The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
NCT ID: NCT03638258
Last Updated: 2022-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
331 participants
INTERVENTIONAL
2018-09-21
2019-05-29
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
DOUBLE
Study Groups
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Roflumilast Cream 0.3%
Roflumilast cream 0.3% topically applied QD for 12 weeks.
Roflumilast Cream 0.3%
Applied once daily for 12 weeks
Roflumilast Cream 0.15%
Roflumilast cream 0.15% topically applied QD for 12 weeks.
Roflumilast Cream 0.15%
Applied once daily for 12 weeks
Vehicle Cream
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
Vehicle Cream
Applied once daily for 12 weeks
Interventions
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Roflumilast Cream 0.3%
Applied once daily for 12 weeks
Roflumilast Cream 0.15%
Applied once daily for 12 weeks
Vehicle Cream
Applied once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and females ages 18 years and older (inclusive)
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
* Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
* In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
* Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Exclusion Criteria
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* Previous treatment with roflumilast cream or its active ingredient
* Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
* Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
* 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.
18 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 35
Beverly Hills, California, United States
Arcutis Clinical Site 29
Northridge, California, United States
Arcutis Clinical Site 28
San Diego, California, United States
Arcutis Clinical Site 27
Santa Monica, California, United States
Arcutis Clinical Site 12
Miami, Florida, United States
Arcutis Clinical Site 16
Sanford, Florida, United States
Arcutis Clinical Site 21
Louisville, Kentucky, United States
Arcutis Clinical Site 34
Clinton Township, Michigan, United States
Arcutis Clinical Site 33
Detroit, Michigan, United States
Arcutis Clinical Site 20
Fridley, Minnesota, United States
Arcutis Clinical Site 22
New York, New York, United States
Arcutis Clinical Site 14
High Point, North Carolina, United States
Arcutis Clinical Site 39
Bexley, Ohio, United States
Arcutis Clinical Site 15
Pittsburgh, Pennsylvania, United States
Arcutis Clinical Site 19
College Station, Texas, United States
Arcutis Clinical Site 37
Houston, Texas, United States
Arcutis Clinical Site 13
Houston, Texas, United States
Arcutis Clinical Site 23
San Antonio, Texas, United States
Arcutis Clinical Site 24
Webster, Texas, United States
Arcutis Clinical Site 31
Norfolk, Virginia, United States
Arcutis Clinical Site 18
Surrey, British Columbia, Canada
Arcutis Clinical Site 11
Surrey, British Columbia, Canada
Arcutis Clinical Site 38
Winnipeg, Manitoba, Canada
Arcutis Clinical Site 10
Ajax, Ontario, Canada
Arcutis Clinical Site 25
London, Ontario, Canada
Arcutis Clinical Site 26
Markham, Ontario, Canada
Arcutis Clinical Site 32
Oakville, Ontario, Canada
Arcutis Clinical Site 17
Peterborough, Ontario, Canada
Arcutis Clinical Site 30
Waterloo, Ontario, Canada
Arcutis Clinical Site 36
Windsor, Ontario, Canada
Countries
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References
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Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2023 Mar;24(2):305-313. doi: 10.1007/s40257-022-00739-3. Epub 2022 Nov 12.
Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARQ-151-201
Identifier Type: -
Identifier Source: org_study_id
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