Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
NCT ID: NCT04804605
Last Updated: 2025-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1220 participants
INTERVENTIONAL
2021-02-25
2024-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARQ-151 Cream 0.05%
Participants applied ARQ-151 Cream 0.05% once daily (qd) for up to 52 weeks.
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Interventions
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ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
ALL
No
Sponsors
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Arcutis Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Berk, MD
Role: STUDY_DIRECTOR
Arcutis Biotherapeutics, Inc.
Locations
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Arcutis Clinical Site 112
Birmingham, Alabama, United States
Arcutis Clinical Site 73
Birmingham, Alabama, United States
Arcutis Clinical Site 63
Scottsdale, Arizona, United States
Arcutis Clinical Site 106
Bryant, Arkansas, United States
Arcutis Clinical Site 116
Fort Smith, Arkansas, United States
Arcutis Clinical Site 69
Beverly Hills, California, United States
Arcutis Clinical Site 81
Inglewood, California, United States
Clinical Site 08
San Francisco, California, United States
Arcutis Clinical Site 31
Santa Monica, California, United States
Arcutis Clinical Site 130
Thousand Oaks, California, United States
Arcutis Clinical Site 123
Centennial, Colorado, United States
Arcutis Clinical Site 59
Coral Gables, Florida, United States
Arcutis Clinical Site 72
Coral Gables, Florida, United States
Arcutis Clinical Site 79
Delray Beach, Florida, United States
Arcutis Clinical Site 103
Hollywood, Florida, United States
Clinical Site 04
Jacksonville, Florida, United States
Arcutis Clinical Site 15
Largo, Florida, United States
Arcutis Clinical Site 67
Miami, Florida, United States
Arcutis Clinical Site 95
Miami, Florida, United States
Arcutis Clinical Site 68
Miami, Florida, United States
Arcutis Clinical Site 29
Sanford, Florida, United States
Clinical Site 01
Tampa, Florida, United States
Arcutis Clinical Site 138
Wellington, Florida, United States
Arcutis Clinical Site 47
Sandy Springs, Georgia, United States
Arcutis Clinical Site 145
Boise, Idaho, United States
Arcutis Clinical Site 13
Rolling Meadows, Illinois, United States
Arcutis Clinical Site 93
Clarksville, Indiana, United States
Clinical Site 22
Plainfield, Indiana, United States
Arcutis Clinical Site 114
West Lafayette, Indiana, United States
Clinical Site 03
Louisville, Kentucky, United States
Arcutis Clinical Site 80
Covington, Louisiana, United States
Arcutis Clinical Site 85
Lake Charles, Louisiana, United States
Arcutis Clinical Site 24
Metairie, Louisiana, United States
Arcutis Clinical Site 76
Rockville, Maryland, United States
Arcutis Clinical Site 94
Bay City, Michigan, United States
Arcutis Clinical Site 88
Clarkston, Michigan, United States
Arcutis Clinical Site 58
Clinton Township, Michigan, United States
Arcutis Clinical Site 66
Detroit, Michigan, United States
Arcutis Clinical Site 132
Troy, Michigan, United States
Clinical Site 10
New Brighton, Minnesota, United States
Arcutis Clinical Site 102
Saint Joseph, Missouri, United States
Arcutis Clinical Site 62
Reno, Nevada, 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 82
Rochester, New York, United States
Arcutis Clinical Site 19
High Point, North Carolina, United States
Arcutis Clinical Site 17
Gresham, Oregon, 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 53
Hershey, Pennsylvania, United States
Arcutis Clinical Site 64
Newtown Square, Pennsylvania, United States
Arcutis Clinical Site 25
Pittsburgh, Pennsylvania, United States
Arcutis Clinical Site 101
Johnston, Rhode Island, United States
Arcutis Clinical Site 77
Charleston, South Carolina, United States
Arcutis Clinical Site 41
Charleston, South Carolina, United States
Clinical Site 33
North Charleston, South Carolina, United States
Arcutis Clinical Site 91
Summerville, South Carolina, United States
Arcutis Clinical Site 60
Murfreesboro, Tennessee, United States
Arcutis Clinical Site 34
Arlington, Texas, United States
Clinical Site 23
Austin, Texas, United States
Arcutis Clinical Site 84
Bellaire, Texas, United States
Arcutis Clinical Site 21
College Station, Texas, United States
Arcutis Clinical Site 126
Frisco, Texas, United States
Arcutis Clinical Site 118
Grapevine, Texas, United States
Arcutis Clinical Site 48
Houston, Texas, United States
Arcutis Clinical Site 35
Houston, Texas, United States
Arcutis Clinical Site 109
Katy, Texas, United States
Clinical Site 20
San Antonio, Texas, United States
Arcutis Clinical Site 49
San Antonio, Texas, United States
Arcutis Clinical Site 74
Orem, Utah, United States
Arcutis Clinical Site 36
West Jordan, Utah, United States
Arcutis Clinical Site 51
Burke, Virginia, United States
Arcutis Clinical Site 40
Norfolk, Virginia, United States
Arcutis Clinical Site 12
Spokane, Washington, United States
Arcutis Clinical Site 133
Kenosha, Wisconsin, United States
Arcutis Clinical Site 70
Calgary, Alberta, Canada
Arcutis Clinical Site 27
Surrey, British Columbia, Canada
Arcutis Clinical Site 55
Winnipeg, Manitoba, Canada
Arcutis Clinical Site 50
Fredericton, New Brunswick, Canada
Arcutis Clinical Site 43
Ajax, Ontario, Canada
Arcutis Clinical Site 52
London, Ontario, Canada
Clinical Site 11
Markham, Ontario, Canada
Clinical Site 46
Mississauga, Ontario, Canada
Arcutis Clinical Site 46
Montréal, Ontario, Canada
Arcutis Clinical Site 61
Peterborough, Ontario, Canada
Arcutis Clinical Site 54
Toronto, Ontario, Canada
Arcutis Clinical Site 39
Waterloo, Ontario, Canada
Clinical Site 09
Windsor, Ontario, Canada
Arcutis Clinical Site 26
Drummondville, Quebec, Canada
Arcutis Clinical Site 45
Montreal, Quebec, Canada
Arcutis Clinical Site 56
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARQ-151-313
Identifier Type: -
Identifier Source: org_study_id