58
🇺🇸Cincinnati, Ohio, United States
Arcutis Clinical Site 04
🇺🇸Houston, Texas, United States
Arcutis Clinical Site 50
🇺🇸Bryant, Arkansas, United States
Arcutis Clinical Site 68
🇺🇸Gilbert, Arizona, United States
Arcutis Clinical Site 69
🇺🇸Montgomery, Alabama, United States
Arcutis Clinical Site 26
🇺🇸Scottsdale, Arizona, United States
Arcutis Clinical Site 59
🇺🇸Fort Smith, Arkansas, United States
Arcutis Clinical Site 71
🇺🇸Little Rock, Arkansas, United States
Arcutis Clinical Site 45
🇺🇸Rancho Santa Margarita, California, United States
Arcutis Clinical Site 33
🇺🇸Coral Gables, Florida, United States
Arcutis Clinical Site 70
🇺🇸Thousand Oaks, California, United States
Arcutis Clinical Site 09
🇺🇸Inglewood, California, United States
Arcutis Clinical Site 48
🇺🇸Boca Raton, Florida, United States
Arcutis Clinical Site 11
🇺🇸Delray Beach, Florida, United States
Arcutis Clinical Site 30
🇺🇸San Diego, California, United States
Arcutis Clinical Site 28
🇺🇸Largo, Florida, United States
Arcutis Clinical Site 12
🇺🇸Coral Gables, Florida, United States
Arcutis Clinical Site 10
🇺🇸Miami Lakes, Florida, United States
Arcutis Clinical Site 43
🇺🇸Miami, Florida, United States
Arcutis Clinical Site 75
🇺🇸Wellington, Florida, United States
Arcutis Clinical Site 20
🇺🇸Sandy Springs, Georgia, United States
Arcutis Clinical Site 42
🇺🇸Clarksville, Indiana, United States
Arcutis Clinical Site 82
🇺🇸Boise, Idaho, United States
Arcutis Clinical Site 54
🇺🇸Brooklyn, New York, United States
Arcutis Clinical Site 47
🇺🇸Saint Joseph, Missouri, United States
Arcutis Clinical Site 44
🇺🇸New York, New York, United States
Arcutis Clinical Site 27
🇺🇸Bellaire, Texas, United States
Arcutis Clinical Site 74
🇺🇸Fort Worth, Texas, United States
Arcutis Clinical Site 76
🇺🇸Charlottesville, Virginia, United States
Arcutis Clinical Site 73
🇨🇦Burlington, Ontario, Canada
Arcutis Clinical Site 78
🇨🇦Saskatoon, Saskatchewan, Canada
Arcutis Clinical Site 39
🇺🇸Summerville, South Carolina, United States
Arcutis Clinical Site 35
🇺🇸North Miami Beach, Florida, United States
Arcutis Clinical Site 52
🇺🇸Portland, Oregon, United States
Arcutis Clinical Site 18
🇺🇸San Antonio, Texas, United States
Arcutis Clinical Site 56
🇺🇸Birmingham, Alabama, United States
Arcutis Clinical Site 62
🇺🇸Charleston, South Carolina, United States
Arcutis Clinical Site 14
🇺🇸Birmingham, Alabama, United States
Arcutis Clinical Site 46
🇺🇸Louisville, Kentucky, United States
Arcutis Clinical Site 22
🇺🇸Louisville, Kentucky, United States
Arcutis Clinical Site 63
🇺🇸Portland, Oregon, United States
Arcutis Clinical Site 02
🇺🇸San Antonio, Texas, United States