Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
NCT ID: NCT04286607
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
333 participants
INTERVENTIONAL
2020-02-12
2024-01-22
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 0.3%
Topical roflumilast
Active treatment
Interventions
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Topical roflumilast
Active treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and females ages 2 years and older (inclusive)
* Subjects with chronic plaque psoriasis who meet eligibility criteria and:
1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
2. Are naïve to treatment with ARQ-151 cream (Cohort 2)
* Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
Exclusion Criteria
* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* 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 investigational product.
* 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.
2 Years
11 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 Biotherapeutics Clinical Site 203
Scottsdale, Arizona, United States
Arcutis Biotherapeutics Clinical Site 239
Beverly Hills, California, United States
Arcutis Biotherapeutics Clinical Site 127
Encinitas, California, United States
Arcutis Biotherapeutics Clinical Site 225
Encino, California, United States
Arcutis Biotherapeutics Clinical Site 509
Fountain Valley, California, United States
Arcutis Biotherapeutics Clinical Site 112
Fremont, California, United States
Arcutis Biotherapeutics Clinical Site 120
Irvine, California, United States
Arcutis Biotherapeutics Clinical Site 508
Los Angeles, California, United States
Arcutis Biotherapeutics Clinical Site 511
Rancho Santa Margarita, California, United States
Arcutis Biotherapeutics Clinical Site 123
San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 220
San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 136
San Francisco, California, United States
Arcutis Biotherapeutics Clinical Site 208
Santa Monica, California, United States
Arcutis Biotherapeutics Clinical Site 215
Santa Monica, California, United States
Arcutis Biotherapeutics Clinical Site 223
Boynton Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 237
DeLand, Florida, United States
Arcutis Biotherapeutics Clinical Site 118
Delray Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 202
Hialeah, Florida, United States
Arcutis Biotherapeutics Clinical Site 228
Largo, Florida, United States
Arcutis Biotherapeutics Clinical Site 131
Miami, Florida, United States
Arcutis Biotherapeutics Clinical Site 201
North Miami Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 137
Ocala, Florida, United States
Arcutis Biotherapeutics Clinical Site 105
Sanford, Florida, United States
Arcutis Biotherapeutics Clinical Site 209
Sweetwater, Florida, United States
Arcutis Clinical Site 602
Boise, Idaho, United States
Arcutis Biotherapeutics Clinical Site 114
Plainfield, Illinois, United States
Arcutis Biotherapeutics Clinical Site 102
Rolling Meadows, Illinois, United States
Arcutis Biotherapeutics Clinical Site 214
Indianapolis, Indiana, United States
Arcutis Biotherapeutics Clinical Site 217
Louisville, Kentucky, United States
Arcutis Biotherapeutics Clinical Site 111
Baton Rouge, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 211
Lake Charles, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 213
Metairie, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 224
New Orleans, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 125
Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 138
Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 101
Brighton, Massachusetts, United States
Arcutis Biotherapeutics Clinical Site 116
Clinton Township, Michigan, United States
Arcutis Biotherapeutics Clinical Site 212
Detroit, Michigan, United States
Arcutis Biotherapeutics Clinical Site 216
Fridley, Minnesota, United States
Arcutis Biotherapeutics Clinical Site 227
Saint Joseph, Missouri, United States
Arcutis Biotherapeutics Clinical Site 219
Las Vegas, Nevada, United States
Arcutis Biotherapeutics Clinical Site 231
Las Vegas, Nevada, United States
Arcutis Biotherapeutics Clinical Site 139
Reno, Nevada, United States
Arcutis Biotherapeutics Clinical Site 240
Reno, Nevada, United States
Arcutis Biotherapeutics Clinical Site 236
Portsmouth, New Hampshire, United States
Arcutis Biotherapeutics Clinical Site 129
East Windsor, New Jersey, United States
Arcutis Biotherapeutics Clinical Site 121
New York, New York, United States
Arcutis Biotherapeutics Clinical Site 130
Rochester, New York, United States
Arcutis Biotherapeutics Clinical Site 108
Stony Brook, New York, United States
Arcutis Biotherapeutics Clinical Site 115
High Point, North Carolina, United States
Arcutis Biotherapeutics Clinical Site 124
Fairborn, Ohio, United States
Arcutis Biotherapeutics Clinical Site 222
Oklahoma City, Oklahoma, United States
Arcutis Biotherapeutics Clinical Site 134
Oklahoma City, Oklahoma, United States
Arcutis Biotherapeutics Clinical Site 229
Broomall, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 128
Duncansville, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 113
Exton, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 135
Pittsburgh, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 233
Knoxville, Tennessee, United States
Arcutis Biotherapeutics Clinical Site 221
Murfreesboro, Tennessee, United States
Arcutis Biotherapeutics Clinical Site 206
Arlington, Texas, United States
Arcutis Biotherapeutics Clinical Site 104
College Station, Texas, United States
Arcutis Biotherapeutics Clinical Site 119
Dallas, Texas, United States
Arcutis Biotherapeutics Clinical Site 519
Frisco, Texas, United States
Arcutis Biotherapeutics Clinical Site 238
Houston, Texas, United States
Arcutis Biotherapeutics Clinical Site 110
San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 117
San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 210
West Jordan, Utah, United States
Arcutis Biotherapeutics Clinical Site 230
Richmond, Virginia, United States
Arcutis Biotherapeutics Clinical Site 132
Calgary, Alberta, Canada
Arcutis Biotherapeutics Clinical Site 207
Surrey, British Columbia, Canada
Arcutis Biotherapeutics Clinical Site 226
Surrey, British Columbia, Canada
Arcutis Biotherapeutics Clinical Site 232
Winnepeg, Manitoba, Canada
Arcutis Biotherapeutics Clinical Site 234
Fredericton, New Brunswick, Canada
Arcutis Biotherapeutics Clinical Site 205
Ajax, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 218
Barrie, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 103
London, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 133
Mississauga, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 140
Ottawa, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 109
Peterborough, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 235
Toronto, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 106
Waterloo, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 204
Windsor, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 107
Montreal, Quebec, Canada
Arcutis Biotherapeutics Clinical Site 126
Québec, Quebec, Canada
Arcutis Clinical Site 601
Santo Domingo, , Dominican Republic
Countries
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Other Identifiers
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ARQ-151-306
Identifier Type: -
Identifier Source: org_study_id
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