Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
NCT ID: NCT04773600
Last Updated: 2024-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
683 participants
INTERVENTIONAL
2021-02-24
2022-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Roflumilast Cream 0.15%
Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks.
Roflumilast Cream
Roflumilast cream 0.15% for topical application
Vehicle Cream
Participants apply vehicle cream qd for 4 weeks.
Vehicle cream
Vehicle cream for topical application
Interventions
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Roflumilast Cream
Roflumilast cream 0.15% for topical application
Vehicle cream
Vehicle cream for topical application
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
6 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 31
Birmingham, Alabama, United States
Arcutis Clinical Site 51
Fort Smith, Arkansas, United States
Arcutis Clinical Site 46
Inglewood, California, United States
Arcutis Clinical Site 19
San Diego, California, United States
Arcutis Clinical Site 36
San Diego, California, United States
Arcutis Clinical Site 13
Santa Monica, California, United States
Arcutis Clinical Site 54
Centennial, Colorado, United States
Arcutis Clinical Site 55
Boca Raton, Florida, United States
Arcutis Clinical Site 30
Coral Gables, Florida, United States
Arcutis Clinical Site 37
Delray Beach, Florida, United States
Arcutis Clinical Site 58
Miami, Florida, United States
Arcutis Clinical Site 41
Miami, Florida, United States
Arcutis Clinical Site 11
Sanford, Florida, United States
Arcutis Clinical Site 57
West Palm Beach, Florida, United States
Arcutis Clinical Site 62
Boise, Idaho, United States
Clinical Site 04
Plainfield, Indiana, United States
Arcutis Clinical Site 43
Louisville, Kentucky, United States
Arcutis Clinical Site 63
Baton Rouge, Louisiana, United States
Arcutis Clinical Site 42
Lake Charles, Louisiana, United States
Arcutis Clinical Site 38
Mandeville, Louisiana, United States
Arcutis Clinical Site 06
Metairie, Louisiana, United States
Arcutis Clinical Site 34
Rockville, Maryland, United States
Arcutis Clinical Site 29
Clinton Township, Michigan, United States
Arcutis Clinical Site 21
Fort Gratiot, Michigan, United States
Arcutis Clinical Site 61
Troy, Michigan, United States
Arcutis Clinical Site 245
Saint Joseph, Missouri, United States
Arcutis Clinical Site 53
New York, New York, United States
Arcutis Clinical Site 39
Rochester, New York, United States
Arcutis Clinical Site 33
Stony Brook, New York, United States
Arcutis Clinical Site 01
High Point, North Carolina, United States
Arcutis Clinical Site 24
Hershey, Pennsylvania, United States
Arcutis Clinical Site 07
Pittsburgh, Pennsylvania, United States
Arcutis Clinical Site 35
Charleston, South Carolina, United States
Arcutis Clinical Site 18
Charleston, South Carolina, United States
Arcutis Clinical Site 15
North Charleston, South Carolina, United States
Clinical Site 05
Austin, Texas, United States
Arcutis Clinical Site 03
College Station, Texas, United States
Arcutis Clinical Site 59
Frisco, Texas, United States
Arcutis Clinical Site 250
Grapevine, Texas, United States
Arcutis Clinical Site 52
Pflugerville, Texas, United States
Arcutis Clinical Site 02
San Antonio, Texas, United States
Arcutis Clinical Site 32
Orem, Utah, United States
Arcutis Clinical Site 22
Burke, Virginia, United States
Arcutis Clinical Site 17
Norfolk, Virginia, United States
Arcutis Clinical Site 12
Calgary, Alberta, Canada
Arcutis Clinical Site 09
Surrey, British Columbia, Canada
Arcutis Clinical Site 26
Winnipeg, Manitoba, Canada
Arcutis Clinical Site 20
Ajax, Ontario, Canada
Arcutis Clinical Site 23
London, Ontario, Canada
Arcutis Clinical Site 25
Toronto, Ontario, Canada
Arcutis Clinical Site 16
Waterloo, Ontario, Canada
Arcutis Clinical Site 08
Drummondville, Quebec, Canada
Arcutis Clinical Site 27
Québec, Quebec, Canada
Countries
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References
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Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARQ-151-312
Identifier Type: -
Identifier Source: org_study_id
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