Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
- Registration Number
- NCT04286607
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- Brief Summary
This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis
- Detailed Description
This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
-
Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
-
Males and females ages 2 years and older (inclusive)
-
Subjects with chronic plaque psoriasis who meet eligibility criteria and:
- Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
- 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.
- Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARQ-151 Cream 0.3% Topical roflumilast -
- Primary Outcome Measures
Name Time Method Occurrence of treatment emergent AEs (TEAEs) 24 weeks The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs
- Secondary Outcome Measures
Name Time Method Achievement of a 100% reduction in PASI over time 24 weeks In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). 24 weeks Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time 24 weeks Achievement of a 90% reduction in PASI over time 24 weeks Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. 24 weeks Achievement of a 75% reduction in PASI over time 24 weeks Change in Worst Itch Numeric Rating Scale) WI-NRS score over time 24 weeks
Trial Locations
- Locations (85)
Arcutis Biotherapeutics Clinical Site 508
🇺🇸Los Angeles, California, United States
Arcutis Biotherapeutics Clinical Site 135
🇺🇸Pittsburgh, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 238
🇺🇸Houston, Texas, United States
Arcutis Biotherapeutics Clinical Site 232
🇨🇦Winnepeg, Manitoba, Canada
Arcutis Biotherapeutics Clinical Site 133
🇨🇦Mississauga, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 214
🇺🇸Indianapolis, Indiana, United States
Arcutis Biotherapeutics Clinical Site 123
🇺🇸San Diego, California, 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 110
🇺🇸San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 509
🇺🇸Fountain Valley, California, United States
Arcutis Biotherapeutics Clinical Site 225
🇺🇸Encino, California, United States
Arcutis Biotherapeutics Clinical Site 220
🇺🇸San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 120
🇺🇸Irvine, California, United States
Arcutis Biotherapeutics Clinical Site 208
🇺🇸Santa Monica, California, United States
Arcutis Biotherapeutics Clinical Site 216
🇺🇸Fridley, Minnesota, United States
Arcutis Biotherapeutics Clinical Site 101
🇺🇸Brighton, Massachusetts, United States
Arcutis Biotherapeutics Clinical Site 203
🇺🇸Scottsdale, Arizona, United States
Arcutis Biotherapeutics Clinical Site 223
🇺🇸Boynton Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 209
🇺🇸Sweetwater, Florida, United States
Arcutis Biotherapeutics Clinical Site 213
🇺🇸Metairie, Louisiana, United States
Arcutis Clinical Site 602
🇺🇸Boise, Idaho, United States
Arcutis Biotherapeutics Clinical Site 237
🇺🇸DeLand, Florida, United States
Arcutis Biotherapeutics Clinical Site 131
🇺🇸Miami, Florida, United States
Arcutis Biotherapeutics Clinical Site 236
🇺🇸Portsmouth, New Hampshire, United States
Arcutis Biotherapeutics Clinical Site 201
🇺🇸North Miami Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 105
🇺🇸Sanford, Florida, United States
Arcutis Biotherapeutics Clinical Site 218
🇨🇦Barrie, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 106
🇨🇦Waterloo, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 202
🇺🇸Hialeah, Florida, United States
Arcutis Biotherapeutics Clinical Site 125
🇺🇸Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 111
🇺🇸Baton Rouge, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 228
🇺🇸Largo, Florida, United States
Arcutis Biotherapeutics Clinical Site 240
🇺🇸Reno, Nevada, United States
Arcutis Biotherapeutics Clinical Site 118
🇺🇸Delray Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 207
🇨🇦Surrey, British Columbia, Canada
Arcutis Biotherapeutics Clinical Site 103
🇨🇦London, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 116
🇺🇸Clinton Township, Michigan, United States
Arcutis Biotherapeutics Clinical Site 210
🇺🇸West Jordan, Utah, United States
Arcutis Biotherapeutics Clinical Site 221
🇺🇸Murfreesboro, Tennessee, United States
Arcutis Clinical Site 601
🇩🇴Santo Domingo, Dominican Republic
Arcutis Biotherapeutics Clinical Site 235
🇨🇦Toronto, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 140
🇨🇦Ottawa, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 239
🇺🇸Beverly Hills, California, United States
Arcutis Biotherapeutics Clinical Site 127
🇺🇸Encinitas, California, United States
Arcutis Biotherapeutics Clinical Site 112
🇺🇸Fremont, California, United States
Arcutis Biotherapeutics Clinical Site 511
🇺🇸Rancho Santa Margarita, California, United States
Arcutis Biotherapeutics Clinical Site 137
🇺🇸Ocala, Florida, 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 138
🇺🇸Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 227
🇺🇸Saint Joseph, Missouri, United States
Arcutis Biotherapeutics Clinical Site 139
🇺🇸Reno, Nevada, United States
Arcutis Biotherapeutics Clinical Site 129
🇺🇸East Windsor, New Jersey, United States
Arcutis Biotherapeutics Clinical Site 115
🇺🇸High Point, North Carolina, United States
Arcutis Biotherapeutics Clinical Site 108
🇺🇸Stony Brook, New York, 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 124
🇺🇸Fairborn, Ohio, United States
Arcutis Biotherapeutics Clinical Site 128
🇺🇸Duncansville, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 229
🇺🇸Broomall, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 113
🇺🇸Exton, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 119
🇺🇸Dallas, Texas, 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 519
🇺🇸Frisco, Texas, United States
Arcutis Biotherapeutics Clinical Site 117
🇺🇸San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 132
🇨🇦Calgary, Alberta, Canada
Arcutis Biotherapeutics Clinical Site 226
🇨🇦Surrey, British Columbia, Canada
Arcutis Biotherapeutics Clinical Site 205
🇨🇦Ajax, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 234
🇨🇦Fredericton, New Brunswick, Canada
Arcutis Biotherapeutics Clinical Site 109
🇨🇦Peterborough, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 126
🇨🇦Québec, Quebec, Canada
Arcutis Biotherapeutics Clinical Site 204
🇨🇦Windsor, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 107
🇨🇦Montreal, Quebec, Canada
Arcutis Biotherapeutics Clinical Site 215
🇺🇸Santa Monica, California, United States
Arcutis Biotherapeutics Clinical Site 233
🇺🇸Knoxville, Tennessee, United States
Arcutis Biotherapeutics Clinical Site 136
🇺🇸San Francisco, California, United States
Arcutis Biotherapeutics Clinical Site 217
🇺🇸Louisville, Kentucky, United States
Arcutis Biotherapeutics Clinical Site 212
🇺🇸Detroit, Michigan, 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 224
🇺🇸New Orleans, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 230
🇺🇸Richmond, Virginia, United States
Arcutis Biotherapeutics Clinical Site 211
🇺🇸Lake Charles, Louisiana, United States